Trial Outcomes & Findings for Effects of Inhaled Treprostinil Sodium for the Treatment of Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis (NCT NCT00703339)

Results Overview

Safety and Tolerability evaluation include any observed or reported changes in vital signs, ECGs, clinical chemistry ,hematological or urinalysis, and any reported symptoms following a single dose administration on the day of dosing and up to the final visit 3-5 days later. Adverse events will be tabulated by total incidence and by individual patient, and the severity, causality and outcomes will also be documented. Each cohort of 4 patients will be fully evaluated as described before proceeding to the escalation to the next dose.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

3-5 days

Results posted on

2018-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	18mcg Inhaled Treprostinil Cohort Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug. Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Inhaled Treprostinil Sodium for the Treatment of Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	18mcg Inhaled Treprostinil Cohort n=1 Participants Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug. Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 3-5 days

Population: Insufficient enrollment, therefore no Participants were analyzed.

Safety and Tolerability evaluation include any observed or reported changes in vital signs, ECGs, clinical chemistry ,hematological or urinalysis, and any reported symptoms following a single dose administration on the day of dosing and up to the final visit 3-5 days later. Adverse events will be tabulated by total incidence and by individual patient, and the severity, causality and outcomes will also be documented. Each cohort of 4 patients will be fully evaluated as described before proceeding to the escalation to the next dose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: acute

Population: Insufficient enrollment, therefore no participants were analyzed.

PK samples will be collected at frequent intervals up to 4 hours following single dosing . Hemodynamic parameters at 4 hours post dosing include heart rate, pulmonary arterial pressure, systemic arterial pressure, right atrial pressure, pulmonary capillary wedge pressure, mixed venous oxygen saturation and cardiac output.

Outcome measures

Outcome data not reported

Adverse Events

18mcg Inhaled Treprostinil Cohort

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	18mcg Inhaled Treprostinil Cohort n=1 participants at risk Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug. Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing.
General disorders Headache	100.0% 1/1 • Number of events 1 • 30 days
General disorders Neck pain at cath site	100.0% 1/1 • Number of events 1 • 30 days
General disorders Fatigue	100.0% 1/1 • Number of events 1 • 30 days

Additional Information

Rosa Negro-Vilar

Lung Rx

Phone: 240-821-1881

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60