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)

• Status: Completed
• Trial end date: 2016-06-26
• Target enrollment: 0
• Participant gender: All

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 Disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Glycopyrrolate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.