Trial Outcomes & Findings for BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology (NCT NCT00367770)

NCT ID: NCT00367770

Last Updated: 2016-09-22

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

37 participants

Primary outcome timeframe

from baseline to week 24

Results posted on

2016-09-22

Participant Flow

Eight centers in six countries: Germany (1), Italy (2), the Netherlands (1), Spain (1), U.K. (2), U.S.A. (1) Patients with stable PAH upon completion of the BREATHE-5 randomized, double-blind, placebocontrolled 16-week study were given option to enter into the open-label extension study.

Participant milestones

Participant milestones
Measure	Tracleer The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
Overall Study STARTED	37
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Tracleer The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Arm n=37 Participants
Age, Continuous	39.8 Years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: from baseline to week 24

Population: The analysis was done in the safety set.

Outcome measures

Outcome measures
Measure	Overall Study Arm n=35 Participants
Change in 6-minute Walk Distance	13.5 m Standard Deviation 57.2

PRIMARY outcome

Timeframe: from baseline to week 24

Population: The analysis was done in the safety set.

Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.

Outcome measures

Outcome measures
Measure	Overall Study Arm n=35 Participants
Change in Borg Dyspnea Index	0.1 units on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: from baseline to week 24

Population: The analysis was done in the safety set.

Number of participants with a change in WHO functional class from baseline to week 24. A change from a higher to a lower functional class (i.e. III to II, III to I or II to I) is considered as an improvement.

Outcome measures

Outcome measures
Measure	Overall Study Arm n=35 Participants
Number of Participants With a Change in WHO Functional Class	13 participants

Adverse Events

Tracleer

Serious events: 7 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tracleer n=37 participants at risk The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	5.4% 2/37 • 24 weeks
Investigations ALANINE AMINOTRANSFERASE INCREASED	2.7% 1/37 • 24 weeks
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	2.7% 1/37 • 24 weeks
Infections and infestations GASTROENTERITIS VIRAL	2.7% 1/37 • 24 weeks
Nervous system disorders LETHARGY	2.7% 1/37 • 24 weeks
Gastrointestinal disorders NAUSEA	2.7% 1/37 • 24 weeks
Cardiac disorders PALPITATIONS	2.7% 1/37 • 24 weeks
Pregnancy, puerperium and perinatal conditions pregnancy	2.7% 1/37 • 24 weeks
General disorders sudden death	2.7% 1/37 • 24 weeks
Gastrointestinal disorders rectal hemorrhage	2.7% 1/37 • 24 weeks

Other adverse events

Other adverse events
Measure	Tracleer n=37 participants at risk The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
General disorders OEDEMA PERIPHERAL	18.9% 7/37 • 24 weeks
General disorders CHEST PAIN	10.8% 4/37 • 24 weeks
General disorders FATIGUE	5.4% 2/37 • 24 weeks
Infections and infestations NASOPHARYNGITIS	13.5% 5/37 • 24 weeks
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	5.4% 2/37 • 24 weeks
Infections and infestations VIRAL INFECTION	5.4% 2/37 • 24 weeks
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	5.4% 2/37 • 24 weeks
Cardiac disorders PALPITATIONS	5.4% 2/37 • 24 weeks
Nervous system disorders DIZZINESS	5.4% 2/37 • 24 weeks
Nervous system disorders HEADACHE	5.4% 2/37 • 24 weeks
Gastrointestinal disorders DIARRHOEA	8.1% 3/37 • 24 weeks
Investigations ALANINE AMINOTRANSFERASE INCREASED	5.4% 2/37 • 24 weeks
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	5.4% 2/37 • 24 weeks
Metabolism and nutrition disorders GOUT	5.4% 2/37 • 24 weeks
Pregnancy, puerperium and perinatal conditions abortion spontaneous	5.4% 2/37 • 24 weeks

Additional Information

Loïc Perchenet, Head of Global Post-Approval Studies

Actelion Pharmaceuticals Ltd.

Phone: +41 61 565 64 57

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60