NCT02449018

A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251

A Randomized, Double Blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Multiple Doses of QBW251 in Patients With COPD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Chronic Obstructive Pulmonary Disease, COPD

Interventions

Type	Name	Description
DRUG	QBW251	QBW251 capsule(s) taken orally twice per day
DRUG	Placebo	Matching placebo capsule(s) taken orally twice per day

Timeline

• Start date: 2015-04-30
• Primary completion: 2016-12-27
• Completion: 2017-01-23
• First posted: 2015-05-20
• Last updated: 2021-01-05
• Results posted: 2018-04-02

Locations

16 sites across 2 countries: United States, Poland

Regulatory

• FDA-regulated drug study