Pulmonary Arterial HypertensionAspireNCT01266265
Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
An observational study of Pulmonary Arterial Hypertension, run by United Therapeutics at 88 sites in United States.
Trial summary
A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- inhaled prostacyclin, prostacyclin and subcutaneous and intravenous prostacyclin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1,333 participants
- Where
- 88 sitesUnited States
- Study dates
- Dec 2010to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: community centers, academic institutions
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
88 sites in 1 country.
88 sites in 1 country
United States88 sites
Akron General Hospital
Akron, Ohio, 44302
Emory University School of Medicine
Atlanta, Georgia, 30322
Georgia Lung Associates, PC
Austell, Georgia, 30106
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21205
Berkeley Cardiovascular Medical Group
Berkeley, California, 94705
Cedars-Sinai Heart Institute
Beverly Hills, California, 90211
Cardiovascular Associates, P.C.
Birmingham, Alabama, 35213
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Tufts - New England Medical Center
Boston, Massachusetts, 02111
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Indiana University Hospital
Carmel, Indiana, 46032
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
MD Total Care, PLLC
Chattanooga, Tennessee, 37419
Northwestern Medical Center
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45267-0564
St. Francis Sleep Allergy & Lung
Clearwater, Florida, 33765
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Davis Heart and Lung Research Institute
Columbus, Ohio, 43210
UT Southwestern Medical Center
Dallas, Texas, 75390
Children's Hospital Denver
Denver, Colorado, 80045
Henry Ford Health System
Detroit, Michigan, 48202
Mercy Fairfield Hospital
Fairfield, Ohio, 45014
Inova Fairfax Hospital
Falls Church, Virginia, 22042
University California San Francisco
Fresno, California, 93721
University of Florida
Gainesville, Florida, 32610
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Mercy Hospital
Iowa City, Iowa, 52245
SUNY Stony Brook University Medical Center
Islandia, New York, 11790
Pulmonary and Critical Care Associates
Jacksonville, Florida, 32204
University of Florida College of Medicine Jacksonville
Jacksonville, Florida, 32209
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
University of Kansas Medical Center
Kansas City, Kansas, 66160
Summit Medical Group
Knoxville, Tennessee, 37909
Lexington Pulmonary and Critical Care
Lexington, South Carolina, 29072
Nebraska Pulmonary Specialties, LLC
Lincoln, Nebraska, 68506
University of Southern California
Los Angeles, California, 90033
West Los Angeles VA Healthcare Center
Los Angeles, California, 90073
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202
Miami Center for Cardiovascular Disease
Miami, Florida, 33136
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Aurora Health Care
Milwaukee, Wisconsin, 53215
Winthrop Pulmonary Associates
Mineola, New York, 11501
University of South Alabama
Mobile, Alabama, 36693
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center
New Brunswick, New Jersey, 08903
North Shore - Long Island Jewish Health System
New Hyde Park, New York, 11040
St. Luke's-Roosevelt Hospital Center
New York, New York, 10019
Columbia University Medical Center
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
Midwest Heart Foundation
Oakbrook Terrace, Illinois, 60181
Central Florida Pulmonary Group, P.A.
Orlando, Florida, 32806
Orlando Heart Center
Orlando, Florida, 32806
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Temple University
Philadelphia, Pennsylvania, 19140
Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, 85013
Pinehurst Medical Clinic
Pinehurst, North Carolina, 28374
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213-2582
Legacy Pulmonary Northwest
Portland, Oregon, 97210
Oregon Clinic, PC
Portland, Oregon, 97220
OHSU-Oregon Health and Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
Mayo Clinic
Rochester, Minnesota, 55905
Mary M Parkes Center
Rochester, New York, 14623
University of California Davis Medical Center
Sacramento, California, 95817
Methodist Healthcare System of San Antonio
San Antonio, Texas, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
University of California, San Francisco
San Francisco, California, 94143
Paloma Medical Group
San Juan Capistrano, California, 92675
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
Stanford Hospital and Clinics
Stanford, California, 94305
Pulmonary Health Physicians
Syracuse, New York, 13210
William Beaumont Hospital
Troy, Michigan, 48085
Cleveland Clinic Florida
Weston, Florida, 33331
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, 80033
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Berks Schuylkill Respiratory Specialists, Ltd.
Wyomissing, Pennsylvania, 19610
About this study
Official title: 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
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- inhaled prostacyclin, prostacyclin, subcutaneous and intravenous prostacyclin, oral ERA, oral PDE5 inhibitors
- 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
- Medical subject headings
- Pulmonary Arterial Hypertension, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled prostacyclinDrug
Also called treprostinil
Tyvaso
inhaled prostacyclinDrug
Also called iloprost, Ventavis
As prescribed by the physician
prostacyclinDrug
Also called epoprostenol sodium, Flolan
As prescribed by the physician
subcutaneous and intravenous prostacyclinDrug
Also called treprostinil , Remodulin
As prescribed by physician
oral ERADrug
Also called bosentan, Tracleer, ambrisentan, Letairis
As prescribed by physician
oral PDE5 inhibitorsDrug
Also called sildenafil, Revatio, tadalafil, Adcirca
As prescribed by physician
| Study group | Role | What they receive |
|---|---|---|
| Tyvaso | The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care. Receives: 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. Receives: Drug: inhaled prostacyclin; Drug: prostacyclin; Drug: subcutaneous and intravenous prostacyclin; Drug: oral ERA; Drug: oral PDE5 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Follow-up every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,333 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266265
- Sponsor's protocol ID
- RIN-PH-403
- Acronym
- Aspire
- Status last verified
- Jan 2016
- First submitted
- 22 Dec 2010
- Last updated
- 17 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zamanian RT, Levine DJ, Bourge RC, De Souza SA, Rosenzweig EB, Alnuaimat H, Burger C, Mathai SC, Leedom N, DeAngelis K, Lim A, De Marco T. An observational study of inhaled-treprostinil respiratory-related safety in patients with pulmonary arterial hypertension. Pulm Circ. 2016 Sep;6(3):329-37. doi: 10.1086/688059.
PubMed 27683610
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution
- ClinicalTrials.gov ID
- NCT01266265
- Acronym / sponsor ID
- Aspire / RIN-PH-403
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- pulmonary arterial hypertension, PAH, treprostinil sodium, Tyvaso, inhalation, Ventavis, iloprost, prostacyclin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,333 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Dec 2010 (estimated)
- Results
- Posted 17 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tyvaso | – | Drug: inhaled prostacyclinThe Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care. |
| Control | – | Drug: inhaled prostacyclin, Drug: prostacyclin, Drug: subcutaneous and intravenous prostacyclin, Drug: oral ERA, Drug: oral PDE5 inhibitorsThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- community centers, academic institutions
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhaled prostacyclinAlso: treprostinilTyvaso | Drug | Tyvaso |
| inhaled prostacyclinAlso: iloprost, VentavisAs prescribed by the physician | Drug | Control |
| prostacyclinAlso: epoprostenol sodium, FlolanAs prescribed by the physician | Drug | Control |
| subcutaneous and intravenous prostacyclinAlso: treprostinil , RemodulinAs prescribed by physician | Drug | Control |
| oral ERAAlso: bosentan, Tracleer, ambrisentan, LetairisAs prescribed by physician | Drug | Control |
| oral PDE5 inhibitorsAlso: sildenafil, Revatio, tadalafil, AdcircaAs prescribed by physician | Drug | Control |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27683610Zamanian RT, Levine DJ, Bourge RC, De Souza SA, Rosenzweig EB, Alnuaimat H, Burger C, Mathai SC, Leedom N, DeAngelis K, Lim A, De Marco T. An observational study of inhaled-treprostinil respiratory-related safety in patients with pulmonary arterial hypertension. Pulm Circ. 2016 Sep;6(3):329-37. doi: 10.1086/688059.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
88 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by United Therapeutics at 88 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Respiratory Tract-Related Adverse Events of Interest (time frame: Follow-up every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01266265, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.