Trial · NCT04129931
PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study
NCT04129931, Phase 2, Completed, University of North Carolina, Chapel Hill
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study. Trials, record NCT04129931. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04129931
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study
- NCT number
- NCT04129931
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 950 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Asthma
- Interventions
- MCT, Clazakizumab, Broncho-Vaxom, Imatinib Mesylate, Cavosonstat, Placebo
- First posted
- 2019-10-17
- Last updated
- 2026-04-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Forced Expiratory Volume in One Second (FEV1) Percent Predicted | Measured at 16 weeks after the start of treatment. | Assessed prior to bronchodilator administration. Efficacy analyses will compare the end-of-period outcome values between test treatment and placebo. |
| Primary | The Juniper Asthma Control Questionnaire (ACQ-6) | Measured at 16 weeks after the start of treatment. | Asthma symptom control is assessed via ACQ-6, the average score of these six items (range 0-6). The seven-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled'. Negative change from baseline values indicate improved asthma control. Efficacy analyses will compare the end-of-period outcome values between test treatment and placebo. |
| Secondary | CompEx Events Per Year | Assessed over 16 weeks of treatment | Composite outcome with exacerbations (CompEx) is an outcome specific to asthma and chronic obstructive pulmonary disease (COPD) that combines clinically-relevant deteriorations with exacerbations. Deterioration events defined based on daily recordings of peak expiratory flow (PEF) morning/evening (L/min), reliever use morning/evening (doses), symptoms morning/evening (score 0-3) from twice-daily recordings. Participants are asked to describe their morning and evening symptoms using the following scale: 0-No symptoms to report, 3-I could not sleep because of my asthma/I could not perform my normal activities because of my asthma. |
| Secondary | Forced Vital Capacity (FVC) Pre-bronchodilation | Measured at 16 weeks after the start of treatment. | Assessed prior to bronchodilator administration |
| Secondary | FEV1 % Predicted Post-bronchodilation | Measured at 16 weeks after the start of treatment. | Assessed after 4 puffs of bronchodilator administration |
| Secondary | Exacerbations | Assessed over 16 weeks of treatment | Annualized rate of severe exacerbations during the 16-week treatment periods, modified intent-to-treat (mITT) population. An asthma exacerbation in PrecISE is defined as a worsening of asthma requiring the use of a systemic corticosteroid (at least 3 days of treatment) to prevent a serious outcome. |
| Secondary | Number of Participants With At Least One Asthma-Free Day | Assessed over 16 weeks of treatment | An asthma free day is a day where 1) there is no use of albuterol rescue (excluding the use of albuterol as pre-exercise treatment), 2) no daytime or nighttime asthma symptoms, 3) no peak expiratory flow of less than 80% of the predetermined reference value. |
| Secondary | Number of Participants With At Least One Symptom-free Day | Assessed over 16 weeks of treatment | A symptom free day is a day with no asthma symptoms (symptom score = 0) for both morning and evening daily diary entries. |
| Secondary | Healthcare Utilization | Assessed over 16 weeks of treatment | The combined total number of: asthma-specific Emergency Department visits, asthma-specific hospital admissions, and asthma-specific ICU admissions. The investigators report the number of participants with at least one asthma-specific Emergency Department visit, asthma-specific hospital admission, or asthma-specific ICU admission |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers17
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U24HL138998 | Data, Modeling,and Coordination Center for PrecISE Network | IVANOVA, ANASTASIA; ANSTROM, KEVIN J | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2017 to 2022 |
Source NIH RePORTER
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/NCT04129931
GET https://conductscience.org/api/trials/v1/NCT04129931/registered