Trial · NCT02630316

Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE

NCT02630316, Phase 2, Phase 3, Completed, United Therapeutics; results first posted 2021-07-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE. Trials, record NCT02630316. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02630316

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Trial

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

Title: Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE
NCT number: NCT02630316
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 326 participants, actual
Lead sponsor: United Therapeutics
Conditions: Pulmonary Hypertension, Interstitial Lung Disease, Combined Pulmonary Fibrosis and Emphysema
Interventions: Inhaled Treprostinil, Placebo
First posted: 2015-12-15
Last updated: 2022-07-27
Results first posted: 2021-07-13

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Change in 6-minute Walk Distance (6MWD) Measured at Peak Exposure From Baseline to Week 16	Baseline and Week 16	The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline to Week 16, correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status. Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Peak exposure 6MWD will occur by conducting 6-minute walk test (6MWT) within 10 to 60 minutes after the most recent dose of study drug dose.
Secondary	Change in Plasma Concentration of N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 16	Baseline and Week 16	The NT-proBNP serum concentration is a useful biomarker associated with changes in right heart morphology and function. NT-proBNP serum concentration will be assessed to compare the severity of heart failure at Baseline and Week 16. Blood for NT-proBNP assessment must be drawn prior to conducting the 6MWT.
Secondary	Incidence of Clinical Worsening	Baseline to Week 16	Subjects were monitored for clinical worsening from the time of randomization until 1 of the following criteria were met: hospitalization due to a cardiopulmonary indication; decrease in 6MWD \>15% from Baseline directly related to the disease under study, at 2 consecutive visits and at least 24 hours apart; death (all causes); or lung transplantation.
Secondary	Change in Peak 6-minute Walk Distance (6MWD) From Baseline to Week 12	Baseline and Week 12	The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline to Week 12, correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status. Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Peak exposure 6MWD will occur by conducting 6MWT within 10 to 60 minutes after the most recent dose of study drug dose.
Secondary	Change in Trough 6-minute Walk Distance (6MWD) From Baseline to Week 15	Baseline and Week 15	The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline to Week 15, correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status. Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Distance \<500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance \>800 meters (with no rests) suggests mild or no limitation. Trough exposure 6MWD will occur by conducting 6-minute walk test (6MWT) at least four hours after the most recent study drug dose.

Source ClinicalTrials.gov

Outcomes5

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 (6MWD) Measured at Peak Exposure From Baseline to Week 16	Baseline and Week 16	All Subjects Dosed	meters	MEDIAN
SECONDARY	Change in Plasma Concentration of N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 16	Baseline and Week 16	Only subjects with Baseline NT-proBNP are included. For subjects who do not have Week 16 measure, the last observation carried forward imputation is used.	pg/mL	MEDIAN
SECONDARY	Incidence of Clinical Worsening	Baseline to Week 16	All Subjects with Clinical Worsening Events	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Peak 6-minute Walk Distance (6MWD) From Baseline to Week 12	Baseline and Week 12	For those subjects who withdrew early due to death, were too ill to walk, or had no 6MWD measure due to clinical worsening event, the 6MWD is set to 0, for all other withdrawals without Week 12 measurement, last observation carried forward (LOCF) is used for imputation.	meters	MEDIAN
SECONDARY	Change in Trough 6-minute Walk Distance (6MWD) From Baseline to Week 15	Baseline and Week 15	For those subjects who withdrew early due to death, were too ill to walk, or had no 6MWD measure due to clinical worsening event, the 6MWD is set to 0, for all other withdrawals without Week 15 measurement, baseline observation carried forward is used for imputation.	meter	MEDIAN

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Change in 6-minute Walk Distance (6MWD) Measured at Peak Exposure From Baseline to Week 16	Placebo	-9.0	Full Range -426 to 179	meters
Change in 6-minute Walk Distance (6MWD) Measured at Peak Exposure From Baseline to Week 16	Inhaled Treprostinil	6.0	Full Range -396 to 183	meters
Change in Plasma Concentration of N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 16	Placebo	20.65	Full Range -5483.3 to 87148.3	pg/mL
Change in Plasma Concentration of N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 16	Inhaled Treprostinil	-22.65	Full Range -11433.0 to 5373.1	pg/mL
Incidence of Clinical Worsening	Placebo	54		Participants
Incidence of Clinical Worsening	Inhaled Treprostinil	37		Participants
Change in Peak 6-minute Walk Distance (6MWD) From Baseline to Week 12	Placebo	-3.0	Full Range -369 to 152	meters
Change in Peak 6-minute Walk Distance (6MWD) From Baseline to Week 12	Inhaled Treprostinil	8.0	Full Range -360 to 192	meters
Change in Trough 6-minute Walk Distance (6MWD) From Baseline to Week 15	Placebo	-9.0	Full Range -369 to 180	meter
Change in Trough 6-minute Walk Distance (6MWD) From Baseline to Week 15	Inhaled Treprostinil	0.0	Full Range -396 to 144	meter

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	163
Overall Study	STARTED	Inhaled Treprostinil	163
Overall Study	COMPLETED	Placebo	128
Overall Study	COMPLETED	Inhaled Treprostinil	130
Overall Study	NOT COMPLETED	Placebo	35
Overall Study	NOT COMPLETED	Inhaled Treprostinil	33

Source ClinicalTrials.gov

Adverse events172

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	Cough	Respiratory, thoracic and mediastinal disorders	Placebo	54	163	56
other	Cough	Respiratory, thoracic and mediastinal disorders	Active Inhaled Treprostinil	71	163	76
other	Headache	Nervous system disorders	Placebo	32	163	34
other	Headache	Nervous system disorders	Active Inhaled Treprostinil	45	163	49
other	Nausea	Gastrointestinal disorders	Placebo	26	163	27
other	Nausea	Gastrointestinal disorders	Active Inhaled Treprostinil	25	163	26
other	Diarrhea	Gastrointestinal disorders	Placebo	19	163	19
other	Diarrhea	Gastrointestinal disorders	Active Inhaled Treprostinil	22	163	24
other	Fatigue	General disorders	Placebo	23	163	24
other	Fatigue	General disorders	Active Inhaled Treprostinil	23	163	24

1 to 10 of 172Source ClinicalTrials.gov

See all 172 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	12	163
Total, all-cause mortality	Active Inhaled Treprostinil	10	163
Total, other adverse events	Placebo	149	163
Total, other adverse events	Active Inhaled Treprostinil	152	163
Total, serious adverse events	Placebo	42	163
Total, serious adverse events	Active Inhaled Treprostinil	38	163

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33440084	DERIVED	PubMed
34214475	DERIVED	PubMed
36115497	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons3

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

Comparison	Source
Inhaled Treprostinil vs Placebo: Incidence of Clinical Worsening	Trial comparisons
Active Inhaled Treprostinil vs Placebo: deaths from any cause	Trial comparisons
Active Inhaled Treprostinil 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/NCT02630316

GET https://conductscience.org/api/trials/v1/NCT02630316/events?page=2

API reference For AI assistants