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NCT04699604 · ClinicalTrials.gov registry record · Phase 3

A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)

A Phase 3 study of Allergic Asthma, sponsored by Bridgette Jones.

Recruiting
Registry status
Phase 3
Development phase
300
Enrollment target
1
Study location

NCT04699604: Recruiting Phase 3 study of Allergic Asthma, sponsored by Bridgette Jones.

NCT04699604 is a Phase 3 study of Allergic Asthma that is actively recruiting participants, run by Bridgette Jones. The registered enrollment target is 300 participants, above the 131-participant average among 4 other Allergic Asthma trials with a reported enrollment target (129% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04699604, a Phase 3 study of Allergic Asthma, is actively recruiting participants, sponsored by Bridgette Jones.

RECRUITING
Registry status
Phase 3
Development phase
300 participants
Enrollment target
1
Study location

Study Summary

This is a randomized, double-blind, placebo-controlled, crossover study comparing asthma control post treatment in African American/Black and Caucasian/White children in both hyper and hypo responsive HILD (Histamine Lontophoresis with Laser Doppler monitoring) phenotypes with uncontrolled persistent allergic asthma using Levocetirizine (LTZ) vs placebo.

Primary Outcome

Determined by change in asthma as determined by the Asthma Control Test (ACT®) or Child-Asthma Control Test (C-ACT®) based on the child's age. Asthma control will be assessed at baseline prior to randomization and then at 6 weeks during both arms (placebo and Levocetrizine) of the study.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Levocetirizine Dihydrochloride

Study Locations (1)

Missouri

  • Children's Mercy Hospital - Kansas City

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2021-04-28
Est. Completion 2026-05-01
Phase Phase 3
Bridgette Jones

1 total trials

What NCT04699604 shows while recruiting

NCT04699604 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 131-participant average among 4 other Allergic Asthma trials with a reported enrollment target (129% higher).

The record links to 1 condition, with Allergic Asthma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04699604 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT04699604 about?

NCT04699604 is a clinical study titled "A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)". This is a randomized, double-blind, placebo-controlled, crossover study comparing asthma control post treatment in African American/Black and Caucasian/White children in both hyper and hypo responsive HILD (Histamine Lontophoresis with Laser Doppler monitoring) phenotypes with uncontrolled persisten...

What is the current status of trial NCT04699604?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2021-04-28. Estimated completion is 2026-05-01.

What conditions does trial NCT04699604 study?

This clinical trial studies the following conditions: Allergic Asthma.

What interventions are being tested in trial NCT04699604?

The interventions under investigation include: Placebo (DRUG), Levocetirizine Dihydrochloride (DRUG).

Who is sponsoring clinical trial NCT04699604?

This trial is sponsored by Bridgette Jones, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04699604 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Allergic Asthma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

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Source: ClinicalTrials.gov NCT04699604, the US trial registry maintained by the National Library of Medicine. NCT04699604 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.