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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.
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.
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 Total Nasal Symptoms Score between patients pre-treated with Zafirlukast and patients treated with a placebo (a look-alike substance that contains no active drug)?
The Total Nasal Symptom Score (TNSS; possible score of 0-12) is the sum of 4 individual subject-assessed symptom scores for
Each of these are evaluated using a scale of
Participants will
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zafirlukast cross-over to Placebo | Experimental | This group will receive the Zafirlukast pre-treatment nasally (400 mcg in 150 mcl in each nostril) once before the allergen challenge (0.87mcg Fel d1 in 100mcl in each nostril) in the first study visit. In the second study visit, they will receive a placebo pre-treatment nasally (150 mcl each nostril) once before the allergen challenge (0.87mcg Fel d1 in 100mcl in each nostril). |
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| Placebo cross-over to Zafirlukast | Experimental | This group will receive a placebo pre-treatment nasally (150 mcl each nostril) once before the allergen challenge (0.87mcg Fel d1 in 100mcl in each nostril) in the first study visit. In the second study visit, they will receive the Zafirlukast pre-treatment nasally (400 mcg in 150 mcl in each nostril) once before the allergen challenge (0.87mcg Fel d1 in 100mcl in each nostril). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zafirlukast | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Nasal Symptom Score (TNSS) | The Total Nasal Symptom Score (TNSS; possible score of 0-12) is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. | Starts at 10 minutes after the cat allergen challenge, then 30, 60, 120, and 240 minutes after. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Ocular Symptom Score (TOSS) | The Total Ocular Symptom Score (TOSS; possible score of 0-12) is the sum of 4 individual subject-assessed symptom scores for itchiness, redness, tearing, and swelling, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. | Starts at 10 minutes after the cat allergen challenge, then 30, 60, 120, and 240 minutes after. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teresa Lloyd, BSRT | Contact | 858-268-2368 | 143 | teresalloyd@allergyandasthma.com |
| Name | Affiliation | Role |
|---|---|---|
| Alex Greiner, MD | Allergy & Asthma Medical Group & Research Center | Principal Investigator |
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| ID | Term |
|---|---|
| C062735 | zafirlukast |
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| Nasal Inspiratory Flow Rate (NIFR) | NIFR is an inexpensive, rapid, easy-to-use objective measure that directly measures nasal airflow during maximal inspiration. NIFR is measured in L/min. | Starts at 10 minutes after the cat allergen challenge, then 30, 60, 120, and 240 minutes after. |