Clinical trial NCT01193049: A Study on the Effects of a Single Dose of Prednisone on Biomarkers of Allergen Responses in Asthmatics (MK-0000-175)
Official title: A Two-Part, Randomized Clinical Trial to Study the Effects of a Single Dose of Prednisone on Biomarkers of Allergen Responses in Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Nasal Allergen Challenge, Inhaled Allergen Challenge, Asthma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
timeFrame: Baseline and 7 hours post-allergen challenge
measure: Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
timeFrame: Baseline and 7 hours post-allergen challenge
Secondary outcomes:
measure: Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
timeFrame: Baseline and 7 hours post-allergen challenge
measure: Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
timeFrame: Baseline and 7 hours post-allergen challenge
measure: Change in Vibration Response Imaging (VRI) After Metacholine Exposure
timeFrame: From 1 to 7 hours post-allergen challenge
measure: Geometric Mean Fold Change From Baseline in RNA Expression for Genes Encoding IL-5 and IL-13 From Sputum at 7 Hours Post-allergen Challenge
timeFrame: Baseline and 7 hours post-allergen challenge
measure: Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
timeFrame: Baseline and 7 hours post-allergen challenge
measure: Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
timeFrame: Baseline and 7 hours post-allergen challenge
measure: Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
timeFrame: Baseline and 7 hours post-allergen challenge
measure: Geometric Mean Fold Change From Baseline in Thymic Stromal Lymphopoietin (TSLP) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
timeFrame: Baseline and 7 hours post-allergen challenge
measure: Geometric Mean Fold Change From Baseline in Interleukin-23 (IL-23) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
timeFrame: Baseline and 7 hours post-allergen challenge
measure: Geometric Mean Fold Change From Baseline in Cytokines From Bronchoalveolar Lavage Fluid (BALf)
timeFrame: Baseline and 23 hours post-allergen challenge
measure: Geometric Mean Fold Change From Baseline in Nasal and Bronchial Eicosanoids and Leukotrienes at 7 Hours Post-allergen Challenge.
timeFrame: Baseline and 7 hours post-allergen challenge
Other outcomes:
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