Clinical trial NCT01758744: Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1
Official title: TAPIT-1: Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Hypertension
COPD
Keywords: COPD PH
COPD associated Pulmonary Hypertension
COPD and Pulmonary Hypertension
Disease
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open Label, Pilot Study Testing the Safety and Efficacy of Inhaled Treprostinil (Tyvaso®) in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD)

Detailed description: This is a pilot study of 10 patients that have COPD-PH. Primary outcome measure is to see if this drug is safe for this patient population and the secondary measure is to see if the drug improves patient functional capacity.

Eligibility criteria: Inclusion Criteria: must have:

* be between the ages of 30 and 80
* have a clinical diagnosis of Gold stage 2 to 4 COPD
* have a diagnosis of pulmonary hypertension established by a historic right heart catheterization
* a minimum weight of 45 Kg
* minimum systolic blood pressure of \>90 mmHg
* be able to perform a six minute walk test
* be able to maintain a oxygen saturation \>88% at rest (with or without oxygen)
* be treated with background therapy for COPD for a minimum of 1 month prior to consideration of enrollment.
* be competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved Informed Consent Form and must sign the form prior to the initiation of any study procedure.

Exclusion Criteria. Cannot have or be:

* The presence of pulmonary venous hypertension defined by a historical right heart catheterization
* Gold Stage I COPD
* documented left ventricular dysfunction as measured by echocardiography
* pregnant or breastfeeding
* Recipient of a lung transplant
* received chronic prostanoid therapy for pulmonary hypertension within 4 weeks prior to the screening appointment
* A requirement of greater than 9 l/min of O2 to maintain oxygen saturations greater than 88% at rest
* No other serious medical conditions

Primary outcomes:
measure: To assess the safety of Tyvaso ® as assessed by changes or stability of acute oxygenation (pulse oximetry) and spirometry (FEV1).
timeFrame: This is a 4 week trial
Secondary outcomes:
measure: New York Heart Association (NYHA) functional class
timeFrame: Change in New York Heart Association (NYHA) functional class assessed at baseline and at week 4.
measure: Six minute walk distance
timeFrame: Change from baseline in 6 minute walk distance at 4 weeks
measure: Clinical Worsening
timeFrame: From the time of randomization to until the subject discontinues from study for any cause, assessed up to 4 weeks
measure: Peripheral Blood Mononuclear Cells (PBMC) phagocytic index (PI) and PBMC gene expression
timeFrame: Change from baseline in PBMC PI and PBMC gene expression at 4 weeks
measure: St. George's Chronic Obstructive Pulmonary Disease (COPD) questionnaire
timeFrame: change from baseline in the St. George's respiratory questionnaire at 4 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Jacksonville
country: United States
facility: University of Florida College of Medicine
state: Florida
Study officials:
affiliation: University of Colorado, Denver
name: Todd M. Bull, M.D.
role: PRINCIPAL_INVESTIGATOR
References: