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

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease; MedDRA version: 19.0Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-001530-28-PL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-14
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Written informed consent
2. Body mass index (BMI) within the range of 18 - 35 kg/m2
3. Patients with a diagnosis of GOLD II-III COPD defined as a post-bronchodilator FEV1/FVC ratio =0.70 and an FEV1 between 30% and 79% predicted, on standard regimen of care unchanged for at least 4 weeks prior to screening
4. Current smokers who smoked = 1ppd on average for last 3 months and have at least a 10 pack year smoking history, or ex-smokers with at least a 10 pack year smoking history
5. Clinical diagnosis of chronic bronchitis
6. LCI = 8 at screening

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

1. Patients with a COPD exacerbation, lower, or upper respiratory tract infection in the 6 weeks prior to screening, during the screening period, or during run-in period
2. Patients receiving daily, systemic steroids
3. Patients with extensive emphysema as determined at screening by HRCT
4. Patients with a diagnosis of severe bronchiectasis or another concomitant pulmonary disease
5. Patients requiring long-term oxygen therapy for daytime hypoxemia
6. Women of childbearing potential

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified