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Bosentan for Poorly Controlled Asthma

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ClinicalTrials.gov Identifier: NCT00815347
Recruitment Status : Terminated (Difficulty in recruitment.)
First Posted : December 30, 2008
Results First Posted : October 1, 2012
Last Update Posted : October 1, 2012
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Mark Metersky, UConn Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: bosentan
Drug: placebo
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 11
Completed 7
Not Completed 4
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  91.7%
>=65 years
1
   8.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
9
  75.0%
Male
3
  25.0%
1.Primary Outcome
Title Change in FEV1
Hide Description [Not Specified]
Time Frame 1, 2, 4 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Bosentan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 7
Mean (95% Confidence Interval)
Unit of Measure: liters
1 hour FEV1
1.50 [1] 
(NA to NA)
1.57 [1] 
(NA to NA)
2 hour FEV1
1.53 [1] 
(NA to NA)
1.57 [1] 
(NA to NA)
4 hour FEV1
1.50 [1] 
(NA to NA)
1.51 [1] 
(NA to NA)
[1]
Confidence interval not evaluable due to small number of participants
2.Primary Outcome
Title Peak Flow
Hide Description [Not Specified]
Time Frame last 7 days of each dosing period
Hide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed, study terminated early
Arm/Group Title Placebo Bosentan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Symptom Scores
Hide Description Symptom score could range from a minimum of 7 (no symptoms) to 35 (severe symptoms)
Time Frame Last 7 days of each dosing period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Bosentan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: score on a scale
19.7  (7.6) 20.1  (3.5)
4.Secondary Outcome
Title FEV1
Hide Description [Not Specified]
Time Frame end of dosing period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Bosentan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: liters
1.46  (0.4) 1.49  (0.47)
5.Secondary Outcome
Title Rescue Beta-agonist
Hide Description [Not Specified]
Time Frame end of each dosing period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Bosentan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: puffs of rescue inhaler
34.6  (19.2) 36.3  (18.9)
6.Secondary Outcome
Title Asthma Control Test Questionnaire
Hide Description Patient reported outcome minimum 5 (no symptoms) maximum 25 (severe symptoms)
Time Frame end of each dosing period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Bosentan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: scores on a scale
13.6  (5.0) 13.1  (3.9)
7.Other Pre-specified Outcome
Title Requirement for Escalation of Controller Medication.
Hide Description [Not Specified]
Time Frame 17 weeks
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Requirement for Urgent Medical Care for Asthma.
Hide Description [Not Specified]
Time Frame 17 weeks
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Ability to Taper Systemic Steroids Among Those Patients Who Are on Systemic Steroids at Study Entry.
Hide Description [Not Specified]
Time Frame 17 weeks
Outcome Measure Data Not Reported
Time Frame 17 weeks
Adverse Event Reporting Description Non-Serious Adverse Events were not Analyzed, Terminated Study
 
Arm/Group Title Bosentan Placebo
Hide Arm/Group Description Bosentan 62.5mg orally, twice a day for four weeks. Placebo orally, twice a day for four weeks.
All-Cause Mortality
Bosentan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bosentan Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      1/11 (9.09%)    
Hepatobiliary disorders     
Abnormal liver function blood tests  [1]  0/9 (0.00%)  0 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
[1]
Very elevated liver function tests, while receiving placebo
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bosentan Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Early termination leading to small numbers of subjects analyzed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: MArk Metersky, MD
Organization: University of Connecticut Health Center
Phone: 860-679-3582
EMail: metersky@nso.uchc.edu
Layout table for additonal information
Responsible Party: Mark Metersky, UConn Health
ClinicalTrials.gov Identifier: NCT00815347     History of Changes
Other Study ID Numbers: 08-287-1
001
First Submitted: December 29, 2008
First Posted: December 30, 2008
Results First Submitted: June 16, 2012
Results First Posted: October 1, 2012
Last Update Posted: October 1, 2012