Trial Outcomes & Findings for 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) (NCT NCT02233543)
NCT ID: NCT02233543
Last Updated: 2018-08-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
38 participants
Primary outcome timeframe
Post 4 weeks administration of QVA149, post 4 weeks administration of placebo
Results posted on
2018-08-06
Participant Flow
Participants were randomized in a 1:1 ratio.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Period 1
STARTED
|
22
|
16
|
|
Period 1
COMPLETED
|
19
|
13
|
|
Period 1
NOT COMPLETED
|
3
|
3
|
|
Period 2
STARTED
|
19
|
13
|
|
Period 2
COMPLETED
|
17
|
12
|
|
Period 2
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
|
Period 1
Participants required other treatment.
|
2
|
3
|
|
Period 2
Adverse Event
|
1
|
0
|
|
Period 2
Participant required other treatment.
|
0
|
1
|
|
Period 2
COPD exacerbation
|
1
|
0
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
All Participants (QVA149/Placebo)
n=38 Participants
Participants received 4 weeks of QVA149 and 4 weeks of placebo according to either of the following sequences: QVA149 first and then placebo, or placebo first and then QVA149.
|
|---|---|
|
Age, Continuous
|
68.4 Years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post 4 weeks administration of QVA149, post 4 weeks administration of placeboPopulation: Only randomized participants with data from both treatments were analyzed.
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.
Outcome measures
| Measure |
QVA149 (Indacaterol/Glycopyrronium)
n=35 Participants
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.
|
Placebo
n=34 Participants
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.
|
|---|---|---|
|
Mean Night-time Blood Oxygenation
|
89.59 Percent Oxygenation
Standard Error 0.30
|
90.04 Percent Oxygenation
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Post 4 weeks administration of QVA149, post 4 weeks administration of placeboPopulation: Only randomized participants with data from both treatments were analyzed.
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.
Outcome measures
| Measure |
QVA149 (Indacaterol/Glycopyrronium)
n=35 Participants
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.
|
Placebo
n=34 Participants
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.
|
|---|---|---|
|
Percent of Time Spent During the Night Below 90 % in Blood Oxygen Saturation
|
44.37 Percent
Standard Error 5.09
|
36.58 Percent
Standard Error 4.84
|
Adverse Events
QVA149 (Indacaterol/Glycopyrronium)
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QVA149 (Indacaterol/Glycopyrronium)
n=35 participants at risk
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.
|
Placebo
n=34 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.9%
1/35
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.9%
1/35
|
2.9%
1/34
|
Other adverse events
| Measure |
QVA149 (Indacaterol/Glycopyrronium)
n=35 participants at risk
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.
|
Placebo
n=34 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Blindness transient
|
2.9%
1/35
|
0.00%
0/34
|
|
General disorders
Fatigue
|
2.9%
1/35
|
2.9%
1/34
|
|
General disorders
Pyrexia
|
2.9%
1/35
|
0.00%
0/34
|
|
Infections and infestations
Bronchitis
|
0.00%
0/35
|
2.9%
1/34
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
3/35
|
5.9%
2/34
|
|
Investigations
Blood glucose increased
|
0.00%
0/35
|
5.9%
2/34
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/35
|
2.9%
1/34
|
|
Nervous system disorders
Paraesthesia
|
2.9%
1/35
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.7%
2/35
|
8.8%
3/34
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/35
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
5/35
|
11.8%
4/34
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
2.9%
1/35
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
2/35
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.9%
1/35
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/35
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/35
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/35
|
0.00%
0/34
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER