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Trial · NCT06385236

Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping

NCT06385236, Phase 4, Recruiting, University of California, San Diego

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping. Trials, record NCT06385236. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06385236

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
NCT number
NCT06385236
Status
Recruiting
Phases
Phase 4
Enrollment
120 participants, estimated
Lead sponsor
University of California, San Diego
Conditions
Moderate to Severe Asthma
Interventions
Dupilumab, Benralizumab
First posted
2024-04-26
Last updated
2024-08-19

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPredicting asthma outcomes and therapeutic responsesAfter 16 weeks (for each biologic)
The primary outcomes of our therapeutic assessments are the genomic signatures that will identify novel predictive biomarkers and provide mechanistic insights to the heterogeneous response to a specific therapy. Our genomic signatures will focus on global gene expression using RNA sequencing (RNA-Seq).
PrimaryResponses to the biologic therapies at the single cell levelAfter 16 weeks (for each biologic)Single cell (sc) RNA-Seq on sputum and blood samples will be assayed at baseline and after each evoked (drug) phenotype.
PrimaryUnique asthma subgroups clinical and molecular endotype approachesAfter 16 weeks (for each biologic)Clinical and molecular endotype will be independently assessed for their prognostic association with treatment response through scRNA-seq and RNA-sequencing data at baseline and following therapy.
SecondaryAsthma Control Questionnaire (ACQ)Assessed through study completion, an average of 60 weeksA simple questionnaire (6-item questionnaire) to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment
SecondaryCompEx eventsAssessed through study completion, an average of 60 weeks
CompEx is a composite outcome specific to asthma that combines clinically relevant deteriorations captured by diary events with exacerbations, thereby providing an increase in power compared to using exacerbations alone. CompEx events include exacerbations and deterioration events.
SecondaryAsthma Quality of Life Questionnaire (AQLQ)Assessed through study completion, an average of 60 weeksA disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease. (32 items with 2-week recall)
SecondaryForced expiratory volume in 1 second (FEV1)Assessed through study completion, an average of 60 weeksLung function (FEV1) will be measured prior to bronchodilator administration by spirometry test.

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.

Papers16

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
10619836BACKGROUNDPubMed
19892860BACKGROUNDPubMed
22386508BACKGROUNDPubMed
23961961BACKGROUNDPubMed
24337046BACKGROUNDPubMed
25192440BACKGROUNDPubMed
26792209BACKGROUNDPubMed
27967215BACKGROUNDPubMed
28461290BACKGROUNDPubMed
28583396BACKGROUNDPubMed

1 to 10 of 16

See all 16 papers

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01HL161362Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and EndotypingTANTISIRA, KELAN G; BLEECKER, EUGENE ROLAND; CHUPP, GEOFFREY L; WEISS, SCOTT TUNIVERSITY OF CALIFORNIA, SAN DIEGONATIONAL HEART, LUNG, AND BLOOD INSTITUTE2022 to 2025

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT06385236

GET https://conductscience.org/api/trials/v1/NCT06385236/registered