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.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01266265
First received: December 22, 2010
Last updated: January 20, 2016
Last verified: January 2016

December 22, 2010
January 20, 2016
December 2010
December 2014   (final data collection date for primary outcome measure)
Prevalence of Respiratory Tract-Related Adverse Events of Interest [ Time Frame: Follow-up every 3 months ] [ Designated as safety issue: Yes ]
Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.
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 ]
Complete list of historical versions of study NCT01266265 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
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Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution
A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
community centers, academic institutions
Pulmonary Arterial Hypertension
  • Drug: inhaled prostacyclin
    Tyvaso
    Other Name: treprostinil
  • 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
  • Tyvaso
    The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
    Intervention: Drug: inhaled prostacyclin
  • Control
    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.
    Interventions:
    • Drug: inhaled prostacyclin
    • Drug: prostacyclin
    • Drug: subcutaneous and intravenous prostacyclin
    • Drug: oral ERA
    • Drug: oral PDE5 inhibitors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1333
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01266265
RIN-PH-403
No
Not Provided
Not Provided
United Therapeutics
United Therapeutics
Not Provided
Not Provided
United Therapeutics
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP