A multi-centre randomized double blind 12-week study to assess the efficacy, safety and tolerability of QVA149 in patients with COPD who have moderate to severe airflow limitatio

Active, not recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-003347-30-HU
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-04
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

•Male and female patients that have signed informed consent and are >/= 40 years of age.
•Patients with stable Chronic Obstructive Pulmonary Disease (COPD) according to GOLD 2011.
•Patients with a post-bronchodilator Force Expiratory Volume in one second (FEV1) of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/ Forced Vital capacity (FVC) <0.70.
•Current or ex-smokers who have a smoking history of at least 10 pack years.
•Patients with an mMRC grade 2 or greater.

Other protocol defined inclusion criteria may apply
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 520
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 480

Exclusion Criteria

•Patients contraindicated for muscarinic antagonist agents and beta-2 agonists.
•Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
•Patients with narrow-angle glaucoma, Benign Prostatic Hyperplasia (BPH) or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
•Patients who had a COPD exacerbation within 6 weeks prior to screening.
•Patients who have a respiratory tract infection within 4 weeks prior to screening.
•Patients requiring long term oxygen therapy prescribed for more than 12 hour per day.
•Patients with a history of asthma.
•Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
•Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
•Patients with concomitant pulmonary disease.
•Patients with a history of certain cardiovascular co-morbid conditions
•Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
•Patients with active pulmonary tuberculosis.
•Patients in the active phase of a pulmonary rehabilitation programme.
•Other protocol-defined exclusion criteria may apply.

Study & Design

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