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Crossover Study of Zafirlukast in Preventing Allergen-induced Signs and Symptoms in Response to Cat Dander Challenge

NCT06069063 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-09-22

No results posted yet for this study

Summary

The goal of this clinical trial is to test the hypothesis that pre-treatment with a nasal dose of Zafirlukast works well in blocking the signs and symptoms of cat dander in patients sensitive to cat dander. The main question it aims to answer is:

• What is the difference in the symptoms of patients pre-treated with Zafirlukast and patients treated with a placebo (a look-alike substance that contains no active drug) when exposed to cat dander?

Participants will screened to see if they qualify for the study based on their reaction to being exposed to cat dander and medical history. If they qualify, they will make two more visits to the allergy center, where they will be pre-treated with either Zafirlukast or a placebo and exposed to cat dander, then observed for four hours.

Participants will

* First be screened for their medical history, the medication they take, and other factors to see if they qualify for the study.

* Participants will then be exposed to a fixed dose of cat dander to test their baseline change in TNSS. Some patients may need to return for a higher dose of cat dander.
* On the next visit, some participants will be pre-treated with Zafirlukast and the rest with a placebo, then they will be exposed to cat dander. Their symptoms will be observed.
* On the final visit, participants who were pre-treated with Zafirlukast on their last visit will be given a placebo. Participants who were pre-treated with a placebo on their last visit will be given Zafirlukast. All participants will then be exposed to cat dander and their symptoms will be observed.

Conditions

  • Allergy to Cats

Interventions

DRUG

Zafirlukast

Oral zafirlukast is approved to treat asthma and been shown in previous trials to be effective in blocking or mitigating the symptoms of people allergic to cat dander

Sponsors & Collaborators

  • Allergy & Asthma Medical Group & Research Center

    lead OTHER

Principal Investigators

  • Alex Greiner, MD · Allergy & Asthma Medical Group & Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2026-06-30
Completion
2026-07-31
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 NCT06069063 on ClinicalTrials.gov