Pulmonary HypertensionPhase 2NCT03012646
Safety and Tolerability of Inhaled Treprostinil in Adult PH Due to COPD
A Phase 2 study testing Inhaled Treprostinil in people with Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease, run by United Therapeutics.
Trial summary
This is a multicenter, single-arm trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Inhaled Treprostinil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2017to Apr 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of WHO Group 3 PH associated with COPD
- Subjects are required to have a right heart catheterization (RHC) within one year prior to the first dose of study drug with the following parameters:
- Pulmonary vascular resistance (PVR) ≥ 4 Wood Units (WU) and
- A left ventricular end diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) of ≤ 12 mmHg if PVR ≥ 4 WU to < 6.25 WU or ≤ 15 mmHg if PVR ≥ 6.25 WU and
- A mean pulmonary arterial pressure (mPAP) of ≥ 30 mmHg
- Clinical Diagnosis of COPD will be made using accepted Global Initiative for Chronic Obstructive Lung Disease (GOLD) diagnostic criteria, including Baseline spirometry with the following documented parameters:
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- FEV1 < 65% predicted, and
- FEV1/ FVC < 70
- Baseline 6MWD ≥ 100 meters
Who cannot join
- The subject has a diagnosis of pulmonary arterial hypertension (PAH) or PH for reasons other than COPD as outlined in inclusion criterion 3. This would include, but is not limited to, the concomitant presence of thromboembolic disease (acute or chronic), untreated or inadequately treated obstructive sleep apnea, connective tissue disease (including but not limited to systemic sclerosis/scleroderma, or systemic lupus erythematosus), sarcoidosis, interstitial lung disease,human immunodeficiency virus-1 infection, and other conditions under WHO Group 1, 2, 4, and 5 classifications.
- The subject has received any Food and Drug Administration (FDA)-approved medication for the treatment of PAH (ie, prostacyclin, prostacyclin receptor agonist, endothelin receptor antagonist [ERA], phosphodiesterase type 5 inhibitor [PDE5-I],or soluble guanylate cyclase [sGC] stimulator) within 60 days of the first dose of study drug, except for acute vasoreactivity testing.
- The subject has evidence of clinically significant left-sided heart disease as defined by the following criteria per the most recent assessment:
- Left ventricular end diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) >15 mmHg (or >12 mmHg if pulmonary vascular resistance [PVR] ≥4 to <6.25 WU)
- Left ventricular ejection fraction <40% as assessed by either angiography or echocardiography.
About this study
Official title: A Prospective, Multicenter, Single-arm Study to Evaluate the Safety and Tolerability of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
This is a multicenter, single-arm trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with Chronic Obstructive Pulmonary Disease (COPD).
- Being tested
- Inhaled Treprostinil
- Keywords
- Treprostinil, PH, COPD, 6 Minute Walk Test
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled TreprostinilDrug
Also called Tyvaso
Inhaled treprostinil (6 mcg/breath) administered four times daily
| Study group | Role | What they receive |
|---|---|---|
| Active Inhaled Treprostinil | Experimental | Active Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Receives: Drug: Inhaled Treprostinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events Among Participants through 48 Weeks
The incidence of adverse events among participants throughout the 48-week study will be measured by the number of participants analyzed and the percentage of those participants who experienced an adverse event.
Measured: 48 weeks
Secondary outcomes (6)
Change in 6-minute Walk Distance (6MWD) from Baseline to Week 48
Measured: Baseline and Week 48
Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 48
Measured: Baseline and Week 48
Change in Forced Expiratory Volume (FEV1) in One Second from Baseline to Week 48
Measured: Baseline and Week 48
Change in Forced Vital Capacity (FVC) from Baseline to Week 48
Measured: Baseline and Week 48
Change in Lung Diffusion Capacity (DLCO) from Baseline to Week 48
Measured: Baseline and Week 48
Change in right ventricular ejection fraction (RVEF) as assessed via cMRI from Baseline to Week 48
Measured: Baseline and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startApr 2017 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012646
- Sponsor's protocol ID
- RIN-PH-203
- Status last verified
- Apr 2017
- First submitted
- 22 Dec 2016
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm Study to Evaluate the Safety and Tolerability of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03012646
- Acronym / sponsor ID
- RIN-PH-203
- Keywords
- Treprostinil, PH, COPD, 6 Minute Walk Test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2017 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, single-arm trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with Chronic Obstructive Pulmonary Disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Inhaled Treprostinil | Experimental | Drug: Inhaled TreprostinilActive Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of WHO Group 3 PH associated with COPD
- Subjects are required to have a right heart catheterization (RHC) within one year prior to the first dose of study drug with the following parameters:
- Clinical Diagnosis of COPD will be made using accepted Global Initiative for Chronic Obstructive Lung Disease (GOLD) diagnostic criteria, including Baseline spirometry with the following documented parameters:
- Baseline 6MWD ≥ 100 meters
Key exclusion criteria (5 listed)
- The subject has a diagnosis of pulmonary arterial hypertension (PAH) or PH for reasons other than COPD as outlined in inclusion criterion 3. This would include, but is not limited to, the concomitant presence of thromboembolic disease (acute or chronic), untreated or inadequately treated obstructive sleep apnea, connective tissue disease (including but not limited to systemic sclerosis/scleroderma, or systemic lupus erythematosus), sarcoidosis, interstitial lung disease,human immunodeficiency virus-1 infection, and other conditions under WHO Group 1, 2, 4, and 5 classifications.
- The subject has received any Food and Drug Administration (FDA)-approved medication for the treatment of PAH (ie, prostacyclin, prostacyclin receptor agonist, endothelin receptor antagonist [ERA], phosphodiesterase type 5 inhibitor [PDE5-I],or soluble guanylate cyclase [sGC] stimulator) within 60 days of the first dose of study drug, except for acute vasoreactivity testing.
- The subject has evidence of clinically significant left-sided heart disease as defined by the following criteria per the most recent assessment:
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 |
|---|---|---|
| Inhaled TreprostinilAlso: TyvasoInhaled treprostinil (6 mcg/breath) administered four times daily | Drug | Active Inhaled Treprostinil |
Primary outcome
Incidence of Adverse Events Among Participants through 48 Weeks
Time frame: 48 weeks
The incidence of adverse events among participants throughout the 48-week study will be measured by the number of participants analyzed and the percentage of those participants who experienced an adverse event.
6 secondary outcomes
Change in 6-minute Walk Distance (6MWD) from Baseline to Week 48
Time frame: Baseline and Week 48
Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 48
Time frame: Baseline and Week 48
Change in Forced Expiratory Volume (FEV1) in One Second from Baseline to Week 48
Time frame: Baseline and Week 48
Change in Forced Vital Capacity (FVC) from Baseline to Week 48
Time frame: Baseline and Week 48
Change in Lung Diffusion Capacity (DLCO) from Baseline to Week 48
Time frame: Baseline and Week 48
Change in right ventricular ejection fraction (RVEF) as assessed via cMRI from Baseline to Week 48
Time frame: Baseline and Week 48
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled Treprostinil in people with Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease, run by United Therapeutics.
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 9 inclusion and 5 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: withdrawn, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of Adverse Events Among Participants through 48 Weeks (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2017.