Status:
COMPLETED
The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.
Detailed Description
This study used a multi-center, randomized, blinded, double-dummy placebo controlled, three-period crossover design to assess the effect of once daily QVA149 q.d vs. placebo and tiotropium 18 μg q.d. ...
Eligibility Criteria
Inclusion
- Patients with moderate to severe stable chronic obstructive pulmonary disease
- Smoking history of 10 pack years
- Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) between 30 - 80%
- Patients must be able to use computer mouse and display
- mMRC grade\>2
Exclusion
- Patients with a history of long QT syndrome
- Patients with Type I or uncontrolled Type II diabetes
- Patients who have had a COPD exacerbation or respiratory tract infection within 6 weeks prior to screening
- Patients with any history of asthma
- Patients with pulmonary lobectomy, lung volume reduction surgery, or lung transplantation
- Patients with concomitant pulmonary disease
- Patients requiring long term oxygen therapy (\>15 h a day)
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT01490125
Start Date
October 1 2011
End Date
August 1 2012
Last Update
December 24 2013
Active Locations (43)
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1
Novartis Investigative Site
Brussels, Belgium, 1000
2
Novartis Investigative Site
Gilly, Belgium, 6060
3
Novartis Investigative Site
Jambes, Belgium, 5100
4
Novartis Investigative Site
Jette, Belgium, 1090