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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Tiotropium

Salmeterol

Fluticasone

Ciclesonide low

Ciclesonide high

Placebo

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Tiotropium+salmeterol+fluticasone

Tiotropium+salmeterol+ciclesonide low

Tiotropium+salmeterol+ciclesonide high

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Trough FEV1 response at the end of each 4 week period of randomised treatment

Secondary Outcome Measures

Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatment

All adverse events

Pulse rate and blood pressure (seated)

FEV1 and FVC morning peak response

FEV1 and FVC evening peak response

FEV1 AUC (0-3h), after 4 weeks of each blinded treatment

FEV1 AUC (12-15h) after 4 weeks of each blinded treatment

FVC AUC (0-3h) after 4 weeks of each blinded treatment

FVC AUC (12-15h) 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

Weekly mean pre-dose morning and evening peak expiratory flow (PEF)

Weekly mean number of occasions of rescue therapy used per day

Mahler Dyspnea Indices (TDI) collected at the end of each treatment period and each wash-out period

Fractional exhaled nitric oxide after 4 weeks of each blinded treatment

Full Information

NCT ID

NCT00535366

First Posted

September 25, 2007

Last Updated

May 22, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00535366

Brief Title

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

Official Title

A Randomised, Phase II, Double-Blind, Double-Dummy, Four-period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 mcg Bid, MDI), Ciclesonide (400 mcg qd, MDI), Ciclesonide (800 mcg qd, MDI) or Placebo in Free Combination With Open-Label Tiotropium (18 mcg qd, HandiHaler) and Salmeterol (50 mcg Bid, Diskus) in Patients With COPD.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tiotropium+salmeterol+fluticasone

Arm Type

Experimental

Arm Title

Tiotropium+salmeterol+ciclesonide low

Arm Type

Experimental

Arm Title

Tiotropium+salmeterol+ciclesonide high

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Tiotropium

Intervention Description

Oral inhalation by HandiHaler® device

Intervention Type

Drug

Intervention Name(s)

Salmeterol

Intervention Description

Oral inhalation from Diskus®

Intervention Type

Drug

Intervention Name(s)

Fluticasone

Intervention Description

Oral inhalation from metered dose inhaler (MDI)

Intervention Type

Drug

Intervention Name(s)

Ciclesonide low

Intervention Description

Oral inhalation from MDI

Intervention Type

Drug

Intervention Name(s)

Ciclesonide high

Intervention Description

Oral inhalation from MDI

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral inhalation from MDI

Primary Outcome Measure Information:

Title

Trough FEV1 response at the end of each 4 week period of randomised treatment

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatment

Time Frame

after 4 weeks of each blinded treatment

Title

All adverse events

Time Frame

24 weeks

Title

Pulse rate and blood pressure (seated)

Time Frame

24 weeks

Title

FEV1 and FVC morning peak response

Time Frame

day 1 and day 28 of each blinded treatment

Title

FEV1 and FVC evening peak response

Time Frame

day 1 and day 28 of each blinded treatment

Title

FEV1 AUC (0-3h), after 4 weeks of each blinded treatment

Time Frame

after 4 weeks of each blinded treatment

Title

FEV1 AUC (12-15h) after 4 weeks of each blinded treatment

Time Frame

after 4 weeks of each blinded treatment

Title

FVC AUC (0-3h) after 4 weeks of each blinded treatment

Time Frame

after 4 weeks of each blinded treatment

Title

FVC AUC (12-15h) after 4 weeks of each blinded treatment

Time Frame

after 4 weeks of each blinded treatment

Title

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

Time Frame

day 1 and day 28 of each blinded treatment

Title

Weekly mean pre-dose morning and evening peak expiratory flow (PEF)

Time Frame

28 weeks

Title

Weekly mean number of occasions of rescue therapy used per day

Time Frame

28 weeks

Title

Mahler Dyspnea Indices (TDI) collected at the end of each treatment period and each wash-out period

Time Frame

28 weeks

Title

Fractional exhaled nitric oxide after 4 weeks of each blinded treatment

Time Frame

after 4 weeks of each blinded treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1249.1.32003 Boehringer Ingelheim Investigational Site

City

Genk

Country

Belgium

Facility Name

1249.1.32001 Boehringer Ingelheim Investigational Site

City

Gent

Country

Belgium

Facility Name

1249.1.32002 Boehringer Ingelheim Investigational Site

City

Hasselt

Country

Belgium

Facility Name

1249.1.32004 Boehringer Ingelheim Investigational Site

City

Oostende

Country

Belgium

Facility Name

1249.1.45001 Boehringer Ingelheim Investigational Site

City

Aarhus C

Country

Denmark

Facility Name

1249.1.49001 Boehringer Ingelheim Investigational Site

City

Großhansdorf

Country

Germany

Facility Name

1249.1.49002 Boehringer Ingelheim Investigational Site

City

Mannheim

Country

Germany

Facility Name

1249.1.49003 Boehringer Ingelheim Investigational Site

City

Weinheim

Country

Germany

Facility Name

1249.1.31002 Boehringer Ingelheim Investigational Site

City

Eindhoven

Country

Netherlands

Facility Name

1249.1.31003 Boehringer Ingelheim Investigational Site

City

Harderwijk

Country

Netherlands

Facility Name

1249.1.31001 Boehringer Ingelheim Investigational Site

City

Heerlen

Country

Netherlands

Facility Name

1249.1.31004 Boehringer Ingelheim Investigational Site

City

Veldhoven

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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

Pulmonary Disease, Chronic Obstructive

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial