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)

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.

Official Title
-----------------
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)

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: QVA149
* Drug: QVA149 Placebo


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First QVA149 (indacaterol/glycopyrronium), then Placebo<br>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. | Drug: QVA149<br>* Delivered once daily via single-dose dry powder inhaler<br>* Other names: Ultibro Breezhaler;Drug: QVA149 Placebo<br>* Placebo delivered once daily via single-dose dry powder inhaler<br>|
| Experimental: First Placebo, then QVA149 (indacaterol/glycopyrronium)<br>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. | Drug: QVA149<br>* Delivered once daily via single-dose dry powder inhaler<br>* Other names: Ultibro Breezhaler;Drug: QVA149 Placebo<br>* Placebo delivered once daily via single-dose dry powder inhaler<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Night-time Blood Oxygenation | 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. | Post 4 weeks administration of QVA149, post 4 weeks administration of placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Time Spent During the Night Below 90 % in Blood Oxygen Saturation | The time during the night spent below 90 % in blood oxygen saturation following 4 weeks administration of QVA149 compared to placebo was assessed. Night time oxygenation (SpO2) was measured using polygraphy. | Post 4 weeks administration of QVA149, post 4 weeks administration of placebo | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, QVA149, nocturnal oxygen levels, combination bronchodilator