Asthma Clinical Trial
Official title:
A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of 52 Weeks Treatment With QGE031 Subcutaneous (s.c). in Asthma Patients Not Adequately Controlled by Medium- or High-dose Inhaled Corticosteroid (ICS) Plus Long Acting β2-agonist (LABA) With or Without Oral Corticosteroid (OCS)
| Verified date | August 2017 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).
| Status | Terminated |
| Enrollment | 10 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 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 2 asthma exacerbations 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. Key Exclusion Criteria: - 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 |
|---|---|---|---|
| Belgium | Novartis Investigative Site | Erpent | |
| Canada | Novartis Investigative Site | Toronto | Ontario |
| Canada | Novartis Investigative Site | Trois-Rivières | Quebec |
| France | Novartis Investigative Site | Le Kremlin Bicetre | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Cottbus | Sachsen |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Leipzig | |
| Germany | Novartis Investigative Site | Marburg | |
| Germany | Novartis Investigative Site | Münster | |
| Hungary | Novartis Investigative Site | Balassagyarmat | |
| Hungary | Novartis Investigative Site | Miskolc | HUN |
| Italy | Novartis Investigative Site | Pisa | PI |
| Japan | Novartis Investigative Site | Chuo-ku | Tokyo |
| Japan | Novartis Investigative Site | Edogawa-ku | Tokyo |
| Japan | Novartis Investigative Site | Habikino-city | Osaka |
| Japan | Novartis Investigative Site | Itabashi-ku | Tokyo |
| Japan | Novartis Investigative Site | Kishiwada-city | Osaka |
| Japan | Novartis Investigative Site | Ota-ku | Tokyo |
| Japan | Novartis Investigative Site | Ota-ku | Tokyo |
| Japan | Novartis Investigative Site | Sagamihara-city | Kanagawa |
| Japan | Novartis Investigative Site | Sakaide-city | Kagawa |
| Japan | Novartis Investigative Site | Sapporo-city | Hokkaido |
| Japan | Novartis Investigative Site | Shinagawa-ku | Tokyo |
| Japan | Novartis Investigative Site | Toshima-ku | Tokyo |
| Japan | Novartis Investigative Site | Yokohama-city | Kanagawa |
| Japan | Novartis Investigative Site | Yokohama-city | Kanagawa |
| Netherlands | Novartis Investigative Site | Harderwijk | |
| Netherlands | Novartis Investigative Site | Leiden | |
| Slovakia | Novartis Investigative Site | Bojnice | Slovak Republic |
| Slovakia | Novartis Investigative Site | Liptovsky Hradok | Slovak Republic |
| Slovakia | Novartis Investigative Site | Nitra | Slovak Republic |
| Slovakia | Novartis Investigative Site | Zvolen | |
| United States | Novartis Investigative Site | Birmingham | Alabama |
| United States | Novartis Investigative Site | Kingwood | Texas |
| United States | Novartis Investigative Site | Plano | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Belgium, Canada, France, Germany, Hungary, Italy, Japan, Netherlands, Slovakia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations | Week 52 | ||
| Secondary | QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations | Week 52 | ||
| Secondary | QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations | Week 52 | ||
| Secondary | QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on the Reduction in Rate of Asthma Exacerbations (by Severity) | Week 52 | ||
| Secondary | QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Time to First Asthma Exacerbations (by Severity) | Week 52 | ||
| Secondary | QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Questionnaire (ACQ) | Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72) | ||
| Secondary | QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Diary (ACD) | Over 52 weeks (Treatment) and 20 weeks (follow-up) | ||
| Secondary | QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Forced Expiratory Volume in 1 Second (FEV1) | Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72) | ||
| Secondary | QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Peak Expiratory Flow (PEF) in the Morning and Evening | Over 52 weeks (Treatment) and 20 weeks (follow-up) | ||
| Secondary | QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Total Daily Symptom Score | Over 52 weeks (Treatment) and 20 weeks (follow-up) | ||
| Secondary | Response to QGE031 Between Atopic Asthma and Non-atopic Asthma | Over 52 weeks (treatment) and 20 weeks (follow up) |
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