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
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
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
Sites / Locations
- 1249.1.32003 Boehringer Ingelheim Investigational Site
- 1249.1.32001 Boehringer Ingelheim Investigational Site
- 1249.1.32002 Boehringer Ingelheim Investigational Site
- 1249.1.32004 Boehringer Ingelheim Investigational Site
- 1249.1.45001 Boehringer Ingelheim Investigational Site
- 1249.1.49001 Boehringer Ingelheim Investigational Site
- 1249.1.49002 Boehringer Ingelheim Investigational Site
- 1249.1.49003 Boehringer Ingelheim Investigational Site
- 1249.1.31002 Boehringer Ingelheim Investigational Site
- 1249.1.31003 Boehringer Ingelheim Investigational Site
- 1249.1.31001 Boehringer Ingelheim Investigational Site
- 1249.1.31004 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
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
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
No
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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