Phase 1
Completed N=11
A Study on the Effects of a Single Dose of Prednisone on Biomarkers of Allergen Responses in Asthmatics (MK-0000-175)
Source: ClinicalTrials.gov NCT01193049 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge — 2.16; 8.60; 1.69; 8.63 Fold Change — p=0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
2.16; 8.60; 1.69; 8.63 | 0.001 sig |
| PRIMARY Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
1.57; 5.86; 1.02; 3.29 | 0.009 sig |
| SECONDARY Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
1.63; 2.04; 1.33; 1.22 | 0.258 |
| SECONDARY Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
1.30; 2.14; 0.86; 1.35 | 0.117 |
| SECONDARY Change in Vibration Response Imaging (VRI) After Metacholine Exposure |
— | — |
| SECONDARY 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 |
4.87; 7.37; 2.90; 3.93 | 0.010 sig |
| SECONDARY Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
0.68; 0.83; 0.84; 1.23 | 0.119 |
| SECONDARY Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
0.80; 1.34; 0.19; 0.39 | 0.003 sig |
| SECONDARY Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
1.35; 1.92; 0.73; 1.19 | 0.143 |
| SECONDARY Geometric Mean Fold Change From Baseline in Thymic Stromal Lymphopoietin (TSLP) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
— | — |
| SECONDARY Geometric Mean Fold Change From Baseline in Interleukin-23 (IL-23) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
— | — |
| SECONDARY Geometric Mean Fold Change From Baseline in Cytokines From Bronchoalveolar Lavage Fluid (BALf) |
— | — |
| SECONDARY Geometric Mean Fold Change From Baseline in Nasal and Bronchial Eicosanoids and Leukotrienes at 7 Hours Post-allergen Challenge. |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT01193049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.