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
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Sponsor:
Inova Health Care Services
Information provided by (Responsible Party):
Inova Health Care Services
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Inhaled Treprostinil Placebo | Inhaled Treprostinil |
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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
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Baseline Characteristics
Arm/Group Title | Inhaled Treprostinil Placebo | Inhaled Treprostinil | Total | |
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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 | |
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1 patient enrolled
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | 1 participants | 1 participants | |
<=18 years | 0 |
0 0.0%
|
0 0.0%
|
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Between 18 and 65 years | 0 |
1 100.0%
|
1 100.0%
|
|
>=65 years | 0 |
0 0.0%
|
0 0.0%
|
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 0 participants | 1 participants | 1 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
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Asian |
0 0.0%
|
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
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Black or African American |
0 0.0%
|
0 0.0%
|
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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%
|
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 0 participants | 1 participants | 1 participants |
1 | 1 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Christopher King, MD |
Organization: | Inova Health Systems |
Phone: | 7037763067 |
EMail: | christopher.king@inova.org |
Publications:
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 |