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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Nedocromil; Drug: Comparator: Mometasone; Drug: Comparator: Montelukast

Study type: Interventional

Funder types: Industry

Identifiers

NCT01061333

0000-176

2010_507 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 4 patient groups

Placebo

Experimental group

Description:

Placebo

Treatment:

Drug: Placebo

Montelukast

Experimental group

Description:

Montelukast

Treatment:

Drug: Comparator: Montelukast

Nedocromil

Experimental group

Description:

Nedocromil

Treatment:

Drug: Nedocromil

Mometasone

Experimental group

Description:

Mometasone

Treatment:

Drug: Comparator: Mometasone