Bosentan for Poorly Controlled Asthma

• ClinicalTrials.gov Identifier: NCT00815347
• Recruitment Status: Terminated
• First Posted: December 30, 2008
• Results First Posted: October 1, 2012
• Last Update Posted: October 1, 2012
• Sponsor: UConn Health
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	All Study Participants
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

Baseline Characteristics

Arm/Group Title		All Study Participants
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
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%

Outcome Measures

1. Primary Outcome

Title	Change in FEV1
Description	[Not Specified]
Time Frame	1, 2, 4 hours after dosing

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Bosentan
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
Description	[Not Specified]
Time Frame	last 7 days of each dosing period

Outcome Measure Data

Analysis Population Description

Data not analyzed, study terminated early

Arm/Group Title	Placebo	Bosentan
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Bosentan
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
Description	[Not Specified]
Time Frame	end of dosing period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Bosentan
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
Description	[Not Specified]
Time Frame	end of each dosing period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Bosentan
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
Description	Patient reported outcome minimum 5 (no symptoms) maximum 25 (severe symptoms)
Time Frame	end of each dosing period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Bosentan
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.
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.
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.
Description	[Not Specified]
Time Frame	17 weeks

Outcome Measure Data Not Reported

Adverse Events

Time Frame	17 weeks
Adverse Event Reporting Description	Non-Serious Adverse Events were not Analyzed, Terminated Study
Arm/Group Title	Bosentan		Placebo
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	--/--		--/--
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
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

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

More Information

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

• Name/Title: MArk Metersky, MD
• Organization: University of Connecticut Health Center
• Phone: 860-679-3582
• EMail: metersky@nso.uchc.edu

• 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