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)

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: QVA149; Drug: QVA149 Placebo

• Registration Number: NCT02233543
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-08
• Study Start: 2014-11-30
• Primary Completion: 2016-06-26
• Study Completion: 2016-06-26
• Results First Submitted: 2017-06-20
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-10
• Last Update Submitted: 2017-11-10
• Results First Posted: 2018-08-06
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First QVA149 (indacaterol/glycopyrronium), then Placebo	QVA149	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.
First QVA149 (indacaterol/glycopyrronium), then Placebo	QVA149 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.
First Placebo, then QVA149 (indacaterol/glycopyrronium)	QVA149	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.
First Placebo, then QVA149 (indacaterol/glycopyrronium)	QVA149 Placebo	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.

Primary Outcome Measures

Name	Time	Method
Mean Night-time Blood Oxygenation	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 Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇸🇪 Uppsala, Sweden