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

Novartis

Status and phase

Completed

Phase 3

Phase 2

Conditions

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

COPD

Treatments

Drug: indacaterol maleate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00396604

CQAB149B2212

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No 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/exclusion criteria may apply.