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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020518-27 | EudraCT Number | From the European Union Drug Regulatory Authorities Clinical Trial System |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone, then Placebo | Experimental | Prednisone in the first crossover treatment period and placebo in the second crossover treatment period |
|
| Placebo, then Prednisone | Experimental | Placebo in the first crossover treatment period and prednisone in the second crossover treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | Prednisone (25 mg) tablets as a single oral dose on Day 1 of each study period |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline and 7 hours post-allergen challenge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Prednisone, Then Placebo | Prednisone in the first double blind treatment period and placebo in the second double blind treatment period |
| FG001 | Placebo, Then Prednisone | Placebo in the first double blind treatment period and prednisone in the second double blind treatment period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Placebo Run-In |
| |||||||||||||
| Washout 1 : 21 Day Washout |
| |||||||||||||
| Period 2 : Double Blind Crossover |
| |||||||||||||
| Washout 2 : 21 Day Washout |
| |||||||||||||
| Period 3 : Double Blind Crossover |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All randomized participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants | Posted | Geometric Mean | 90% Confidence Interval | Fold Change | Baseline and 7 hours post-allergen challenge |
|
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All participants in this crossover study received both prednisone and placebo.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prednisone | All participants who received at least one dose of prednisone |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp and Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Drug | Matching placebo tablets as a single oral dose on Day 1 of each study period |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and 7 hours post-allergen challenge |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | All participants who received at least one dose of placebo |
|
|
|
| Primary | 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. | All randomized participants | Posted | Geometric Mean | 90% Confidence Interval | Fold Change | Baseline and 7 hours post-allergen challenge |
|
|
|
|
| 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 | 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. | All randomized participants | Posted | Geometric Mean | 90% Confidence Interval | Fold Change | Baseline and 7 hours post-allergen challenge |
|
|
|
|
| Secondary | 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. | All randomized participants | Posted | Geometric Mean | 90% Confidence Interval | Fold Change | Baseline and 7 hours post-allergen challenge |
|
|
|
|
| Secondary | 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. | As all VRI results showed no allergen or treatment-related signals these results are not presented. | Posted | From 1 to 7 hours post-allergen challenge |
|
|
| 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 | 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. | All randomized participants | Posted | Geometric Mean | 90% Confidence Interval | Fold Change | Baseline and 7 hours post-allergen challenge |
|
|
|
|
| Secondary | 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. | All randomized participants | Posted | Geometric Mean | 90% Confidence Interval | Fold Change | Baseline and 7 hours post-allergen challenge |
|
|
|
|
| Secondary | 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. | All randomized participants | Posted | Geometric Mean | 90% Confidence Interval | Fold Change | Baseline and 7 hours post-allergen challenge |
|
|
|
|
| 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 | 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. | All randomized participants | Posted | Geometric Mean | 90% Confidence Interval | Fold Change | Baseline and 7 hours post-allergen challenge |
|
|
|
|
| Secondary | 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. | As TSLP levels were too low to detect, this analysis was not performed and results are not presented. | Posted | Baseline and 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 | 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. | As IL-23 levels were too low to detect, this analysis was not performed and results are not presented. | Posted | Baseline and 7 hours post-allergen challenge |
|
|
| Secondary | 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. | As concentrations of cytokines were below the lower limit of quantitation this analysis was not performed, and results are not presented. | Posted | Baseline and 23 hours post-allergen challenge |
|
|
| Secondary | 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. | As this same approach in a parallel study was unfruitful, these data were not pursued, and results are not presented. | Posted | Baseline and 7 hours post-allergen challenge |
|
|
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | Placebo | All participants who received at least one dose of placebo | 0 | 11 | 4 | 11 |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 |
|
| Influenza Like Illness | General disorders | MedDRA 14.1 |
|
| Seasonal Allergy | Immune system disorders | MedDRA 14.1 |
|
| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA 14.1 |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
|
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| ANOVA |
| <0.001 |
1-sided p-value, α = 0.05 |
| GM FR from Placebo : NE |
| 0.31 |
| 2-Sided |
| 90 |
| 0.22 |
| 0.43 |
| No |
| Superiority or Other |
| Correlation between SP and NE of FC from BL in IL-13 after placebo treatment. | Pearson's correlation coefficient | 0.962 | Unadjusted for Baseline and Period Effects | Correlation FC from BL: SP vs NE | -0.02 | No | Superiority or Other |
| Correlation between SP and NE of FR from placebo in IL-13 after prednisone treatment. | Pearson's correlation coefficient | 0.83 | Unadjusted for Baseline and Period Effects | Correlation FR from Placebo: SP vs NE | 0.07 | No | Superiority or Other |
GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.
| ANOVA |
| 0.681 |
1-sided p-value, α = 0.05 |
| GM FR from Placebo: NE |
| 1.08 |
| 2-Sided |
| 90 |
| 0.80 |
| 1.46 |
| No |
| Superiority or Other |
GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.
| ANOVA |
| 0.011 |
1-sided p-value, α = 0.05 |
| GM FR from Placebo: NE |
| 0.64 |
| 2-Sided |
| 90 |
| 0.47 |
| 0.86 |
| No |
| Superiority or Other |
GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) for IL-13.
| ANOVA |
| 0.020 |
1-sided p-value, α = 0.05 |
| GM FR from Placebo: IL-13 |
| 1.35 |
| 2-Sided |
| 90 |
| 1.07 |
| 1.71 |
| No |
| Superiority or Other |
GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from NE.
| ANOVA |
| 0.103 |
1-sided p-value, α = 0.05 |
| GM FR from Placebo: NE |
| 0.68 |
| 2-Sided |
| 90 |
| 0.41 |
| 1.14 |
| No |
| Superiority or Other |
GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in IL-1β from NE.
| ANOVA |
| 0.036 |
1-sided p-value, α = 0.05 |
| GM FR from Placebo: NE |
| 0.49 |
| 2-Sided |
| 90 |
| 0.26 |
| 0.93 |
| No |
| Superiority or Other |
GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in MIP-1β from NE.
| ANOVA |
| 0.056 |
1-sided p-value, α = 0.05 |
| GM FR from Placebo: NE |
| 0.61 |
| 2-Sided |
| 90 |
| 0.37 |
| 1.02 |
| No |
| Superiority or Other |