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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: Nedocromil

• Registration Number: NCT01061333
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Study Start: 2010-06
• Primary Completion: 2011-02
• Study Completion: 2011-03
• Results First Submitted: 2012-04-26
• Results First Submitted QC: 2012-04-26
• Results First Posted: 2012-05-28
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Nedocromil	Nedocromil	Nedocromil

Primary Outcome Measures

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

Secondary Outcome Measures

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