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Anakinra as a Rescue Treatment for Allergic Inflammation

NCT04035109 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2022-06-08

No results posted yet for this study

Summary

Participants with mild asthma who are sensitized to either house dust mite or cat hair allergen will undergo nasal instillation of the allergen to elicit nasal allergy symptoms. The participants will be treated in a cross-over fashion with either placebo (saline) or anakinra to determine if anakinra will reduce nasal airway eosinophil recruitment, eosinophil activation, release of inflammatory mediators, mucins, and gene expression changes in epithelial cells.

Conditions

  • Asthma, Allergic

Interventions

DRUG

Anakinra

A single 1mg/kg subcutaneous injection (up to 100mg) of anakinra will be administered after nasal allergen challenge.

DRUG

Preservative-free 0.9% sodium chloride (Placebo)

A single subcutaneous injection of sodium chloride (placebo) will be administered after nasal allergen challenge.

BIOLOGICAL

House dust mite allergen

Standardized house dust mite (Dermatophagoides farinae) allergen extract (provided by Greer Laboratories, Lenoir, NC). Participants who are sensitized to house dust mite (determined by skin prick testing) will undergo intranasal challenge with house dust mite allergen extract. All participants will undergo allergen challenge with a single allergen (house dust mite or cat hair).

BIOLOGICAL

Cat hair allergen

Standardized cat hair allergen extract (provided by Greer Laboratories, Lenoir, NC). Participants who are sensitized to cat hair (determined by skin prick testing) will undergo intranasal challenge with cat hair allergen extract. All participants will undergo allergen challenge with a single allergen (house dust mite or cat hair).

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Michelle Hernandez · Associate Professor of Pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2022-10-31
Completion
2023-10-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04035109 on ClinicalTrials.gov