Status:
NOT_YET_RECRUITING
Crossover Study of Zafirlukast in Preventing Allergen-induced Signs and Symptoms in Response to Cat Dander Challenge
Lead Sponsor:
Allergy & Asthma Medical Group & Research Center
Conditions:
Allergy to Cats
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 d...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- Active nonsmoking males and females between the ages of 18-65 with allergic rhinitis triggered by cat dander exposure.
- Concomitant medication limited to "as needed" including for mild asthma.
- Baseline resting blood pressure les than or equal to 140/90 mm Hg.
- Baseline resting heart rate less than or equal to 100 beats/min.
- Baseline NIFR must be ≥ 50 L/min.
- Females of childbearing age may participate only if they have a negative urine pregnancy test, are non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.
- The ability to give informed consent and comply with study procedures.
Exclusion
- Receiving immunotherapy for cat allergy
- Predictable seasonal allergy during the study period
- Newly (\< 2 weeks) diagnosed with Corona Virus Disease (COVID-19)
- Regular use of controller medication for moderate to severe asthma
- Subject works with cats or keeps a cat as a pet.
- Inability or unwillingness to give written informed consent.
- History of upper/lower respiratory tract infection, requiring systemic steroids, antibiotics, and or emergency room (ER) visit or urgent care within 6 weeks of screening visit.
- History of adverse reaction or allergy to Zafirlukast
- History of neurological, hepatic, renal, diabetic mellitus, thyroid disorder, psychiatric, addiction or other medical conditions that may interfere with the interpretation of data or the patient's participation in the study or may increase safety concerns per investigator discretion.
- History of cardiovascular diseases including uncontrolled hypertension (blood pressure \>160/100 mmHg), ischemic heart disease, congestive heart failure (New York Heart Association III or IV), valvular heart disease or cardiomyopathy (e.g., depressed left ventricular ejection fraction by echo, arrhythmias).
- Known allergy or sensitivity to atropine or ipratropium bromide.
- Documented or self-reported current history of alcoholism or drug abuse.
- Baseline Spirometry Forced Expiratory Volume in first second (FEV1) \<70% of predicted
- Participated in another research trial and received investigational drug within 30 days or 5 half-lives, whichever is longer
- Unwillingness or inability to comply with study procedures.
Key Trial Info
Start Date :
December 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06069063
Start Date
December 5 2025
End Date
July 1 2026
Last Update
September 22 2025
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