Asthma
Conditions
Keywords
Nasal Allergen Challenge, Inhaled Allergen Challenge, Asthma
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.
Interventions
DRUGPrednisone
Prednisone (25 mg) tablets as a single oral dose on Day 1 of each study period
DRUGPlacebo
Matching placebo tablets as a single oral dose on Day 1 of each study period
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Baseline and 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. |
| Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Baseline and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vibration Response Imaging (VRI) After Metacholine Exposure | From 1 to 7 hours post-allergen challenge | 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. |
| 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 | Baseline and 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. |
| Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Baseline and 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. |
| Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Baseline and 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. |
| Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Baseline and 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. |
| Geometric Mean Fold Change From Baseline in Thymic Stromal Lymphopoietin (TSLP) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Baseline and 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. |
| Geometric Mean Fold Change From Baseline in Interleukin-23 (IL-23) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Baseline and 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. |
| Geometric Mean Fold Change From Baseline in Cytokines From Bronchoalveolar Lavage Fluid (BALf) | Baseline and 23 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 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. |
| Geometric Mean Fold Change From Baseline in Nasal and Bronchial Eicosanoids and Leukotrienes at 7 Hours Post-allergen Challenge. | Baseline and 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. |
| Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Baseline and 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. |
| Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Baseline and 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All randomized participants | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 33.5 years STANDARD_DEVIATION 7.6 |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 11 | 4 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
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.
Time frame: Baseline and 7 hours post-allergen challenge
Population: All randomized participants
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prednisone | Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Sputum | 1.57 Fold Change |
| Prednisone | Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Nasal Exudate | 1.02 Fold Change |
| Placebo | Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Sputum | 5.86 Fold Change |
| Placebo | Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Nasal Exudate | 3.29 Fold Change |
Comparison: GM FR is the GM of individual FC(Prednisone)/FC (Placebo) from SP.p-value: 0.00990% CI: [0.12, 0.62]ANOVA
Comparison: GM FR is the GM of individual FC Prednisone)/FC(Placebo) from NE.p-value: <0.00190% CI: [0.22, 0.43]ANOVA
Comparison: Correlation between SP and NE of FC from BL in IL-13 after placebo treatment.p-value: 0.962Pearson's correlation coefficient
Comparison: Correlation between SP and NE of FR from placebo in IL-13 after prednisone treatment.p-value: 0.83Pearson's correlation coefficient
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.
Time frame: Baseline and 7 hours post-allergen challenge
Population: All randomized participants
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prednisone | Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Sputum | 2.16 Fold Change |
| Prednisone | Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Nasal Exudate | 1.69 Fold Change |
| Placebo | Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Sputum | 8.60 Fold Change |
| Placebo | Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Nasal Exudate | 8.63 Fold Change |
Comparison: GM Fold Reduction (FR) is the GM of individual FC(Prednisone)/FC (Placebo) from SP.p-value: 0.00190% CI: [0.14, 0.46]ANOVA
Comparison: GM FR is the GM of individual FC(Prednisone)/FC(Placebo) from NE.p-value: <0.00190% CI: [0.13, 0.3]ANOVA
Comparison: Correlation between SP and NE of FC from BL in IL-5 after placebo treatment.p-value: 0.553Pearson's correlation coefficient
Comparison: Correlation between SP and NE of FR from placebo in IL-5 after prednisone treatment.p-value: 0.964Pearson's correlation coefficient
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.
Time frame: From 1 to 7 hours post-allergen challenge
Population: As all VRI results showed no allergen or treatment-related signals these results are not presented.
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.
Time frame: Baseline and 23 hours post-allergen challenge
Population: As concentrations of cytokines were below the lower limit of quantitation this analysis was not performed, and results are not presented.
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.
Time frame: Baseline and 7 hours post-allergen challenge
Population: All randomized participants
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prednisone | Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Sputum | 1.30 Fold Change |
| Prednisone | Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Nasal Exudates | 0.86 Fold Change |
| Placebo | Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Sputum | 2.14 Fold Change |
| Placebo | Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Nasal Exudates | 1.35 Fold Change |
Comparison: GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from SP.p-value: 0.11790% CI: [0.3, 1.24]ANOVA
Comparison: GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.p-value: 0.01190% CI: [0.47, 0.86]ANOVA
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.
Time frame: Baseline and 7 hours post-allergen challenge
Population: All randomized participants
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prednisone | Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Sputum | 0.68 Fold Change |
| Prednisone | Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Nasal Exudates | 0.84 Fold Change |
| Placebo | Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Sputum | 0.83 Fold Change |
| Placebo | Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Nasal Exudates | 1.23 Fold Change |
Comparison: GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from SP.p-value: 0.11990% CI: [0.62, 1.09]ANOVA
Comparison: GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from NE.p-value: 0.10390% CI: [0.41, 1.14]ANOVA
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.
Time frame: Baseline and 7 hours post-allergen challenge
Population: All randomized participants
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prednisone | Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Sputum | 0.80 Fold Change |
| Prednisone | Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Nasal Exudates | 0.19 Fold Change |
| Placebo | Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Sputum | 1.34 Fold Change |
| Placebo | Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Nasal Exudates | 0.39 Fold Change |
Comparison: GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-1β from SP.p-value: 0.00390% CI: [0.46, 0.77]ANOVA
Comparison: GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in IL-1β from NE.p-value: 0.03690% CI: [0.26, 0.93]ANOVA
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.
Time frame: Baseline and 7 hours post-allergen challenge
Population: As IL-23 levels were too low to detect, this analysis was not performed and results are not presented.
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.
Time frame: Baseline and 7 hours post-allergen challenge
Population: All randomized participants
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prednisone | Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Sputum | 1.35 Fold Change |
| Prednisone | Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Nasal Exudates | 0.73 Fold Change |
| Placebo | Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Sputum | 1.92 Fold Change |
| Placebo | Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Nasal Exudates | 1.19 Fold Change |
Comparison: GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in MIP-1β from SP.p-value: 0.14390% CI: [0.4, 1.24]ANOVA
Comparison: GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in MIP-1β from NE.p-value: 0.05690% CI: [0.37, 1.02]ANOVA
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.
Time frame: Baseline and 7 hours post-allergen challenge
Population: As this same approach in a parallel study was unfruitful, these data were not pursued, and results are not presented.
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.
Time frame: Baseline and 7 hours post-allergen challenge
Population: All randomized participants
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prednisone | 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 | IL-5 | 4.87 Fold Change |
| Prednisone | 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 | IL-13 | 2.90 Fold Change |
| Placebo | 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 | IL-5 | 7.37 Fold Change |
| Placebo | 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 | IL-13 | 3.93 Fold Change |
Comparison: GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) for IL-5.p-value: 0.0190% CI: [1.15, 1.99]ANOVA
Comparison: GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) for IL-13.p-value: 0.0290% CI: [1.07, 1.71]ANOVA
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.
Time frame: Baseline and 7 hours post-allergen challenge
Population: As TSLP levels were too low to detect, this analysis was not performed and results are not presented.
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.
Time frame: Baseline and 7 hours post-allergen challenge
Population: All randomized participants
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prednisone | Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Sputum | 1.63 Fold Change |
| Prednisone | Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Nasal Exudates | 1.33 Fold Change |
| Placebo | Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Sputum | 2.04 Fold Change |
| Placebo | Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge | Nasal Exudates | 1.22 Fold Change |
Comparison: GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from SP.p-value: 0.25890% CI: [0.43, 1.47]ANOVA
Comparison: GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.p-value: 0.68190% CI: [0.8, 1.46]ANOVA