Asthma Clinical Trial
— KALOSOfficial title:
A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants With Inadequately Controlled Asthma
This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care
Status | Recruiting |
Enrollment | 2200 |
Est. completion date | March 21, 2025 |
Est. primary completion date | March 21, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. 12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control. 2. Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1. 3. Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1. 4. ACQ-7 total score =1.5 at Visits 1, 3, and 5 (pre-randomization). 5. FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization) - Participants = 18 years of age: < 80% - Participants 12 to <18 years of age: < 90% 6. FEV1 post-albuterol at V2 or V3 (if repeat needed). - Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL. - Participants 12 to <18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3. - Note: Even if there is documented history of reversibility, all participants must be assessed for reversibility at Visit 2 (and Visit 3, if reversibility is not demonstrated at Visit 2) to provide reversibility baseline data for characterization. 7. Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol. 8. Demonstrate acceptable MDI/pMDI administration technique. 9. Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation). 10. eDiary 14-day compliance =70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization). 11. No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization. Exclusion Criteria: 1. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1. 2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate. 2b. Any marketed or investigational biologics within 3 months or 5 half-lives of V1, whichever is longer and must not be used during study duration. 3. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana). 4. Current evidence of Chronic Obstructive Pulmonary Disease (COPD). 5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1. 5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study. 5c. Depot corticosteroid use for any reason within 3 months of V1. 6. Use of Long-Acting Muscarinic Antagonist (LAMA), either alone or as part of an inhaled combination therapy, in the 12 weeks prior to V1. 7. Use of oral beta2-agonist within 3 months of V1. 8. Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration. 9. Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1. 10. Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s). 11. Hospitalization for asthma within 2 months of Visit 1. 12. Known history of drug or alcohol abuse within 12 months of Visit 1. 13. Regular use of a nebulizer or a home nebulizer for receiving asthma medications. 14. Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration. 15. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in the protocol is prohibited for use during study duration. 16. Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI. 17. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members. 18. For women only - currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator. Please refer to the study protocol for the complete inclusion and exclusion criteria list. |
Country | Name | City | State |
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Argentina | Research Site | Buenos Aires | |
Argentina | Research Site | Buenos Aires | |
Argentina | Research Site | Buenos Aires | |
Argentina | Research Site | Caba | |
Argentina | Research Site | Caba | |
Argentina | Research Site | Caba | |
Argentina | Research Site | Ciudad Autonoma de Buenos Aire | |
Argentina | Research Site | Ciudad de Buenos Aires | |
Argentina | Research Site | Córdoba | |
Argentina | Research Site | Florida | |
Argentina | Research Site | Mar del Plata | |
Argentina | Research Site | Mendoza | |
Argentina | Research Site | Ranelagh | |
Argentina | Research Site | Rosario | |
Argentina | Research Site | Rosario | |
Argentina | Research Site | San Fernando | |
Australia | Research Site | Darlinghurst | |
Australia | Research Site | Melbourne | |
Australia | Research Site | South Brisbane | |
Australia | Research Site | Spearwood | |
Belgium | Research Site | Bruxelles | |
Belgium | Research Site | Edegem | |
Belgium | Research Site | Liège | |
Belgium | Research Site | Namur | |
Belgium | Research Site | Roeselare | |
Bulgaria | Research Site | Dupnitsa | |
Bulgaria | Research Site | Dupnitsa | |
Bulgaria | Research Site | Haskovo | |
Bulgaria | Research Site | Kozloduy | |
Bulgaria | Research Site | Lovech | |
Bulgaria | Research Site | Pazardzhik | |
Bulgaria | Research Site | Petrich | |
Bulgaria | Research Site | Pleven | |
Bulgaria | Research Site | Pleven | |
Bulgaria | Research Site | Ruse | |
Bulgaria | Research Site | Ruse | |
Bulgaria | Research Site | Sevlievo | |
Bulgaria | Research Site | Sliven | |
Bulgaria | Research Site | Smolyan | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Stara Zagora | |
Bulgaria | Research Site | Stara Zagora | |
Bulgaria | Research Site | Varna | |
Bulgaria | Research Site | Veliko Tarnovo | |
Bulgaria | Research Site | Vidin | |
Bulgaria | Research Site | Vratsa | |
Canada | Research Site | Ajax | Ontario |
Canada | Research Site | Burlington | Ontario |
Canada | Research Site | Calgary | Alberta |
Canada | Research Site | Edmonton | Alberta |
Canada | Research Site | Edmonton | Alberta |
Canada | Research Site | Hamilton | Ontario |
Canada | Research Site | Kelowna | British Columbia |
Canada | Research Site | London | Ontario |
Canada | Research Site | Lower Sackville | Nova Scotia |
Canada | Research Site | Mount Pearl | Newfoundland and Labrador |
Canada | Research Site | Newmarket | Ontario |
Canada | Research Site | Niagara Falls | Ontario |
Canada | Research Site | Niagara Falls | Ontario |
Canada | Research Site | Quebec | |
Canada | Research Site | Quebec | |
Canada | Research Site | Quebec | |
Canada | Research Site | Sherwood Park | Alberta |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Vancouver | British Columbia |
Canada | Research Site | Vancouver | British Columbia |
Canada | Research Site | Winnipeg | Manitoba |
Canada | Research Site | Winnipeg | Manitoba |
Chile | Research Site | Curico | |
Chile | Research Site | Quillota | |
Chile | Research Site | Santiago | |
Chile | Research Site | Santiago | |
Chile | Research Site | Santiago | |
Chile | Research Site | Santiago | |
Chile | Research Site | Santiago | |
Chile | Research Site | Talca | |
Chile | Research Site | Temuco | |
Chile | Research Site | Viña del Mar | |
Chile | Research Site | Viña del Mar | |
Denmark | Research Site | Aalborg | |
Denmark | Research Site | Hjørring | |
Denmark | Research Site | Hvidovre | |
Denmark | Research Site | Vejle | |
Hungary | Research Site | Balassagyarmat | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Edelény | |
Hungary | Research Site | Encs | |
Hungary | Research Site | Farkasgyepü | |
Hungary | Research Site | Gödöllo | |
Hungary | Research Site | Hajdúnánás | |
Hungary | Research Site | Hódmezovásárhely | |
Hungary | Research Site | Komárom | |
Hungary | Research Site | Pécs | |
Hungary | Research Site | Siófok | |
Hungary | Research Site | Szeged | |
Hungary | Research Site | Szeged | |
Hungary | Research Site | Szigetvár | |
India | Research Site | Ahmedabad | |
India | Research Site | Aligarh | |
India | Research Site | Bangalore | |
India | Research Site | Belagavi | |
India | Research Site | Bengaluru | |
India | Research Site | Coimbatore | |
India | Research Site | Dehradun | |
India | Research Site | Gurgaon | |
India | Research Site | Hyderabad | |
India | Research Site | Jaipur | |
India | Research Site | Jaipur | |
India | Research Site | Mohali | |
India | Research Site | Mumbai | |
India | Research Site | Nagpur | |
India | Research Site | New Delhi | |
India | Research Site | New Delhi | |
India | Research Site | New Delhi | |
India | Research Site | Noida | |
India | Research Site | Thane | |
India | Research Site | Vishakhapatnam | |
Italy | Research Site | Bari | |
Italy | Research Site | Battipaglia | |
Italy | Research Site | Biancavilla | |
Italy | Research Site | Casatenovo | |
Italy | Research Site | Catanzaro | |
Italy | Research Site | Cona | |
Italy | Research Site | Firenze | |
Italy | Research Site | Garbagnate Milanese | |
Italy | Research Site | Milano | |
Italy | Research Site | Monserrato | |
Italy | Research Site | Napoli | |
Italy | Research Site | Napoli | |
Italy | Research Site | Pisa | |
Italy | Research Site | Roma | |
Italy | Research Site | Roma | |
Italy | Research Site | Salerno | |
Italy | Research Site | Sassari | |
Japan | Research Site | Chino-shi | |
Japan | Research Site | Chuo-ku | |
Japan | Research Site | Chuo-ku | |
Japan | Research Site | Chuo-ku | |
Japan | Research Site | Chuo-ku | |
Japan | Research Site | Fukui-shi | |
Japan | Research Site | Fukuoka-shi | |
Japan | Research Site | Fukuoka-shi | |
Japan | Research Site | Fukuoka-shi | |
Japan | Research Site | Habikino-shi | |
Japan | Research Site | Hamamatsu-shi | |
Japan | Research Site | Higashiibaraki-gun | |
Japan | Research Site | Himeji-shi | |
Japan | Research Site | Hiroshima-shi, Naka-ku | |
Japan | Research Site | Hitachinaka-shi | |
Japan | Research Site | Ikoma-shi | |
Japan | Research Site | Kagoshima-shi | |
Japan | Research Site | Kanazawa-shi | |
Japan | Research Site | Kishiwada-shi | |
Japan | Research Site | Kitakyusyu | |
Japan | Research Site | Kiyose-shi | |
Japan | Research Site | Kokubunji-shi | |
Japan | Research Site | Kyoto-shi | |
Japan | Research Site | Kyoto-shi | |
Japan | Research Site | Meguro-ku | |
Japan | Research Site | Miyazaki-shi | |
Japan | Research Site | Nagaoka-shi | |
Japan | Research Site | Nagoya-shi | |
Japan | Research Site | Nankoku-shi | |
Japan | Research Site | Obihiro | |
Japan | Research Site | Oita-shi | |
Japan | Research Site | Omuta-shi | |
Japan | Research Site | Osaka-shi | |
Japan | Research Site | Osaka-shi | |
Japan | Research Site | Osaka-shi | |
Japan | Research Site | Saga-shi | |
Japan | Research Site | Sakaide-shi | |
Japan | Research Site | Sapporo-shi | |
Japan | Research Site | Sapporo-shi | |
Japan | Research Site | Setagaya-ku | |
Japan | Research Site | Setagaya-ku | |
Japan | Research Site | Shibuya-ku | |
Japan | Research Site | Shimotsuga-gun | |
Japan | Research Site | Shinagawa-ku | |
Japan | Research Site | Shinagawa-ku | |
Japan | Research Site | Shinjuku-ku | |
Japan | Research Site | Shinjuku-ku | |
Japan | Research Site | Shizuoka | |
Japan | Research Site | Takarazuka-shi | |
Japan | Research Site | Tanabe-shi | |
Japan | Research Site | Toon-shi | |
Japan | Research Site | Toshima-ku | |
Japan | Research Site | Toshima-ku | |
Japan | Research Site | Toshima-ku | |
Japan | Research Site | Toyama-shi | |
Japan | Research Site | Tsuchiura-shi | |
Japan | Research Site | Utsunomiya-shi | |
Japan | Research Site | Yanagawa-shi | |
Japan | Research Site | Yokohama-shi | |
Japan | Research Site | Yokohama-shi | |
Japan | Research Site | Yokohama-shi | |
Japan | Research Site | Yokohama-shi | |
Japan | Research Site | Yokohama-shi | |
Korea, Republic of | Research Site | Cheongju-si | |
Korea, Republic of | Research Site | Gangwon-do | |
Korea, Republic of | Research Site | Jeonju-si | |
Korea, Republic of | Research Site | Seongnam-si | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Suwon-si | |
Korea, Republic of | Research Site | Uijeongbu | |
Korea, Republic of | Research Site | Ulsan | |
Netherlands | Research Site | Deventer | |
Netherlands | Research Site | Eindhoven | |
Netherlands | Research Site | Heerlen | |
Netherlands | Research Site | Nijmegen | |
Netherlands | Research Site | Zutphen | |
New Zealand | Research Site | Auckland | |
New Zealand | Research Site | Auckland | |
New Zealand | Research Site | Grafton | |
New Zealand | Research Site | Nawton | |
New Zealand | Research Site | Nelson | |
New Zealand | Research Site | Rotorua | |
New Zealand | Research Site | Wellington | |
Peru | Research Site | Cusco | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Peru | Research Site | Piura | |
Philippines | Research Site | Baguio | |
Philippines | Research Site | Baguio City | |
Philippines | Research Site | Caloocan City | |
Philippines | Research Site | Davao City | |
Philippines | Research Site | Davao City | |
Philippines | Research Site | Iloilo City | |
Philippines | Research Site | Iloilo City | |
Philippines | Research Site | Las Pinas | |
Philippines | Research Site | Lipa City | |
Philippines | Research Site | Los Baños | |
Philippines | Research Site | Manila | |
Philippines | Research Site | Manila | |
Philippines | Research Site | Marilao | |
Philippines | Research Site | Pasig City | |
Philippines | Research Site | Quezon City | |
Philippines | Research Site | Quezon City | |
Philippines | Research Site | Quezon City | |
Poland | Research Site | Bialystok | |
Poland | Research Site | Bialystok | |
Poland | Research Site | Bydgoszcz | |
Poland | Research Site | Czestochowa | |
Poland | Research Site | Karczew | |
Poland | Research Site | Katowice | |
Poland | Research Site | Kielce | |
Poland | Research Site | Krakow | |
Poland | Research Site | Kraków | |
Poland | Research Site | Kraków | |
Poland | Research Site | Lublin | |
Poland | Research Site | Piaseczno | |
Poland | Research Site | Poznan | |
Poland | Research Site | Poznan | |
Poland | Research Site | Poznan | |
Poland | Research Site | Poznan | |
Poland | Research Site | Poznan | |
Poland | Research Site | Poznan | |
Poland | Research Site | Rzeszow | |
Poland | Research Site | Rzeszów | |
Poland | Research Site | Rzeszów | |
Poland | Research Site | Sosnowiec | |
Poland | Research Site | Sosnowiec | |
Poland | Research Site | Strzelce Opolskie | |
Poland | Research Site | Szczecin | |
Poland | Research Site | Tarnów | |
Poland | Research Site | Wroclaw | |
Poland | Research Site | Wroclaw | |
Puerto Rico | Research Site | Caguas | |
Puerto Rico | Research Site | Guaynabo | |
Puerto Rico | Research Site | Ponce | |
Puerto Rico | Research Site | San Juan | |
Romania | Research Site | Bra?ov | |
Romania | Research Site | Brasov | |
Romania | Research Site | Brasov | |
Romania | Research Site | Bucharest | |
Romania | Research Site | Bucharest | |
Romania | Research Site | Ia?i | |
Romania | Research Site | Timisoara | |
Spain | Research Site | Barcelona | |
Spain | Research Site | Benalmádena | |
Spain | Research Site | Coslada | |
Spain | Research Site | Girona | |
Spain | Research Site | L'Hospitalet de Llobregat | |
Spain | Research Site | Madrid | |
Spain | Research Site | Madrid | |
Spain | Research Site | Málaga | |
Spain | Research Site | Marbella (Málaga) | |
Spain | Research Site | Pozuelo de Alarcón | |
Spain | Research Site | Santander | |
Spain | Research Site | Santiago De Compostela-Coruña | |
Spain | Research Site | Valencia | |
Spain | Research Site | Zaragoza | |
Spain | Research Site | Zaragoza | |
Taiwan | Research Site | Changhua | |
Taiwan | Research Site | Kaohsiung | |
Taiwan | Research Site | Kaohsiung | |
Taiwan | Research Site | Kaohsiung City | |
Taiwan | Research Site | New Taipei | |
Taiwan | Research Site | Taichung | |
Taiwan | Research Site | Taichung | |
Taiwan | Research Site | Tainan | |
Taiwan | Research Site | Taipei | |
Taiwan | Research Site | Taipei | |
Taiwan | Research Site | Taipei City | |
Taiwan | Research Site | Tao-Yuan | |
Thailand | Research Site | Bang Kra So | |
Thailand | Research Site | Bangkok | |
Thailand | Research Site | Bangkok | |
Thailand | Research Site | Bangkok | |
Thailand | Research Site | Hat Yai | |
Thailand | Research Site | Hatyai | |
Thailand | Research Site | Khon Kaen | |
Thailand | Research Site | Mae Rim | |
Thailand | Research Site | Muang | |
Thailand | Research Site | Muang | |
Thailand | Research Site | Mueang | |
Thailand | Research Site | Mueang Chanthaburi | |
United States | Research Site | Adairsville | Georgia |
United States | Research Site | Albuquerque | New Mexico |
United States | Research Site | Albuquerque | New Mexico |
United States | Research Site | Amarillo | Texas |
United States | Research Site | Anderson | South Carolina |
United States | Research Site | Atlanta | Georgia |
United States | Research Site | Austin | Texas |
United States | Research Site | Bangor | Maine |
United States | Research Site | Baytown | Texas |
United States | Research Site | Beaumont | Texas |
United States | Research Site | Bellevue | Nebraska |
United States | Research Site | Birmingham | Alabama |
United States | Research Site | Boerne | Texas |
United States | Research Site | Boston | Massachusetts |
United States | Research Site | Brandon | Florida |
United States | Research Site | Brick | New Jersey |
United States | Research Site | Bronx | New York |
United States | Research Site | Bronx | New York |
United States | Research Site | Brownsburg | Indiana |
United States | Research Site | Burlington | Vermont |
United States | Research Site | Champaign | Illinois |
United States | Research Site | Charlotte | North Carolina |
United States | Research Site | Charlotte | North Carolina |
United States | Research Site | Chesterfield | Missouri |
United States | Research Site | Chicago | Illinois |
United States | Research Site | Chicago | Illinois |
United States | Research Site | Chicago | Illinois |
United States | Research Site | Cincinnati | Ohio |
United States | Research Site | Cincinnati | Ohio |
United States | Research Site | Clarksville | Tennessee |
United States | Research Site | Clinton | South Carolina |
United States | Research Site | Colorado Springs | Colorado |
United States | Research Site | Columbia | Maryland |
United States | Research Site | Columbus | Georgia |
United States | Research Site | Covina | California |
United States | Research Site | Crowley | Louisiana |
United States | Research Site | Cudahy | Wisconsin |
United States | Research Site | Cypress | Texas |
United States | Research Site | Dallas | Texas |
United States | Research Site | Denver | North Carolina |
United States | Research Site | DuBois | Pennsylvania |
United States | Research Site | Duluth | Georgia |
United States | Research Site | East Providence | Rhode Island |
United States | Research Site | Edmond | Oklahoma |
United States | Research Site | El Paso | Texas |
United States | Research Site | Encinitas | California |
United States | Research Site | Fargo | North Dakota |
United States | Research Site | Flint | Michigan |
United States | Research Site | Franklin | Tennessee |
United States | Research Site | Fresno | California |
United States | Research Site | Gastonia | North Carolina |
United States | Research Site | Georgetown | Texas |
United States | Research Site | Georgetown | Kentucky |
United States | Research Site | Grants Pass | Oregon |
United States | Research Site | Greenville | South Carolina |
United States | Research Site | Hampton | Georgia |
United States | Research Site | Hannibal | Missouri |
United States | Research Site | Harlingen | Texas |
United States | Research Site | Houston | Texas |
United States | Research Site | Houston | Texas |
United States | Research Site | Houston | Texas |
United States | Research Site | Huntsville | Alabama |
United States | Research Site | Indianapolis | Indiana |
United States | Research Site | Kerrville | Texas |
United States | Research Site | Kingwood | West Virginia |
United States | Research Site | Lafayette | Louisiana |
United States | Research Site | Laguna Hills | California |
United States | Research Site | Lake Charles | Louisiana |
United States | Research Site | Lakewood | Colorado |
United States | Research Site | Lampasas | Texas |
United States | Research Site | Las Vegas | Nevada |
United States | Research Site | Lawrenceville | Georgia |
United States | Research Site | Lincoln | Nebraska |
United States | Research Site | Little Rock | Arkansas |
United States | Research Site | Long Beach | California |
United States | Research Site | Los Angeles | California |
United States | Research Site | Los Angeles | California |
United States | Research Site | Louisville | Kentucky |
United States | Research Site | Manassas | Virginia |
United States | Research Site | Maumee | Ohio |
United States | Research Site | Medford | Oregon |
United States | Research Site | Mesquite | Texas |
United States | Research Site | Miami | Florida |
United States | Research Site | Mission Hills | California |
United States | Research Site | Missoula | Montana |
United States | Research Site | Mooresville | North Carolina |
United States | Research Site | Morgantown | West Virginia |
United States | Research Site | New Hyde Park | New York |
United States | Research Site | New Windsor | New York |
United States | Research Site | New York | New York |
United States | Research Site | New York | New York |
United States | Research Site | Newport Beach | California |
United States | Research Site | Newport News | Virginia |
United States | Research Site | North Charleston | South Carolina |
United States | Research Site | Northridge | California |
United States | Research Site | Ocala | Florida |
United States | Research Site | Ogden | Utah |
United States | Research Site | Oklahoma City | Oklahoma |
United States | Research Site | Orangeburg | South Carolina |
United States | Research Site | Palm Harbor | Florida |
United States | Research Site | Pearland | Texas |
United States | Research Site | Phoenix | Arizona |
United States | Research Site | Phoenix | Arizona |
United States | Research Site | Pittsburgh | Pennsylvania |
United States | Research Site | Pittsburgh | Pennsylvania |
United States | Research Site | Plano | Texas |
United States | Research Site | Potomac | Maryland |
United States | Research Site | Raleigh | North Carolina |
United States | Research Site | Reading | Pennsylvania |
United States | Research Site | Red Oak | Texas |
United States | Research Site | Rincon | Georgia |
United States | Research Site | River Forest | Illinois |
United States | Research Site | Saint Louis | Missouri |
United States | Research Site | Saint Louis | Missouri |
United States | Research Site | Saint Petersburg | Florida |
United States | Research Site | San Antonio | Texas |
United States | Research Site | San Antonio | Texas |
United States | Research Site | San Antonio | Texas |
United States | Research Site | San Diego | California |
United States | Research Site | Saraland | Alabama |
United States | Research Site | Savannah | Georgia |
United States | Research Site | Scottdale | Pennsylvania |
United States | Research Site | Scottsdale | Arizona |
United States | Research Site | Smithfield | Pennsylvania |
United States | Research Site | Staten Island | New York |
United States | Research Site | Stockbridge | Georgia |
United States | Research Site | Stockton | California |
United States | Research Site | Sugar Land | Texas |
United States | Research Site | Sun City West | Arizona |
United States | Research Site | Tallahassee | Florida |
United States | Research Site | Tampa | Florida |
United States | Research Site | Thousand Oaks | California |
United States | Research Site | Toledo | Ohio |
United States | Research Site | Tomball | Texas |
United States | Research Site | Tomball | Texas |
United States | Research Site | Toms River | New Jersey |
United States | Research Site | Tucson | Arizona |
United States | Research Site | Tucson | Arizona |
United States | Research Site | Tulsa | Oklahoma |
United States | Research Site | Tulsa | Oklahoma |
United States | Research Site | Tyrone | Georgia |
United States | Research Site | Upland | California |
United States | Research Site | Valdosta | Georgia |
United States | Research Site | Waldorf | Maryland |
United States | Research Site | Waterbury | Connecticut |
United States | Research Site | West Des Moines | Iowa |
United States | Research Site | West Valley City | Utah |
United States | Research Site | Westminster | California |
United States | Research Site | Winter Garden | Florida |
Vietnam | Research Site | Ha Noi | |
Vietnam | Research Site | Hanoi | |
Vietnam | Research Site | Ho Chi Minh | |
Vietnam | Research Site | Ho Chi Minh | |
Vietnam | Research Site | Ho Chi Minh | |
Vietnam | Research Site | Ho Chi Minh City | |
Vietnam | Research Site | Hochiminh |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Vietnam, Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Denmark, Hungary, India, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Peru, Philippines, Poland, Puerto Rico, Romania, Spain, Taiwan, Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 | Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 | 24 Weeks | |
Primary | Rate of severe asthma exacerbations | Primary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations | Up to 52 weeks | |
Secondary | Change from baseline in morning pre-dose trough FEV1 at Week 24 | Change from baseline in morning pre-dose trough FEV1 at Week 24 | 24 Weeks | |
Secondary | Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (=0.5 decrease equals response) at Week 24 | Percentage of responders in ACQ-7 (=0.5 decrease equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008 | 24 weeks | |
Secondary | Percentage of responders in ACQ-5 (=0.5 decrease equals response) at Week 24 | Percentage of responders in ACQ-5 (=0.5 decrease equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008 | 24 Weeks | |
Secondary | Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) (=0.5 increase equals response) at Week 24 | Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s) +12) (=0.5 increase equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008 | 24 weeks | |
Secondary | Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (=4.0 unit decrease equals response) at Week 24 | Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (=4.0 unit decrease equals response) at Week 24 | 24 Weeks | |
Secondary | Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1 | Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1 | Day 1 | |
Secondary | Time to first severe asthma exacerbation | Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008:
Time to first severe asthma exacerbation |
Up to 52 Weeks | |
Secondary | Rate of moderate/severe asthma exacerbations | Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008:
Rate of moderate/severe asthma exacerbations |
Up to 52 Weeks | |
Secondary | Time to first moderate/severe asthma exacerbation | Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008:
Time to first moderate/severe asthma exacerbation |
Up to 52 Weeks | |
Secondary | Rate of severe asthma exacerbations for participants with percent predicted FEV1 = 55% at baseline. | Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations for participants with percent predicted FEV1 = 55% at baseline. | Up to 52 Weeks | |
Secondary | Rate of severe asthma exacerbations for participants with = 1 severe exacerbation in the 12 months prior to Visit 1. | Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations for participants with = 1 severe exacerbation in the 12 months prior to Visit 1. | Up to 52 Weeks |
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