Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
Results First Received: December 15, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: inhaled prostacyclin
Drug: prostacyclin
Drug: subcutaneous and intravenous prostacyclin
Drug: oral ERA
Drug: oral PDE5 inhibitors

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period for this study was February 2010 to December 2014. All sites were located in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Control

The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of Baseline visit, but treated with any other FDA approved PAH therapy as part of routine care.

inhaled prostacyclin: As prescribed by the physician prostacyclin: As prescribed by the physician subcutaneous and intravenous prostacyclin: As prescribed by physician oral ERA: As prescribed by physician oral PDE5 inhibitors: As prescribed by physician


Participant Flow:   Overall Study
    Tyvaso   Control
STARTED   666   667 
COMPLETED   461   477 
NOT COMPLETED   205   190 
Death                95                73 
Lost to Follow-up                23                28 
Withdrawal by Subject                13                11 
Respiratory-related adverse event                2                1 
Transferred care to another provider                22                28 
Stopped/changed PAH medication(s)                16                9 
Enrolled in another clinical study                15                26 
Non-compliance                8                5 
Lung transplant                6                5 
Site closed early                4                3 
Clinical worsening                1                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

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.
Total Total of all reporting groups

Baseline Measures
   Tyvaso   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 666   667   1333 
Age 
[Units: Years]
Median (Full Range)
 57.5 
 (5 to 90) 
 57.0 
 (3 to 97) 
 57.25 
 (3 to 97) 
Gender 
[Units: Participants]
     
Female   519   532   1051 
Male   147   135   282 
Disease etiology [1] 
[Units: Participants]
     
Idiopathic/heritable/drug- or toxin-induced   341   389   730 
Connective tissue disease   223   195   418 
Congential heart disease   55   37   92 
HIV infection/porto-pulmonary   53   55   108 
Other   9   4   13 
[1] Patients were instructed to select all that apply.
Race [1] 
[Units: Participants]
     
White   483   510   993 
Black/African American   116   107   223 
Other/race not disclosed   42   33   75 
Asian   21   15   36 
Native Hawaiian/Pacific Islander   3   1   4 
American Indian/Alaska Native   2   1   3 
[1] Patients were instructed to select all that apply.
Years Since PAH Diagnosis 
[Units: Years]
Median (Full Range)
 2.9 
 (0 to 32.0) 
 2.9 
 (0 to 26.0) 
 2.9 
 (0 to 32.0) 
Baseline PAH Medication [1] 
[Units: Participants]
     
Tyvaso (treprostinil) inhalation   666   0   666 
Remodulin (treprostinil)   2   150   152 
Flolan (epoprostenol)   2   44   46 
Veletri (epoprostinol)   0   36   36 
Ventavis (iloprost) inhalation   0   33   33 
Revatio (sildenafil citrate)   294   236   530 
Adcirca (tadalafil)   239   224   463 
Letairis (ambrisentan)   250   200   450 
Tracleer (bosentan)   164   203   367 
Opsumit (macitentan)   4   2   6 
Adempas (riociguat)   2   2   4 
[1] Patients were instructed to select all that apply.


  Outcome Measures

1.  Primary:   Prevalence of Respiratory Tract-Related Adverse Events of Interest   [ Time Frame: Follow-up every 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Nicole Leedom
Organization: United Therapeutics Corporation
phone: 919-425-5870
e-mail: nleedom@unither.com



Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01266265     History of Changes
Other Study ID Numbers: RIN-PH-403
Study First Received: December 22, 2010
Results First Received: December 15, 2015
Last Updated: January 20, 2016
Health Authority: United States: Food and Drug Administration