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

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease, COPD

Treatments: Drug: QBW251; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02449018

CQBW251X2201

Details and patient eligibility

About

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)

Enrollment: 92 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 2 patient groups, including a placebo group

QBW251

Experimental group

Description:

QBW251 will be provided to participants during 70 days

Treatment:

Drug: QBW251

Placebo

Placebo Comparator group

Description:

Placebo will be provided to participants during 70 days

Treatment:

Drug: Placebo