Asthma Clinical Trial
Official title:
A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
| Verified date | June 2018 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Primary Objective:
To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent
asthma.
Secondary Objectives:
- To evaluate the safety and tolerability of dupilumab.
- To evaluate the effect of dupilumab on improving participant-reported outcomes including
health-related quality of life.
- To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.
| Status | Completed |
| Enrollment | 1902 |
| Est. completion date | November 23, 2017 |
| Est. primary completion date | July 29, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility |
Inclusion criteria: -Adults and adolescent participants with a physician diagnosis of asthma for =12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria: a) Existing treatment with medium to high dose ICS (=250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose =1 month prior to Visit 1. i) Note for Japan: for participants aged 18 years and older, ICS must be on =200 mcg of fluticasone propionate twice daily or equivalent; for participants aged 12 to 17 years, ICS must be =100 mcg of fluticasone propionate twice daily or equivalent). ii) Participants requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose =1 month prior to Visit 1. Exclusion criteria: - Participants <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, participant recruitment will be restricted to those who are =18 years of age). - Weight is less than 30 kilograms. - Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function. - A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit). - Evidence of lung disease(s) other than asthma, either clinical evidence or imaging (Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per local standard of care. - Note for Japan: According to the request from the health authority, chest X-ray should be performed at screening visit if there is no chest imaging (Chest X-ray, computed tomography [CT], magnetic resonance imaging [MRI]) available within 3 months prior to screening to exclude participants with suspected active or untreated latent tuberculosis. - Current smoker or cessation of smoking within 6 months prior to Visit 1. - Previous smoker with a smoking history >10 pack-years. - Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Investigational Site Number 032006 | Bahia Blanca | |
| Argentina | Investigational Site Number 032002 | Buenos Aires | |
| Argentina | Investigational Site Number 032001 | Caba | |
| Argentina | Investigational Site Number 032003 | Caba | |
| Argentina | Investigational Site Number 032007 | Caba | |
| Argentina | Investigational Site Number 032010 | Caba | |
| Argentina | Investigational Site Number 032011 | Caba | |
| Argentina | Investigational Site Number 032005 | Capital Federal | |
| Argentina | Investigational Site Number 032008 | La Plata | |
| Argentina | Investigational Site Number 032004 | Rosario | |
| Argentina | Investigational Site Number 032012 | San Miguel De Tucuman | |
| Argentina | Investigational Site Number 032009 | San Miguel De Tucumán | |
| Australia | Investigational Site Number 036005 | Campbelltown | |
| Australia | Investigational Site Number 036001 | Clayton | |
| Australia | Investigational Site Number 036002 | Frankston | |
| Australia | Investigational Site Number 036006 | Glen Osmond | |
| Australia | Investigational Site Number 036003 | Murdoch | |
| Australia | Investigational Site Number 036004 | Parkville | |
| Brazil | Investigational Site Number 076009 | Florianópolis | |
| Brazil | Investigational Site Number 076001 | Porto Alegre | |
| Brazil | Investigational Site Number 076007 | Porto Alegre | |
| Brazil | Investigational Site Number 076003 | Salvador | |
| Brazil | Investigational Site Number 076013 | São Bernardo Do Campo | |
| Brazil | Investigational Site Number 076006 | Sao Paulo | |
| Brazil | Investigational Site Number 076008 | Sao Paulo | |
| Brazil | Investigational Site Number 076012 | Sao Paulo | |
| Brazil | Investigational Site Number 076002 | Sorocaba | |
| Canada | Investigational Site Number 124019 | Burlington | |
| Canada | Investigational Site Number 124009 | Calgary | |
| Canada | Investigational Site Number 124003 | Mississauga | |
| Canada | Investigational Site Number 124001 | Montreal | |
| Canada | Investigational Site Number 124010 | Montreal | |
| Canada | Investigational Site Number 124012 | Montreal | |
| Canada | Investigational Site Number 124013 | Ottawa | |
| Canada | Investigational Site Number 124014 | Quebec | |
| Canada | Investigational Site Number 124018 | Quebec | |
| Canada | Investigational Site Number 124008 | Sherbrooke | |
| Canada | Investigational Site Number 124002 | Toronto | |
| Canada | Investigational Site Number 124015 | Toronto | |
| Canada | Investigational Site Number 124007 | Trois-Rivieres | |
| Canada | Investigational Site Number 124006 | Vancouver | |
| Chile | Investigational Site Number 152015 | Concepción | |
| Chile | Investigational Site Number 152003 | Quillota | |
| Chile | Investigational Site Number 152001 | Santiago | |
| Chile | Investigational Site Number 152002 | Santiago | |
| Chile | Investigational Site Number 152005 | Santiago | |
| Chile | Investigational Site Number 152007 | Santiago | |
| Chile | Investigational Site Number 152008 | Santiago | |
| Chile | Investigational Site Number 152009 | Santiago | |
| Chile | Investigational Site Number 152014 | Santiago | |
| Chile | Investigational Site Number 152017 | Santiago | |
| Chile | Investigational Site Number 152004 | Talca | |
| Chile | Investigational Site Number 152013 | Talcahuano | |
| Chile | Investigational Site Number 152016 | Temuco | |
| Chile | Investigational Site Number 152010 | Valdivia | |
| Chile | Investigational Site Number 152011 | Viña Del Mar | |
| Chile | Investigational Site Number 152012 | Viña Del Mar | |
| Colombia | Investigational Site Number 170001 | Bogota | |
| Colombia | Investigational Site Number 170006 | Bogota | |
| Colombia | Investigational Site Number 170002 | Bogotá | |
| Colombia | Investigational Site Number 170003 | Bogotá | |
| France | Investigational Site Number 250002 | Brest | |
| France | Investigational Site Number 250013 | Lille | |
| France | Investigational Site Number 250011 | Lille Cedex | |
| France | Investigational Site Number 250004 | Lyon | |
| France | Investigational Site Number 250010 | Marseille | |
| France | Investigational Site Number 250005 | Montpellier | |
| France | Investigational Site Number 250003 | Nantes Cedex 1 | |
| France | Investigational Site Number 250001 | Paris | |
| France | Investigational Site Number 250012 | Paris | |
| France | Investigational Site Number 250008 | Strasbourg | |
| France | Investigational Site Number 250014 | Vandoeuvre-Les-Nancy | |
| Germany | Investigational Site Number 276006 | Berlin | |
| Germany | Investigational Site Number 276003 | Bochum | |
| Germany | Investigational Site Number 276010 | Frankfurt Am Main | |
| Germany | Investigational Site Number 276004 | Hannover | |
| Germany | Investigational Site Number 276009 | Koblenz | |
| Germany | Investigational Site Number 276007 | Lübeck | |
| Germany | Investigational Site Number 276001 | Mainz | |
| Germany | Investigational Site Number 276005 | Rüdersdorf | |
| Hungary | Investigational Site Number 348003 | Gödöllö | |
| Italy | Investigational Site Number 380004 | Ancona | |
| Italy | Investigational Site Number 380005 | Catania | |
| Italy | Investigational Site Number 380003 | Ferrara | |
| Italy | Investigational Site Number 380006 | Firenze | |
| Italy | Investigational Site Number 380010 | Foggia | |
| Italy | Investigational Site Number 380002 | Modena | |
| Italy | Investigational Site Number 380009 | Palermo | |
| Italy | Investigational Site Number 380001 | Pisa | |
| Italy | Investigational Site Number 380014 | Reggio Emilia | |
| Italy | Investigational Site Number 380011 | Torino | |
| Japan | Investigational Site Number 392185 | Akashi-Shi | |
| Japan | Investigational Site Number 392128 | Asahikawa-Shi | |
| Japan | Investigational Site Number 392118 | Chiyoda-Ku | |
| Japan | Investigational Site Number 392112 | Chuo-Ku | |
| Japan | Investigational Site Number 392157 | Fukui-Shi | |
| Japan | Investigational Site Number 392137 | Fukuoka-Shi | |
| Japan | Investigational Site Number 392117 | Fukuyama-Shi | |
| Japan | Investigational Site Number 392121 | Habikino-Shi | |
| Japan | Investigational Site Number 392154 | Higashiosaka-Shi | |
| Japan | Investigational Site Number 392109 | Himeji-Shi | |
| Japan | Investigational Site Number 392108 | Hiroshima-Shi | |
| Japan | Investigational Site Number 392158 | Hiroshima-Shi | |
| Japan | Investigational Site Number 392107 | Iizuka-Shi | |
| Japan | Investigational Site Number 392101 | Isesaki-Shi | |
| Japan | Investigational Site Number 392147 | Itabashi-Ku | |
| Japan | Investigational Site Number 392150 | Kagoshima-Shi | |
| Japan | Investigational Site Number 392178 | Kagoshima-Shi | |
| Japan | Investigational Site Number 392110 | Kanazawa-Shi | |
| Japan | Investigational Site Number 392136 | Kanazawa-Shi | |
| Japan | Investigational Site Number 392142 | Kasuga-Shi | |
| Japan | Investigational Site Number 392166 | Kawaguchi-Shi | |
| Japan | Investigational Site Number 392119 | Kishiwada-Shi | |
| Japan | Investigational Site Number 392162 | Kobe-Shi | |
| Japan | Investigational Site Number 392182 | Kodaira-Shi | |
| Japan | Investigational Site Number 392174 | Kokubunji-Shi | |
| Japan | Investigational Site Number 392131 | Koshi-Shi | |
| Japan | Investigational Site Number 392183 | Koshigaya-Shi | |
| Japan | Investigational Site Number 392129 | Kurashiki-Shi | |
| Japan | Investigational Site Number 392153 | Kyoto-Shi | |
| Japan | Investigational Site Number 392176 | Kyoto-Shi | |
| Japan | Investigational Site Number 392184 | Kyoto-Shi | |
| Japan | Investigational Site Number 392133 | Machida-Shi | |
| Japan | Investigational Site Number 392135 | Matsuyama-Shi | |
| Japan | Investigational Site Number 392172 | Mibu | |
| Japan | Investigational Site Number 392114 | Minato-Ku | |
| Japan | Investigational Site Number 392122 | Minato-Ku | |
| Japan | Investigational Site Number 392144 | Minato-Ku | |
| Japan | Investigational Site Number 392106 | Mizunami-Shi | |
| Japan | Investigational Site Number 392164 | Muroran-Shi | |
| Japan | Investigational Site Number 392161 | Nagakute-Shi | |
| Japan | Investigational Site Number 392163 | Nagoya-Shi | |
| Japan | Investigational Site Number 392102 | Naka-Gun | |
| Japan | Investigational Site Number 392125 | Nakano-Ku | |
| Japan | Investigational Site Number 392115 | Naruto-Shi | |
| Japan | Investigational Site Number 392187 | Obihiro-Shi | |
| Japan | Investigational Site Number 392177 | Ome-Shi | |
| Japan | Investigational Site Number 392152 | Osaka Sayama-Shi | |
| Japan | Investigational Site Number 392155 | Osaka Sayama-Shi | |
| Japan | Investigational Site Number 392170 | Osaki-Shi | |
| Japan | Investigational Site Number 392120 | Ota-Ku | |
| Japan | Investigational Site Number 392127 | Ota-Ku | |
| Japan | Investigational Site Number 392138 | Ota-Shi | |
| Japan | Investigational Site Number 392123 | Oura-Gun | |
| Japan | Investigational Site Number 392169 | Sagamihara-Shi | |
| Japan | Investigational Site Number 392149 | Sapporo-Shi | |
| Japan | Investigational Site Number 392179 | Seto-Shi | |
| Japan | Investigational Site Number 392186 | Shibuya-Ku | |
| Japan | Investigational Site Number 392139 | Shinagawa-Ku | |
| Japan | Investigational Site Number 392167 | Shinagawa-Ku | |
| Japan | Investigational Site Number 392130 | Shinjuku-Ku | |
| Japan | Investigational Site Number 392165 | Sumida-Ku | |
| Japan | Investigational Site Number 392146 | Tachikawa-Shi | |
| Japan | Investigational Site Number 392173 | Tachikawa-Shi | |
| Japan | Investigational Site Number 392103 | Tokyo | |
| Japan | Investigational Site Number 392113 | Tomakomai-Shi | |
| Japan | Investigational Site Number 392151 | Tsu-Shi | |
| Japan | Investigational Site Number 392168 | Uozu-Shi | |
| Japan | Investigational Site Number 392132 | Urasoe-Shi | |
| Japan | Investigational Site Number 392134 | Uruma-Shi | |
| Japan | Investigational Site Number 392116 | Wakayama-Shi | |
| Japan | Investigational Site Number 392140 | Yokohama-Shi | |
| Japan | Investigational Site Number 392159 | Yonago-Shi | |
| Korea, Republic of | Investigational Site Number 410002 | Bucheon-Si | |
| Korea, Republic of | Investigational Site Number 410015 | Busan | |
| Korea, Republic of | Investigational Site Number 410003 | Cheongju-Si | |
| Korea, Republic of | Investigational Site Number 410013 | Incheon | |
| Korea, Republic of | Investigational Site Number 410004 | Seoul | |
| Korea, Republic of | Investigational Site Number 410005 | Seoul | |
| Korea, Republic of | Investigational Site Number 410006 | Seoul | |
| Korea, Republic of | Investigational Site Number 410007 | Seoul | |
| Korea, Republic of | Investigational Site Number 410008 | Seoul | |
| Korea, Republic of | Investigational Site Number 410009 | Seoul | |
| Korea, Republic of | Investigational Site Number 410010 | Seoul | |
| Korea, Republic of | Investigational Site Number 410011 | Seoul | |
| Korea, Republic of | Investigational Site Number 410012 | Seoul | |
| Korea, Republic of | Investigational Site Number 410001 | Suwon | |
| Korea, Republic of | Investigational Site Number 410014 | Uijeongbu-Si | |
| Mexico | Investigational Site Number 484006 | Chihuahua | |
| Mexico | Investigational Site Number 484013 | Chihuahua | |
| Mexico | Investigational Site Number 484014 | Cuautitlan Izcalli | |
| Mexico | Investigational Site Number 484008 | Durango | |
| Mexico | Investigational Site Number 484001 | Guadalajara | |
| Mexico | Investigational Site Number 484010 | México | |
| Mexico | Investigational Site Number 484004 | Mexico City | |
| Mexico | Investigational Site Number 484003 | Monterrey | |
| Mexico | Investigational Site Number 484007 | Monterrey | |
| Mexico | Investigational Site Number 484012 | San Juan Del Rio | |
| Mexico | Investigational Site Number 484011 | Veracruz | |
| Mexico | Investigational Site Number 484015 | Zapopan | |
| Poland | Investigational Site Number 616006 | Bialystok | |
| Poland | Investigational Site Number 616003 | Gdansk | |
| Poland | Investigational Site Number 616007 | Krakow | |
| Poland | Investigational Site Number 616001 | Lodz | |
| Poland | Investigational Site Number 616005 | Lodz | |
| Poland | Investigational Site Number 616009 | Lodz | |
| Poland | Investigational Site Number 616002 | Poznan | |
| Poland | Investigational Site Number 616004 | Sopot | |
| Poland | Investigational Site Number 616008 | Strzelce Opolskie | |
| Russian Federation | Investigational Site Number 643013 | Ekaterinburg | |
| Russian Federation | Investigational Site Number 643001 | Moscow | |
| Russian Federation | Investigational Site Number 643002 | Moscow | |
| Russian Federation | Investigational Site Number 643003 | Moscow | |
| Russian Federation | Investigational Site Number 643004 | Moscow | |
| Russian Federation | Investigational Site Number 643005 | Moscow | |
| Russian Federation | Investigational Site Number 643006 | Moscow | |
| Russian Federation | Investigational Site Number 643011 | Ryazan | |
| Russian Federation | Investigational Site Number 643008 | Saint-Petersburg | |
| Russian Federation | Investigational Site Number 643009 | Saint-Petersburg | |
| Russian Federation | Investigational Site Number 643007 | St-Petersburg | |
| Russian Federation | Investigational Site Number 643010 | St-Petersburg | |
| Russian Federation | Investigational Site Number 643012 | Yaroslavl | |
| South Africa | Investigational Site Number 710009 | Brandfort | |
| South Africa | Investigational Site Number 710001 | Cape Town | |
| South Africa | Investigational Site Number 710002 | Cape Town | |
| South Africa | Investigational Site Number 710003 | Cape Town | |
| South Africa | Investigational Site Number 710004 | Cape Town | |
| South Africa | Investigational Site Number 710010 | Cape Town | |
| South Africa | Investigational Site Number 710011 | Cape Town | |
| South Africa | Investigational Site Number 710005 | Durban | |
| South Africa | Investigational Site Number 710006 | Durban | |
| South Africa | Investigational Site Number 710007 | Pretoria | |
| Spain | Investigational Site Number 724001 | Barcelona | |
| Spain | Investigational Site Number 724002 | Barcelona | |
| Spain | Investigational Site Number 724010 | Palma De Mallorca | |
| Spain | Investigational Site Number 724005 | Pozuelo De Alarcón | |
| Spain | Investigational Site Number 724004 | Sant Boi De Llobregat | |
| Spain | Investigational Site Number 724006 | Santiago De Compostela | |
| Spain | Investigational Site Number 724008 | Sevilla | |
| Spain | Investigational Site Number 724007 | Valencia | |
| Taiwan | Investigational Site Number 158002 | Kaohsiung | |
| Taiwan | Investigational Site Number 158004 | Kaohsiung | |
| Taiwan | Investigational Site Number 158008 | New Taipei City | |
| Taiwan | Investigational Site Number 158005 | Taichung | |
| Taiwan | Investigational Site Number 158007 | Taichung | |
| Taiwan | Investigational Site Number 158001 | Taipei | |
| Taiwan | Investigational Site Number 158009 | Taipei | |
| Taiwan | Investigational Site Number 158006 | Taoyuan | |
| Turkey | Investigational Site Number 792004 | Ankara | |
| Turkey | Investigational Site Number 792008 | Ankara | |
| Turkey | Investigational Site Number 792003 | Bursa | |
| Turkey | Investigational Site Number 792001 | Istanbul | |
| Turkey | Investigational Site Number 792007 | Istanbul | |
| Turkey | Investigational Site Number 792005 | Izmir | |
| Turkey | Investigational Site Number 792010 | Izmir | |
| Turkey | Investigational Site Number 792009 | Kirikkale | |
| Turkey | Investigational Site Number 792011 | Kocaeli | |
| Turkey | Investigational Site Number 792002 | Mersin | |
| Turkey | Investigational Site Number 792006 | Rize | |
| Ukraine | Investigational Site Number 804007 | Chernivtsi | |
| Ukraine | Investigational Site Number 804023 | Dnipro | |
| Ukraine | Investigational Site Number 804004 | Ivano-Frankivsk | |
| Ukraine | Investigational Site Number 804009 | Ivano-Frankivsk | |
| Ukraine | Investigational Site Number 804001 | Kharkiv | |
| Ukraine | Investigational Site Number 804005 | Kharkiv | |
| Ukraine | Investigational Site Number 804021 | Kharkiv | |
| Ukraine | Investigational Site Number 804003 | Kyiv | |
| Ukraine | Investigational Site Number 804008 | Kyiv | |
| Ukraine | Investigational Site Number 804011 | Kyiv | |
| Ukraine | Investigational Site Number 804013 | Kyiv | |
| Ukraine | Investigational Site Number 804016 | Kyiv | |
| Ukraine | Investigational Site Number 804017 | Kyiv | |
| Ukraine | Investigational Site Number 804006 | Odessa | |
| Ukraine | Investigational Site Number 804002 | Poltava | |
| Ukraine | Investigational Site Number 804014 | Ternopil | |
| Ukraine | Investigational Site Number 804012 | Vinnytsya | |
| Ukraine | Investigational Site Number 804022 | Zaporizhia | |
| United Kingdom | Investigational Site Number 826001 | Bradford | |
| United Kingdom | Investigational Site Number 826002 | London | |
| United Kingdom | Investigational Site Number 826005 | Newcastle Upon Tyne | |
| United Kingdom | Investigational Site Number 826007 | Portsmouth | |
| United Kingdom | Investigational Site Number 826006 | South Shields | |
| United Kingdom | Investigational Site Number 826003 | Sutton-In-Ashfield | |
| United States | Investigational Site Number 840062 | Amarillo | Texas |
| United States | Investigational Site Number 840098 | Austin | Texas |
| United States | Investigational Site Number 840037 | Aventura | Florida |
| United States | Investigational Site Number 840109 | Bakersfield | California |
| United States | Investigational Site Number 840080 | Baltimore | Maryland |
| United States | Investigational Site Number 840064 | Bangor | Maine |
| United States | Investigational Site Number 840051 | Bellevue | Washington |
| United States | Investigational Site Number 840047 | Birmingham | Alabama |
| United States | Investigational Site Number 840038 | Boerne | Texas |
| United States | Investigational Site Number 840018 | Boynton Beach | Florida |
| United States | Investigational Site Number 840105 | Brandon | Florida |
| United States | Investigational Site Number 840111 | Brick | New Jersey |
| United States | Investigational Site Number 840031 | Bronx | New York |
| United States | Investigational Site Number 840004 | Centennial | Colorado |
| United States | Investigational Site Number 840082 | Charleston | South Carolina |
| United States | Investigational Site Number 840083 | Charlotte | North Carolina |
| United States | Investigational Site Number 840126 | Charlotte | North Carolina |
| United States | Investigational Site Number 840017 | Chevy Chase | Maryland |
| United States | Investigational Site Number 840101 | Chicago | Illinois |
| United States | Investigational Site Number 840046 | Cincinnati | Ohio |
| United States | Investigational Site Number 840040 | Clackamas | Oregon |
| United States | Investigational Site Number 840092 | Clearwater | Florida |
| United States | Investigational Site Number 840025 | Colorado Springs | Colorado |
| United States | Investigational Site Number 840052 | Costa Mesa | California |
| United States | Investigational Site Number 840124 | Cypress | Texas |
| United States | Investigational Site Number 840008 | Dallas | Texas |
| United States | Investigational Site Number 840094 | Dallas | Texas |
| United States | Investigational Site Number 840034 | Denver | Colorado |
| United States | Investigational Site Number 840130 | Denver | Colorado |
| United States | Investigational Site Number 840035 | Draper | Utah |
| United States | Investigational Site Number 840108 | Durham | North Carolina |
| United States | Investigational Site Number 840112 | Edmond | Oklahoma |
| United States | Investigational Site Number 840023 | El Paso | Texas |
| United States | Investigational Site Number 840059 | Fairfax | Virginia |
| United States | Investigational Site Number 840056 | Flagstaff | Arizona |
| United States | Investigational Site Number 840032 | Fort Mitchell | Kentucky |
| United States | Investigational Site Number 840022 | Fort Worth | Texas |
| United States | Investigational Site Number 840027 | Fort Worth | Texas |
| United States | Investigational Site Number 840116 | Fresno | California |
| United States | Investigational Site Number 840084 | Gainesville | Georgia |
| United States | Investigational Site Number 840073 | Gaithersburg | Maryland |
| United States | Investigational Site Number 840099 | Gilbert | Arizona |
| United States | Investigational Site Number 840107 | Greensboro | North Carolina |
| United States | Investigational Site Number 840117 | Greenville | South Carolina |
| United States | Investigational Site Number 840100 | Greer | South Carolina |
| United States | Investigational Site Number 840085 | Hershey | Pennsylvania |
| United States | Investigational Site Number 840122 | Hialeah | Florida |
| United States | Investigational Site Number 840007 | High Point | North Carolina |
| United States | Investigational Site Number 840089 | Iowa City | Iowa |
| United States | Investigational Site Number 840106 | Jamaica | New York |
| United States | Investigational Site Number 840013 | Kansas City | Missouri |
| United States | Investigational Site Number 840066 | Killeen | Texas |
| United States | Investigational Site Number 840029 | Lincoln | Rhode Island |
| United States | Investigational Site Number 840132 | Little Rock | Arkansas |
| United States | Investigational Site Number 840050 | Live Oak | Texas |
| United States | Investigational Site Number 840045 | Long Beach | California |
| United States | Investigational Site Number 840011 | Los Angeles | California |
| United States | Investigational Site Number 840061 | Los Angeles | California |
| United States | Investigational Site Number 840097 | Los Angeles | California |
| United States | Investigational Site Number 840053 | Loxahatchee Groves | Florida |
| United States | Investigational Site Number 840070 | McKinney | Texas |
| United States | Investigational Site Number 840128 | McKinney | Texas |
| United States | Investigational Site Number 840039 | Medford | Oregon |
| United States | Investigational Site Number 840069 | Miami | Florida |
| United States | Investigational Site Number 840049 | Middleburg Heights | Ohio |
| United States | Investigational Site Number 840005 | Minneapolis | Minnesota |
| United States | Investigational Site Number 840019 | Mission Viejo | California |
| United States | Investigational Site Number 840026 | Missoula | Montana |
| United States | Investigational Site Number 840077 | Murray | Utah |
| United States | Investigational Site Number 840102 | New Haven | Connecticut |
| United States | Investigational Site Number 840065 | New York | New York |
| United States | Investigational Site Number 840125 | Newport Beach | California |
| United States | Investigational Site Number 840014 | North Dartmouth | Massachusetts |
| United States | Investigational Site Number 840041 | North Hollywood | California |
| United States | Investigational Site Number 840071 | Ocala | Florida |
| United States | Investigational Site Number 840123 | Ocala | Florida |
| United States | Investigational Site Number 840068 | Ocean City | New Jersey |
| United States | Investigational Site Number 840115 | Ocoee | Florida |
| United States | Investigational Site Number 840121 | Oklahoma City | Oklahoma |
| United States | Investigational Site Number 840078 | Omaha | Nebraska |
| United States | Investigational Site Number 840009 | Owensboro | Kentucky |
| United States | Investigational Site Number 840003 | Papillion | Nebraska |
| United States | Investigational Site Number 840010 | Philadelphia | Pennsylvania |
| United States | Investigational Site Number 840067 | Philadelphia | Pennsylvania |
| United States | Investigational Site Number 840081 | Philadelphia | Pennsylvania |
| United States | Investigational Site Number 840028 | Pittsburgh | Pennsylvania |
| United States | Investigational Site Number 840091 | Pittsburgh | Pennsylvania |
| United States | Investigational Site Number 840118 | Plano | Texas |
| United States | Investigational Site Number 840001 | Portland | Oregon |
| United States | Investigational Site Number 840016 | Princeton | New Jersey |
| United States | Investigational Site Number 840036 | Redwood City | California |
| United States | Investigational Site Number 840113 | Richmond | Virginia |
| United States | Investigational Site Number 840015 | River Forest | Illinois |
| United States | Investigational Site Number 840076 | Rochester | New York |
| United States | Investigational Site Number 840020 | Rolling Hills Estates | California |
| United States | Investigational Site Number 840074 | Roseville | California |
| United States | Investigational Site Number 840002 | Saint Louis | Missouri |
| United States | Investigational Site Number 840093 | Saint Louis | Missouri |
| United States | Investigational Site Number 840012 | San Antonio | Texas |
| United States | Investigational Site Number 840129 | San Antonio | Texas |
| United States | Investigational Site Number 840021 | San Jose | California |
| United States | Investigational Site Number 840055 | Sarasota | Florida |
| United States | Investigational Site Number 840044 | Savannah | Georgia |
| United States | Investigational Site Number 840087 | Scottsdale | Arizona |
| United States | Investigational Site Number 840133 | Sealy | Texas |
| United States | Investigational Site Number 840057 | South Burlington | Vermont |
| United States | Investigational Site Number 840114 | South Miami | Florida |
| United States | Investigational Site Number 840054 | Spartanburg | South Carolina |
| United States | Investigational Site Number 840043 | Spokane | Washington |
| United States | Investigational Site Number 840119 | Spring | Texas |
| United States | Investigational Site Number 840048 | Tampa | Florida |
| United States | Investigational Site Number 840042 | Toledo | Ohio |
| United States | Investigational Site Number 840096 | Toms River | New Jersey |
| United States | Investigational Site Number 840104 | Tulsa | Oklahoma |
| United States | Investigational Site Number 840079 | Twin Falls | Idaho |
| United States | Investigational Site Number 840127 | White Marsh | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi | Regeneron Pharmaceuticals |
United States, Argentina, Australia, Brazil, Canada, Chile, Colombia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Poland, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom,
Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, Busse WW, Ford L, Sher L, FitzGerald JM, Katelaris C, Tohda Y, Zhang B, Staudinger H, Pirozzi G, Amin N, Ruddy M, Akinlade B, Khan A, Chao J, Martincova R, Graham NMH, Hamilton JD, Swanson BN, S — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population | A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. | Baseline to Week 52 | |
| Primary | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Week 12 | |
| Secondary | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Week 12 | |
| Secondary | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L | A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. | Baseline to Week 52 | |
| Secondary | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Week 12 | |
| Secondary | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L | A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. | Baseline to Week 52 | |
| Secondary | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Week 12 | |
| Secondary | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L | A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. | Baseline to Week 52 | |
| Secondary | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline | A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. | Baseline to Week 52 | |
| Secondary | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Week 12 | |
| Secondary | Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population | The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life. | Baseline, Week 24 | |
| Secondary | Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L | The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life. | Baseline, Week 24 | |
| Secondary | Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population | The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control. | Baseline, Week 24 | |
| Secondary | Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population | A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations (resulted hospitalization or emergency room visit) that occurred during the treatment period divided by the total number of participant-years treated. | Baseline to Week 52 | |
| Secondary | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Week 12 | |
| Secondary | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Week 12 | |
| Secondary | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Week 12 | |
| Secondary | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Week 12 | |
| Secondary | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Weeks 2, 4, 8, 24, 36, and 52 | |
| Secondary | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Weeks 2, 4, 8, 24, 36, and 52 | |
| Secondary | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | |
| Secondary | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma. | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | |
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | |
| Secondary | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | FEF is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF25-75% is defined as the mean forced expiratory flow between the 25% and 75% of the FVC. | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | |
| Secondary | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | |
| Secondary | Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population | LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated. | Baseline to Week 52 | |
| Secondary | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | The time to first severe exacerbation was defined as follows: date of the first event - randomization date +1. For participants who had no event on or before Visit 18 (Week 52) or last contact date, the time was censored at the date of Visit 18 or the last contact date, whichever was earlier. The median time to first severe exacerbation was not estimated; therefore, the probability of severe exacerbation at Weeks 12, 24, 36, and 52, are presented as the descriptive statistics. | Baseline up to Week 52 | |
| Secondary | Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | The time to first LOAC event was defined as follows: date of the first event - first dose date +1. For participants who had no event on or before last dose date + 14 days or last contact date, the time was censored at the last dose date + 14 days or the last contact date, whichever was earlier. | Baseline up to Week 52 | |
| Secondary | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control. | Baseline, Weeks 2, 4, 8, 12, 36, and 52 | |
| Secondary | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | The ACQ-7 has 7 questions, the first 5 questions assess the most common asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze plus short-acting bronchodilator use, and FEV1 (pre-bronchodilator % predicted). Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). Clinic staff scored the FEV1% predicted on a 7-point scale. The questions were equally weighted and the ACQ-7 total score was mean of the scores of all 7 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control. | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | |
| Secondary | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0= No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma. | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | |
| Secondary | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual. | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | |
| Secondary | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night. | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | |
| Secondary | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded daily by the participants in an electronic diary/peak expiratory flow (PEF) meter. In the case that Nebulizer solutions were used as an alternative delivery method, the nebulizer dose was converted to number of puffs as per following conversion factor: salbutamol/albuterol nebulizer solution (2.5 mg) corresponds to 4 puffs. | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | |
| Secondary | Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population | The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life. | Baseline, Weeks 12, 36, and 52 | |
| Secondary | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable). | Baseline, Weeks 12, 24, 36, and 52 | |
| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | The HADS is a general scale to detect states of anxiety and depression already used and validated in asthma, which includes HADS-A and HADS-D subscales. The instrument is comprised of 14 items: 7 related to anxiety (HADS-A) and 7 to depression (HADS-D). Each item on the questionnaire is scored from 0-3. The anxiety/depression score is the sum of the scores of the 7 related items; one can score between 0 and 21 for either anxiety or depression. And the total score is the sum of the scores of the 14 items ranging from 0 (no symptoms) to 42 (severe symptoms), with higher scores indicating higher anxiety/depression complains. | Baseline, Weeks 12, 24, 36, and 52 | |
| Secondary | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life. | Baseline, Weeks 12, 24, 36, and 52 | |
| Secondary | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | RQLQ(S)+12 is a self-administered questionnaire with standardized activities developed to measure health-related quality of life signs and symptoms that are most problematic in those 12 to 75 years of age, as a result of perennial or seasonal allergic rhinitis. There are 28 items on RQLQ(S) in 7 domains: activities (3 items), sleep (3 items), non-nose/eye symptoms (7 items), practical problems (3 items), nasal symptoms (4 items), eye symptoms (4 items) and emotional (4 items). RQLQ(S)+12 responses are based on 7-point likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled). Individual items within RQLQ(S)+12 are equally weighted. The overall score is calculated as the mean score of all items. Higher scores indicated more health-related quality of life impairment (lower scores better). | Baseline, Weeks 12, 24, 36, and 52 |
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