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

NCT ID: NCT00396604

Last Updated: 2011-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-01-31

Brief Summary

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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

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Conditions

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Pulmonary Disease, Chronic Obstructive COPD Lung Diseases, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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indacaterol maleate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: PRINCIPAL_INVESTIGATOR

Novartis

Locations

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Novartis

Vilvoorde, , Belgium

Site Status

Countries

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Belgium

References

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Hosoe M, Woessner R, Matsushima S, Lawrence D, Kramer B. Efficacy, safety and pharmacokinetics of indacaterol in Caucasian and Japanese patients with chronic obstructive pulmonary disease: a comparison of data from two randomized, placebo-controlled studies. Clin Drug Investig. 2011;31(4):247-55. doi: 10.2165/11586520-000000000-00000.

Reference Type DERIVED
PMID: 21184620 (View on PubMed)

Other Identifiers

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CQAB149B2212

Identifier Type: -

Identifier Source: org_study_id