Phase 3
Completed N=129
Effect of Indacaterol on Inspiratory Capacity (IC)
Source: ClinicalTrials.gov NCT01012765 ↗Enrolled (actual)
129
Serious AEs
1.4%
Results posted
Feb 2012
Primary outcomePrimary: Peak Inspiratory Capacity (IC) After 21 Days of Treatment — 2.69; 2.48; 2.63 Liters
Summary
This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD). In particular, spirometric timepoints are included to elucidate the peak-IC in a period of approximately 4 hour post inhalation
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Inspiratory Capacity (IC) After 21 Days of Treatment |
2.69; 2.48; 2.63 | — |
| SECONDARY Trough IC After 20 Days of Treatment |
2.43; 2.28; 2.39 | — |
| SECONDARY Peak Residual Volume (RV) After 21 Days of Treatment |
3.77; 4.17; 3.79 | — |
| SECONDARY Peak Total Lung Capacity (TLC) After 21 Days of Treatment |
7.25; 7.38; 7.25 | — |
| SECONDARY Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment |
0.52; 0.57; 0.53 | — |
| SECONDARY Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment |
2.05; 3.08; 2.00 | — |
| SECONDARY FEV1 30 Minutes Post-dose After 21 Days of Treatment |
1.92; 1.68; 1.91 | — |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment |
1.80; 1.61; 1.78 | — |
Eligibility Criteria
Inclusion Criteria
- Co-operative outpatients with a diagnosis of COPD (moderate as classified by the GOLD Guidelines, 2008) and including:
- Smoking history of at least 10 pack years
- Post-bronchodilator FEV1 <80% and ≥50% of the predicted normal value (Visit 2).
- Post-bronchodilator FEV1/forced vital capacity (FVC) <70% (Visit 2).
Exclusion Criteria
- Patients who received any corticosteroid (including inhaled) for 3 months prior to screening
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01012765). 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.