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OpenTrials
Completed

NCT Number: NCT01266265

Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies

A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Associates, P.C., Birmingham, Alabama, United States

Loading trial locations.

About this study

A post marketing surveillance to determine the type and incidence of oro/nasopharyngeal or pulmonary adverse events that may occur in patients treated with commercially available Tyvaso®(treprostinil) Inhalation Solution. A comparison will be made to the type and incidence of events in patients receiving other FDA approved therapies for pulmonary arterial hypertension, as a control measure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of PAH, WHO GROUP I
  • Prescribed and is currently receiving Tyvaso and/or other FDA-approved therapy for the treatment of PAH
  • Willing and able to provide written informed consent

Exclusion criteria

  • Previous initiation and permanent discontinuation of Tyvaso
  • Participation in an investigational clinical drug or device trial within 30 days of enrollment
  • Current or past diagnosis of lung neoplasm
  • Active gastrointestinal or pulmonary bleed at enrollment
  • Planned surgical intervention for treatment of PAH e.g., atrial septostomy or transplant

Treatment and study plan

inhaled prostacyclin

Drug

Tyvaso

Other names: treprostinil

prostacyclin

Drug

As prescribed by the physician

Other names: epoprostenol sodium, Flolan

subcutaneous and intravenous prostacyclin

Drug

As prescribed by physician

Other names: treprostinil , Remodulin

oral ERA

Drug

As prescribed by physician

Other names: bosentan, Tracleer, ambrisentan, Letairis

oral PDE5 inhibitors

Drug

As prescribed by physician

Other names: sildenafil, Revatio, tadalafil, Adcirca

Primary outcomes

  1. Prevalence of Respiratory Tract-Related Adverse Events of Interest

    Time frame: Follow-up every 3 months

    Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.

Sponsors and collaborators

Lead sponsor

United Therapeutics

Industry

Registry information

Official study title

A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution

Acronym: Aspire

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 24, 2010
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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