Phase 3
Completed N=89
The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT00620022 ↗Enrolled (actual)
89
Serious AEs
2.4%
Results posted
Aug 2011
Primary outcomePrimary: Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period — 586; 475 Seconds
Summary
This study compared the effect of indacaterol (300 μg once daily [od]) on exercise endurance with that of placebo in patients with moderate to severe chronic obstructive pulmonary disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period |
586; 475 | — |
| SECONDARY Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose |
2.39; 2.25 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure.
- Co-operative outpatients with a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD), as classified by the GOLD Guidelines (2006), and:
- Smoking history of at least 20 pack years.
- Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value.
- Post-bronchodilator FEV1/forced vital capacity (FVC) < 70%.
Exclusion Criteria
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential.
- Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period.
- Patients requiring oxygen therapy or who experience oxygen desaturation to < 80% during cycle exercise on room air.
- Patients with a Wmax value < 20 W (as determined by the incremental cycle endurance test) at screening.
- Patients who have had a respiratory tract infection within 6 weeks prior to screening.
- Patients with contra-indications of cardiopulmonary exercise testing.
- Patients with concomitant pulmonary disease.
- Patients with a history (up to and including the screening visit) of asthma.
- Patients with diabetes Type I or uncontrolled diabetes Type II.
- Any patient with lung cancer or a history of lung cancer.
- Any patient with active cancer or a history of cancer with less than 5 years disease free survival time.
- Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at the collection of informed consent visit (Visit 1) or randomization is prolonged.
- Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
- Patients unable to successfully use a dry powder inhaler device, metered dose inhaler (MDI), or perform spirometry measurements.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT00620022). 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.