A Multicenter, 4-week Crossover (Total Duration 12 Weeks), Placebo-controlled, Double-blind Study to Determine the Impact of QVA149 (Indacaterol/Glycopyrronium) 85/43 µg on Nocturnal Oxygen Levels in Chronic Obstructive Pulmonary Disease (COPD)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Mean Night-time Blood Oxygenation
Study Overview
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 Disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
First QVA149 (indacaterol/glycopyrronium), then Placebo
Participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day followed by 2 weeks washout. Then participants received 4 weeks of placebo once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day.
Intervention: QVA149 (Drug)
First QVA149 (indacaterol/glycopyrronium), then Placebo
Participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day followed by 2 weeks washout. Then participants received 4 weeks of placebo once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day.
Intervention: QVA149 Placebo (Drug)
First Placebo, then QVA149 (indacaterol/glycopyrronium)
Participants received 4 weeks of placebo once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day followed by 2 weeks washout. Then participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day.
Intervention: QVA149 (Drug)
First Placebo, then QVA149 (indacaterol/glycopyrronium)
Participants received 4 weeks of placebo once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day followed by 2 weeks washout. Then participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day.
Intervention: QVA149 Placebo (Drug)
Outcomes
Primary Outcomes
Mean Night-time Blood Oxygenation
Time Frame: Post 4 weeks administration of QVA149, post 4 weeks administration of placebo
The mean night-time blood oxygenation following 4 weeks administration of QVA149 compared to placebo was assessed. Night time oxygenation (SpO2) was measured using polygraphy.
Secondary Outcomes
- Percent of Time Spent During the Night Below 90 % in Blood Oxygen Saturation(Post 4 weeks administration of QVA149, post 4 weeks administration of placebo)