Pulmonary Arterial HypertensionPhase 1BREEZENCT03950739

Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso

A Phase 1 study testing Treprostinil Inhalation Powder in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This was a Phase 1b safety and tolerability single-sequence study in which PAH subjects on a stable regimen of Tyvaso switched to a corresponding dose of TreT. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Arterial Hypertension
What is being tested?: Treprostinil Inhalation Powder
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 16 sitesUnited States
Study dates: 17 Sep 2019to 22 Aug 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject voluntarily gave informed consent to participate in the study.
Subject was aged 18 years or older at the time of signing informed consent.
Women of childbearing potential were those who had experienced menarche and who had not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or were not postmenopausal (defined as amenorrhea for at least 12 consecutive months). WOCBP must have been nonpregnant (as confirmed by a urine pregnancy test at Screening prior to initiating study medication), nonlactating, and did 1 of the following:
Abstained from intercourse (when it was in line with their preferred and usual lifestyle), or
Used 2 medically acceptable, highly effective forms of contraception for the duration of study, and at least 30 days after discontinuing TreT. Medically acceptable, highly effective forms of contraception included approved hormonal contraceptives (oral, injectable, and implantable), intrauterine devices or systems, and barrier methods (such as a condom or diaphragm) when used with a spermicide.
Males with a partner of childbearing potential must have used a condom for the duration of treatment and for at least 48 hours after discontinuing TreT.

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Subject was diagnosed with PAH as defined by the following World Health Organization (WHO) Group 1 categories:
Idiopathic/familial
Associated with unrepaired or repaired congenital systemic-to-pulmonary shunts (repaired ≥5 years prior to Screening)
Associated with collagen vascular disease
Associated with human immunodeficiency virus
Associated with appetite suppressant/other drug or toxin use
Subject must have started Tyvaso ≥3 months prior to the Baseline Visit and was currently on a stable regimen (no change in dose within 30 days of Baseline Visit) of Tyvaso (6 to 12 breaths QID).
Baseline 6MWD ≥150 m.
If the subject was currently receiving other approved background therapy (eg, endothelin receptor antagonist or phosphodiesterase type 5 inhibitor or both), the subject must have been on a stable dose with no additions or discontinuations for a minimum of 30 days prior to Screening.
The subject had evidence of forced expiratory volume in 1 second (FEV1) ≥60% and FEV1/forced vital capacity ratio ≥60% during the 6 months prior to enrollment.
In the opinion of the Investigator, the subject was able to communicate effectively with study personnel, and was considered reliable, willing, and likely to be cooperative with protocol requirements, including all study visits.

Who cannot join

Subject was pregnant or lactating.
Subject was diagnosed with pulmonary hypertension for reasons other than WHO Group 1 as outlined in Inclusion Criterion 5 (including but not limited to portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, hemolytic anemia, sarcoidosis).
Subject had a history of uncontrolled sleep apnea, parenchymal lung disease, or hemodynamically significant left-sided heart disease (including but not limited to aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease).
Subject was currently taking any other prostacyclin analogue or agonist, including but not limited to selexipag, epoprostenol, iloprost, or beraprost; except for acute vasoreactivity testing.
Subject experienced an acute exacerbation of disease or hospitalization for any reason within 30 days of the Screening Visit or between Screening and Baseline.
Subject was WHO Functional Class IV at Screening.

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Subject had used any investigational drug/device or participated in any other investigational study with therapeutic intent within 30 days prior to the Screening Visit.
Subject had a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to treprostinil or excipients in the investigational product.
Subject had conditions that, in the opinion of the Investigator, would make the subject ineligible.
Subject was not able to perform inhalation maneuvers that met inspiratory training criteria.
Subject had a musculoskeletal disorder (eg, arthritis affecting the lower limbs, recent hip or knee joint replacement) or any disease that would likely be the primary limit to ambulation, or was connected to a machine that was not portable enough to allow for a 6MWT.
Subject had a new type of chronic therapy (including but not limited to oxygen, a different class of vasodilator, diuretic, and digoxin) for pulmonary hypertension added within 30 days of the Screening Phase.
Initiation of pulmonary rehabilitation within 12 weeks prior to the Baseline Visit.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Emory University Hospital
Atlanta, Georgia, 30322
University of Maryland Medical Center Division of Cardiology
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35233
UT Southwestern Medical Center
Dallas, Texas, 75390
Houston Methodist Hospital
Houston, Texas, 77030
Ascension / St. Vincent's Lung Institute
Jacksonville, Florida, 32204
Mayo Clinic Florida
Jacksonville, Florida, 32224
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Department of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, 90073
University of Louisville Clinical Trials Unit
Louisville, Kentucky, 40202
Ochsner Medical Center
New Orleans, Louisiana, 70121
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Penn Medicine University City
Philadelphia, Pennsylvania, 19104
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23230
University of South Florida Center for Advanced Lung Disease
Tampa, Florida, 33606
Cleveland Clinic Florida
Weston, Florida, 33331

Other trials in United States

About this study

Official title: An Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects With Pulmonary Arterial Hypertension Currently Using Tyvaso

This was a Phase 1b safety and tolerability single-sequence study in which PAH subjects on a stable regimen of Tyvaso switched to a corresponding dose of TreT.

Read the detailed description

United Therapeutics Corporation (UTC) developed a combination drug-device product comprised of a dry powder formulation of Treprostinil Inhalation Powder (TreT) and a small, portable, dry powder inhaler. In this Phase 1b safety and tolerability study, patients with PAH on a stable dose of Tyvaso (6 to 12 breaths 4 times daily [QID]) were evaluated after switching to a corresponding dose of TreT. Patients underwent PK assessments, safety assessments, a 6-Minute Walk Test (6MWT), and questionnaires for satisfaction/preference for inhaled devices and patient-reported PAH symptoms and impact. Following 3 weeks of treatment with TreT, patients were offered the opportunity to participate in the Optional Extension Phase until the drug/device became commercially available.

Conditions: Pulmonary Arterial Hypertension
Being tested: Treprostinil Inhalation Powder
Keywords: prostacyclin
Medical subject headings: Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treprostinil Inhalation PowderDrug
Also called TreT
Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)

Study groups in NCT03950739
Study group	Role	What they receive
Tyvaso to TreT	Experimental	Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose. Receives: Drug: Treprostinil Inhalation Powder

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in 6-Minute Walk Distance (6MWD) From Baseline to Week 3
6MWD was evaluated at study entry and after 3 weeks of treatment with TreT.
Measured: From Baseline to 3 weeks of treatment with TreT
Subject Satisfaction With and Preference for Inhaled Treprostinil Devices
Subject satisfaction with and preference for the inhaled treprostinil device was evaluated with the Preference Questionnaire for Inhaled Treprostinil Devices (PQ-ITD). The PQ-ITD is a questionnaire given to evaluate subject satisfaction with and preference for inhaled treprostinil devices. The questionnaire provides 12 different statements around inhaled device satisfaction and allows for 5 response options: strongly disagree, disagree, neutral, agree, and strongly agree.
Measured: After 3 weeks of treatment with TreT (after switching from the Tyvaso Inhalation System)
Change in Patient-reported PAH Symptoms and Impact From Baseline to Week 3
Patient-reported PAH symptoms and impact were evaluated with the PAH Symptoms and Impact (PAH-SYMPACT) Questionnaire. The PAH-SYMPACT is a 23-item patient-reported outcome questionnaire that consists of 11 symptom items, 11 impact items, and 1 item on oxygen use. The symptom items are divided into cardiopulmonary and cardiovascular domains, and the impact items are divided into physical and emotional/cognitive domains. Symptom and impact domain scores (range 0 to 4) are calculated as the sum of the scores for the items included in the domain divided by the number of items in the domain.
For all domains, a higher score indicates more severe symptoms/impacts.
Measured: From Baseline to 3 weeks of treatment with TreT
Change in Patient-reported PAH Symptoms and Impact From Baseline to Week 11 (for Subjects Participating in the OEP)
Patient-reported PAH symptoms and impact were evaluated with the PAH Symptoms and Impact (PAH-SYMPACT) Questionnaire. The PAH-SYMPACT is a 23-item patient-reported outcome questionnaire that consists of 11 symptom items, 11 impact items, and 1 item on oxygen use. The symptom items are divided into cardiopulmonary and cardiovascular domains, and the impact items are divided into physical and emotional/cognitive domains. Symptom and impact domain scores (range 0 to 4) are calculated as the sum of the scores for the items included in the domain divided by the number of items in the domain.
For all domains, a higher score indicates more severe symptoms/impacts.
Measured: From Baseline to 11 weeks of treatment with TreT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 201922 Aug 2023

First posted15 May 2019
Study start17 Sep 2019
Primary completion22 Aug 2023
Study completion22 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single-sequence in which subjects on a stable regimen of Tyvaso switched to a corresponding dose of TreT
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03950739
Sponsor's protocol ID: TIP-PH-101
Acronym: BREEZE
Status last verified: Aug 2024
First submitted: 9 May 2019
Last updated: 1 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Sahay S, Palevsky H, El-Kersh K, Restrepo-Jaramillo R, Bajwa AA, Desai S, Joly JM, Spikes LA, Eggert MS, Johri S, Shapiro SM, Fisher MR, Shah TG, Ramani GV, Mehta JP, Thrasher CM, Deng C, Smith P, Broderick M, Burger CD. BREEZE Optional Extension Phase: Long-term safety and efficacy of treprostinil dry powder inhaler (Tyvaso DPI) in pulmonary arterial hypertension. Respir Med. 2025 Nov;248:108318. doi: 10.1016/j.rmed.2025.108318. Epub 2025 Aug 27.
PubMed 40882760
Spikes LA, Bajwa AA, Burger CD, Desai SV, Eggert MS, El-Kersh KA, Fisher MR, Johri S, Joly JM, Mehta J, Palevsky HI, Ramani GV, Restrepo-Jaramillo R, Sahay S, Shah TG, Deng C, Miceli M, Smith P, Shapiro SM. BREEZE: Open-label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI in patients with pulmonary arterial hypertension. Pulm Circ. 2022 Apr 7;12(2):e12063. doi: 10.1002/pul2.12063. eCollection 2022 Apr.
PubMed 35514770

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects With Pulmonary Arterial Hypertension Currently Using Tyvaso
ClinicalTrials.gov ID: NCT03950739
Acronym / sponsor ID: BREEZE / TIP-PH-101
Conditions: Pulmonary Arterial Hypertension
Keywords: prostacyclin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: United TherapeuticsIndustry (pharma, biotech, devices)
Study start: 17 Sep 2019 (actual)
Primary completion: 22 Aug 2023 (actual)
Study completion: 22 Aug 2023 (actual)
First posted: 15 May 2019 (actual)
Results: Posted 1 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This was a Phase 1b safety and tolerability single-sequence study in which PAH subjects on a stable regimen of Tyvaso switched to a corresponding dose of TreT.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single-sequence in which subjects on a stable regimen of Tyvaso switched to a corresponding dose of TreT

Arm	Type	Receives
Tyvaso to TreT	Experimental	Drug: Treprostinil Inhalation PowderEach subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Subject voluntarily gave informed consent to participate in the study.
Subject was aged 18 years or older at the time of signing informed consent.
Women of childbearing potential were those who had experienced menarche and who had not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or were not postmenopausal (defined as amenorrhea for at least 12 consecutive months). WOCBP must have been nonpregnant (as confirmed by a urine pregnancy test at Screening prior to initiating study medication), nonlactating, and did 1 of the following:
Males with a partner of childbearing potential must have used a condom for the duration of treatment and for at least 48 hours after discontinuing TreT.
Subject was diagnosed with PAH as defined by the following World Health Organization (WHO) Group 1 categories:

Key exclusion criteria (13 listed)

Subject was pregnant or lactating.
Subject was diagnosed with pulmonary hypertension for reasons other than WHO Group 1 as outlined in Inclusion Criterion 5 (including but not limited to portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, hemolytic anemia, sarcoidosis).
Subject had a history of uncontrolled sleep apnea, parenchymal lung disease, or hemodynamically significant left-sided heart disease (including but not limited to aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease).
Subject was currently taking any other prostacyclin analogue or agonist, including but not limited to selexipag, epoprostenol, iloprost, or beraprost; except for acute vasoreactivity testing.
Subject experienced an acute exacerbation of disease or hospitalization for any reason within 30 days of the Screening Visit or between Screening and Baseline.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treprostinil Inhalation PowderAlso: TreTTreprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)	Drug	Tyvaso to TreT

Primary outcome

Change in 6-Minute Walk Distance (6MWD) From Baseline to Week 3
Time frame: From Baseline to 3 weeks of treatment with TreT
6MWD was evaluated at study entry and after 3 weeks of treatment with TreT.
Subject Satisfaction With and Preference for Inhaled Treprostinil Devices
Time frame: After 3 weeks of treatment with TreT (after switching from the Tyvaso Inhalation System)
Subject satisfaction with and preference for the inhaled treprostinil device was evaluated with the Preference Questionnaire for Inhaled Treprostinil Devices (PQ-ITD). The PQ-ITD is a questionnaire given to evaluate subject satisfaction with and preference for inhaled treprostinil devices. The questionnaire provides 12 different statements around inhaled device satisfaction and allows for 5 response options: strongly disagree, disagree, neutral, agree, and strongly agree.
Change in Patient-reported PAH Symptoms and Impact From Baseline to Week 3
Time frame: From Baseline to 3 weeks of treatment with TreT
Patient-reported PAH symptoms and impact were evaluated with the PAH Symptoms and Impact (PAH-SYMPACT) Questionnaire. The PAH-SYMPACT is a 23-item patient-reported outcome questionnaire that consists of 11 symptom items, 11 impact items, and 1 item on oxygen use. The symptom items are divided into cardiopulmonary and cardiovascular domains, and the impact items are divided into physical and emotional/cognitive domains. Symptom and impact domain scores (range 0 to 4) are calculated as the sum of the scores for the items included in the domain divided by the number of items in the domain. For all domains, a higher score indicates more severe symptoms/impacts.
Change in Patient-reported PAH Symptoms and Impact From Baseline to Week 11 (for Subjects Participating in the OEP)
Time frame: From Baseline to 11 weeks of treatment with TreT
Patient-reported PAH symptoms and impact were evaluated with the PAH Symptoms and Impact (PAH-SYMPACT) Questionnaire. The PAH-SYMPACT is a 23-item patient-reported outcome questionnaire that consists of 11 symptom items, 11 impact items, and 1 item on oxygen use. The symptom items are divided into cardiopulmonary and cardiovascular domains, and the impact items are divided into physical and emotional/cognitive domains. Symptom and impact domain scores (range 0 to 4) are calculated as the sum of the scores for the items included in the domain divided by the number of items in the domain. For all domains, a higher score indicates more severe symptoms/impacts.

Results and safety

Results posted to the registry on 1 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tyvaso to TreT	51	49

Primary outcome: Change in 6-Minute Walk Distance (6MWD) From Baseline to Week 3

Time frame: From Baseline to 3 weeks of treatment with TreT. Mean (Standard Deviation). Unit: meters

Measure	Tyvaso to TreT n = 46
Value	11.5 (32.9)

Population analysed: Safety Population with 6MWD measurements at Week 3

Primary outcome: Subject Satisfaction With and Preference for Inhaled Treprostinil Devices

Time frame: After 3 weeks of treatment with TreT (after switching from the Tyvaso Inhalation System). Count of participants. Unit: Participants

Measure	Tyvaso to TreT n = 46
Strongly Disagree	0
Disagree	0
Neutral	1
Agree	5
Strongly Agree	40

Population analysed: Safety Population with PQ-ITD responses at Week 3

Primary outcome: Change in Patient-reported PAH Symptoms and Impact From Baseline to Week 3

Time frame: From Baseline to 3 weeks of treatment with TreT. Mean (Standard Deviation). Unit: score on a scale

Measure	Tyvaso to TreT n = 46
Cardiopulmonary Symptoms Domain Score	-0.05 (0.27)
Cardiovascular Symptoms Domain Score	-0.06 (0.33)
Physical Impacts Domain Score	-0.14 (0.46)
Cognitive/Emotional Impacts Domain Score	-0.17 (0.40)

Population analysed: Safety Population with PAH-SYMPACT scores at Week 3

Primary outcome: Change in Patient-reported PAH Symptoms and Impact From Baseline to Week 11 (for Subjects Participating in the OEP)

Time frame: From Baseline to 11 weeks of treatment with TreT. Mean (Standard Deviation). Unit: score on a scale

Measure	Tyvaso to TreT n = 37
Cardiopulmonary Symptoms Domain Score	-0.04 (0.36)
Cardiovascular Symptoms Domain Score	-0.05 (0.40)
Physical Impacts Domain Score	-0.20 (0.59)
Cognitive/Emotional Impacts Domain Score	-0.13 (0.51)

Population analysed: Safety Population with PAH-SYMPACT scores at Week 11

Adverse events

Time frame: All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tyvaso to TreT 32 mcg (Treatment Phase)	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Tyvaso to TreT 48 mcg (Treatment Phase)	1 of 27 (3.7%)	17 of 27 (63%)	0 of 27
Tyvaso to TreT 64 mcg (Treatment Phase)	1 of 22 (4.5%)	14 of 22 (63.6%)	0 of 22
Tyvaso to TreT 32 mcg (Optional Extension Phase)	1 of 2 (50%)	2 of 2 (100%)	0 of 2
Tyvaso to TreT 48 mcg (Optional Extension Phase)	12 of 26 (46.2%)	25 of 26 (96.2%)	0 of 26
Tyvaso to TreT 64 mcg (Optional Extension Phase)	12 of 21 (57.1%)	20 of 21 (95.2%)	1 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40882760Sahay S, Palevsky H, El-Kersh K, Restrepo-Jaramillo R, Bajwa AA, Desai S, Joly JM, Spikes LA, Eggert MS, Johri S, Shapiro SM, Fisher MR, Shah TG, Ramani GV, Mehta JP, Thrasher CM, Deng C, Smith P, Broderick M, Burger CD. BREEZE Optional Extension Phase: Long-term safety and efficacy of treprostinil dry powder inhaler (Tyvaso DPI) in pulmonary arterial hypertension. Respir Med. 2025 Nov;248:108318. doi: 10.1016/j.rmed.2025.108318. Epub 2025 Aug 27.
Derived from this study: PubMed 35514770Spikes LA, Bajwa AA, Burger CD, Desai SV, Eggert MS, El-Kersh KA, Fisher MR, Johri S, Joly JM, Mehta J, Palevsky HI, Ramani GV, Restrepo-Jaramillo R, Sahay S, Shah TG, Deng C, Miceli M, Smith P, Shapiro SM. BREEZE: Open-label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI in patients with pulmonary arterial hypertension. Pulm Circ. 2022 Apr 7;12(2):e12063. doi: 10.1002/pul2.12063. eCollection 2022 Apr.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treprostinil Inhalation Powder in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 6-Minute Walk Distance (6MWD) From Baseline to Week 3 (time frame: From Baseline to 3 weeks of treatment with TreT). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03950739, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.