Back to resultsA Multicenter, 4-week Crossover (Total Duration 12 Weeks) to Determine the Impact of QVA149 on Nocturnal Oxygen Levels in Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
QVA149
QVA149 Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, QVA149, nocturnal oxygen levels, combination bronchodilator
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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
First QVA149 (indacaterol/glycopyrronium), then Placebo
First Placebo, then QVA149 (indacaterol/glycopyrronium)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02233543
First Posted
August 19, 2014
Last Updated
November 10, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02233543
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 30, 2014 (Actual)
Primary Completion Date
June 26, 2016 (Actual)
Study Completion Date
June 26, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, QVA149, nocturnal oxygen levels, combination bronchodilator
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First QVA149 (indacaterol/glycopyrronium), then Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
First Placebo, then QVA149 (indacaterol/glycopyrronium)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
QVA149
Other Intervention Name(s)
indacaterol/glycopyrronium,, Ultibro Breezhaler
Intervention Description
Delivered once daily via single-dose dry powder inhaler
Intervention Type
Drug
Intervention Name(s)
QVA149 Placebo
Intervention Description
Placebo delivered once daily via single-dose dry powder inhaler
Primary Outcome Measure Information:
Title
Mean Night-time Blood Oxygenation
Description
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.
Time Frame
Post 4 weeks administration of QVA149, post 4 weeks administration of placebo
Secondary Outcome Measure Information:
Title
Percent of Time Spent During the Night Below 90 % in Blood Oxygen Saturation
Description
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.
Time Frame
Post 4 weeks administration of QVA149, post 4 weeks administration of placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Novartis Investigative Site
City
Aarhus
ZIP/Postal Code
8000 C
Country
Denmark
Facility Name
Novartis Investigative Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Novartis Investigative Site
City
Bergen
ZIP/Postal Code
-N5021
Country
Norway
Facility Name
Novartis Investigative Site
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Novartis Investigative Site
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Learn more about this trial
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)
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