Trial record 2 of 6 for:    inhaled treprostinil sodium | Open Studies

Pulmonary Rehab in COPD: Response to Tyvaso

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Inova Health Care Services
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT02178566
First received: June 22, 2014
Last updated: June 30, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Study Start Date: July 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: July 2016 (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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02178566

Contacts
Contact: Christopher King, MD 703-776-3582 christopher.king@inova.org
Contact: Melodie C Wuorinen, RN, BSN 703-776-6485 melodie.wuorinen@inova.org

Locations
United States, Virginia
Inova Fairfax Medical Campus Not yet 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
Study First Received: June 22, 2014
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2015