Trial intelligence / Profile preview

Inhaled Treprostinil in COPD Pulmonary Rehabilitation

NCT02178566Phase 2

Key facts

Status: Terminated
Start: Aug 2015
Primary completion: Jan 2019
Countries: 1
Sponsor: Inova Health System
Modality: Orthosteric Ligands

Drugs: treprostinil
Conditions: chronic obstructive pulmonary disease (COPD)

Overview

Phase 2, randomised, double-blind trial in chronic obstructive pulmonary disease (COPD) comparing Inhaled Treprostinil Placebo with Inhaled Treprostinil (2 arms). Primary endpoint: Distance Walked on 6-Minute Walk Test at 9 weeks. Started Aug 2015; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Inhaled Treprostinil Placebo
Placebo + Albuterol prior to PR sessions
Inhaled Treprostinil
Treprostinil + Albuterol prior to PR sessions

Who it enrols

Patients >= 40 years with moderate to severe COPD (FEV1/FVC < 0.7 and FEV1 <= 60%), >= 10 pack-year smoking history, stable on medications, without recent exacerbations, severe obesity, or significant cardiovascular/renal/hepatic comorbidities.

Endpoints

Primary

Distance Walked on 6-Minute Walk Test9 weeks

Secondary

St. George's Respiratory Questionnaire Score9 weeks
Clinical COPD Questionnaire Score9 weeks
BODE Index9 weeks
Lowest nadir of oxygen saturation on 6-minute walk test9 weeks
Number of exacerbations9 weeks
Number of ER visits9 weeks
Number of hospitalizations9 weeks
Change in measures of strength training9 weeks

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