Trial Outcomes & Findings for 12-week Open-label Evaluation of Efficacy and Safety of Indacaterol (NCT NCT01232894)
NCT ID: NCT01232894
Last Updated: 2013-11-19
Results Overview
The Clinical Chronic Obstructive Pulmonary disease (COPD) Questionnaire (CCQ) is a self-administered questionnaire containing ten questions, divided into three domains: symptoms, mental and functional state. The questions are based on a 7-point scale where a '0' means having no limitations and a '6' means extreme or complete limitations. The final score is the mean of all ten questions. The CCQ score was recalculated according to the paper by Van der Molen et al., 2003. The statistical significance remained the same.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
90 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2013-11-19
Participant Flow
90 participants were screened and enrolled into the study. The participants were randomized in a 2:1 ratio. Out of 90 participants randomized, 87 received study drug and were included in the Safety set for analysis.
Participant milestones
| Measure |
Indacaterol
indacaterol 150 µg once-daily via single-dose dry powder inhaler
|
Long-acting beta2-agonist
Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
30
|
|
Overall Study
Received Study Drug
|
59
|
28
|
|
Overall Study
COMPLETED
|
48
|
22
|
|
Overall Study
NOT COMPLETED
|
12
|
8
|
Reasons for withdrawal
| Measure |
Indacaterol
indacaterol 150 µg once-daily via single-dose dry powder inhaler
|
Long-acting beta2-agonist
Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
5
|
|
Overall Study
Physician Decision
|
2
|
1
|
Baseline Characteristics
12-week Open-label Evaluation of Efficacy and Safety of Indacaterol
Baseline characteristics by cohort
| Measure |
Indacaterol
n=60 Participants
indacaterol 150 µg once-daily via single-dose dry powder inhaler
|
Long-acting beta2-agonist
n=30 Participants
Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
65.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Full analysis Set: all patients who received at least one dose of study drug and have evaluable data for analysis.
The Clinical Chronic Obstructive Pulmonary disease (COPD) Questionnaire (CCQ) is a self-administered questionnaire containing ten questions, divided into three domains: symptoms, mental and functional state. The questions are based on a 7-point scale where a '0' means having no limitations and a '6' means extreme or complete limitations. The final score is the mean of all ten questions. The CCQ score was recalculated according to the paper by Van der Molen et al., 2003. The statistical significance remained the same.
Outcome measures
| Measure |
Indacaterol
n=55 Participants
indacaterol 150 µg once-daily via single-dose dry powder inhaler
|
Long-acting beta2-agonist
n=24 Participants
Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
|
|---|---|---|
|
Change From Baseline on Clinical COPD Questionnaire (CCQ) Score
Baseline
|
1.8 units on a scale
Standard Deviation 1.0
|
1.7 units on a scale
Standard Deviation 0.7
|
|
Change From Baseline on Clinical COPD Questionnaire (CCQ) Score
12 weeks
|
1.7 units on a scale
Standard Deviation 1.1
|
1.9 units on a scale
Standard Deviation 1.0
|
Adverse Events
Indacaterol
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Long-acting beta2-agonist
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indacaterol
n=59 participants at risk
indacaterol 150 µg once-daily via single-dose dry powder inhaler
|
Long-acting beta2-agonist
n=28 participants at risk
Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
1.7%
1/59 • Number of events 1 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
0.00%
0/28 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
|
Cardiac disorders
Pericarditis
|
1.7%
1/59 • Number of events 1 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
0.00%
0/28 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
|
Cardiac disorders
Ventricular fibrillation
|
1.7%
1/59 • Number of events 1 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
0.00%
0/28 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
|
Infections and infestations
Sinusitis
|
1.7%
1/59 • Number of events 1 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
0.00%
0/28 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
|
Nervous system disorders
Brain stem haemorrhage
|
1.7%
1/59 • Number of events 1 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
0.00%
0/28 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
|
Nervous system disorders
Dizziness
|
1.7%
1/59 • Number of events 1 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
0.00%
0/28 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.7%
1/59 • Number of events 1 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
0.00%
0/28 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
Other adverse events
| Measure |
Indacaterol
n=59 participants at risk
indacaterol 150 µg once-daily via single-dose dry powder inhaler
|
Long-acting beta2-agonist
n=28 participants at risk
Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
5.1%
3/59 • Number of events 4 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
0.00%
0/28 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.8%
4/59 • Number of events 4 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
10.7%
3/28 • Number of events 3 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
4/59 • Number of events 4 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
3.6%
1/28 • Number of events 1 • Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
|
Additional Information
Study Director
Novartis
Phone: 41 61 324 1111
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.
- Publication restrictions are in place
Restriction type: OTHER