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

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ClinicalTrials.gov Identifier: NCT02178566
Recruitment Status : Terminated (Unable to enroll)
First Posted : July 1, 2014
Results First Posted : April 12, 2022
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Intervention Drug: Inhaled Treprostinil
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Inhaled Treprostinil Placebo Inhaled Treprostinil
Hide Arm/Group Description 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 . 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 .
Period Title: Overall Study
Started [1] 0 1 [1]
Completed [1] 0 0 [1]
Not Completed 0 1
Reason Not Completed
patient did not complete due to noncompliance             0             1
[1]
no data available
Arm/Group Title Inhaled Treprostinil Placebo Inhaled Treprostinil Total
Hide Arm/Group Description 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 . 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 . Total of all reporting groups
Overall Number of Baseline Participants 0 1 1
Hide Baseline Analysis Population Description
1 patient enrolled
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
<=18 years 0
0
   0.0%
0
   0.0%
Between 18 and 65 years 0
1
 100.0%
1
 100.0%
>=65 years 0
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 0 participants 1 participants 1 participants
61 61  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
Female 0
0
   0.0%
0
   0.0%
Male 0
1
 100.0%
1
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
White
1
 100.0%
1
 100.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 1 participants 1 participants
1 1
1.Primary Outcome
Title Distance Walked on 6MWT
Hide Description 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
Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
no patient completed. one patient consented but did not complete the study
Arm/Group Title Inhaled Treprostinil Placebo Inhaled Treprostinil
Hide Arm/Group Description:

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 .

No patient completed

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 .

no patient completed
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description Patients monitored from dosing to end of study treatment period.
 
Arm/Group Title Inhaled Treprostinil Placebo Inhaled Treprostinil
Hide Arm/Group Description

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 .

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 .

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 .

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 .
All-Cause Mortality
Inhaled Treprostinil Placebo Inhaled Treprostinil
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0      0/1 (0.00%)    
Hide Serious Adverse Events
Inhaled Treprostinil Placebo Inhaled Treprostinil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Inhaled Treprostinil Placebo Inhaled Treprostinil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      1/1 (100.00%)    
General disorders     
Lightheadedness * 1 [1]  0/0  0 1/1 (100.00%)  2
1
Term from vocabulary, other
*
Indicates events were collected by non-systematic assessment
[1]
Patient reported jittery feeling and lightheadedness
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher King, MD
Organization: Inova Health Systems
Phone: 7037763067
EMail: christopher.king@inova.org
Publications:
Layout table for additonal information
Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT02178566    
Other Study ID Numbers: Inova-TY-PR-001
First Submitted: June 22, 2014
First Posted: July 1, 2014
Results First Submitted: December 17, 2021
Results First Posted: April 12, 2022
Last Update Posted: April 12, 2022