A Phase 1 interventional study of Prednisone and Placebo in Asthma, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-09-04.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 11 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 132 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
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Exclusion Criteria:
Prednisone in the first crossover treatment period and placebo in the second crossover treatment period
Drug: Prednisone · Drug: Placebo
Placebo in the first crossover treatment period and prednisone in the second crossover treatment period
Drug: Prednisone · Drug: Placebo
Prednisone (25 mg) tablets as a single oral dose on Day 1 of each study period
Matching placebo tablets as a single oral dose on Day 1 of each study period
Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, nasal exudates (NE) and sputum (SP) were collected, then the concentrations of IL-5 were determined from NE and SP collected after 7 hours and previously at baseline (BL), to derive the fold change (FC) from BL for each participant. The geometric mean (GM) was determined by averaging FC from BL for all analyzed participants.
Time frame: Baseline and 7 hours post-allergen challenge
Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-13 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
Time frame: Baseline and 7 hours post-allergen challenge
Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of TARC were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
Time frame: Baseline and 7 hours post-allergen challenge
Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of Eotaxin-3 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
Time frame: Baseline and 7 hours post-allergen challenge
Change in Vibration Response Imaging (VRI) After Metacholine Exposure
One hour before treatment with prednisone/placebo, participants inhaled for 2 minutes a nebulised solution of metacholine (0.13 ml/min); then one hour after prednisone/placebo treatment were challenged with allergens. From 1 to 7 hours after allergen challenge, ventilatory heterogeneity was assessed by Vibration Response Imaging (VRI) by monitoring the following: inspiration/expiration (I/E) amplitude ratio, I/E duration ratio, synchrony duration, and quantitative lung data.
Time frame: From 1 to 7 hours post-allergen challenge
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
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, SP were collected, then the RNA expression profiles of IL-5 and IL-13 genes were determined from SP collected after 7 hours and previously at baseline, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
Time frame: Baseline and 7 hours post-allergen challenge
Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-17 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
Time frame: Baseline and 7 hours post-allergen challenge
Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
Time frame: Baseline and 7 hours post-allergen challenge
Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of MIP-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
Time frame: Baseline and 7 hours post-allergen challenge
Geometric Mean Fold Change From Baseline in Thymic Stromal Lymphopoietin (TSLP) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of TSLP were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.
Time frame: Baseline and 7 hours post-allergen challenge
Geometric Mean Fold Change From Baseline in Interleukin-23 (IL-23) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-23 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was plan to be determined by averaging FC from BL for all analyzed participants.
Time frame: Baseline and 7 hours post-allergen challenge
Geometric Mean Fold Change From Baseline in Cytokines From Bronchoalveolar Lavage Fluid (BALf)
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 23 hours had elapsed, BALf were collected, then the concentrations of IL-5, IL-13, and TARC were determined from BALf collected after 23 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.
Time frame: Baseline and 23 hours post-allergen challenge
Geometric Mean Fold Change From Baseline in Nasal and Bronchial Eicosanoids and Leukotrienes at 7 Hours Post-allergen Challenge.
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then prostaglandin and leukotriene concentrations were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.
Time frame: Baseline and 7 hours post-allergen challenge
| Milestone | Prednisone, Then Placebo | Placebo, Then Prednisone |
|---|---|---|
| Started | 5 | 6 |
| Completed | 5 | 6 |
| Not completed | 0 | 0 |
| Milestone | Prednisone, Then Placebo | Placebo, Then Prednisone |
|---|---|---|
| Started | 5 | 6 |
| Completed | 5 | 6 |
| Not completed | 0 | 0 |
| Milestone | Prednisone, Then Placebo | Placebo, Then Prednisone |
|---|---|---|
| Started | 5 | 6 |
| Completed | 5 | 6 |
| Not completed | 0 | 0 |
| Milestone | Prednisone, Then Placebo | Placebo, Then Prednisone |
|---|---|---|
| Started | 5 | 6 |
| Completed | 5 | 6 |
| Not completed | 0 | 0 |
| Milestone | Prednisone, Then Placebo | Placebo, Then Prednisone |
|---|---|---|
| Started | 5 | 6 |
| Completed | 5 | 6 |
| Not completed | 0 | 0 |
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, nasal exudates (NE) and sputum (SP) were collected, then the concentrations of IL-5 were determined from NE and SP collected after 7 hours and previously at baseline (BL), to derive the fold change (FC) from BL for each participant. The geometric mean (GM) was determined by averaging FC from BL for all analyzed participants.
| Fold Change | Prednisone | Placebo |
|---|---|---|
| Sputum | 2.16 (1.25 to 3.74) | 8.60 (3.82 to 19.34) |
| Nasal Exudate | 1.69 (0.88 to 3.26) | 8.63 (4.45 to 16.77) |
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-13 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
| Fold Change | Prednisone | Placebo |
|---|---|---|
| Sputum | 1.57 (1.21 to 2.04) | 5.86 (2.57 to 13.36) |
| Nasal Exudate | 1.02 (0.65 to 1.58) | 3.29 (1.82 to 5.95) |
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of TARC were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
| Fold Change | Prednisone | Placebo |
|---|---|---|
| Sputum | 1.63 (1.22 to 2.17) | 2.04 (1.21 to 3.46) |
| Nasal Exudates | 1.33 (0.88 to 2.01) | 1.22 (0.96 to 1.57) |
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of Eotaxin-3 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
| Fold Change | Prednisone | Placebo |
|---|---|---|
| Sputum | 1.30 (0.67 to 2.51) | 2.14 (1.41 to 3.24) |
| Nasal Exudates | 0.86 (0.56 to 1.31) | 1.35 (0.66 to 2.74) |
One hour before treatment with prednisone/placebo, participants inhaled for 2 minutes a nebulised solution of metacholine (0.13 ml/min); then one hour after prednisone/placebo treatment were challenged with allergens. From 1 to 7 hours after allergen challenge, ventilatory heterogeneity was assessed by Vibration Response Imaging (VRI) by monitoring the following: inspiration/expiration (I/E) amplitude ratio, I/E duration ratio, synchrony duration, and quantitative lung data.
No measurements were reported for this outcome.
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, SP were collected, then the RNA expression profiles of IL-5 and IL-13 genes were determined from SP collected after 7 hours and previously at baseline, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
| Fold Change | Prednisone | Placebo |
|---|---|---|
| IL-5 | 4.87 (3.20 to 7.39) | 7.37 (5.96 to 9.11) |
| IL-13 | 2.90 (2.42 to 3.48) | 3.93 (3.02 to 5.13) |
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-17 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
| Fold Change | Prednisone | Placebo |
|---|---|---|
| Sputum | 0.68 (0.58 to 0.80) | 0.83 (0.71 to 0.98) |
| Nasal Exudates | 0.84 (0.48 to 1.46) | 1.23 (1.14 to 1.33) |
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
| Fold Change | Prednisone | Placebo |
|---|---|---|
| Sputum | 0.80 (0.55 to 1.17) | 1.34 (0.86 to 2.09) |
| Nasal Exudates | 0.19 (0.14 to 0.27) | 0.39 (0.24 to 0.63) |
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of MIP-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
| Fold Change | Prednisone | Placebo |
|---|---|---|
| Sputum | 1.35 (0.75 to 2.43) | 1.92 (0.94 to 3.93) |
| Nasal Exudates | 0.73 (0.47 to 1.13) | 1.19 (0.70 to 2.01) |
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of TSLP were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.
No measurements were reported for this outcome.
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-23 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was plan to be determined by averaging FC from BL for all analyzed participants.
No measurements were reported for this outcome.
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 23 hours had elapsed, BALf were collected, then the concentrations of IL-5, IL-13, and TARC were determined from BALf collected after 23 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.
No measurements were reported for this outcome.
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then prostaglandin and leukotriene concentrations were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prednisone | — | 0/11 (0%) | 1/11 (9.1%) |
| Placebo | — | 0/11 (0%) | 4/11 (36.4%) |
| Event | Prednisone | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 0/11 | 1/11 |
| VomitingGastrointestinal disorders | 0/11 | 1/11 |
| Influenza Like IllnessGeneral disorders | 1/11 | 0/11 |
| Seasonal AllergyImmune system disorders | 0/11 | 1/11 |
| Wrist FractureInjury, poisoning and procedural complications | 0/11 | 1/11 |
| Oropharyngeal PainRespiratory, thoracic and mediastinal disorders | 0/11 | 1/11 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 33.5 ± 7.6 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 1 |
| Male | 10 |
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