Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: QAW039

• Registration Number: NCT03226392
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-21
• Study Start: 2017-10-31
• Primary Completion: 2019-07-05
• Disposition First Submitted: 2019-07-18
• Study Completion: 2019-08-01
• Results First Submitted: 2020-01-31
• Results First Submitted QC: 2020-02-17
• Disposition First Submitted QC: 2020-02-17
• Results First Posted: 2020-02-28
• Disposition First Posted: 2020-02-28
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 704

Inclusion Criteria

• A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
• Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks prior to Visit 1.
• FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18 years.
• Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days of the placebo run- in period.
• Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in period.
• Demonstrated reversible airway obstruction.
• Asthma control questionnaire (ACQ) score ≥ 1.5.

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Exclusion Criteria

• Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.

• A resting QTcF (Fridericia) ≥450 msec (male) or

  ≥460 msec (female).

• Pregnant or nursing (lactating) women.

• Serious co-morbidities.

• Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.

Other protocol-defined inclusion/exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo once daily
QAW039	QAW039	QAW039 once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pre-dose FEV1	Baseline and Week 12	Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Number of Puffs of SABA Taken Per Day	Baseline (daily mean for up to three weeks prior to baseline visit) and Week 12 (daily mean post baseline up to Week 12)	Daily use of SABA (the number of rescue medication puffs taken in the previous 12 hours) was recorded using a patient electronic diary (referred to as eDiary or eDiary/ePEF). Patients were instructed to routinely complete the patient diary twice daily - at the same time each morning and each evening, approximately 12 hours apart.
Change From Baseline in Daytime Asthma Symptom Score	Baseline and Week 12	Daytime asthma symptoms are evaluated through four questions and each of them will be rated on a scale of 0 to 6. Higher scores indicate more severe asthma-related symptoms. A mean score is calculated for the responses to 4 questions.
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score	Baseline and Week 12	AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇻🇳 Ho Chi Minh, Vietnam