Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, FEV1, indacaterol
Brief summary
This study compared the efficacy of indacaterol versus placebo in COPD patients classified as GOLD 2014 Patient Group B. This was a 2-arm parallel group study that recruited COPD patients classified by GOLD Patient Gorup B. On successful completion of run-in period, patients were randomized in the ratio 1:1 to receive prn salbutamol plus: 1. Indacaterol 150ug or 2. Placebo for indacaterol all once daily (od) for 26 weeks. The primary objective (trough FEV1) was assessed after 12 weeks.
Interventions
DRUGIndacaterol
Indacaterol 150µg capsules for inhalation daily
DRUGPlacebo
Matching placebo indacaterol capsules for inhalation daily
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female adults aged ≥40 years, who have provided their consent and signed an Informed Consent Form. Written informed consent must be obtained before any assessment is performed. 2. Patients diagnosed with COPD at 40 years of age or older. 3. Patients with smoking history of at least 10 pack years, both current and ex-smokers are eligible. (Ten pack years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc) 4. Patients with stable COPD in Patient Group B according to GOLD 2014.
Exclusion criteria
1. Use of other investigational drugs within 5 half-lives of enrollment, or \[within 30 days /until the expected PD effect has returned to baseline\], whichever is longer. 2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 4. Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or 1 or more exacerbation resulting in hospitalization in the 12 months prior to Visit 1. 5. Patients who have COPD exacerbation or infection 6 weeks prior to Visit 1. 6. Patients who develop a moderate or severe COPD exacerbation during the period between Visit 1 and Visit 2. 7. Patients with a history of asthma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks | at week 12 | To compare the effects of indacaterol 150ug once dialy (od) to placebo in GOLD 2014 Group B COPD patients, in terms of 24-hour postdose (trough) forced expiratory volume in 1 second (FEV1) after 12 weeks of dosing. |
Countries
Hong Kong
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Indacaterol 150 mcg Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) | 13 |
| Placebo Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) | 11 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal of informed consent | 1 | 1 |
Baseline characteristics
| Characteristic | Indacaterol 150 mcg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 7.2 | 68.8 years STANDARD_DEVIATION 14.96 | 66 years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 11 | 4 / 13 |
| serious Total, serious adverse events | 1 / 11 | 2 / 13 |
Outcome results
Primary
Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks
To compare the effects of indacaterol 150ug once dialy (od) to placebo in GOLD 2014 Group B COPD patients, in terms of 24-hour postdose (trough) forced expiratory volume in 1 second (FEV1) after 12 weeks of dosing.
Time frame: at week 12
Population: Full Analysis Set (FAS) - would include all randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients would be analyzed according to the treatment assigned at randomization.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Indacaterol 150 mcg | Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks | 1.76 Liters | Standard Error 0.067 |
| Placebo | Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks | 1.86 Liters | Standard Error 0.061 |
p-value: 0.26295% CI: [-0.26, 0.07]mixed models for repeated measures (MMRM