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

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ClinicalTrials.gov Identifier: NCT01266265
Recruitment Status : Completed
First Posted : December 24, 2010
Results First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

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

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

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.

Study Type : Observational
Actual Enrollment : 1333 participants
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
Study Start Date : December 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Group/Cohort Intervention/treatment
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 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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266265


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Sponsors and Collaborators
United Therapeutics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01266265     History of Changes
Other Study ID Numbers: RIN-PH-403
First Posted: December 24, 2010    Key Record Dates
Results First Posted: February 17, 2016
Last Update Posted: February 17, 2016
Last Verified: January 2016

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

Additional relevant MeSH terms:
Treprostinil
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Tezosentan
Sildenafil Citrate
Tadalafil
Iloprost
Phosphodiesterase 5 Inhibitors
Bosentan
Ambrisentan
Epoprostenol
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Antihypertensive Agents
Endothelin Receptor Antagonists
Platelet Aggregation Inhibitors