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

Phase 2

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive; COPD; Lung Diseases, Obstructive

• Registration Number: NCT00396604
• 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 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.

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: 2006-10
• Study First Submitted: 2006-11-06
• Study First Submitted QC: 2006-11-06
• Study First Posted: 2006-11-07
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-24
• Last Update Posted: 2011-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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%

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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
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

Trial Locations

Locations (1)

Novartis; 🇧🇪 Vilvoorde, Belgium