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Inhaled Treprostinil in Patients With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD) (PERFECTOLE)

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ClinicalTrials.gov Identifier: NCT03794583
Recruitment Status : Enrolling by invitation
First Posted : January 7, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
United Therapeutics
Information provided by (Responsible Party):
Lung Biotechnology PBC

Brief Summary:
This open-label study will evaluate the safety of continued therapy with inhaled treprostinil in subjects who have completed Study RIN-PH-304. 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 subjects who completed all scheduled study visits during the Treatment Period of Study RIN-PH-304.

Subjects 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 United Therapeutics Corp. RIN-PH-305 Original Protocol Lung Biotechnology PBC Inhaled Treprostinil Version Date 05 September 2018 Confidential Page 12 criteria are met. The RIN-PH-304 final study visit and the RIN-PH-305 Enrollment Visit will occur on the same day.

All subjects will reinitiate inhaled treprostinil at a dose of 3 breaths at 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 of 12 breaths (72 mcg) four times a day (QID) or to maximum tolerability. If there are adverse events (AEs) that are dose related, the dosing can be adjusted to tolerability.

Study visits will occur at enrollment, Week 6, and quarterly thereafter. The study may be terminated at any time by the Sponsor for reasons that may include, but are not limited to, commercial availability of inhaled treprostinil for PH-COPD and Sponsor termination of the development for the indication of PH-COPD.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This study is not blinded. All patients will begin titration of study drug once the ICF has been signed and 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 : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Inhaled treprostinil solution
Inhaled treprostinil solution (6mcg/breath), 4 times daily (QID) during waking hours.
Drug: Inhaled treprostinil solution
Inhaled treprostinil solution (6 mcg/breath), 4 times daily (QID) during waking hours.




Primary Outcome Measures :
  1. Incidence of treatment-related adverse events [ Time Frame: Change in incidence from enrollment to end of study, estimated up to 2 years. ]
    Descriptive analyses of all adverse events will be performed. Incidence will be analyzed by the percentage of subjects who experienced an adverse event until study completion.

  2. Severity of treatment-related adverse events [ Time Frame: Change in severity from enrollment to end of study, estimated up to 2 years. ]
    Descriptive analyses of all adverse events will be performed.


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. ]
    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.

  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 subjects 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. Pulse Oximetry [ Time Frame: Assessed at enrollment, Week 6, and then every 12 weeks through study completion, estimated up to 2 years. ]
    Pulse Oximetry will include the collection of saturation peripheral capillary oxygenation (SpO2) and HR.



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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. Subject voluntarily gives informed consent to participate in the study.
  2. Subject participated in Study RIN-PH-304 and completed all scheduled study visits.
  3. Women of childbearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must be practicing abstinence or using 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). Subject must have a negative urine pregnancy test at the Enrollment Visit.
  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 subject is pregnant or lactating.
  2. The subject was prematurely discontinued from Study RIN-PH-304.
  3. The subject is intolerant to prostanoid therapy.
  4. The subject is scheduled to receive another investigational drug, device, or therapy during the course of this study.
  5. 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
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
Lung Biotechnology PBC
United Therapeutics

Responsible Party: Lung Biotechnology PBC
ClinicalTrials.gov Identifier: NCT03794583     History of Changes
Other Study ID Numbers: RIN-PH-305
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lung Biotechnology PBC:
Treprostinil
Lung Diseases
Hypertension
Vascular Diseases

Additional relevant MeSH terms:
Hypertension
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Pharmaceutical Solutions
Treprostinil
Antihypertensive Agents