Asthma Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind, Placebo and Active-controlled Study With Exploratory Dose-ranging to Investigate the Efficacy and Safety of 16 Weeks Treatment With Subcutaneous (s.c.) QGE031 in Asthma Patients Not Adequately Controlled With High-dose Inhaled Corticosteroids and Long Acting β2-agonists
Verified date | August 2017 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.
Status | Completed |
Enrollment | 471 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Key Inclusion Criteria: - A diagnosis of allergic asthma , uncontrolled on current medication. - History of at least 1 asthma exacerbation during the last 1 year - Forced Expiratory Volume in one second (FEV1) of = 40% and = 80% of the predicted normal value; reversibility following administration of bronchodilator must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used). Key Exclusion Criteria: - Baseline IgE levels or body weight outside the omalizumab dosing table. - Use of tobacco products within the previous 6 months (Social occasional smokers may be included). - Recent asthma attack/exacerbation or asthma worsening/ respiratory infection. |
Country | Name | City | State |
---|---|---|---|
Argentina | Novartis Investigative Site | Buenos Aires | |
Argentina | Novartis Investigative Site | Buenos Aires | |
Argentina | Novartis Investigative Site | Caba | Buenos Aires |
Argentina | Novartis Investigative Site | Caba | Buenos Aires |
Argentina | Novartis Investigative Site | Caba | Capital Federal |
Argentina | Novartis Investigative Site | Mar del Plata | Buenos Aires |
Argentina | Novartis Investigative Site | Mendoza | |
Argentina | Novartis Investigative Site | Mendoza | |
Argentina | Novartis Investigative Site | Rosario | Santa Fe |
Argentina | Novartis Investigative Site | Rosario | Santa Fe |
Argentina | Novartis Investigative Site | San Miguel de Tucuman | Tucuman |
Argentina | Novartis Investigative Site | Santa Fe | |
Argentina | Novartis Investigative Site | Santa Fe | Rosario |
Canada | Novartis Investigative Site | Montreal | Quebec |
Canada | Novartis Investigative Site | Ottawa | Ontario |
Canada | Novartis Investigative Site | Quebec | |
Canada | Novartis Investigative Site | St-Charles-Borromée | Quebec |
Czechia | Novartis Investigative Site | Breclav | |
Czechia | Novartis Investigative Site | Brno | |
Czechia | Novartis Investigative Site | Brno | Czech Republic |
Czechia | Novartis Investigative Site | Tabor | |
Czechia | Novartis Investigative Site | Teplice | CZE |
Czechia | Novartis Investigative Site | Trutnov | Czech Republic |
Finland | Novartis Investigative Site | Helsinki | |
Finland | Novartis Investigative Site | Tampere | |
Finland | Novartis Investigative Site | Turku | |
France | Novartis Investigative Site | Le Kremlin Bicetre | |
France | Novartis Investigative Site | Marseille | |
France | Novartis Investigative Site | Montpellier | |
France | Novartis Investigative Site | Strasbourg | |
Germany | Novartis Investigative Site | Frankfurt | |
Germany | Novartis Investigative Site | Hamburg | |
Germany | Novartis Investigative Site | Homburg | |
Germany | Novartis Investigative Site | Leipzig | |
Germany | Novartis Investigative Site | Leipzig | |
Germany | Novartis Investigative Site | Mainz | |
Germany | Novartis Investigative Site | Roth | |
Germany | Novartis Investigative Site | Rüdersdorf | |
Guatemala | Novartis Investigative Site | Guatemala City | GTM |
Guatemala | Novartis Investigative Site | Guatemala City | GTM |
Guatemala | Novartis Investigative Site | Guatemala City | |
Hungary | Novartis Investigative Site | Budapest | |
Hungary | Novartis Investigative Site | Debrecen | |
Hungary | Novartis Investigative Site | Pecs | |
Hungary | Novartis Investigative Site | Torokbalint | |
India | Novartis Investigative Site | Dhantoli | Nagpur |
India | Novartis Investigative Site | Karamsad | Gujrat |
India | Novartis Investigative Site | Panjim | Goa |
Israel | Novartis Investigative Site | Haifa | |
Israel | Novartis Investigative Site | Jerusalem | |
Israel | Novartis Investigative Site | Jerusalem | |
Israel | Novartis Investigative Site | Kfar-Saba | |
Israel | Novartis Investigative Site | Petach Tikva | |
Israel | Novartis Investigative Site | Rehovot | |
Italy | Novartis Investigative Site | Messina | ME |
Italy | Novartis Investigative Site | Milano | MI |
Italy | Novartis Investigative Site | Padova | PD |
Italy | Novartis Investigative Site | Pisa | PI |
Italy | Novartis Investigative Site | Reggio Emilia | RE |
Italy | Novartis Investigative Site | Verona | VR |
Korea, Republic of | Novartis Investigative Site | Bucheon-Si | Gyeonggi-Do |
Korea, Republic of | Novartis Investigative Site | Cheongju-si | Chungcheongbuk-do |
Korea, Republic of | Novartis Investigative Site | Gwangju | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
Korea, Republic of | Novartis Investigative Site | Suwon | Gyeonggi-do |
Mexico | Novartis Investigative Site | Guadalajara | Jalisco |
Mexico | Novartis Investigative Site | México, D.F. | Distrito Federal |
Panama | Novartis Investigative Site | Panama City | |
Poland | Novartis Investigative Site | Bialystok | |
Poland | Novartis Investigative Site | Lodz | |
Portugal | Novartis Investigative Site | Coimbra | |
Portugal | Novartis Investigative Site | Lisboa | |
Portugal | Novartis Investigative Site | Lisboa | |
Portugal | Novartis Investigative Site | Porto | |
Portugal | Novartis Investigative Site | Vila Nova de Gaia | |
Romania | Novartis Investigative Site | Brasov | |
Romania | Novartis Investigative Site | Brasov | |
Romania | Novartis Investigative Site | Brasov | |
Romania | Novartis Investigative Site | Bucharest | District 3 |
Romania | Novartis Investigative Site | Bucharest | District 3 |
Romania | Novartis Investigative Site | Bucharest | ROM |
Romania | Novartis Investigative Site | Bucuresti | District 1 |
Romania | Novartis Investigative Site | Bucuresti | |
Romania | Novartis Investigative Site | Bucuresti | |
Romania | Novartis Investigative Site | Cluj Napoca | |
Romania | Novartis Investigative Site | Cluj-Napoca | |
Romania | Novartis Investigative Site | Constanta | Jud. Constanta |
Romania | Novartis Investigative Site | Pitesti | |
Russian Federation | Novartis Investigative Site | Barnaul | |
Russian Federation | Novartis Investigative Site | Chelyabinsk | |
Russian Federation | Novartis Investigative Site | Chelyabinsk | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | N.Novgorod | |
Russian Federation | Novartis Investigative Site | Nizhny Novgorod | |
Russian Federation | Novartis Investigative Site | Penza | |
Russian Federation | Novartis Investigative Site | Ryazan | |
Russian Federation | Novartis Investigative Site | Saint Petersburg | |
Russian Federation | Novartis Investigative Site | Saratov | |
Russian Federation | Novartis Investigative Site | St-Petersburg | |
Russian Federation | Novartis Investigative Site | St. Petersburg | |
Russian Federation | Novartis Investigative Site | Yaroslavl | |
Singapore | Novartis Investigative Site | Singapore | |
Singapore | Novartis Investigative Site | Singapore | |
Slovakia | Novartis Investigative Site | Bardejov | |
Slovakia | Novartis Investigative Site | Bratislava | |
Slovakia | Novartis Investigative Site | Bratislava | Slovak Republic |
Slovakia | Novartis Investigative Site | Kosice | |
Slovakia | Novartis Investigative Site | Nitra | Slovak Republic |
Slovakia | Novartis Investigative Site | Prievidza | |
Slovakia | Novartis Investigative Site | Ruzomberok | |
Slovakia | Novartis Investigative Site | Trencin | |
South Africa | Novartis Investigative Site | Cape Town | |
South Africa | Novartis Investigative Site | Cape Town | |
South Africa | Novartis Investigative Site | Durban | |
Turkey | Novartis Investigative Site | Aydin | |
Turkey | Novartis Investigative Site | Fatih / Istanbul | |
Turkey | Novartis Investigative Site | Istanbul | |
Turkey | Novartis Investigative Site | Istanbul | |
Turkey | Novartis Investigative Site | Izmir | |
Turkey | Novartis Investigative Site | Mersin | |
United Kingdom | Novartis Investigative Site | Birmingham | |
United Kingdom | Novartis Investigative Site | Bradford | West Yorkshire |
United Kingdom | Novartis Investigative Site | East Yorkshire | |
United Kingdom | Novartis Investigative Site | Southampton | |
United States | Novartis Investigative Site | Brooklyn | New York |
United States | Novartis Investigative Site | Cincinnati | Ohio |
United States | Novartis Investigative Site | Columbia | Maryland |
United States | Novartis Investigative Site | Evansville | Indiana |
United States | Novartis Investigative Site | Everett | Washington |
United States | Novartis Investigative Site | Fairfax | Virginia |
United States | Novartis Investigative Site | Fresno | California |
United States | Novartis Investigative Site | Hawaiian Gardens | California |
United States | Novartis Investigative Site | Lincoln | Rhode Island |
United States | Novartis Investigative Site | Mineola | New York |
United States | Novartis Investigative Site | Minneapolis | Minnesota |
United States | Novartis Investigative Site | Mount Pleasant | South Carolina |
United States | Novartis Investigative Site | Novi | Michigan |
United States | Novartis Investigative Site | Omaha | Nebraska |
United States | Novartis Investigative Site | Owensboro | Kentucky |
United States | Novartis Investigative Site | Papillion | Nebraska |
United States | Novartis Investigative Site | Riverside | California |
United States | Novartis Investigative Site | Salt Lake City | Utah |
United States | Novartis Investigative Site | San Jose | California |
United States | Novartis Investigative Site | Summerville | South Carolina |
United States | Novartis Investigative Site | Vista | California |
United States | Novartis Investigative Site | Waldorf | Maryland |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Argentina, Canada, Czechia, Finland, France, Germany, Guatemala, Hungary, India, Israel, Italy, Korea, Republic of, Mexico, Panama, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, South Africa, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo | The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7. | Week 16 | |
Secondary | Change From Baseline in ACQ-7 Score | The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7. A negative change from baseline indicates improvement. | Baseline, Weeks 4, 8, 12, 16 and 28 | |
Secondary | Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1 | The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7. | Week 16 | |
Secondary | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score | The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to participants with asthma. The 32 items in the AQLQ were divided into four domain-specific scores and a total score as follows: Activity limitations = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items); Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items); Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items); Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items); and Overall Score = Mean of Items 1 to 32 (32 items). Each item of the AQLQ was equally weighted and scored along a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. The mean overall score ranged from 1 to 7. A positive change from baseline indicates improvement. | Baseline, Week 16, Week 28 | |
Secondary | Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication | Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement. | Baseline, Week 16 |
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