Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)
A Randomised, Double-blind, Double-dummy, Placebo-controlled, Crossover 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)
1 other identifier
interventional
76
2 countries
2
Brief Summary
Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 24, 2006
CompletedFirst Posted
Study publicly available on registry
January 25, 2006
CompletedNovember 1, 2013
October 1, 2013
11 months
January 24, 2006
October 31, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).
Secondary Outcomes (11)
Trough forced vital capacity (FVC) response after 4 weeks (change from baseline)
baseline until week 28
Peak response (FEV1 and FVC) to first dose
within 3 hours to first dose
Peak response (FEV1 and FVC) after 4 weeks
within 3 hours after 4 weeks
FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks
after 4 weeks
FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks
after first dose and after 4 weeks
- +6 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of COPD
- FEV1 \< 60% predicted
- FEV1 \< 70% of FVC
- Smoking history of 10 pack-years
You may not qualify if:
- Significant other disease than COPD
- Recent history of MI (1 year or less)
- Cardiac arrhythmia requiring drug therapy
- History of asthma, allergic rhinitis or eosinophil count \> 600 mm3
- Symptomatic prostatic hypertrophy or bladder neck obstruction
- Known narrow-angle glaucoma
- Abnormal baseline hematology, blood chemistry or urinalysis
- History of cancer within last 5 years
- Life-threatening pulmonary obstruction
- Cystic fibrosis or bronchiectasis
- Tuberculosis
- Pulmonary resection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Boehringer Ingelheim Investigational Site
Study Chairs Or Principal Investigators, Belgium
Boehringer Ingelheim Investigational Site
Study Chairs Or Principal Investigators, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim KG
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 24, 2006
First Posted
January 25, 2006
Study Start
August 1, 2002
Primary Completion
July 1, 2003
Last Updated
November 1, 2013
Record last verified: 2013-10