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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 October 2021
• Main ID: NCT03215758
• Date of registration: 11/07/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
• Scientific title: A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
• Date of first enrolment: November 1, 2017
• Target sample size: 675
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03215758
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Germany, Hungary, Mexico, Philippines, Saudi Arabia, Slovakia, South Africa, Turkey, United States

Key inclusion & exclusion criteria

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.

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.



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Placebo

Drug: QAW039

Primary Outcome(s)

Change From Baseline in Pre-dose FEV1 at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Change From Baseline in Asthma Quality of Life (AQLQ+12) Score [Time Frame: Week 12]

Change From Baseline in Daily Use of SABA [Time Frame: 12 weeks]

Change From Baseline in Daytime Asthma Symptom Score [Time Frame: 12 weeks]

Secondary ID(s)

2017-001273-16

CQAW039A2316

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03215758