Trial · NCT03399604

Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil

NCT03399604, Phase 3, Completed, Liquidia Technologies, Inc.; results first posted 2024-07-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil. Trials, record NCT03399604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03399604

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Trial

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

Title: Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil
NCT number: NCT03399604
Status: Completed
Phases: Phase 3
Enrollment: 121 participants, actual
Lead sponsor: Liquidia Technologies, Inc.
Conditions: Primary Pulmonary Hypertension
Interventions: LIQ861 Inhaled Treprostinil
First posted: 2018-01-16
Last updated: 2024-07-30
Results first posted: 2024-07-30

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events	Baseline, Week 2, Month 1, Month 2 Visits, with bimonthly follow up for up to 16 months.	There were two treatment arms analyzed for events in the study. All subjects that participated in the PK study were part of the transition group and not analyzed separately for adverse events. Treatment-Emergent Adverse Events and Serious Adverse Events will be grouped by MedDRA System Organ Class, dose level, time on drug, and relationship to dose titration

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events	Baseline, Week 2, Month 1, Month 2 Visits, with bimonthly follow up for up to 16 months.	The Safety Population included all subjects who received at least 1 inhalation of LIQ861.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group1

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

Outcome	Group	Category	Value	Spread	Units
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events	LIQ861 Inhaled Treprostinil		121		Participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	LIQ861 Inhaled Treprostinil	121
Overall Study	COMPLETED	LIQ861 Inhaled Treprostinil	92
Overall Study	NOT COMPLETED	LIQ861 Inhaled Treprostinil	29

Source ClinicalTrials.gov

Adverse events86

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	LIQ861 Add-On	41	121	41
other	Cough	Respiratory, thoracic and mediastinal disorders	Tyvaso Transition	23	121	23
other	Dysponea	Respiratory, thoracic and mediastinal disorders	LIQ861 Add-On	10	121	10
other	Dysponea	Respiratory, thoracic and mediastinal disorders	Tyvaso Transition	13	121	13
other	Throat irritation	Respiratory, thoracic and mediastinal disorders	LIQ861 Add-On	14	121	14
other	Throat irritation	Respiratory, thoracic and mediastinal disorders	Tyvaso Transition	8	121	8
other	Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	LIQ861 Add-On	6	121	6
other	Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Tyvaso Transition	2	121	2
other	Headache	Nervous system disorders	LIQ861 Add-On	23	121	23
other	Headache	Nervous system disorders	Tyvaso Transition	18	121	18

1 to 10 of 86Source ClinicalTrials.gov

See all 86 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LIQ861 Add-On	0	121
Total, all-cause mortality	Tyvaso Transition	0	121
Total, other adverse events	LIQ861 Add-On	66	121
Total, other adverse events	Tyvaso Transition	55	121
Total, serious adverse events	LIQ861 Add-On	15	121
Total, serious adverse events	Tyvaso Transition	6	121

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33282202	DERIVED

Source 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 comparisons2

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

Comparison	Source
LIQ861 Add-On vs Tyvaso Transition: deaths from any cause	Trial comparisons
LIQ861 Add-On vs Tyvaso Transition: 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/NCT03399604

GET https://conductscience.org/api/trials/v1/NCT03399604/events?page=2

API reference For AI assistants