Trial Outcomes & Findings for Pulmonary Rehab in Chronic Obstructive Pulmonary Disease (COPD): Response to Tyvaso (NCT NCT02178566)

Last Updated: 2022-04-12

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

9 weeks

Results posted on

2022-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	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 .	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 .
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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 .	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 .
Overall Study patient did not complete due to noncompliance	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	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 .	Inhaled Treprostinil n=1 Participants 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 n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	—	61 years n=7 Participants	61 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 weeks

Population: no patient completed. one patient consented but did not complete the study

Outcome measures

Outcome data not reported

Adverse Events

Inhaled Treprostinil Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inhaled Treprostinil

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	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 . 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 .	Inhaled Treprostinil n=1 participants at risk 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 .
General disorders Lightheadedness	— 0/0 • 1 year Patients monitored from dosing to end of study treatment period.	100.0% 1/1 • Number of events 2 • 1 year Patients monitored from dosing to end of study treatment period.

Additional Information

Christopher King, MD

Inova Health Systems

Phone: 7037763067

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place