Phase 4
Completed N=24
Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations
Source: ClinicalTrials.gov NCT02418468 ↗Enrolled (actual)
24
Serious AEs
12.5%
Results posted
Jul 2017
Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks — 1.76; 1.86 Liters — p=0.262
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks |
1.76; 1.86 | 0.262 |
Eligibility Criteria
Inclusion criteria
- 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.
- Patients diagnosed with COPD at 40 years of age or older.
- 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)
- Patients with stable COPD in Patient Group B according to GOLD 2014.
Exclusion criteria
- 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.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- 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.
- 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.
- Patients who have COPD exacerbation or infection 6 weeks prior to Visit 1.
- Patients who develop a moderate or severe COPD exacerbation during the period between Visit 1 and Visit 2.
- Patients with a history of asthma.
Data sourced from ClinicalTrials.gov (NCT02418468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.