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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-01-23

Brief Summary

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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)

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease, COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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QBW251

QBW251 will be provided to participants during 70 days

Group Type EXPERIMENTAL

QBW251

Intervention Type DRUG

QBW251 capsule(s) taken orally twice per day

Placebo

Placebo will be provided to participants during 70 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo capsule(s) taken orally twice per day

Interventions

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QBW251

QBW251 capsule(s) taken orally twice per day

Intervention Type DRUG

Placebo

Matching placebo capsule(s) taken orally twice per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No