Trial Outcomes & Findings for Effect of Sildenafil on Diffusion Capacity in Patients With PH and Parenchymal Lung Disease (NCT NCT01948518)

Results Overview

Determine the acute effect of oral sildenafil on diffusion capacity in patients with diffuse parenchymal lung disease and concomitant pulmonary hypertension

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Baseline and one hour

Results posted on

2014-09-30

Participant Flow

Participant milestones

Participant milestones
Measure	Sildenafil 20 mg of oral sildenafil, single dose at baseline Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Sildenafil on Diffusion Capacity in Patients With PH and Parenchymal Lung Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sildenafil n=15 Participants 20 mg of oral sildenafil, single dose at baseline Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug.
Age, Continuous	58.6 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and one hour

Determine the acute effect of oral sildenafil on diffusion capacity in patients with diffuse parenchymal lung disease and concomitant pulmonary hypertension

Outcome measures

Outcome measures
Measure	Sildenafil n=15 Participants 20 mg of oral sildenafil, single dose at baseline Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug.
Change in Diffusion Capacity Measured at Baseline and One Hour.	-0.26 ml/min/mmHg Standard Deviation 0.94

SECONDARY outcome

Timeframe: Baseline and one hour

The change in 6 minutes walk distance from baseline one hour after receiving 20 mg of sildenafil orally will be measured.

Outcome measures

Outcome measures
Measure	Sildenafil n=15 Participants 20 mg of oral sildenafil, single dose at baseline Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug.
Change in 6 Minute Walk Distance Baseline	1195 feet Standard Deviation 407
Change in 6 Minute Walk Distance One Hour	1214 feet Standard Deviation 383

Adverse Events

Sildenafil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Umur Hatipoğlu, MD

Cleveland Clinic

Phone: 216-636-5344

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place