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Pulmonary Rehab in COPD: Response to Tyvaso

This study is currently recruiting participants.
Verified August 2017 by Inova Health Care Services
Sponsor:
ClinicalTrials.gov Identifier:
NCT02178566
First Posted: July 1, 2014
Last Update Posted: August 18, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Inova Health Care Services
  Purpose
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Inhaled Treprostinil Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pulmonary Rehabilitation in COPD: Response to Inhaled Treprostinil (Tyvaso)

Resource links provided by NLM:


Further study details as provided by Inova Health Care Services:

Primary Outcome Measures:
  • distance walked on 6MWT [ Time Frame: 9 weeks ]
    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


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 9 weeks ]
    To assess the effect inhaled treprostinil, administered prior to pulmonary rehabilitation in COPD patients, on secondary outcomes including quality of life (as measured by the St. George's respiratory questionnaire, Clinical COPD Questionaire), BODE index, lowest nadir of oxygen saturation on 6 minute walk test, number of exacerbations, ER visits, hospitalizations, and change in measures of strength training.


Estimated Enrollment: 34
Actual Study Start Date: August 2015
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Inhaled Treprostinil Placebo
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
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 .
Other Name: Tyvaso
Active Comparator: Inhaled Treprostinil
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
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 .
Other Name: Tyvaso

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing to sign informed consent prior to initiation of any study mandated procedure
  2. Male or female ≥ 40 years of age
  3. Women of childbearing potential must use a reliable method of contraception from screening until 1 month after end of study medication
  4. 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
  5. Current or past smokers of ≥ 10 pack years
  6. 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.
  7. 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)

Exclusion Criteria:

  1. 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
  2. BMI > 40 kg/m2
  3. Unstable coronary artery disease, unstable angina, or myocardial infarction within 3 months prior to screening
  4. History of pulmonary edema, or uncontrolled heart failure
  5. Uncontrolled systemic hypertension with a blood pressure >180/105 mmHg at rest
  6. Systemic hypotension with systolic blood pressure < 85 mmHg
  7. Uncontrolled arrhythmias
  8. History of syncope
  9. Planned surgical intervention during the study period
  10. 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
  11. Severe hepatic impairment (Child-Pugh Class C)
  12. 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
  13. Pregnant or nursing
  14. Currently (within 30 days prior to enrollment) taking specific pulmonary arterial hypertension therapy (e.g., bosentan, ambrisentan, tadalafil, sildenafil, epoprostenol, treprostinil, iloprost, beraprost), sildenafil and tadalafil for erectile dysfunction is permitted
  15. Initiation of a pulmonary rehabilitation program within 3 months prior to screening or initiation or changes during the study
  16. Participation in any other clinical trial, except observational, or receipt of an investigational medicinal product within 30 days prior to RHC visit
  17. Known concomitant life-threatening disease with a life expectancy < 6 months
  18. Known hypersensitivity to treprostinil or any of the excipients of the drug formulations.
  19. Known hypersensitivity to inhaled nitric oxide
  Contacts and Locations
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): NCT02178566


Contacts
Contact: Christopher King, MD 703-776-3582 christopher.king@inova.org
Contact: Edwinia Battle, RN, BSN 703-776-3067 edwinia.battle@inova.org

Locations
United States, Virginia
Inova Fairfax Medical Campus Recruiting
Falls Church, Virginia, United States, 22042
Contact: Christopher King, Md    703-776-3582      
Principal Investigator: Christopher King, Md         
Principal Investigator: Steven Nathan, Md         
Sponsors and Collaborators
Inova Health Care Services
Investigators
Principal Investigator: Steven Nathan, MD Inova Fairfax Medical Campus
Principal Investigator: Christopher King, MD Inova Fairfax Medical Campus
  More Information

Publications:
Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT02178566     History of Changes
Other Study ID Numbers: Inova-TY-PR-001
First Submitted: June 22, 2014
First Posted: July 1, 2014
Last Update Posted: August 18, 2017
Last Verified: August 2017

Keywords provided by Inova Health Care Services:
COPD
Trepostinil
Pulmonary Rehabilitation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents