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

Phase 2

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Tiotropium; Drug: Salmeterol; Drug: Ciclesonide high; Drug: Fluticasone; Drug: Placebo; Drug: Ciclesonide low

• Registration Number: NCT00535366
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-25
• Study First Submitted QC: 2007-09-25
• Study First Posted: 2007-09-26
• Study Start: 2007-10
• Primary Completion: 2008-09
• Disposition First Submitted: 2014-04-30
• Status Verified: 2014-05
• Disposition First Submitted QC: 2014-05-22
• Last Update Submitted: 2014-05-22
• Disposition First Posted: 2014-05-30
• Last Update Posted: 2014-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tiotropium+salmeterol+ciclesonide high	Ciclesonide high	-
Placebo	Salmeterol	-
Tiotropium+salmeterol+fluticasone	Tiotropium	-
Tiotropium+salmeterol+fluticasone	Fluticasone	-
Placebo	Placebo	-
Tiotropium+salmeterol+ciclesonide low	Ciclesonide low	-
Tiotropium+salmeterol+ciclesonide high	Salmeterol	-
Tiotropium+salmeterol+ciclesonide low	Tiotropium	-
Tiotropium+salmeterol+ciclesonide low	Salmeterol	-
Tiotropium+salmeterol+fluticasone	Salmeterol	-
Tiotropium+salmeterol+ciclesonide high	Tiotropium	-
Placebo	Tiotropium	-

Primary Outcome Measures

Name	Time	Method
Trough FEV1 response at the end of each 4 week period of randomised treatment	4 weeks

Secondary Outcome Measures

Name	Time	Method
FEV1 AUC (0-3h), after 4 weeks of each blinded treatment	after 4 weeks of each blinded treatment
Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatment	after 4 weeks of each blinded treatment
All adverse events	24 weeks
Pulse rate and blood pressure (seated)	24 weeks
FEV1 and FVC morning peak response	day 1 and day 28 of each blinded treatment
FEV1 and FVC evening peak response	day 1 and day 28 of each blinded treatment
FEV1 AUC (12-15h) after 4 weeks of each blinded treatment	after 4 weeks of each blinded treatment
FVC AUC (0-3h) after 4 weeks of each blinded treatment	after 4 weeks of each blinded treatment
FVC AUC (12-15h) after 4 weeks of each blinded treatment	after 4 weeks of each blinded treatment
Trough and peak inspiratory capacity (IC) and vital capacity (VC) response in the morning of day 1 and at day 28 of each treatment period	day 1 and day 28 of each blinded treatment
Weekly mean pre-dose morning and evening peak expiratory flow (PEF)	28 weeks
Weekly mean number of occasions of rescue therapy used per day	28 weeks
Mahler Dyspnea Indices (TDI) collected at the end of each treatment period and each wash-out period	28 weeks
Fractional exhaled nitric oxide after 4 weeks of each blinded treatment	after 4 weeks of each blinded treatment

Trial Locations

Locations (12)

1249.1.32002 Boehringer Ingelheim Investigational Site; 🇧🇪 Hasselt, Belgium

1249.1.32001 Boehringer Ingelheim Investigational Site; 🇧🇪 Gent, Belgium

1249.1.31003 Boehringer Ingelheim Investigational Site; 🇳🇱 Harderwijk, Netherlands

1249.1.31002 Boehringer Ingelheim Investigational Site; 🇳🇱 Eindhoven, Netherlands

1249.1.31004 Boehringer Ingelheim Investigational Site; 🇳🇱 Veldhoven, Netherlands

1249.1.49003 Boehringer Ingelheim Investigational Site; 🇩🇪 Weinheim, Germany

1249.1.32004 Boehringer Ingelheim Investigational Site; 🇧🇪 Oostende, Belgium

1249.1.32003 Boehringer Ingelheim Investigational Site; 🇧🇪 Genk, Belgium

1249.1.49001 Boehringer Ingelheim Investigational Site; 🇩🇪 Großhansdorf, Germany

1249.1.45001 Boehringer Ingelheim Investigational Site; 🇩🇰 Aarhus C, Denmark

1249.1.49002 Boehringer Ingelheim Investigational Site; 🇩🇪 Mannheim, Germany

1249.1.31001 Boehringer Ingelheim Investigational Site; 🇳🇱 Heerlen, Netherlands