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Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD

NCT ID: NCT00535366

Last Updated: 2014-05-30

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

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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This efficacy and safety study compares four different combinations of blinded inhaled steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic obstructive pulmonary disease (COPD). The primary objective is the effect on lung function parameters.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Tiotropium+salmeterol+fluticasone

Group Type EXPERIMENTAL

Tiotropium

Intervention Type DRUG

Oral inhalation by HandiHaler® device

Salmeterol

Intervention Type DRUG

Oral inhalation from Diskus®

Fluticasone

Intervention Type DRUG

Oral inhalation from metered dose inhaler (MDI)

Tiotropium+salmeterol+ciclesonide low

Group Type EXPERIMENTAL

Tiotropium

Intervention Type DRUG

Oral inhalation by HandiHaler® device

Salmeterol

Intervention Type DRUG

Oral inhalation from Diskus®

Ciclesonide low

Intervention Type DRUG

Oral inhalation from MDI

Tiotropium+salmeterol+ciclesonide high

Group Type EXPERIMENTAL

Tiotropium

Intervention Type DRUG

Oral inhalation by HandiHaler® device

Salmeterol

Intervention Type DRUG

Oral inhalation from Diskus®

Ciclesonide high

Intervention Type DRUG

Oral inhalation from MDI

Placebo

Group Type PLACEBO_COMPARATOR

Tiotropium

Intervention Type DRUG

Oral inhalation by HandiHaler® device

Salmeterol

Intervention Type DRUG

Oral inhalation from Diskus®

Placebo

Intervention Type DRUG

Oral inhalation from MDI

Interventions

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Tiotropium

Oral inhalation by HandiHaler® device

Intervention Type DRUG

Salmeterol

Oral inhalation from Diskus®

Intervention Type DRUG

Fluticasone

Oral inhalation from metered dose inhaler (MDI)

Intervention Type DRUG

Ciclesonide low

Oral inhalation from MDI

Intervention Type DRUG

Ciclesonide high

Oral inhalation from MDI

Intervention Type DRUG

Placebo

Oral inhalation from MDI

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Relatively stable, moderate to severe COPD
* Male or female patients 40 years of age or older.
* Current or ex-smokers with a smoking history of more than 10 pack years

Exclusion Criteria

* Other significant disease that can influence the study results or be a safety risk for the patient
* Other medication that can influence the study results
* Hypersensitivity to the study medication
* Patients with unstable COPD
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1249.1.32003 Boehringer Ingelheim Investigational Site

Genk, , Belgium

Site Status

1249.1.32001 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

Site Status

1249.1.32002 Boehringer Ingelheim Investigational Site

Hasselt, , Belgium

Site Status

1249.1.32004 Boehringer Ingelheim Investigational Site

Ostend, , Belgium

Site Status

1249.1.45001 Boehringer Ingelheim Investigational Site

Aarhus C, , Denmark

Site Status

1249.1.49001 Boehringer Ingelheim Investigational Site

Großhansdorf, , Germany

Site Status

1249.1.49002 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

Site Status

1249.1.49003 Boehringer Ingelheim Investigational Site

Weinheim, , Germany

Site Status

1249.1.31002 Boehringer Ingelheim Investigational Site

Eindhoven, , Netherlands

Site Status

1249.1.31003 Boehringer Ingelheim Investigational Site

Harderwijk, , Netherlands

Site Status

1249.1.31001 Boehringer Ingelheim Investigational Site

Heerlen, , Netherlands

Site Status

1249.1.31004 Boehringer Ingelheim Investigational Site

Veldhoven, , Netherlands

Site Status

Countries

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Belgium Denmark Germany Netherlands

Other Identifiers

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Eudract2007-003169-42

Identifier Type: -

Identifier Source: secondary_id

1249.1

Identifier Type: -

Identifier Source: org_study_id

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