Clinical trial NCT02336425: Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-01-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
timeFrame: Week 52
Secondary outcomes:
measure: QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
timeFrame: Week 52
measure: QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations
timeFrame: Week 52
measure: QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on the Reduction in Rate of Asthma Exacerbations (by Severity)
timeFrame: Week 52
measure: QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Time to First Asthma Exacerbations (by Severity)
timeFrame: Week 52
measure: QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Questionnaire (ACQ)
timeFrame: Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
measure: QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Diary (ACD)
timeFrame: Over 52 weeks (Treatment) and 20 weeks (follow-up)
measure: QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
measure: QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Peak Expiratory Flow (PEF) in the Morning and Evening
timeFrame: Over 52 weeks (Treatment) and 20 weeks (follow-up)
measure: QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Total Daily Symptom Score
timeFrame: Over 52 weeks (Treatment) and 20 weeks (follow-up)
measure: Response to QGE031 Between Atopic Asthma and Non-atopic Asthma
timeFrame: Over 52 weeks (treatment) and 20 weeks (follow up)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Kingwood
country: United States
facility: Novartis Investigative Site
state: Texas
city: Plano
country: United States
facility: Novartis Investigative Site
state: Texas
city: Erpent
country: Belgium
facility: Novartis Investigative Site
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Trois-Rivières
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Le Kremlin Bicetre
country: France
facility: Novartis Investigative Site
city: Cottbus
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Münster
country: Germany
facility: Novartis Investigative Site
city: Miskolc
country: Hungary
facility: Novartis Investigative Site
state: HUN
city: Balassagyarmat
country: Hungary
facility: Novartis Investigative Site
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sakaide-city
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Sagamihara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Habikino-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Kishiwada-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Harderwijk
country: Netherlands
facility: Novartis Investigative Site
city: Leiden
country: Netherlands
facility: Novartis Investigative Site
city: Bojnice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Liptovsky Hradok
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Zvolen
country: Slovakia
facility: Novartis Investigative Site
Study officials:
References: