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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Ciclesonide low; Drug: Ciclesonide high; Drug: Placebo; Drug: Salmeterol; Drug: Tiotropium; Drug: Fluticasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00535366

1249.1

Eudract2007-003169-42

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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103 participants in 4 patient groups, including a placebo group

Tiotropium+salmeterol+fluticasone

Experimental group

Treatment:

Drug: Tiotropium

Drug: Salmeterol

Drug: Fluticasone

Tiotropium+salmeterol+ciclesonide low

Experimental group

Treatment:

Drug: Tiotropium

Drug: Ciclesonide low

Drug: Salmeterol

Tiotropium+salmeterol+ciclesonide high

Experimental group

Treatment:

Drug: Tiotropium

Drug: Ciclesonide high

Drug: Salmeterol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Tiotropium

Drug: Salmeterol