Phase 2
Completed N=92
A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251
Source: ClinicalTrials.gov NCT02449018 ↗Enrolled (actual)
92
Serious AEs
4.4%
Results posted
Apr 2018
Primary outcomePrimary: Change From Baseline in Lung Clearance Index (LCI) — -0.03; -0.16 Days — p=0.130
Summary
To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo administered orally, on airway function, lung volume, and quality of life in patients with chronic obstructive pulmonary disease (COPD)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Lung Clearance Index (LCI) |
-0.03; -0.16 | 0.130 |
| SECONDARY Change From Baseline in FEV1 Pre-bronchodilator |
0.04; -0.02 | — |
| SECONDARY Change From Baseline in FEV1 Post-bronchodilator |
0.05; -0.02 | — |
| SECONDARY Change From Baseline in FVC Pre Bronchodilator |
0.07; 0.01 | — |
| SECONDARY Change From Baseline in FVC Post- Bronchodilator |
0.03; 0.01 | — |
| SECONDARY Change From Baseline in TLC |
0.01; -0.07 | — |
| SECONDARY Change From Baseline in RV |
0.03; -0.02 | — |
| SECONDARY Change From Baseline in FRC |
0.01; -0.02 | — |
| SECONDARY Change From Baseline in DLCO |
-0.91; -0.25 | — |
| SECONDARY Plasma Concentration of QBW251 by TMax (0-8hours) |
1.27; 1.98 | — |
| SECONDARY Plasma Concentration of QBW251 by CMax (0-8hours) |
1250; 1640 | — |
| SECONDARY Plasma Concentration of QBW251 by AUClast (0-8hours) |
3830; 6840 | — |
| SECONDARY Plasma Concentration of QBW251 by AUC0-12h |
— | — |
Eligibility Criteria
Inclusion Criteria: Must have a diagnosis of GOLD II-III chronic obstructive pulmonary disease (COPD); Must have clinical diagnosis of chronic bronchitis; Must be either a current smoker (smoked ≤ 1 pack per day on average for the last 3 months with at least a 10 pack year smoking history) OR an ex-smoker with at least a 10 pack year smoking history; Exclusion Criteria: Must not be receiving chronic, daily, systemic steroids; Must not have severe emphysema (determined by HRCT); Must not have had a COPD exacerbation or respiratory tract infection requiring antibiotics or oral steroids or hospitalization within 6 weeks of screening; Must not be pregnant or nursing or a woman of child bearing potential; Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02449018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.