PARBO: Bosentan and Pulmonary Endothelial Function

• Sponsor: Prof David S Celermajer (Other)
• Overall Status: Completed
• CT.gov ID: NCT01721564
• Collaborator: (none)
• Enrollment: 8
• Arm: 1
• Duration (Months): 44

Study Details

Study Description

Brief Summary

6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Drug: Bosentan	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pulmonary Artery Remodelling With Bosentan
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bosentan 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months	Drug: Bosentan; 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months

Outcome Measures

Primary Outcome Measures

1. Acetylcholine Vascular Reactivity Response [Baseline and 6 months]

   Percent pulmonary flow change from baseline after acetylcholine

Secondary Outcome Measures

1. Intravascular Ultrasound - Pulmonary Artery Wall Thickness [baseline and 6 months]

   Change in intima-media thickness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pulmonary arterial hypertension; idiopathic and connective tissue disease associated

• Confirmed or invasive haemodynamic:

• Mean pulmonary arterial pressure greater than or equal to 25 millimeters of mercury

• Pulmonary capillary wedge pressure less than 15 millimeters of mercury

• No prior pulmonary hypertension specific therapy

• Ability to provide informed consent

Exclusion Criteria:

• Contra-indications to medications used to test endothelial function; acetylcholine, sodium nitroprusside, NG-Monomethyl-L-Arginine, L-arginine

• Advanced renal disease

• Previous allergic reaction to contrast agents

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Prof David S Celermajer

Investigators

• Principal Investigator: David S Celermajer, MBBS, PhD, DSc, Royal Prince Alfred Hospital, Sydney, Australia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof David S Celermajer, Scandrett Professor of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia
• ClinicalTrials.gov Identifier: NCT01721564
• Other Study ID Numbers: X05-0255
• First Posted: Nov 4, 2012
• Last Update Posted: Oct 19, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Pulmonary Arterial Hypertension; Hypertension; Bosentan

Study Results

Participant Flow

Arm/Group Title	Bosentan
Arm/Group Description	62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
Period Title: Overall Study
STARTED	8
COMPLETED	8
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Bosentan
Arm/Group Description	62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months
Overall Participants	8
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 62.5%
>=65 years	3 37.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (4)
Sex: Female, Male (Count of Participants)
Female	5 62.5%
Male	3 37.5%
Region of Enrollment (participants) [Number]
Australia	8 100%

Outcome Measures

1. Primary Outcome

Title	Acetylcholine Vascular Reactivity Response
Description	Percent pulmonary flow change from baseline after acetylcholine
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bosentan
Arm/Group Description	62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
Measure Participants	8
Mean (Standard Deviation) [percentage of baseline]	180 (20)

2. Secondary Outcome

Title	Intravascular Ultrasound - Pulmonary Artery Wall Thickness
Description	Change in intima-media thickness
Time Frame	baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bosentan
Arm/Group Description	62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
Measure Participants	8
Mean (Standard Deviation) [percentage of baseline]	34 (2)

Adverse Events

Arm/Group Title	Bosentan
Arm/Group Description	62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months
All Cause Mortality
	Bosentan
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Bosentan
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	Bosentan
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.