Phase 4
Completed N=38
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)
Source: ClinicalTrials.gov NCT02233543 ↗Enrolled (actual)
38
Serious AEs
2.9%
Results posted
Aug 2018
Primary outcomePrimary: Mean Night-time Blood Oxygenation — 89.59; 90.04 Percent Oxygenation — p=0.2419
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Night-time Blood Oxygenation |
89.59; 90.04 | 0.2419 |
| SECONDARY Percent of Time Spent During the Night Below 90 % in Blood Oxygen Saturation |
44.37; 36.58 | 0.2016 |
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.
Data sourced from ClinicalTrials.gov (NCT02233543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.