Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tiotropium
HandiHaler
Respimat SMI
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Sites / Locations
- Division of Pulmonary and Critical Care Medicine
- Boehringer Ingelheim Investigational Site
- San Jose Clinical Research
- Boehringer Ingelheim Investigational Site
- National Jewish Medical and Research Center
- LSU MC-Sheveport
- Minisota Lung Center
- Wake Forest University School of Medicine
- Spartanburg Medical Research
- Boehringer Ingelheim Investigational Site
- Montreal Chest Institute - McGill University Health Centre
Outcomes
Primary Outcome Measures
Trough FEV1 response determined at the end of each 4-week period of randomised treatment.
Secondary Outcome Measures
Tiotropium plasma concentration data and urinary excretion data
Trough forced vital capacity (FVC) response
Peak response (FEV1 and FVC)
FEV1 AUC 0-12h and FVC AUC 0-12h response
FEV1 AUC 0-3h and FVC AUC 0-3h response
Individual FEV1and FVC measurements
pre-dose morning and evening peak expiratory flow rate (PEFR)
Number of occasions of rescue therapy used
Median time to onset of therapeutic response after first dose (FEV1)
Number of patients with 15% response above baseline for each treatment at each time point after first dose and after 4 weeks
Full Information
NCT ID
NCT00239447
First Posted
October 14, 2005
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT00239447
Brief Title
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD
Official Title
Efficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler
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 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
131 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Type
Device
Intervention Name(s)
HandiHaler
Intervention Type
Device
Intervention Name(s)
Respimat SMI
Primary Outcome Measure Information:
Title
Trough FEV1 response determined at the end of each 4-week period of randomised treatment.
Time Frame
at the end of each 4-week period
Secondary Outcome Measure Information:
Title
Tiotropium plasma concentration data and urinary excretion data
Time Frame
at the end of each 4-week period
Title
Trough forced vital capacity (FVC) response
Time Frame
after 4 weeks
Title
Peak response (FEV1 and FVC)
Time Frame
within 3 hours after first dose, after 4 weeks
Title
FEV1 AUC 0-12h and FVC AUC 0-12h response
Time Frame
after 4 weeks
Title
FEV1 AUC 0-3h and FVC AUC 0-3h response
Time Frame
after the first dose, after 4 weeks
Title
Individual FEV1and FVC measurements
Time Frame
during study course of 28 weeks
Title
pre-dose morning and evening peak expiratory flow rate (PEFR)
Time Frame
during study course of 28 weeks
Title
Number of occasions of rescue therapy used
Time Frame
during study course of 28 weeks
Title
Median time to onset of therapeutic response after first dose (FEV1)
Time Frame
after first dose and after 4 weeks
Title
Number of patients with 15% response above baseline for each treatment at each time point after first dose and after 4 weeks
Time Frame
up to 28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim BV/Alkmaar
Official's Role
Study Chair
Facility Information:
Facility Name
Division of Pulmonary and Critical Care Medicine
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
San Jose Clinical Research
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206-2762
Country
United States
Facility Name
LSU MC-Sheveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Minisota Lung Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Montreal Chest Institute - McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.249_U05-1949.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.249_literature.pdf
Description
Related Info
Learn more about this trial
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD
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