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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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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

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Prednisone, then Placebo

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

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

Prednisone (25 mg) tablets as a single oral dose on Day 1 of each study period

Placebo

Intervention Type DRUG

Matching placebo tablets as a single oral dose on Day 1 of each study period

Placebo, then Prednisone

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

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

Prednisone (25 mg) tablets as a single oral dose on Day 1 of each study period

Placebo

Intervention Type DRUG

Matching placebo tablets as a single oral dose on Day 1 of each study period

Interventions

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Prednisone

Prednisone (25 mg) tablets as a single oral dose on Day 1 of each study period

Intervention Type DRUG

Placebo

Matching placebo tablets as a single oral dose on Day 1 of each study period

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No