A Study of the Safety and Effectiveness of Experimental Inhaled Treprostinil For Pulmonary Hypertension due to COPD

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Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease, COPD, Pulmonary Hypertension, PH-COPD
Type: Drug study, Phase 3
Target:
10 Participants
Investigator:
Description
This study involves research about experimental inhaled treprostinil. This study will test its effectiveness in improving exercise ability in patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD). Its effects will be compared to an inactive solution, or placebo. A placebo looks like the study drug, but does not contain the study drug’s active ingredient(s).

Inhaled treprostinil (brand name Tyvaso®) is FDA approved for other diseases. In this study, inhaled treprostinil is considered to be an investigational (not approved by the FDA) treatment for PH-COPD.

Inhaled treprostinil will be given by a handheld inhalation device. The "study nebulizer" is called the Tyvaso® Inhalation System.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  1. Subject voluntarily gives informed consent to participate in the study.
  2. Males and females 18 years of age and above at the time of informed consent. a. Women of child-bearing 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, [<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 pregnancy test at the Screening Visit 1 and Period 1 Baseline Visit (Study Week 1). b. 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.
  3. Diagnosis of WHO Group 3 PH-COPD.
  4. Clinical diagnosis of chronic obstructive pulmonary disease (COPD) will be made using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) diagnostic criteria and post-bronchodilator spirometry with the following documented parameters must be measured during Screening Visit 1 (prior to start of low dose inhaled treprostinil): a. Forced expiratory volume in 1 second (FEV1) <65% predicted, and b. FEV1/Forced vital capacity (FVC) <70
  5. The subject has a resting saturation peripheral capillary oxygenation (SpO2) ≥90%, with or without supplemental oxygen, but not to exceed 10 L/min oxygen supplementation by any mode of delivery at rest during Screening Visit 1.
  6. At Screening Visit 1 prior to start of low dose inhaled treprostinil, a 6MWD ≥100 meters.
  7. Have a RHC including a vasodilator test, with and without an oxygen challenge, performed at Screening Visit 1. Previous hemodynamic assessments obtained within 90 days prior to the Screening Visit 1 are acceptable and a repeat assessment is not needed at Screening). The following parameters must be documented for eligibility: a. PVR >4 Wood units, and b. A pulmonary artery wedge pressure (PAWP) or left ventricular end-diastolic pressure (LVEDP) of <15 mmHg, and c. A PAPm of ≥30 mmHg
  8. Subjects on a supportive medication therapy (eg, anticoagulants, diuretics, oxygen, etc) must be on a stable and optimized dose for ≥30 days prior to Screening Visit 1 and remain on stable doses throughout the Screening Period. Exceptions are the discontinuation or dose changes of anticoagulants and/or dose change of diuretics.
  9. Subjects must be post recovery from an acute respiratory event or hospitalization for respiratory insufficiency, and on a stable and optimized dose of chronic medications for COPD for ≥60 days prior to Screening Visit 1, and remain on stable doses throughout the Screening Period.
  10. In the opinion of the Investigator, the subject can communicate effectively with study personnel and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.

Exclusion criteria:

  1. The subject has a diagnosis of either pulmonary arterial hypertension (PAH) or pulmonary hypertension (PH) due to reasons other than COPD. This would include, but is not limited to, chronic thromboembolic pulmonary hypertension or acute/recent deep vein thrombosis or pulmonary embolism, 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.
  2. 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 Screening Visit 1, except for acute vasoreactivity testing.
  3. The subject has had any prior intolerance to prostanoid therapy.
  4. Inability to tolerate low dose (3 breaths, 18 mcg) study drug and/or unable to follow dosing regimen during Screening Period (pre-randomization).
  5. The subject has evidence of clinically significant left-sided heart disease (including but not limited to left ventricular ejection fraction <40%, left ventricular hypertrophy, or significant valvular disease). Note: Subjects with abnormal left ventricular function attributable to the effects of right ventricular overload will not be excluded, but a discussion with and approval by the Sponsor Medical Monitor is needed.
  6. The subject is receiving >10 L/min of oxygen supplementation by any mode of delivery at rest between Screening Visit 1 and Period 1 Baseline Visit (Study Week 1; prerandomization).
  7. Currently using any inhaled tobacco products, electronic cigarettes, inhaled marijuana, or significant history of drug abuse within 6 months prior to Screening Visit 1.
  8. Exacerbation of COPD (including hospitalization or outpatient therapy) for active pulmonary or upper respiratory infection within 60 days prior to Screening Visit 1.
  9. Initiation of pulmonary rehabilitation within 12 weeks prior to Screening Visit 1 or, in the opinion of the Investigator, is likely to be needed during the study Treatment Period.
  10. The subject has an uncontrolled medical condition deemed by an Investigator to pose an undue risk to the subject.
  11. The subject has any form of congenital heart disease or congenital heart defect (repaired or unrepaired; other than a patent foramen ovale) or other conditions, such as congestive heart disease, coronary artery disease, or valvular heart disease.
  12. The subject has a Body Mass Index ≥45 kg/m2 at Screening Visit 1.
  13. The subject has any musculoskeletal disorder (ie, arthritis of the lower limbs which limits ambulation, recent hip or knee joint replacement, artificial leg), or has any other condition that would limit ambulation.
  14. Use of any investigational drug/device or participation in any investigational study with therapeutic intent within 30 days prior to Screening Visit 1.
  15. Any other clinically significant illness or abnormal laboratory value(s) (measured during the Screening Period) that, in the opinion of the Investigator, might adversely affect the interpretation of the study data.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $100 per visit for your time and effort.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for up to 30 weeks and will include about 8 office visits to the study doctor.
Recruitment period
From Sept. 5, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Macey Sockolov
Research Topic
Conditions:
  • Pulmonary Hypertension
  • Chronic Obstructive Pulmonary Disease