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

Phase 2

Completed

• Conditions: Asthma

• Registration Number: NCT00403637
• Lead Sponsor: Novartis

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 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-06
• Study First Submitted QC: 2006-11-24
• Study First Posted: 2006-11-27
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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
FEV1 at time points 30 min, 1, 2 and 4 h post-dose

Trial Locations

Locations (5)

North Carolina Clinical Research; 🇺🇸 Raleigh, North Carolina, United States

Colorado Allergy and Asthma Centres, P.C.; 🇺🇸 Denver, Colorado, United States

Northeast Medical Research Associates, Inc.; 🇺🇸 North Dartmouth, Massachusetts, United States

Clinical Research Institute; 🇺🇸 Minneapolis, Minnesota, United States

The Clinical Research Center; 🇺🇸 St Louis, Missouri, United States