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

COPD 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 vs. Placebo in Patients With Moderate to Severe COPD.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396604
• Other study ID #: CQAB149B2212
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 6, 2006
• Last updated: October 24, 2011
• Start date: October 2006
• Est. completion date: January 2007

Study information

• Verified date: October 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Pharmaceutical Inspectorate
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Chronic Disease
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• indacaterol maleate

Locations

Country	Name	City	State
Belgium	Novartis	Vilvoorde

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Belgium, 

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 4hours post-dose
Secondary	Percent change in FEV1 at time points 30 min, 1, 2 and 4 hours, 23 hours 10min and 23 hours 45 min post dose
Secondary	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
Secondary	Standardized FEV1 area under the curve (AUC) between baseline and 4 hours