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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01266265
First received: December 22, 2010
Last updated: July 15, 2014
Last verified: July 2014
  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:


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 Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tyvaso
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
Tyvaso
Other Name: treprostinil
Control
The control group will consist of patients receiving any 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.

  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
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 ClinicalTrials.gov identifier: NCT01266265

  Show 88 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: July 15, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014