Trial · NCT01805687
Single Dose Bronchodilatory Study in Asthma
NCT01805687, Phase 4, Completed, Cornerstone Therapeutics Inc.; results first posted 2014-08-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Single Dose Bronchodilatory Study in Asthma. Trials, record NCT01805687. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01805687
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Single Dose Bronchodilatory Study in Asthma
- NCT number
- NCT01805687
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 25 participants, actual
- Lead sponsor
- Cornerstone Therapeutics Inc.
- Conditions
- Asthma
- Interventions
- Zileuton extended release
- First posted
- 2013-03-06
- Last updated
- 2014-09-03
- Results first posted
- 2014-08-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in FEV1 | 12 Hours | |
| Secondary | Area Under the Curve (AUC) | 72 Hours | |
| Secondary | Number of Subjects With Adverse Events | 72 Hours |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in FEV1 | 12 Hours | Liter | MEAN | |
| SECONDARY | Area Under the Curve (AUC) | 72 Hours | |||
| SECONDARY | Number of Subjects With Adverse Events | 72 Hours |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in FEV1 | Zileuton Extended Release | 2.84 | Standard Deviation 0.706 | Liter |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zileuton Extended Release | 25 | |
| Overall Study | COMPLETED | Zileuton Extended Release | 25 | |
| Overall Study | NOT COMPLETED | Zileuton Extended Release | 0 |
Source ClinicalTrials.gov
Adverse events1
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 | Abnormal Liver Function | Hepatobiliary disorders | Zileuton Extended Release | 3 | 25 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zileuton Extended Release | ||
| Total, other adverse events | Zileuton Extended Release | 3 | 25 |
| Total, serious adverse events | Zileuton Extended Release | 0 | 25 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01805687
GET https://conductscience.org/api/trials/v1/NCT01805687/registered