EUCTR2011-006050-91-NL
Active, not recruiting
Not Applicable
A study to compare the efficacy and safety of once daily QVA149 vs. the once daily concurrent administration of QAB149 plus NVA237 in patients with moderate to severe chronic obstructive pulmonary disease - BEACO
ovartis Pharma Service AG0 sites184 target enrollmentMarch 5, 2012
ConditionsChronic Obstructive Pulmonary Disease (COPD)MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsOnbrez Breezhaler
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Sponsor
- ovartis Pharma Service AG
- Enrollment
- 184
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female adults aged \=40 yrs
- •Smoking history of at least 10 pack years
- •Diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2010\)
- •Post\-bronchodilator FEV1 \< 80% and \= 30% of the predicted normal value and post\-bronchodilator FEV1/FVC (forced vital capacity) \<70%
- •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 92
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
- •Patients with concomitant pulmonary disease
- •Patients with a history of asthma
- •Any patient with lung cancer or a history of lung cancer
- •Patients with a history of certain cardiovascular co\-morbid conditions
- •Patients with a known history and diagnosis of alpha\-1 antitrypsin deficiency
- •Patients in the active phase of a supervised pulmonary rehabilitation program
- •Patients contraindicated for inhaled anticholinergic agents and ß2 agonists
- •Other protocol defined inclusion criteria may apply
Outcomes
Primary Outcomes
Not specified
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