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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-03-31

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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

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

Montelukast

Group Type EXPERIMENTAL

Comparator: Montelukast

Intervention Type DRUG

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

Nedocromil

Group Type EXPERIMENTAL

Nedocromil

Intervention Type DRUG

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

Mometasone

Group Type EXPERIMENTAL

Comparator: Mometasone

Intervention Type DRUG

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

Interventions

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Nedocromil

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

Intervention Type DRUG

Comparator: Montelukast

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

Intervention Type DRUG

Comparator: Mometasone

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Singulair

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No