Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma

Novartis

Status and phase

Completed

Phase 3

Phase 2

Conditions

Asthma

Treatments

Drug: indacaterol maleate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00403637

CQAB149A2228

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 persistent asthma. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week

Enrollment

45 patients

Sex

All

Ages

12 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and females 12 - 75 years of age with a diagnosis of persistent asthma
Daily treatment with a bronchodilator and daily dose of at least 100 µg beclomethasone dipropionate or equivalent
FEV1 at Visit 1 at least 50% of the predicted normal value
FEV1 reversibility at least 15%

Exclusion criteria

Use of tobacco products within 6 months prior to Visit 1 or a smoking history of more than 10 pack years
Chronic Obstructive Pulmonary Disease (COPD)
Seasonal allergy where asthma is likely to deteriorate during the period of the study
Emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months
A respiratory tract infection within the previous 6 weeks Other protocol-defined exclusion criteria may apply