Brief Summary
A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies
Brief Title
Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Pulmonary Arterial Hypertension
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
NCT Id
NCT01266265
Org Class
Industry
Org Full Name
United Therapeutics
Org Study Id
RIN-PH-403
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution
Primary Outcomes
Outcome Description
Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.
Outcome Measure
Prevalence of Respiratory Tract-Related Adverse Events of Interest
Outcome Time Frame
Follow-up every 3 months
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
community centers, academic institutions
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
James Tauras
Investigator Email
jtauras@montefiore.org
Investigator Phone
Categories Mesh Debug
Heart/Cardiovascular --- PULMONARY ARTERIAL HYPERTENSION
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
MeSH Terms
PULMONARY ARTERIAL HYPERTENSION
RESPIRATORY ASPIRATION
HYPERTENSION, PULMONARY
LUNG DISEASES
RESPIRATORY TRACT DISEASES
RESPIRATION DISORDERS
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
TREPROSTINIL
ILOPROST
EPOPROSTENOL
INJECTIONS, SUBCUTANEOUS
BOSENTAN
AMBRISENTAN
PHOSPHODIESTERASE 5 INHIBITORS
SILDENAFIL CITRATE
TADALAFIL
PROSTAGLANDINS, SYNTHETIC
PROSTAGLANDINS
EICOSANOIDS
FATTY ACIDS, UNSATURATED
FATTY ACIDS
LIPIDS
AUTACOIDS
INFLAMMATION MEDIATORS
BIOLOGICAL FACTORS
PROSTAGLANDINS I
INJECTIONS
DRUG ADMINISTRATION ROUTES
DRUG THERAPY
THERAPEUTICS
BENZENESULFONAMIDES
SULFONAMIDES
AMIDES
ORGANIC CHEMICALS
BENZENE DERIVATIVES
HYDROCARBONS, AROMATIC
HYDROCARBONS, CYCLIC
HYDROCARBONS
SULFONES
SULFUR COMPOUNDS
PYRIMIDINES
HETEROCYCLIC COMPOUNDS, 1-RING
HETEROCYCLIC COMPOUNDS
PHOSPHODIESTERASE INHIBITORS
ENZYME INHIBITORS
MOLECULAR MECHANISMS OF PHARMACOLOGICAL ACTION
PHARMACOLOGIC ACTIONS
CHEMICAL ACTIONS AND USES
PIPERAZINES
PURINES
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
CARBOLINES
PYRIDINES
INDOLE ALKALOIDS
INDOLES
HETEROCYCLIC COMPOUNDS, 3-RING