Trial Outcomes & Findings for Bosentan for Poorly Controlled Asthma (NCT NCT00815347)

NCT ID: NCT00815347

Last Updated: 2012-10-01

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: 1, 2, 4 hours after dosing
• Results posted on: 2012-10-01

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	11
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bosentan for Poorly Controlled Asthma

Baseline characteristics by cohort

Measure	All Study Participants n=12 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1, 2, 4 hours after dosing

Outcome measures

Measure	Placebo n=7 Participants	Bosentan n=7 Participants
Change in FEV1 1 hour FEV1	1.50 liters Confidence interval not evaluable due to small number of participants	1.57 liters Confidence interval not evaluable due to small number of participants
Change in FEV1 2 hour FEV1	1.53 liters Confidence interval not evaluable due to small number of participants	1.57 liters Confidence interval not evaluable due to small number of participants
Change in FEV1 4 hour FEV1	1.50 liters Confidence interval not evaluable due to small number of participants	1.51 liters Confidence interval not evaluable due to small number of participants

PRIMARY outcome

Timeframe: last 7 days of each dosing period

Population: Data not analyzed, study terminated early

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Last 7 days of each dosing period

Symptom score could range from a minimum of 7 (no symptoms) to 35 (severe symptoms)

Outcome measures

Measure	Placebo n=7 Participants	Bosentan n=7 Participants
Symptom Scores	19.7 score on a scale Standard Deviation 7.6	20.1 score on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: end of dosing period

Outcome measures

Measure	Placebo n=7 Participants	Bosentan n=7 Participants
FEV1	1.46 liters Standard Deviation 0.4	1.49 liters Standard Deviation 0.47

SECONDARY outcome

Timeframe: end of each dosing period

Outcome measures

Measure	Placebo n=7 Participants	Bosentan n=7 Participants
Rescue Beta-agonist	34.6 puffs of rescue inhaler Standard Deviation 19.2	36.3 puffs of rescue inhaler Standard Deviation 18.9

SECONDARY outcome

Timeframe: end of each dosing period

Patient reported outcome minimum 5 (no symptoms) maximum 25 (severe symptoms)

Outcome measures

Measure	Placebo n=7 Participants	Bosentan n=7 Participants
Asthma Control Test Questionnaire	13.6 scores on a scale Standard Deviation 5.0	13.1 scores on a scale Standard Deviation 3.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 17 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 17 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 17 weeks

Outcome measures

Outcome data not reported

Adverse Events

Bosentan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bosentan n=9 participants at risk Bosentan 62.5mg orally, twice a day for four weeks.	Placebo n=11 participants at risk Placebo orally, twice a day for four weeks.
Hepatobiliary disorders Abnormal liver function blood tests	0.00% 0/9 • 17 weeks Non-Serious Adverse Events were not Analyzed, Terminated Study	9.1% 1/11 • Number of events 1 • 17 weeks Non-Serious Adverse Events were not Analyzed, Terminated Study

Other adverse events

Adverse event data not reported

Additional Information

MArk Metersky, MD

University of Connecticut Health Center

Phone: 860-679-3582

Email: metersky@nso.uchc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place