Phase 3
Completed N=54
Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity
Source: ClinicalTrials.gov NCT00999908 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment — 2.705; 2.630; 2.557 Liters
Summary
This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment |
2.705; 2.630; 2.557 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment |
1.744; 1.767; 1.642 | — |
| SECONDARY Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment |
3.140; 3.176; 3.048 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:
- Smoking history of at least 10 pack-years.
- Forced expiratory volume in 1 second (FEV1) < 80% and ≥ 50% of the predicted normal value.
- Post-bronchodilator FEV1/Force vital capacity (FVC) < 0.7.
Exclusion Criteria
- Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening.
- Patients who have had a respiratory tract infection within 6 weeks prior to screening.
- Patients with concomitant pulmonary disease.
- Patients with alpha-1-antitrypsin deficiency.
- Patients with contraindications for tiotropium treatment.
- Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT00999908). 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.