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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01266265
Acronym
Aspire
Enrollment
1333
Registered
2010-12-24
Start date
2010-12-31
Completion date
2014-12-31
Last updated
2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

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

Brief summary

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

Interventions

DRUGinhaled prostacyclin

Tyvaso

DRUGprostacyclin

As prescribed by the physician

DRUGsubcutaneous and intravenous prostacyclin

As prescribed by physician

DRUGoral ERA

As prescribed by physician

DRUGoral PDE5 inhibitors

As prescribed by physician

Sponsors

United Therapeutics
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Respiratory Tract-Related Adverse Events of InterestFollow-up every 3 monthsPercentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.

Countries

United States

Participant flow

Recruitment details

The recruitment period for this study was February 2010 to December 2014. All sites were located in the United States.

Participants by arm

ArmCount
Tyvaso
The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care. inhaled prostacyclin: Tyvaso
666
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.
667
Total1,333

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyClinical worsening11
Overall StudyDeath9573
Overall StudyEnrolled in another clinical study1526
Overall StudyLost to Follow-up2328
Overall StudyLung transplant65
Overall StudyNon-compliance85
Overall StudyRespiratory-related adverse event21
Overall StudySite closed early43
Overall StudyStopped/changed PAH medication(s)169
Overall StudyTransferred care to another provider2228
Overall StudyWithdrawal by Subject1311

Baseline characteristics

CharacteristicTyvasoTotalControl
Age, Continuous57.5 years57.25 years57.0 years
Baseline PAH Medication
Adcirca (tadalafil)
239 participants463 participants224 participants
Baseline PAH Medication
Adempas (riociguat)
2 participants4 participants2 participants
Baseline PAH Medication
Flolan (epoprostenol)
2 participants46 participants44 participants
Baseline PAH Medication
Letairis (ambrisentan)
250 participants450 participants200 participants
Baseline PAH Medication
Opsumit (macitentan)
4 participants6 participants2 participants
Baseline PAH Medication
Remodulin (treprostinil)
2 participants152 participants150 participants
Baseline PAH Medication
Revatio (sildenafil citrate)
294 participants530 participants236 participants
Baseline PAH Medication
Tracleer (bosentan)
164 participants367 participants203 participants
Baseline PAH Medication
Tyvaso (treprostinil) inhalation
666 participants666 participants0 participants
Baseline PAH Medication
Veletri (epoprostinol)
0 participants36 participants36 participants
Baseline PAH Medication
Ventavis (iloprost) inhalation
0 participants33 participants33 participants
Disease etiology
Congential heart disease
55 participants92 participants37 participants
Disease etiology
Connective tissue disease
223 participants418 participants195 participants
Disease etiology
HIV infection/porto-pulmonary
53 participants108 participants55 participants
Disease etiology
Idiopathic/heritable/drug- or toxin-induced
341 participants730 participants389 participants
Disease etiology
Other
9 participants13 participants4 participants
Race
American Indian/Alaska Native
2 participants3 participants1 participants
Race
Asian
21 participants36 participants15 participants
Race
Black/African American
116 participants223 participants107 participants
Race
Native Hawaiian/Pacific Islander
3 participants4 participants1 participants
Race
Other/race not disclosed
42 participants75 participants33 participants
Race
White
483 participants993 participants510 participants
Sex: Female, Male
Female
519 Participants1051 Participants532 Participants
Sex: Female, Male
Male
147 Participants282 Participants135 Participants
Years Since PAH Diagnosis2.9 years2.9 years2.9 years

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
403 / 666388 / 667
serious
Total, serious adverse events
96 / 66694 / 667

Outcome results

Primary

Prevalence of Respiratory Tract-Related Adverse Events of Interest

Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.

Time frame: Follow-up every 3 months

ArmMeasureGroupValue (NUMBER)
TyvasoPrevalence of Respiratory Tract-Related Adverse Events of InterestBleeding from the upper or lower respiratory tract16 percentage of participants
TyvasoPrevalence of Respiratory Tract-Related Adverse Events of InterestUpper or lower respiratory tract infection37 percentage of participants
TyvasoPrevalence of Respiratory Tract-Related Adverse Events of InterestIrritation/pain of nose, mouth, larynx, pharynx17 percentage of participants
TyvasoPrevalence of Respiratory Tract-Related Adverse Events of InterestWheezing, bronchospasm, or asthma/COPD exacerbate12 percentage of participants
TyvasoPrevalence of Respiratory Tract-Related Adverse Events of InterestAny Event52 percentage of participants
ControlPrevalence of Respiratory Tract-Related Adverse Events of InterestWheezing, bronchospasm, or asthma/COPD exacerbate13 percentage of participants
ControlPrevalence of Respiratory Tract-Related Adverse Events of InterestAny Event51 percentage of participants
ControlPrevalence of Respiratory Tract-Related Adverse Events of InterestBleeding from the upper or lower respiratory tract14 percentage of participants
ControlPrevalence of Respiratory Tract-Related Adverse Events of InterestIrritation/pain of nose, mouth, larynx, pharynx10 percentage of participants
ControlPrevalence of Respiratory Tract-Related Adverse Events of InterestUpper or lower respiratory tract infection40 percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026