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Trial record 1 of 1 for:    treprostinil | RIN-PH-403 | United States, Florida
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Study of Incidence of Respiratory Tract Adverse Events in Patients Treated With Tyvaso® Compared to Other FDA Approved Pulmonary Arterial Hypertension (PAH) Therapies (Aspire)

This study is currently recruiting participants.
Verified October 2012 by United Therapeutics
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01266265
First received: December 22, 2010
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Describe the type and incidence of oro-/nasopharyngeal and pulmonary adverse events that may be associated with current or recent treatment with Tyvaso for PAH [ Time Frame: Follow-up every 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare the incidence of selected oro-/nasopharyngeal and pulmonary adverse events in patients treated with Tyvaso for PAH with patients not treated with Tyvaso for PAH [ Time Frame: Follow-up every 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1320
Study Start Date: December 2010
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tyvaso Drug: inhaled prostacyclin
Tyvaso
Other Name: treprostinil
Control
Any other FDA approved therapies for PAH
 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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community centers, academic institutions

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266265

  Show 87 Study Locations
Sponsors and Collaborators
United Therapeutics
  More Information

No publications provided

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01266265     History of Changes
Other Study ID Numbers: RIN-PH-403
Study First Received: December 22, 2010
Last Updated: October 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by United Therapeutics:
treprostinil sodium
Tyvaso
Remodulin
pulmonary arterial hypertension
PAH
inhalation
Ventavis
iloprost
prostacyclin
epoprostenol sodium
Flolan
 subcutaneous and intravenous prostacyclin analogue
oral ERA
bosentan
Tracleer
ambrisentan
Letairis
oral PDE5 inhibitors
sildenafil
Revatio
tadalafil
Adcirca

Additional relevant MeSH terms:
Treprostinil
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Epoprostenol
Iloprost
Bosentan
Tezosentan
Sildenafil
 Tadalafil
Phosphodiesterase 5 Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013