A randomized, double-blind, placebo controlled, multicentre study to determine the effect of QVA149 on lung function in patients with Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary DiseaseMedDRA version: 9.1Level: LLTClassification code 10009033Term: Chronic obstructive pulmonary disease
- Registration Number
- EUCTR2007-003655-36-BE
- Lead Sponsor
- ovartis Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
Male or female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
Patients with moderate to severe stable COPD according to the GOLD Guidelines 2006
Patients who have smoking history of at least 10 pack years.
Patients with a post-bronchodilator FEV1 =30% and < 80% of the predicted normal and post-bronchodilator FEV1/FVC <0.70.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test.
Patients requiring long term oxygen therapy (> 15h a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation of their airways disease in the 6 weeks prior to Visit 1 or during the run-in period.
Patients with any history of asthma
Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
Patients with any history of asthma indicated by but not limited to a blood eosinophil count > 400/mm3.
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (excluding stable AF), uncontrolled hypertension, narrow-angle glaucoma, symptomatic prostatic hyperplasia, clinically significant elevated PSA levels at screening, bladder-neck obstruction or moderate to severe renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at Visit 2 is prolonged (>440 ms for males or >460 for females).
Treatments for COPD and allied conditions: the following medications should not be used between Visits 1 and 18. The minimum washout prior to Visit 2 is specified below:
The long acting anticholinergic agent tiotropium (bromide): 7 days.
Short acting anticholinergics: 8 h.
Fixed combinations of beta 2-agonists and inhaled corticosteroids: 48 h.
(Patients taking fixed dose combinations of ß2 agonisists and inhaled corticosteroids must be switched to the equivalent inhaled corticosteroid as monotherapy plus salbutamol/albuterol as rescue therapy at least 48 hours before Visit 2)
Long-acting beta 2-agonists: 48 h.
Short acting beta 2-agonists (other than those prescribed in the study): 6 hours.
Theophylline (any formulation): 7 days
NOTE: During the screening period and the 7 day washout periods administration of a fixed combination of a ß2-agonist and inhaled muscarinic antagonist is acceptable if deemed appropriate by the investigator. At no other time during the study will this regimen be acceptable. A minimum of 8 hours washout prior to visit assessments is mandatory.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method