Trial · NCT01266265
Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
NCT01266265, Completed, United Therapeutics; results first posted 2016-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies. Trials, record NCT01266265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01266265
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
- NCT number
- NCT01266265
- Status
- Completed
- Enrollment
- 1,333 participants, actual
- Lead sponsor
- United Therapeutics
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- inhaled prostacyclin, inhaled prostacyclin, prostacyclin, subcutaneous and intravenous prostacyclin, oral ERA, oral PDE5 inhibitors
- First posted
- 2010-12-24
- Last updated
- 2016-02-17
- Results first posted
- 2016-02-17
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Prevalence of Respiratory Tract-Related Adverse Events of Interest | Follow-up every 3 months | Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Prevalence of Respiratory Tract-Related Adverse Events of Interest | Follow-up every 3 months | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Prevalence of Respiratory Tract-Related Adverse Events of Interest | Tyvaso | Any Event | 52 | percentage of participants | |
| Prevalence of Respiratory Tract-Related Adverse Events of Interest | Control | Any Event | 51 | percentage of participants | |
| Prevalence of Respiratory Tract-Related Adverse Events of Interest | Tyvaso | Bleeding from the upper or lower respiratory tract | 16 | percentage of participants | |
| Prevalence of Respiratory Tract-Related Adverse Events of Interest | Control | Bleeding from the upper or lower respiratory tract | 14 | percentage of participants | |
| Prevalence of Respiratory Tract-Related Adverse Events of Interest | Tyvaso | Irritation/pain of nose, mouth, larynx, pharynx | 17 | percentage of participants | |
| Prevalence of Respiratory Tract-Related Adverse Events of Interest | Control | Irritation/pain of nose, mouth, larynx, pharynx | 10 | percentage of participants | |
| Prevalence of Respiratory Tract-Related Adverse Events of Interest | Tyvaso | Upper or lower respiratory tract infection | 37 | percentage of participants | |
| Prevalence of Respiratory Tract-Related Adverse Events of Interest | Control | Upper or lower respiratory tract infection | 40 | percentage of participants | |
| Prevalence of Respiratory Tract-Related Adverse Events of Interest | Tyvaso | Wheezing, bronchospasm, or asthma/COPD exacerbate | 12 | percentage of participants | |
| Prevalence of Respiratory Tract-Related Adverse Events of Interest | Control | Wheezing, bronchospasm, or asthma/COPD exacerbate | 13 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tyvaso | 666 | |
| Overall Study | STARTED | Control | 667 | |
| Overall Study | COMPLETED | Tyvaso | 461 | |
| Overall Study | COMPLETED | Control | 477 | |
| Overall Study | NOT COMPLETED | Tyvaso | 205 | |
| Overall Study | NOT COMPLETED | Control | 190 |
Source ClinicalTrials.gov
Adverse events138
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cough | Respiratory, thoracic and mediastinal disorders | Tyvaso | 122 | 666 | 155 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Control | 106 | 667 | 119 |
| other | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Tyvaso | 99 | 666 | 129 |
| other | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Control | 115 | 667 | 158 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Tyvaso | 89 | 666 | 117 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Control | 80 | 667 | 109 |
| other | Bronchitis | Respiratory, thoracic and mediastinal disorders | Tyvaso | 57 | 666 | 75 |
| other | Bronchitis | Respiratory, thoracic and mediastinal disorders | Control | 56 | 667 | 73 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Tyvaso | 55 | 666 | 63 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Control | 66 | 667 | 85 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tyvaso | ||
| Total, all-cause mortality | Control | ||
| Total, other adverse events | Tyvaso | 403 | 666 |
| Total, other adverse events | Control | 388 | 667 |
| Total, serious adverse events | Tyvaso | 96 | 666 |
| Total, serious adverse events | Control | 94 | 667 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27683610 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tyvaso vs Control: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01266265
GET https://conductscience.org/api/trials/v1/NCT01266265/events?page=2