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

Merck Sharp & Dohme LLC16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

NedocromilDRUG

Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge

Comparator: MontelukastDRUG

Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge

Comparator: MometasoneDRUG

Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Forced Expiratory Volume in 1 Second (FEV1)

Maximal percent drop in FEV1 at 20 minutes post allergen challenge

Time frame: 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

Time frame: 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

Time frame: Pre-allergen challenge and 20 minutes post allergen challenge

Secondary Outcomes

Allergen-induced Changes in Urinary 9P

Fold change over baseline in Urinary 9P at 2 hours post allergen challenge

Time frame: 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

Time frame: Baseline and 2 hours post allergen challenge

Allergen-induced Concentrations of Sputum LTC4

Concentrations of LTC4 in sputum at 2 hours post-allergen challenge

Time frame: 2 hours post allergen challenge

Allergen-induced Concentrations of Sputum LTD4

Concentrations of LTD4 in sputum at 2 hours post-allergen challenge

Time frame: 2 hours post allergen challenge

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.