Trial · NCT00815347
Bosentan for Poorly Controlled Asthma
NCT00815347, Phase 2, Terminated, UConn Health; results first posted 2012-10-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bosentan for Poorly Controlled Asthma. Trials, record NCT00815347. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00815347
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bosentan for Poorly Controlled Asthma
- NCT number
- NCT00815347
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- UConn Health
- Conditions
- Asthma
- Interventions
- bosentan, placebo
- First posted
- 2008-12-30
- Last updated
- 2012-10-01
- Results first posted
- 2012-10-01
- Limitations and caveats
- Early termination leading to small numbers of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in FEV1 | 1, 2, 4 hours after dosing | |
| Primary | Peak Flow | last 7 days of each dosing period | |
| Primary | Symptom Scores | Last 7 days of each dosing period | Symptom score could range from a minimum of 7 (no symptoms) to 35 (severe symptoms) |
| Secondary | FEV1 | end of dosing period | |
| Secondary | Rescue Beta-agonist | end of each dosing period | |
| Secondary | Asthma Control Test Questionnaire | end of each dosing period | Patient reported outcome minimum 5 (no symptoms) maximum 25 (severe symptoms) |
| Other | Requirement for Escalation of Controller Medication. | 17 weeks | |
| Other | Requirement for Urgent Medical Care for Asthma. | 17 weeks | |
| Other | Ability to Taper Systemic Steroids Among Those Patients Who Are on Systemic Steroids at Study Entry. | 17 weeks |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in FEV1 | 1, 2, 4 hours after dosing | liters | MEAN | |
| PRIMARY | Peak Flow | last 7 days of each dosing period | Data not analyzed, study terminated early | ||
| PRIMARY | Symptom Scores | Last 7 days of each dosing period | score on a scale | MEAN | |
| SECONDARY | FEV1 | end of dosing period | liters | MEAN | |
| SECONDARY | Rescue Beta-agonist | end of each dosing period | puffs of rescue inhaler | MEAN | |
| OTHER_PRE_SPECIFIED | Requirement for Escalation of Controller Medication. | 17 weeks | |||
| OTHER_PRE_SPECIFIED | Requirement for Urgent Medical Care for Asthma. | 17 weeks | |||
| OTHER_PRE_SPECIFIED | Ability to Taper Systemic Steroids Among Those Patients Who Are on Systemic Steroids at Study Entry. | 17 weeks | |||
| SECONDARY | Asthma Control Test Questionnaire | end of each dosing period | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in FEV1 | Placebo | 1 hour FEV1 | 1.50 | 95% Confidence Interval NA to NA | liters |
| Change in FEV1 | Bosentan | 1 hour FEV1 | 1.57 | 95% Confidence Interval NA to NA | liters |
| Change in FEV1 | Placebo | 2 hour FEV1 | 1.53 | 95% Confidence Interval NA to NA | liters |
| Change in FEV1 | Bosentan | 2 hour FEV1 | 1.57 | 95% Confidence Interval NA to NA | liters |
| Change in FEV1 | Placebo | 4 hour FEV1 | 1.50 | 95% Confidence Interval NA to NA | liters |
| Change in FEV1 | Bosentan | 4 hour FEV1 | 1.51 | 95% Confidence Interval NA to NA | liters |
| Symptom Scores | Placebo | 19.7 | Standard Deviation 7.6 | score on a scale | |
| Symptom Scores | Bosentan | 20.1 | Standard Deviation 3.5 | score on a scale | |
| FEV1 | Placebo | 1.46 | Standard Deviation 0.4 | liters | |
| FEV1 | Bosentan | 1.49 | Standard Deviation 0.47 | liters |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Study Participants | 11 | |
| Overall Study | COMPLETED | All Study Participants | 7 | |
| Overall Study | NOT COMPLETED | All Study Participants | 4 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Abnormal liver function blood tests | Hepatobiliary disorders | Bosentan | 0 | 9 | 0 |
| serious | Abnormal liver function blood tests | Hepatobiliary disorders | Placebo | 1 | 11 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bosentan | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Bosentan | 0 | 0 |
| Total, other adverse events | Placebo | 0 | 0 |
| Total, serious adverse events | Bosentan | 0 | 9 |
| Total, serious adverse events | Placebo | 1 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Bosentan vs Placebo: 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/NCT00815347
GET https://conductscience.org/api/trials/v1/NCT00815347/registered