Phase 2
Completed N=568
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT00557466 ↗Enrolled (actual)
568
Serious AEs
1.1%
Results posted
Jan 2013
Primary outcomePrimary: The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) — 0.051; 0.073; 0.076; 0.121 liters
Summary
This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) |
0.051; 0.073; 0.076; 0.121; 0.098; 0.005 | — |
| SECONDARY Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose |
1.407; 1.461; 1.441; 1.500; 1.541; 1.315 | — |
| SECONDARY The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 |
0.028; 0.054; 0.060; 0.073; 0.140; -0.009 | — |
| SECONDARY Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1 |
1.371; 1.422; 1.427; 1.438; 1.535; 1.321 | — |
| SECONDARY Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 |
80.9; 84.4; 101.4; 105.3; 115.0; 85.7 | — |
| SECONDARY Change From Baseline in Morning and Evening Peak Expiratory Flow |
3.10; 19.91; 23.63; 11.11; 16.06; -4.24 | — |
| SECONDARY Number of Participants Using Rescue Medication |
74; 61; 73; 65; 65; 70 | — |
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 (which include any adjustment to their current COPD treatment)
- Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines, 2006) and:
- Smoking history of at least 10 pack years
- Post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% and ≥30% of the predicted normal value.
- Post-bronchodilator FEV1/Forced vital capacity (FVC) < 70%
Exclusion Criteria
- Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception.
- Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.
- Patients with a history of asthma.
- Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study.
- Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00557466). 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.