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Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients.

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00563381
First received: November 22, 2007
Last updated: November 27, 2013
Last verified: July 2012
Results First Received: March 29, 2011  
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 bromide
Drug: Salmeterol
Drug: Placebo Salmeterol
Drug: Placebo Tiotropium

  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
There were 8 patients (4:4 on Tiotropium and Salmeterol respectively) randomized but not treated

Reporting Groups
  Description
Tiotropium Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily

Participant Flow:   Overall Study
    Tiotropium   Salmeterol
STARTED   3707 [1]   3669 [1] 
COMPLETED   3122 [2]   3021 [2] 
NOT COMPLETED   585   648 
Adverse Event                264                292 
Protocol Violation                66                74 
Lost to Follow-up                7                15 
Withdrawal by Subject                192                209 
Lack of Efficacy                32                24 
Individual different reasons                24                34 
[1] Started treatment
[2] Completed treatment



  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.
No text entered.

Reporting Groups
  Description
Tiotropium Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
Salmeterol Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
Total Total of all reporting groups

Baseline Measures
   Tiotropium   Salmeterol   Total 
Overall Participants Analyzed 
[Units: Participants]
 3707   3669   7376 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.9  (9.0)   62.8  (9.0)   62.9  (9.0) 
Gender 
[Units: Participants]
     
Female   948   922   1870 
Male   2759   2747   5506 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   5   3   8 
Black   9   9   18 
White   3693   3657   7350 


  Outcome Measures
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1.  Primary:   First Occurrence of (Moderate or Severe) COPD Exacerbation   [ Time Frame: 52 weeks ]

2.  Secondary:   COPD Exacerbations Per Patient-year Leading to Hospitalisation   [ Time Frame: 52 weeks ]

3.  Secondary:   Number of Participants With at Least One COPD Exacerbation   [ Time Frame: 52 weeks ]

4.  Secondary:   COPD Exacerbations Per Patient-year   [ Time Frame: 52 weeks ]

5.  Secondary:   First Occurrence of COPD Exacerbation Leading to Hospitalization   [ Time Frame: 52 weeks ]

6.  Secondary:   Number of Participants With at Least One COPD Exacerbation Leading to Hospitalisation   [ Time Frame: 52 weeks ]

7.  Secondary:   Occurrence of Premature Discontinuation of Trial Medication   [ Time Frame: 52 weeks ]

8.  Secondary:   Number of Participants With Premature Discontinuation of Trial Medication   [ Time Frame: 52 weeks ]

9.  Secondary:   First Occurrence of COPD Exacerbation or Discontinuation of Trial Medication Because of Worsening of Underlying Disease, Whichever Comes First   [ Time Frame: 52 weeks ]

10.  Secondary:   First Occurrence of COPD Exacerbations Treated With Systemic Steroids   [ Time Frame: 52 weeks ]

11.  Secondary:   First Occurrence of COPD Exacerbations Treated With Antibiotics   [ Time Frame: 52 weeks ]

12.  Secondary:   First Occurrence of COPD Exacerbations Treated With Systemic Steroids and Antibiotics   [ Time Frame: 52 weeks ]

13.  Secondary:   COPD Exacerbations Treated With Systemic Steroids Per Patient-year   [ Time Frame: 52 weeks ]

14.  Secondary:   COPD Exacerbations Treated With Antibiotics Per Patient-year   [ Time Frame: 52 weeks ]

15.  Secondary:   COPD Exacerbations Treated With Systemic Steroids and Antibiotics Per Patient-year   [ Time Frame: 52 weeks ]

16.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 1   [ Time Frame: 16 weeks ]

17.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 2   [ Time Frame: 16 weeks ]

18.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 3   [ Time Frame: 16 weeks ]

19.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 4   [ Time Frame: 16 weeks ]

20.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 5   [ Time Frame: 16 weeks ]

21.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 6   [ Time Frame: 16 weeks ]

22.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 7   [ Time Frame: 16 weeks ]

23.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 8   [ Time Frame: 16 weeks ]

24.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 9   [ Time Frame: 16 weeks ]

25.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 10   [ Time Frame: 16 weeks ]

26.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 11   [ Time Frame: 16 weeks ]

27.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 12   [ Time Frame: 16 weeks ]

28.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 13   [ Time Frame: 16 weeks ]

29.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 14   [ Time Frame: 16 weeks ]

30.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 15   [ Time Frame: 16 weeks ]

31.  Secondary:   Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 16   [ Time Frame: 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00563381     History of Changes
Other Study ID Numbers: 205.389
EUDRACT2007-001840-33
Study First Received: November 22, 2007
Results First Received: March 29, 2011
Last Updated: November 27, 2013
Health Authority: Austria: AGES, Oesterreichische Agentur für Gesundheit und Ernaehrungssicherheit
Belgium: AFMPS - Agence Fédérale des Médicaments et des Produits des Santé
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Denmark: The Danish Medicines Agency
Finland: Finnish Medicines Agency
France: AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé)
Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)
Great Britain: Medicines and Heathcare Products Regulatory Agency
Hungary: ORSZÁGOS GYÓGYSZERÉSZETI INTÉZET
Israel: not applicable
Italy: COMITATO ETICO DELLA PROVINCIA DI FERRARA
Latvia: State Agency of Medicines
Lithuania: Lithuanian Bioethics Committee
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Poland: Agency for Registration of Medicinal Products, Medical Devices & Biocides
Portugal: INFARMED - Instituto Nacional da Farmácia e do Medicamento
Romania: National Medicines Agency
Russia: Federal Service On Surveillance In Healthcare And Social Development Of Russian Federation
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Turkey: Ministery Of Health / Central Ethics Committee
Ukraine: The State Pharmacological Center of Ministry of Health of Ukraine
United States: Food and Drug Administration