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Trial record 1 of 1 for:    aspire tyvaso
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Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies (Aspire)

This study has been completed.
Information provided by (Responsible Party):
United Therapeutics Identifier:
First received: December 22, 2010
Last updated: January 20, 2016
Last verified: January 2016
A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies

Condition Intervention
Pulmonary Arterial Hypertension Drug: inhaled prostacyclin Drug: prostacyclin Drug: subcutaneous and intravenous prostacyclin Drug: oral ERA Drug: oral PDE5 inhibitors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution

Resource links provided by NLM:

Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • 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.

Enrollment: 1333
Study Start Date: December 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
Drug: inhaled prostacyclin
Other Name: treprostinil
The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
Drug: inhaled prostacyclin
As prescribed by the physician
Other Name: iloprost, Ventavis
Drug: prostacyclin
As prescribed by the physician
Other Name: epoprostenol sodium, Flolan
Drug: subcutaneous and intravenous prostacyclin
As prescribed by physician
Other Name: treprostinil , Remodulin
Drug: oral ERA
As prescribed by physician
Other Names:
  • bosentan, Tracleer
  • ambrisentan, Letairis
Drug: oral PDE5 inhibitors
As prescribed by physician
Other Names:
  • sildenafil, Revatio
  • tadalafil, Adcirca

Detailed Description:
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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
community centers, academic institutions

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01266265

  Show 88 Study Locations
Sponsors and Collaborators
United Therapeutics
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: United Therapeutics Identifier: NCT01266265     History of Changes
Other Study ID Numbers: RIN-PH-403
Study First Received: December 22, 2010
Results First Received: December 15, 2015
Last Updated: January 20, 2016

Keywords provided by United Therapeutics:
treprostinil sodium
oral treprostinil
pulmonary arterial hypertension
epoprostenol sodium
subcutaneous and intravenous prostacyclin analogue
oral ERA
oral PDE5 inhibitors

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Phosphodiesterase 5 Inhibitors
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Antihypertensive Agents
Endothelin Receptor Antagonists
Platelet Aggregation Inhibitors processed this record on September 21, 2017