Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)

A Randomized, Double-blind, Double-dummy, Active (Formoterol 12 µg b.i.d) and Placebo Controlled, Multi-center, 5 Period Crossover Study to Assess the Bronchodilatory Efficacy and Safety of Single Doses of Indacaterol 150 µg, 300 µg and 600 µg Delivered Via Single Dose Dry Powder Inhaler vs. Placebo in Patients With Moderate to Severe COPD.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00396604

Enrollment

Registered

2006-11-07

Start date

2006-10-31

Completion date

2007-01-31

Last updated

2011-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive

Keywords

indacaterol, long acting beta agonist

Brief summary

The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, once- indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week.

Interventions

DRUGindacaterol maleate

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Male and females aged 40-75 years with COPD and symptoms such as cough, sputum production, and shortness of breath. * Smoking history of at least 10 pack years * FEV1 less than 65% of the predicted normal value and at least 0.75 L * Pre-bronchodilator FEV1/FVC less than 70%

Exclusion criteria

* A history of asthma or COPD diagnosis before the age of 40 * Hospitalization for COPD exacerbation within the previous 6 weeks * Respiratory tract infection within 6 weeks * Use of long-term oxygen therapy * Diabetes type I or uncontrolled diabetes type II * Clinically relevant laboratory abnormality or clinically significant condition * Corrected QT interval (QTc) above 430 ms for males and 450 ms for females, or a history of QTc prolongation. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Lung function measured 24 hours after having taken medication, by a special test called forced expiratory volume in 1 second (FEV1)	—

Secondary

Measure	Time frame
FEV1 at time points 30 min, 1, 2 and 4hours post-dose	—
Percent change in FEV1 at time points 30 min, 1, 2 and 4 hours, 23 hours 10min and 23 hours 45 min post dose	—
Forced vital capacity (FVC) at time points 30 min, 1, 2 and 4 hours, 23 hours 10 min and 23 hours 45 min post dose	—
Standardized FEV1 area under the curve (AUC) between baseline and 4 hours	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026