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

NCT01061333 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-09-04

Study results available
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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.

Conditions

Interventions

DRUG

Nedocromil

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

DRUG

Comparator: Montelukast

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

DRUG

Comparator: Mometasone

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

DRUG

Placebo

Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-02-28
Completion
2011-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01061333 on ClinicalTrials.gov