A Study on the Effects of a Single Dose of Prednisone on Biomarkers of Allergen Responses in Asthmatics (MK-0000-175)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Prednisone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01193049

0000-175

2010-020518-27 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the relationship between upper and lower airway allergen-induced cytokine responses in mild asthmatics by attempting to demonstrate the following: 1) a positive correlation between allergen-induced Type 2 T-helper cell (Th2) cytokines (interleukins 5 and 13) in sputum and nasal exudates; and 2) a positive correlation between effects of prednisone versus placebo on Th2 cytokines in sputum and nasal exudates.

Enrollment: 11 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a clinical history of mild to moderate asthma for at least 6 months, but otherwise is in good health
• Participant with allergic rhinitis and asthma has a history of nonseasonal airway symptoms in response to aeroallergens OR has seasonal symptoms but can be evaluated out-of-season
• Is clinically stable and free of respiratory infection or change in allergen exposure for at least 4 weeks prior to start of study

Exclusion criteria

• Has intolerance to the study drug, inhaled salbutamol, antihistamines, or any other potential asthma/anaphylaxis rescue medication
• Has intolerance to lidocaine/lignocaine, sedatives, atropine or glycopyrrolate, or any other medication associated with bronchoscopy
• Has taken oral parenteral corticosteroids within 8 weeks or inhaled corticosteroids/nasal corticosteroids within 5 weeks of screening and/or during the study
• Has recent (4 weeks) or ongoing upper or lower respiratory tract infection
• Has active allergic rhinitis at screening
• Has received a vaccination within 3 weeks of screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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11 participants in 2 patient groups

Prednisone, then Placebo

Experimental group

Description:

Prednisone in the first crossover treatment period and placebo in the second crossover treatment period

Treatment:

Drug: Placebo

Drug: Prednisone

Placebo, then Prednisone

Experimental group

Description:

Placebo in the first crossover treatment period and prednisone in the second crossover treatment period

Treatment:

Drug: Placebo

Drug: Prednisone