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

Asthma Clinical Trial

Official title:

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 (SDDPI) vs. Placebo in Patients With Persistent Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403637
• Other study ID #: CQAB149A2228
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 6, 2006
• Last updated: November 16, 2016
• Start date: November 2006
• Est. completion date: February 2007

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• indacaterol maleate

Locations

Country	Name	City	State
United States	Colorado Allergy and Asthma Centres, P.C.	Denver	Colorado
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Northeast Medical Research Associates, Inc.	North Dartmouth	Massachusetts
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	The Clinical Research Center	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung function measured 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second "(FEV1)
Secondary	FEV1 at time points 30 min, 1, 2 and 4 h post-dose
Secondary	Percent change in FEV1 at time points 30 min, 1, 2 and 4 h, 23 h 10 min and 23 h 45 min post dose
Secondary	Forced vital capacity (FVC) at time points 30 min, 1, 2 and 4 h, 23 h 10 min and 23 h 45 min post dose

External Links

•   Results for CQAB149A2228 from the Novartis Clinical Trials website