Early Airway Response to Allergen in Asthmatics (MK-0000-176)

Study Overview
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Brief Summary
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This study will assess the Early Airway Response (EAR) associated change in forced expiratory volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of nedocromil, montelukast, and mometasone.

Official Title
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A Two-Part, Randomized, Placebo-Controlled, Crossover Trial to Evaluate the Differential Effects of Inhaled Nedocromil, Oral Montelukast, and Inhaled Mometasone on Markers of the Early Airway Response to Allergen in Asthmatics

Conditions
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Asthma

Intervention / Treatment
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* Drug: Nedocromil
* Drug: Comparator: Montelukast
* Drug: Comparator: Mometasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of mild to moderate Asthma In good general health (except for asthma) Stable and free of respiratory infection Nonsmoker Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees to use 2 acceptable methods of birth control) Exclusion Criteria: Nursing mother Recent or ongoing upper or lower respiratory tract infection Unable to refrain from or anticipates the use of any prescription and non-prescription drugs Consumes excessive amounts of alcohol or caffeine History of stroke, chronic seizures, or major neurological disorder History of cancer Received a vaccination within the past 3 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br>Placebo | Drug: Placebo<br>* Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet<br>|
| Experimental: Montelukast<br>Montelukast | Drug: Comparator: Montelukast<br>* Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge<br>* Other names: Singulair;|
| Experimental: Nedocromil<br>Nedocromil | Drug: Nedocromil<br>* Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge<br>|
| Experimental: Mometasone<br>Mometasone | Drug: Comparator: Mometasone<br>* Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Forced Expiratory Volume in 1 Second (FEV1) | Maximal percent drop in FEV1 at 20 minutes post allergen challenge | Pre-allergen challenge and 20 minutes after allergen challenge | 
| Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes | Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge | Pre-allergen challenge and 5 minutes post allergen challenge | 
| Change in Plasma 9P at 20 Minutes | Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge | Pre-allergen challenge and 20 minutes post allergen challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergen-induced Changes in Urinary 9P | Fold change over baseline in Urinary 9P at 2 hours post allergen challenge | Baseline and 2 hours post allergen challenge | 
| Allergen-induced Changes in Urinary Leukotriene (LT) E4 | Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge | Baseline and 2 hours post allergen challenge | 
| Allergen-induced Concentrations of Sputum LTC4 | Concentrations of LTC4 in sputum at 2 hours post-allergen challenge | 2 hours post allergen challenge | 
| Allergen-induced Concentrations of Sputum LTD4 | Concentrations of LTD4 in sputum at 2 hours post-allergen challenge | 2 hours post allergen challenge | 
| Allergen-induced Concentrations of Sputum LTE4 | Concentrations of LTE4 in sputum at 2 hours post-allergen challenge | 2 hours post allergen challenge |