Tiotropium Respimat Pharmacokinetic Study in COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01222533
First received: October 15, 2010
Last updated: May 7, 2014
Last verified: August 2013
Results First Received: November 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: Tiotropium medium
Drug: Tiotropium low
Drug: Tiotropium high
Drug: Tiotropium 18mcg
Drug: Tiotropium placebo

  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
No text entered.

Reporting Groups
  Description
Study Overall Total number of patients randomised and treated in the study. This was a randomised 5-period crossover trial. 154 patients were randomised to one of 15 sequences and treated. The trial was blinded within the 4 Respimat treatments, but open for the HandiHaler treatment. Each of the 5 treatment regimens was taken for 4 weeks without washouts between treatment periods.

Participant Flow:   Overall Study
    Study Overall  
STARTED     154 [1]
Received Placebo     147  
Received Tio R1.25     147  
Received Tio R2.5     145  
Received Tio R5     150  
Received Tio HH18     146  
COMPLETED     140 [2]
NOT COMPLETED     14  
Adverse Event                 5  
Withdrawal by Subject                 5  
Unknown                 4  
[1] Entered and treated.
[2] Completed planned observation time (week 21)



  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
Study Overall Total number of patients randomised and treated in the study.

Baseline Measures
    Study Overall  
Number of Participants  
[units: participants]
  154  
Age  
[units: years]
Mean ± Standard Deviation
  63.1  ± 7.8  
Gender  
[units: Number¬†of¬†participants]
 
Female     37  
Male     117  



  Outcome Measures
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1.  Primary:   Maximum Plasma Concentration at Steady-state (Cmax,ss)   [ Time Frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing. ]

2.  Primary:   Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss)   [ Time Frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing. ]

3.  Secondary:   Trough Forced Expiratory Volume in One Second (FEV1) at the End of Each Treatment Period   [ Time Frame: 4 weeks ]

4.  Secondary:   FEV1 Area Under the Curve 0 to 6 Hours (AUC0-6h) at the End of Each Treatment Period   [ Time Frame: 4 weeks ]

5.  Secondary:   FEV1 Area Under the Curve 0 to 3 Hours (AUC0-3h) at the End of Each Treatment Period   [ Time Frame: 4 weeks ]

6.  Secondary:   Trough Forced Vital Capacity (FVC) at the End of Each Treatment Period   [ Time Frame: 4 weeks ]

7.  Secondary:   FVC AUC0-6h at the End of Each Treatment Period   [ Time Frame: 4 weeks ]

8.  Secondary:   FVC AUC0-3h at the End of Each Treatment Period   [ Time Frame: 4 weeks ]

9.  Secondary:   FEV1 at Each Planned Time at the End of Each Treatment Period   [ Time Frame: 4 weeks ]

10.  Secondary:   FVC at Each Planned Time at the End of Each Treatment Period   [ Time Frame: 4 weeks ]

11.  Secondary:   Area Under the Curve 0 to 1 Hour at Steady-state (AUC0-1h,ss)   [ Time Frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing. ]

12.  Secondary:   Time to Maximum Plasma Concentration at Steady-state (Tmax,ss)   [ Time Frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing. ]

13.  Secondary:   Amount of Drug Eliminated in Urine at Steady-state (Ae0-6h,ss)   [ Time Frame: Based on urine sampling for PK assessments done at 4 weeks in the following intervals: -1 to 0 hour (h), 0 to 2 h and 2 to 6 h post-dosing. ]

14.  Secondary:   Pre-dose Plasma Concentration at Steady-state (Cpre,ss)   [ Time Frame: Based on blood sampling for PK assessments done at 4 weeks at the following time point: 5 minutes (min) before first dosing of study drug (baseline) ]

15.  Secondary:   Renal Clearance at Steady-state (CL R,0-6h,ss)   [ Time Frame: Based on blood and urine sampling for PK assessments done at 4 weeks over 6 h post dosing. ]

16.  Secondary:   Minimum Plasma Concentration at Steady-state (Cmin,ss)   [ Time Frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing. ]

17.  Other Pre-specified:   Maximum Heart Rate (HR)   [ Time Frame: 6.5 hours (including pre dose) ]

18.  Other Pre-specified:   Mean Heart Rate (HR)   [ Time Frame: 6.5 hours (including pre dose) ]

19.  Other Pre-specified:   SVPB Total   [ Time Frame: 6.5 hours (including pre dose) ]

20.  Other Pre-specified:   SVPB Runs   [ Time Frame: 6.5 hours (including pre dose) ]

21.  Other Pre-specified:   SVPB Pairs   [ Time Frame: 6.5 hours (including pre dose) ]

22.  Other Pre-specified:   SVPB Singles   [ Time Frame: 6.5 hours (including pre dose) ]

23.  Other Pre-specified:   VPB Total   [ Time Frame: 6.5 hours (including pre dose) ]

24.  Other Pre-specified:   VPB Runs   [ Time Frame: 6.5 hours (including pre dose) ]

25.  Other Pre-specified:   VPB Pairs   [ Time Frame: 6.5 hours (including pre dose) ]

26.  Other Pre-specified:   VPB Singles   [ Time Frame: 6.5 hours (including pre dose) ]


  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
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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:
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


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01222533     History of Changes
Other Study ID Numbers: 205.458, 2009-016251-21
Study First Received: October 15, 2010
Results First Received: November 13, 2012
Last Updated: May 7, 2014
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Central Committee Research Involving Human Subjects