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Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01126437
First received: May 6, 2010
Last updated: May 20, 2014
Last verified: May 2014
History of Changes
Results First Received: May 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: tiotropium 18 mcg
Drug: tiotropium 1.25 mcg (2 actuations/day)
Drug: tiotropium 2.5 mcg (2 actuations/day)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This table summarizes study treatment disposition and reasons for discontinuation of study medication. Deaths that caused discontinuation from trial medications are included in AEs. Lost to follow−up indicates status at time of discontinuation of trial medication. Vital status was ascertained for 99.7% of patients.

Reporting Groups
  Description
Tiotropium 2.5 mcg and Placebo

Patients receive one of the active tiotropium arms daily

tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day
Tiotropium 5 mcg and Placebo

Patients receive one of the active tiotropium arms daily

tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)
Tiotropium 18 mcg and Placebo

Patients receive one of the active tiotropium arms daily

tiotropium 18 mcg: HandiHaler

Participant Flow:   Overall Study
    Tiotropium 2.5 mcg and Placebo     Tiotropium 5 mcg and Placebo     Tiotropium 18 mcg and Placebo  
STARTED     5741     5729     5713  
COMPLETED     4400 [1]   4399 [1]   4400 [1]
NOT COMPLETED     1341     1330     1313  
Not treated                 11                 18                 19  
Sites with data irregularities/fraud                 6                 6                 7  
Adverse Event                 602                 606                 635  
Lack of Efficacy                 65                 60                 59  
Protocol Violation                 64                 66                 41  
Lost to Follow-up                 52                 63                 55  
Withdrawal by Subject                 331                 335                 319  
Other reason not specified                 210                 176                 178  
[1] See Pre-Assignment Details above for comments.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set (TS): This analysis set included all randomized subjects without data irregularities who were documented to have taken at least one dose of investigational treatment.

Reporting Groups
  Description
Tiotropium 2.5 mcg and Placebo

Patients receive one of the active tiotropium arms daily

tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day
Tiotropium 5 mcg and Placebo

Patients receive one of the active tiotropium arms daily

tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)
Tiotropium 18 mcg and Placebo

Patients receive one of the active tiotropium arms daily

tiotropium 18 mcg: HandiHaler
Total Total of all reporting groups

Baseline Measures
    Tiotropium 2.5 mcg and Placebo     Tiotropium 5 mcg and Placebo     Tiotropium 18 mcg and Placebo     Total  
Number of Participants  
[units: participants]
 		  5724     5705     5687     17116  
Age  
[units: years]
Mean (Standard Deviation) 		  65.1  (9.1)     64.9  (9.1)     65.0  (9.0)     65.0  (9.1)  
Gender  
[units: participants]
 		       
Female     1656     1571     1652     4879  
Male     4068     4134     4035     12237  



  Outcome Measures
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1.  Primary:   Time to All-Cause Mortality   [ Time Frame: Up to 3 years ]
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2.  Primary:   Time to First COPD Exacerbation   [ Time Frame: Up to 3 years ]
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3.  Secondary:   Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients)   [ Time Frame: Up to 3 years ]
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4.  Secondary:   Number of COPD Exacerbations   [ Time Frame: Up to 3 years ]
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5.  Secondary:   Time to First Hospitalization Associated With COPD Exacerbation   [ Time Frame: Up to 3 years ]
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6.  Secondary:   Number of Hospitalizations Associated With COPD Exacerbation   [ Time Frame: Up to 3 years ]
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7.  Secondary:   Time to First Moderate to Severe COPD Exacerbation   [ Time Frame: Up to 3 years ]
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8.  Secondary:   Time to Onset of First Major Adverse Cardiovascular Event (MACE)   [ Time Frame: Up to 3 years ]
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9.  Secondary:   Time to Death From Major Adverse Cardiovascular Event (MACE)   [ Time Frame: Up to 3 years ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01126437     History of Changes
Other Study ID Numbers: 205.452
2009-015713-51 ( EudraCT Number: EudraCT )
Study First Received: May 6, 2010
Results First Received: May 20, 2014
Last Updated: May 20, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
China: Food and Drug Administration
Columbia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Agency for Medicinal Product and Medical Devices
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Georgia: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Guatemala: Ministry of Public Health and Social Assistance
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ethics Committee
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Malaysia: Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: Central Committee Research Involving Human Subjects
New Zealand: Multi-Regional Ethics Committee
Norway: Norwegian Medicines Agency
Panama: Ministry of Health
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Philippines: Bureau of Food and Drugs
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan: Department of Health
Thailand: Food and Drug Administration
Tunisia: Ministry of Public Health
Turkey: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration