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 Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00563381

First received: November 22, 2007

Last updated: July 10, 2012

Last verified: July 2012

History of Changes

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
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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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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
Number of Participants [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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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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 ]

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10. Secondary:

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

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11. Secondary:

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

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

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

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15. Secondary:

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

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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 ]

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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 ]

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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 ]

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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 ]

Show Outcome Measure 19

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 ]

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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 ]

Show Outcome Measure 21

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 ]

Show Outcome Measure 22

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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Limitations and Caveats

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.

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

No publications provided by Boehringer Ingelheim Pharmaceuticals

Publications automatically indexed to this study:

Rabe KF, Fabbri LM, Vogelmeier C, Kögler H, Schmidt H, Beeh KM, Glaab T. Seasonal distribution of COPD exacerbations in the prevention of exacerbations with tiotropium in COPD trial. Chest. 2013 Mar;143(3):711-9.

Vogelmeier C, Hederer B, Glaab T, Schmidt H, Rutten-van Mölken MP, Beeh KM, Rabe KF, Fabbri LM; POET-COPD Investigators. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med. 2011 Mar 24;364(12):1093-103.

Beeh KM, Hederer B, Glaab T, Müller A, Rutten-van Moelken M, Kesten S, Vogelmeier C. Study design considerations in a large COPD trial comparing effects of tiotropium with salmeterol on exacerbations. Int J Chron Obstruct Pulmon Dis. 2009;4:119-25. Epub 2009 Apr 15.

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:	July 10, 2012
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

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