Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma

Phase 2TerminatedNCT02336425

Novartis Pharmaceuticals10 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

QGE031

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (37)

Novartis Investigative Site

Birmingham, Alabama, United States

Novartis Investigative Site

Kingwood, Texas, United States

Novartis Investigative Site

Plano, Texas, United States

Novartis Investigative Site

Erpent, Belgium

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Outcomes

Primary Outcomes

QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations

Time frame: Week 52

Secondary Outcomes

QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations

Time frame: Week 52

QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations

Time frame: Week 52

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on the Reduction in Rate of Asthma Exacerbations (by Severity)

Time frame: Week 52

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Time to First Asthma Exacerbations (by Severity)

Time frame: Week 52

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Questionnaire (ACQ)

Time frame: Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Diary (ACD)

Time frame: Over 52 weeks (Treatment) and 20 weeks (follow-up)

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Forced Expiratory Volume in 1 Second (FEV1)

Time frame: Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Peak Expiratory Flow (PEF) in the Morning and Evening

Time frame: Over 52 weeks (Treatment) and 20 weeks (follow-up)

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Total Daily Symptom Score

Time frame: Over 52 weeks (Treatment) and 20 weeks (follow-up)

Response to QGE031 Between Atopic Asthma and Non-atopic Asthma

Time frame: Over 52 weeks (treatment) and 20 weeks (follow up)