Status:
COMPLETED
A Multicenter, 4-week Crossover (Total Duration 12 Weeks) to Determine the Impact of QVA149 on Nocturnal Oxygen Levels in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
The purpose of this study was to determine whether a fixed dose combination of indacaterol and glycopyrronium (QVA149) has an impact on night-time blood oxygen levels in Chronic Obstructive Pulmonary ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of COPD (according to GOLD guidelines, updated 2014) with a post-bronchodilator FEV1/FVC \<0.70
- Patients with a post-bronchodilator FEV1 ≥30% and \<60% of the predicted normal value
- Resting daytime oxygen saturation levels measured by pulse oximetry of ≤95% SpO2
- Smoking history of at least 10 pack years (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years)
Exclusion
- An exacerbation of COPD (treatment with oral or parenteral antibiotics and/or glucocorticosteroids and/or hospitalization related to COPD) within 4 weeks prior to screening or during the run-in period
- Diagnosed asthma
- Patients receiving regular long term oxygen therapy (LTOT)
- Ongoing / planned rehabilitation during the study period
- Three or more awakenings during the night leading to toilet visit or other reasons for exiting the bed during the last week prior to the screening visit due to non-COPD reasons
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
November 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2016
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT02233543
Start Date
November 30 2014
End Date
June 26 2016
Last Update
August 6 2018
Active Locations (5)
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1
Novartis Investigative Site
Aarhus, Denmark, 8000 C
2
Novartis Investigative Site
Hvidovre, Denmark, 2650
3
Novartis Investigative Site
Bergen, Norway, -N5021
4
Novartis Investigative Site
Gothenburg, Sweden, 413 45