Study of efficacy and safety of QAW039 when added to standard-of-care asthma therapy in patients with uncontrolled asthma

Phase 1

• Conditions: Asthma; MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-001272-40-HU
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-17
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 650

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 65
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 455
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified