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 Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-06-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

QVA149

Intervention Type DRUG

Delivered once daily via single-dose dry powder inhaler

QVA149 Placebo

Intervention Type DRUG

Placebo delivered once daily via single-dose dry powder inhaler

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.

Group Type EXPERIMENTAL

QVA149

Intervention Type DRUG

Delivered once daily via single-dose dry powder inhaler

QVA149 Placebo

Intervention Type DRUG

Placebo delivered once daily via single-dose dry powder inhaler

Interventions

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QVA149

Delivered once daily via single-dose dry powder inhaler

Intervention Type DRUG

QVA149 Placebo

Placebo delivered once daily via single-dose dry powder inhaler

Intervention Type DRUG

Other Intervention Names

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indacaterol/glycopyrronium, Ultibro Breezhaler

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No