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Bosentan for Poorly Controlled Asthma

This study has been terminated.
(Difficulty in recruitment.)
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Mark Metersky, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00815347
First received: December 29, 2008
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
Results First Received: June 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: bosentan
Drug: 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
All Study Participants Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.

Participant Flow:   Overall Study
    All Study Participants  
STARTED     11  
COMPLETED     7  
NOT COMPLETED     4  



  Baseline Characteristics
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Reporting Groups
  Description
All Study Participants Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
 		  12  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     1  
Gender  
[units: participants]
 		 
Female     9  
Male     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in FEV1   [ Time Frame: 1, 2, 4 hours after dosing ]
  Show Outcome Measure 1

2.  Primary:   Peak Flow   [ Time Frame: last 7 days of each dosing period ]
  Show Outcome Measure 2

3.  Primary:   Symptom Scores   [ Time Frame: Last 7 days of each dosing period ]
  Show Outcome Measure 3

4.  Secondary:   FEV1   [ Time Frame: end of dosing period ]
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5.  Secondary:   Rescue Beta-agonist   [ Time Frame: end of each dosing period ]
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6.  Secondary:   Asthma Control Test Questionnaire   [ Time Frame: end of each dosing period ]
  Show Outcome Measure 6

7.  Other Pre-specified:   Requirement for Escalation of Controller Medication.   [ Time Frame: 17 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Other Pre-specified:   Requirement for Urgent Medical Care for Asthma.   [ Time Frame: 17 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Other Pre-specified:   Ability to Taper Systemic Steroids Among Those Patients Who Are on Systemic Steroids at Study Entry.   [ Time Frame: 17 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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 NOT 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.


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
Early termination leading to small numbers of subjects analyzed.  


Results Point of Contact:  
Name/Title: MArk Metersky, MD
Organization: University of Connecticut Health Center
phone: 860-679-3582
e-mail: metersky@nso.uchc.edu


No publications provided


Responsible Party: Mark Metersky, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00815347     History of Changes
Other Study ID Numbers: 08-287-1, 001
Study First Received: December 29, 2008
Results First Received: June 16, 2012
Last Updated: September 28, 2012
Health Authority: United States: Food and Drug Administration