Trial · NCT00517933

Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis

NCT00517933, Phase 3, Completed, Duke University; results first posted 2013-08-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis. Trials, record NCT00517933. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00517933

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis
NCT number: NCT00517933
Status: Completed
Phases: Phase 3
Enrollment: 180 participants, actual
Lead sponsor: Duke University
Conditions: Pulmonary Fibrosis, Hypertension, Pulmonary
Interventions: Sildenafil Citrate, Placebo
First posted: 2007-08-17
Last updated: 2015-06-24
Results first posted: 2013-08-23
Limitations and caveats: Findings are limited to patients with advanced IPF. It is unknown if treatment effect was driven by particular subgroup of patients. Study was too short and enrolled too few to assess duration of effect.

Source ClinicalTrials.gov

Registered outcomes30

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)	Measured at Week 12	This is a binary score (1 or 0) with 1 being better than 0. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Secondary	6-minute Walk Distance (6MWT)	Baseline, 6 week, 12 week	The 6MWT measures the distance that a participant can walk in a period of 6 minutes.
Secondary	Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance	Baseline, week 12	The 6MWT measures the distance that a participant can walk in a period of 6 minutes. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Secondary	Desaturation During 6-minute Walk Test (6MWT)	Week 12	The 6MWT was stopped when the pulse oximetry (SpO2) dropped to below 80% for six consecutive seconds. The estimates are based on the Kaplan-Meier event curves with minutes walked as the x-axis.
Secondary	Change in Dyspnea	Measured from enrollment to 12 weeks (phase I)	The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better.
Secondary	University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total	Baseline, 6 weeks, 12 weeks	The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better. (Raw scores) Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Secondary	Change in Forced Vital Capacity (FVC) Adjusted Values	Baseline, Week 12	Change in FVC (liters) from baseline (time 0) to week 12 comparing the sildenafil and placebo groups. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Secondary	Forced Vital Capacity (FVC)	Baseline, Week 6, Week 12	Raw scores of FVC (liters) from baseline (time 0) to week 6 and 12 comparing the sildenafil and placebo groups
Secondary	Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values	Baseline, Week 12	Change in DLCO (% predicted) measured at baseline (time 0), and week 12 comparing the sildenafil and placebo groups. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Secondary	Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)	Baseline, Week 6, Week 12	Raw scores of DLCO (% predicted) measured at baseline (time 0), week 6, and week 12 comparing the sildenafil and placebo groups

1 to 10 of 30Source ClinicalTrials.gov

See all 30 registered outcomes

Outcomes30

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)	Measured at Week 12		participants	NUMBER
SECONDARY	6-minute Walk Distance (6MWT)	Baseline, 6 week, 12 week		meters	MEAN
SECONDARY	Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance	Baseline, week 12		meters	MEAN
SECONDARY	Desaturation During 6-minute Walk Test (6MWT)	Week 12	ITT population	percentage of participants	NUMBER
SECONDARY	Change in Dyspnea	Measured from enrollment to 12 weeks (phase I)		units on a scale	MEAN
SECONDARY	University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total	Baseline, 6 weeks, 12 weeks		units on a scale	MEAN
SECONDARY	Change in Forced Vital Capacity (FVC) Adjusted Values	Baseline, Week 12	ITT	liters	LEAST_SQUARES_MEAN
SECONDARY	Forced Vital Capacity (FVC)	Baseline, Week 6, Week 12	ITT	liters	MEAN
SECONDARY	Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values	Baseline, Week 12	ITT	percentage of predicted (DLCO)	LEAST_SQUARES_MEAN
SECONDARY	Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)	Baseline, Week 6, Week 12	ITT	percentage of predicted (DLCO)	MEAN

1 to 10 of 30Source ClinicalTrials.gov

See all 30 outcomes

Results by group166

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)	Sildenafil		9		participants
Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)	Placebo		6		participants
6-minute Walk Distance (6MWT)	Sildenafil	1st baseline	246.93	Standard Deviation 99.11	meters
6-minute Walk Distance (6MWT)	Placebo	1st baseline	267.71	Standard Deviation 127.75	meters
6-minute Walk Distance (6MWT)	Sildenafil	2nd baseline	246.39	Standard Deviation 103.40	meters
6-minute Walk Distance (6MWT)	Placebo	2nd baseline	269.55	Standard Deviation 129.83	meters
6-minute Walk Distance (6MWT)	Sildenafil	6 week	237.29	Standard Deviation 121.48	meters
6-minute Walk Distance (6MWT)	Placebo	6 week	257.55	Standard Deviation 139.44	meters
6-minute Walk Distance (6MWT)	Sildenafil	12 week	239.09	Standard Deviation 126.39	meters
6-minute Walk Distance (6MWT)	Placebo	12 week	249.48	Standard Deviation 138.46	meters

1 to 10 of 166Source ClinicalTrials.gov

See all 166 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1	STARTED	Sildenafil / Sildenafil	89
Period 1	STARTED	Placebo / Sildenafil	91
Period 1	COMPLETED	Sildenafil / Sildenafil	81
Period 1	COMPLETED	Placebo / Sildenafil	85
Period 1	NOT COMPLETED	Sildenafil / Sildenafil	8
Period 1	NOT COMPLETED	Placebo / Sildenafil	6
Period 2	STARTED	Sildenafil / Sildenafil	79
Period 2	STARTED	Placebo / Sildenafil	83
Period 2	COMPLETED	Sildenafil / Sildenafil	73
Period 2	COMPLETED	Placebo / Sildenafil	70

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events78

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Sildenafil	13	89	17
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Placebo	13	91	15
other	Cough	Respiratory, thoracic and mediastinal disorders	Sildenafil	10	89	10
other	Cough	Respiratory, thoracic and mediastinal disorders	Placebo	7	91	7
other	Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	Sildenafil	2	89	2
other	Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	Placebo	5	91	5
other	Upper respiratory tract infection	Infections and infestations	Sildenafil	7	89	7
other	Upper respiratory tract infection	Infections and infestations	Placebo	7	91	8
other	Bronchitis	Infections and infestations	Sildenafil	1	89	1
other	Bronchitis	Infections and infestations	Placebo	6	91	6

1 to 10 of 78Source ClinicalTrials.gov

See all 78 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sildenafil
Total, all-cause mortality	Placebo
Total, other adverse events	Sildenafil	72	89
Total, other adverse events	Placebo	62	91
Total, serious adverse events	Sildenafil	13	89
Total, serious adverse events	Placebo	15	91

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20484178	DERIVED	PubMed
25890798	DERIVED	PubMed
26111071	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10HL080413	Idiopathic Pulmonary Fibrosis Clinical Research Network	ANSTROM, KEVIN J	DUKE UNIVERSITY	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2005 to 2013

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Sildenafil vs Placebo: Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)	Trial comparisons
Sildenafil vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00517933

GET https://conductscience.org/api/trials/v1/NCT00517933/registered?page=2

API reference For AI assistants