Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT01126437
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17183
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tiotropium 2.5 mcg and placebo tiotropium 1.25 mcg (2 actuations/day) Patients receive one of the active tiotropium arms daily tiotropium 18 mcg and placebo tiotropium 18 mcg Patients receive one of the active tiotropium arms daily tiotropium 5 mcg and placebo tiotropium 2.5 mcg (2 actuations/day) Patients receive one of the active tiotropium arms daily
- Primary Outcome Measures
Name Time Method Time to All-Cause Mortality Up to 3 years Number of patients with all-cause mortality
Time to First COPD Exacerbation Up to 3 years Defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).
"Onset of exacerbation" was defined by the onset of first recorded symptom. The "end of exacerbation" was decided by the investigator based on clinical judgement.
Exacerbations were classified as follows:
Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization.
- Secondary Outcome Measures
Name Time Method Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients) Up to 3 years Trough forced expiratory volume in one second (FEV1) over 120 weeks (in a substudy of 1370 patients)
Number of COPD Exacerbations Up to 3 years The number of COPD exacerbations. COPD exacerbation defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).
Time to First Hospitalization Associated With COPD Exacerbation Up to 3 years The results presented below are for the patients with hospitalizations due to COPD exacerbations.
Number of Hospitalizations Associated With COPD Exacerbation Up to 3 years Total number of hospitalizations associated with COPD exacerbation.
Time to First Moderate to Severe COPD Exacerbation Up to 3 years COPD exacerbation defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).
Exacerbations classified as follows:
Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization.
Results presented below are number of patients with moderate to severe exacerbations.Time to Onset of First Major Adverse Cardiovascular Event (MACE) Up to 3 years Time to onset of first major adverse cardiovascular event (MACE). MACE was defined as: Fatal event in the system organ classes of cardiac and vascular disorders, Preferred terms: sudden death, cardiac death, sudden cardiac death, Outcome events of myocardial infarction (serious and non-serious), Outcome events of stroke (serious and non-serious) and Outcome events of TIA (serious and non-serious). The results presented below are for the number of patients with MACE.
Time to Death From Major Adverse Cardiovascular Event (MACE) Up to 3 years The results presented below are number of patients with death from MACE.
Trial Locations
- Locations (1191)
205.452.01107 Boehringer Ingelheim Investigational Site
🇺🇸Athens, Alabama, United States
205.452.01023 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
205.452.01035 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
205.452.01052 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
205.452.01219 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
205.452.01227 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
205.452.01280 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
205.452.01198 Boehringer Ingelheim Investigational Site
🇺🇸Florence, Alabama, United States
205.452.01244 Boehringer Ingelheim Investigational Site
🇺🇸Mobile, Alabama, United States
205.452.01041 Boehringer Ingelheim Investigational Site
🇺🇸Montgomery, Alabama, United States
Scroll for more (1181 remaining)205.452.01107 Boehringer Ingelheim Investigational Site🇺🇸Athens, Alabama, United States