QBW251B2201

Trial objective
Characterize the dose-response relationship of QBW251 administered orally over 12 weeks on lung function, compared to placebo when added to inhaled triple combination therapy (long-acting β2- agonist/long-acting muscarinic receptor antagonist/inhaled corticosteroid; LABA/LAMA/ICS.

Disease area
Moderate to severe COPD

Status
Granted ethics approval, not open.

CI/PI
Dr David Collier

Sponsor
Novartis

Funder
Novartis

Study summary
This study uses a 6 treatment arm, parallel-group, randomized, double-blind study design. Approximately 900 male and female COPD patients are randomized into the trial and initially undergo a screening period of 1 week. This screening period (Weeks -3 to -2) serves to assess eligibility and to taper patients off disallowed medications. Subsequently, patients enter the run-in period (2 weeks; Days -14 to 1) to establish baseline values for symptom assessments, to standardize the COPD background therapy (triple combination LABA/LAMA/ICS), and to complete eligibility assessments. At visit Run-In 2 final eligibility will be assessed. Eligible patients will move into the Day 1 visit where they are stratified according to their smoking status (current or ex-smoker) and severity of airflow limitation (FEV1 ≥ 30% to < 50% and ≥ 50% to < 80%) and then randomized into 1 of 6 treatment arms with a randomization ratio of 2:2:1:1:1:2 (450 mg b.i.d., 300 mg b.i.d., 150 mg b.i.d., 75 mg b.i.d., 25 mg b.i.d., placebo - see also Figure 3-1). Day 1 also generates additional baseline data and study treatment is initiated.

Sample size and duration
1200; 1 year

Enquiries 
ellen.mapperley@novartis.com
w.y.james@qmul.ac.uk