Phase 2
Completed N=27
An Exploratory Study, to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With Chronic Obstructive Pulmonary Disease(COPD)
Source: ClinicalTrials.gov NCT00636961 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14 — 2.36; 2.05; 2.37; 2.10 Liters
Summary
This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14 |
2.36; 2.05; 2.37; 2.10 | — |
| SECONDARY Static Inspiratory Capacity (IC) at Day 14 |
2.55; 2.37 | — |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry on Day 14 |
1.68; 1.53 | — |
| SECONDARY Chronic Activity Related Breathlessness Measured by Transition Dyspnoea Index (TDI) at Day 14 |
1.0; -2.3 | — |
| SECONDARY Dyspnoea Measured by Borg CR10 Scale at Day 1, Day 14 |
8.2; 7.9; 8.1; 8.7; 5.9; 5.8 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects,
- 40 to 80 years of age,
- with a documented diagnosis of mild, moderate or severe chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and >20-pack year history of smoking, a post-bronchodilator 40% ≤ FEV1 ≤ 80% of predicted normal and post-bronchodilator FEV1/FVC 120% predicted normal
Exclusion Criteria
- No COPD exacerbations within 6 weeks prior to dosing,
- no concomitant lung disease such as asthma,
- no requirement for long term oxygen treatment or history of lung reduction surgery.
- No medical conditions that would interfere with the performance of spirometry or clinical exercise testing.
- Any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from participating in the study e.g. uncontrolled hypertension or unstable ischemic heart disease
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00636961). 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.