Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
indacaterol, COPD, Long-acting beta2-agonist (LABA)
Brief summary
In this 12-week study, patients were randomized to either open-label indacaterol or standard of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were assessed.
Interventions
DRUGIndacaterol
Indacaterol 150 µg once-daily via single-dose dry powder inhaler
Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and: * Post-bronchodilator forced expiratory volume in 1 second (FEV1) \<80% and ≥30% of the predicted normal value * Post-bronchodilator FEV1/FVC (Forced Vital Capacity) \<70% * Current COPD bronchodilator treatment that includes a LABA bronchodilator or a fixed dose combination of LABA and Inhaled Corticosteroid (ICS)
Exclusion criteria
* Patients with a history of asthma * Patients who are currently being treated for COPD with tiotropium (Spiriva®) * Patients with diabetes Type I or uncontrolled diabetes Type II * Patients with a history of certain cardiovascular comorbid conditions Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on Clinical COPD Questionnaire (CCQ) Score | Baseline and 12 weeks | 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. |
Countries
Israel
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Indacaterol indacaterol 150 µg once-daily via single-dose dry powder inhaler | 60 |
| Long-acting beta2-agonist Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy | 30 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 5 |
Baseline characteristics
| Characteristic | Indacaterol | Long-acting beta2-agonist | Total |
|---|---|---|---|
| Age Continuous | 65.4 years STANDARD_DEVIATION 9.9 | 64.8 years STANDARD_DEVIATION 9.9 | 65.2 years STANDARD_DEVIATION 9.9 |
| Sex: Female, Male Female | 14 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Male | 46 Participants | 20 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 59 | 4 / 28 |
| serious Total, serious adverse events | 3 / 59 | 0 / 28 |
Outcome results
Primary
Change From Baseline on Clinical COPD Questionnaire (CCQ) Score
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.
Time frame: Baseline and 12 weeks
Population: Full analysis Set: all patients who received at least one dose of study drug and have evaluable data for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Indacaterol | Change From Baseline on Clinical COPD Questionnaire (CCQ) Score | Baseline | 1.8 units on a scale | Standard Deviation 1 |
| Indacaterol | Change From Baseline on Clinical COPD Questionnaire (CCQ) Score | 12 weeks | 1.7 units on a scale | Standard Deviation 1.1 |
| Long-acting beta2-agonist | Change From Baseline on Clinical COPD Questionnaire (CCQ) Score | Baseline | 1.7 units on a scale | Standard Deviation 0.7 |
| Long-acting beta2-agonist | Change From Baseline on Clinical COPD Questionnaire (CCQ) Score | 12 weeks | 1.9 units on a scale | Standard Deviation 1 |