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Trial record 1 of 1 for:    03794583
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Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD) (PERFECT OLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03794583
Recruitment Status : Enrolling by invitation
First Posted : January 7, 2019
Last Update Posted : August 30, 2022
Sponsor:
Collaborator:
Lung Biotechnology PBC
Information provided by (Responsible Party):
United Therapeutics

Brief Summary:
This open-label study will evaluate the safety of continued therapy with inhaled treprostinil in participants who have completed Study RIN-PH-304 (NCT03496623). This study hypothesizes that long-term safety findings will be similar to those observed in the randomized, placebo-controlled, double-blind, adaptive study 'A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)(RIN-PH-304).

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Chronic Obstructive Pulmonary Disease Drug: Inhaled treprostinil solution Phase 3

Detailed Description:

This is a multi-center, open-label study for eligible participants who completed all scheduled study visits during the Treatment Period of Study RIN-PH-304.

Participants who provide informed consent for this open-label extension study on or prior to the final study visit of RIN-PH-304 may participate in the study, provided all other eligibility criteria are met. The RIN-PH-304 final study visit and the RIN-PH-305 Enrollment Visit will occur on the same day.

All participants will reinitiate inhaled treprostinil at 3 breathes (18 micrograms [mcg]) 4 times daily (QID) during waking hours. Study drug doses should be maximized to tolerability throughout the study, and dose titrations should occur as rapidly as possible (as directed by the Investigator) with a target dosing regimen of 15 breaths QID or the maximum tolerated dose.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This trial is not blinded. All participants will begin titration of study drug once all entry criteria have been met.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of Inhaled Treprostinil in Patients With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)
Actual Study Start Date : December 21, 2018
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : July 31, 2025


Arm Intervention/treatment
Experimental: Inhaled Treprostinil Solution
Inhaled treprostinil solution (0.6 milligrams per milliliter [mg/mL], 6 mcg/breath) QID during waking hours.
Drug: Inhaled treprostinil solution
Inhaled treprostinil solution per dose and schedule specified in the arm




Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From enrollment to end of study, estimated up to 2 years. ]

Secondary Outcome Measures :
  1. 6 Minute Walk Distance (6MWD) [ Time Frame: Assessed at enrollment, Week 6, and then every 12 weeks through study completion, estimated up to 2 years. ]
    Participants 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.

  2. Borg Dyspnea Score [ Time Frame: Assessed at enrollment, Week 6, and then every 12 weeks through study completion, estimated up to 2 years. ]
    The modified 0-10 category-ratio Borg scale is one in which the participants rate the maximum level of dyspnea they experienced during the Six Minute Walk Test (6MWT). Scores range from 0 (for the best condition) and 10 (for the worst condition).

  3. N-terminal Pro-brain Natriuretic Peptide (NT-pro-BNP) [ Time Frame: Assessed at enrollment, Week 6, and then every 12 weeks through study completion, estimated up to 2 years. ]
    The NT-proBNP concentration is a biomarker associated with changes in right heart morphology and function.

  4. Saturation Peripheral Capillary Oxygenation (SpO2) [ Time Frame: Assessed at enrollment, Week 6, and then every 12 weeks through study completion, estimated up to 2 years. ]
    SpO2 will be assessed via pulse oximetry.

  5. Heart Rate [ Time Frame: Assessed at enrollment, Week 6, and then every 12 weeks through study completion, estimated up to 2 years. ]
    Heart rate will be assessed via pulse oximetry

  6. Change in Baseline in Patient Global Assessment (PGA) [ Time Frame: Week 6, Year 1 or Discontinuation Visit (whichever occurs first) ]
    The PGA is used to rate participant fatigue and shortness of breath. Participants will use the Sponsor-provided smart device for at-home capture of PGA data.

  7. Change from Baseline in Actigraphy [ Time Frame: Baseline, Week 6, Year 1 or Discontinuation Visit (whichever occurs first) ]
    Daily physical activity, including overall, non-sedentary, and moderate to vigorous physical activity will be measured via a wrist-worn medical grade physical activity monitor (actigraph).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant voluntarily gives informed consent to participate in the study.
  2. Participant completed Study RIN-PH-304.
  3. Women of childbearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must agree to practice abstinence or use 2 highly effective methods of contraception (defined as a method of birth control that results in a low failure rate, [less than 1% per year], such as approved hormonal contraceptives, barrier methods [such as condom or diaphragm] used with a spermicide, or an intrauterine device) for the duration of study treatment and for 48 hours after discontinuing study drug.
  4. Males with a partner of childbearing potential must agree to use a barrier method (condom) with a spermicide for the duration of treatment and for at least 48 hours after discontinuing study drug.

Exclusion Criteria:

  1. The participant is pregnant or lactating.
  2. The participant was prematurely discontinued from Study RIN-PH-304.
  3. The participant is intolerant to inhaled prostanoid therapy.
  4. The participant is unwilling or unable to use Sponsor-provided devices (actigraph, spirometer, or smart device).
  5. The participant is scheduled to receive another investigational drug, device, or therapy during the course of this study.
  6. Any other clinically significant illness or abnormal laboratory value(s) that, in the opinion of the Investigator, might adversely affect the interpretation of the study data.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794583


Locations
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Sponsors and Collaborators
United Therapeutics
Lung Biotechnology PBC
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Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT03794583    
Other Study ID Numbers: RIN-PH-305
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: August 30, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by United Therapeutics:
Treprostinil
Lung Diseases
Hypertension
Vascular Diseases
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents