Pulmonary Rehab in Chronic Obstructive Pulmonary Disease (COPD): Response to Tyvaso

NCT02178566 | Terminated Phase 2 Results DMC

• 1 other identifier: Inova-TY-PR-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators' hypothesis is that pretreating patients with COPD with inhaled treprostinil prior to pulmonary rehabilitation sessions will result in improved exercise tolerance during sessions. This in turn will lead to an increased response to pulmonary rehabilitation, resulting in improved exercise tolerance and quality of life.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Trepostinil; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Distance Walked on 6MWT

  To determine the effect of inhaled treprostinil, administered prior to pulmonary rehabilitation sessions, on the six minute walk test distance (6MWT) in COPD patients after completing an 8 week course of pulmonary rehabilitation

  9 weeks

Study Arms (2)

Inhaled Treprostinil Placebo

PLACEBO COMPARATOR

A dose of placebo resembling inhaled treprostinil will be administered to all study participants in the placebo comparator arm prior to each of their Pulmonary Rehab sessions. A dose of inhaled albuterol will be administered prior to each inhaled agent. Vitals signs will be taken prior to administering the dose and no medication will be given if the systolic blood pressure in \< 85 mm Hg. Three puffs of inhaled trepostinil dose will be administered each time to all patients .

Drug: Inhaled Treprostinil

Inhaled Treprostinil

ACTIVE COMPARATOR

A dose of inhaled treprostinil will be administered to all study participants prior to each of their Pulmonary Rehab sessions. A dose of inhaled albuterol will be administered prior to each inhaled agent. Vitals signs will be taken prior to administering the dose and no medication will be given if the systolic blood pressure in \< 85 mm Hg. Three puffs of inhaled treprostinil dose will be administered each time to all patients .

Drug: Inhaled Treprostinil

Interventions

Inhaled Treprostinil DRUG

A dose of inhaled treprostinil or placebo will be administered to all study participants prior to each of their Pulmonary Rehab sessions. Three puffs of inhaled treprostinil dose will be administered each time to all patients .

Also known as: Tyvaso

Inhaled Treprostinil; Inhaled Treprostinil Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign informed consent prior to initiation of any study mandated procedure
• Male or female ≥ 40 years of age
• Women of childbearing potential must use a reliable method of contraception from screening until 1 month after end of study medication
• Clinical diagnosis of moderate to severe COPD, with an obstructive pattern on pulmonary function tests showing both:
• FEV1/FVC \< 0.7 and
• FEV1 ≤ 60% of predicted value, on standard COPD therapy
• Current or past smokers of ≥ 10 pack years
• If taking oral (\< 20 mg/day of prednisone equivalent) or inhaled corticosteroids, inhaled beta-agonists (short and long acting), or inhaled muscarinic antagonists (short and long acting), or statins the dose must be stable for at least 30 days prior to initial PR visit.
• Ability to adequately participate in exercise testing/pulmonary rehabilitation program with supplemental oxygen use over the period of the study (in the best opinion of the investigator)

You may not qualify if:

• Patients fulfilling one or more of the following criteria of documented COPD exacerbation within 1 months prior to screening:
• Use of antibiotics for COPD exacerbation
• Initiation or dose increase of steroids (inhaled, oral or intravenous) for COPD exacerbation
• Hospitalization for COPD exacerbation
• BMI \> 40 kg/m2
• Unstable coronary artery disease, unstable angina, or myocardial infarction within 3 months prior to screening
• History of pulmonary edema, or uncontrolled heart failure
• Uncontrolled systemic hypertension with a blood pressure \>180/105 mmHg at rest
• Systemic hypotension with systolic blood pressure \< 85 mmHg
• Uncontrolled arrhythmias
• History of syncope
• Planned surgical intervention during the study period
• Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results including musculo-skeletal limitations, peripheral arterial disease, drug or alcohol dependence or psychiatric disease
• Severe hepatic impairment (Child-Pugh Class C)
• Chronic renal insufficiency, as defined by serum creatinine of \> 2.5 mg/dL or estimated creatinine clearance \< 30 mL/min or the requirement for dialysis

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

Related Publications (2)

• Dernaika TA, Beavin M, Kinasewitz GT. Iloprost improves gas exchange and exercise tolerance in patients with pulmonary hypertension and chronic obstructive pulmonary disease. Respiration. 2010;79(5):377-82. doi: 10.1159/000242498. Epub 2009 Sep 25.

  PMID: 19786728 BACKGROUND

• Hegewald MJ, Elliott CG. Sustained improvement with iloprost in a COPD patient with severe pulmonary hypertension. Chest. 2009 Feb;135(2):536-537. doi: 10.1378/chest.08-1515.

  PMID: 19201716 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christopher King, MD
• Organization: Inova Health Systems

christopher.king@inova.org

7037763067

Study Officials

• Steven Nathan, MD

  Inova Fairfax Medical Campus

  PRINCIPAL INVESTIGATOR

• Christopher King, MD

  Inova Fairfax Medical Campus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2014
• First Posted: July 1, 2014
• Study Start: August 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: April 12, 2022
• Results First Posted: April 12, 2022

Record last verified: 2022-03

Locations

US (1)