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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01126437
Other study ID # 205.452
Secondary ID 2009-015713-51
Status Completed
Phase Phase 3
First received May 6, 2010
Last updated May 20, 2014
Start date May 2010
Est. completion date May 2013
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Clinical Trial 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.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
tiotropium 18 mcg
HandiHaler
tiotropium 1.25 mcg (2 actuations/day)
soft mist inhaler 2 actuations=2 puffs/day
tiotropium 2.5 mcg (2 actuations/day)
soft mist inhaler (2 actuations=2 puffs/day)

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Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Colombia,  Croatia,  Denmark,  Finland,  France,  Georgia,  Germany,  Greece,  Guatemala,  Hungary,  India,  Ireland,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Panama,  Peru,  Philippines,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Tunisia,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to All-Cause Mortality Number of patients with all-cause mortality Up to 3 years No
Primary Time to First 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).
"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.
Up to 3 years No
Secondary Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients) Trough forced expiratory volume in one second (FEV1) over 120 weeks (in a substudy of 1370 patients) Up to 3 years No
Secondary Number of COPD Exacerbations 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). Up to 3 years No
Secondary Time to First Hospitalization Associated With COPD Exacerbation The results presented below are for the patients with hospitalizations due to COPD exacerbations. Up to 3 years No
Secondary Number of Hospitalizations Associated With COPD Exacerbation Total number of hospitalizations associated with COPD exacerbation. Up to 3 years No
Secondary Time to First Moderate to Severe COPD Exacerbation 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.
Up to 3 years No
Secondary Time to Onset of First Major Adverse Cardiovascular Event (MACE) 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. Up to 3 years No
Secondary Time to Death From Major Adverse Cardiovascular Event (MACE) The results presented below are number of patients with death from MACE. Up to 3 years No
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