EUCTR2011-006050-91-DK
Active, not recruiting
Phase 1
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 enrollmentApril 2, 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
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Sponsor
- ovartis Pharma Service AG
- Enrollment
- 184
- Status
- Active, not recruiting
- Last Updated
- 9 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
Similar Trials
Active, not recruiting
Not Applicable
Comparison of safety and efficacy of the combination product QVA149A against the concurrent administration of the individual components, QAB149 and NVA237, in patients with chronic obstructive pulmonary disease (COPD)EUCTR2011-006050-91-SEovartis Pharma Service AG184
Completed
Phase 3
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 (CQVA149A2326)COPDchronic obstructive pulmonary disease10038716NL-OMON37459ovartis Pharma BV70
Active, not recruiting
Not Applicable
Comparison of safety and efficacy of the combination product QVA149A against the concurrent administration of the individual components, QAB149 and NVA237, in patients with chronic obstructive pulmonary disease (COPD)Chronic 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]EUCTR2011-006050-91-NLovartis Pharma Service AG184
Active, not recruiting
Not Applicable
Comparison of safety and efficacy of the combination product QVA149A against the concurrent administration of the individual components, QAB149 and NVA237, in patients with chronic obstructive pulmonary disease (COPD)EUCTR2011-006050-91-ATovartis Pharma Services AG184
Active, not recruiting
Phase 1
A research study looking at how safe somapacitan is and how well it works in children who need help to grow – REAL 9CTIS2022-501055-87-01ovo Nordisk A/S44