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

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

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 Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Comparator: Montelukast; Drug: Nedocromil; Drug: Comparator: Mometasone

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: February 1, 2010
• First Submitted That Met QC Criteria: February 2, 2010
• First Posted (Estimate): February 3, 2010

Study Record Updates

• Last Update Posted (Estimate): September 4, 2015
• Last Update Submitted That Met QC Criteria: September 3, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Immunologic Factors; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Anti-Allergic Agents; Mast Cell Stabilizers; Montelukast; Mometasone Furoate; Nedocromil
• Other Study ID Numbers: 0000-176; 2010_507 (Other Identifier: Merck)