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Study of the Inflammation and Airway Changes That Occur After Exposure to Allergen in Asthmatics

Mechanistic Study of Epithelial miRNAs and T-cell Recruitment Dynamics That Occur After Allergen Challenge in Patients With Asthma.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02230189
Acronym
ACE
Enrollment
28
Registered
2014-09-03
Start date
2015-03-31
Completion date
2020-01-31
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Allergen challenge

Brief summary

This protocol describes a single site mechanistic study to investigate microRNAs (miRNAs) that are differentially expressed in the airway epithelium of patients with asthma at baseline and in response to allergen challenge. We hypothesize that allergen exposure enhances airway smooth muscle contractility and epithelial cell mRNA/miRNA production as a consequence of locally increased T-cell derived cytokine production. The study will involve three visits over the course of approximately 14 days. At Visit 1, participants will be characterized in detail with lung function testing, methacholine challenge testing, and allergen skin prick testing. At Visit 2, participants will undergo bronchoscopy with segmental allergen administration of either cat or dust mite standardized allergen extract. At Visit 3 (either 24 hours later or 7 days later), bronchoscopy will be performed to collect airway samples including bronchoalveolar lavage (BAL), epithelial brushings and endobronchial biopsies. Sample analysis will include measurement of miRNA and mRNA expression in epithelial brushings (RNAseq and qPCR); analysis of cell surface markers on BAL cells and blood cells; and collection of endobronchial biopsies for immunostaining of immune cells localization, immunoblotting of smooth cell protein phosphorylation, analysis of mucin content and smooth muscle cell subculture. A total of 38 subjects (26 asthmatics with stable or well-controlled asthma, 6 allergic non-asthmatics and 6 non-allergic non-asthmatics) will complete the study.

Interventions

BIOLOGICALSegmental airway allergen challenge
PROCEDUREBronchoscopy
DIAGNOSTIC_TESTSpirometry
DIAGNOSTIC_TESTAllergen skin prick test

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
Prescott Woodruff
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Single group before and after administration of allergen

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

Allergic/Non-Asthmatic subjects and Allergic/Asthmatic subjects Inclusion Criteria: * Positive skin test to dust mite or cat allergen Non-Allergic/Non-Asthmatic subjects Inclusion Criteria: * Negative skin test to panel of 12 allergens, including dust mite and cat allergen All groups

Exclusion criteria

* History of intubation for asthma exacerbation * Use of Xolair (omalizumab) within the last 6 months * Immunotherapy with cat or dust mite extract now or in the past 5 years * ≥ 10 pack-years smoking or any smoking in the past year * Other lung diseases, such as sarcoidosis, bronchiectasis or active lung infection * History of dermatographia * History of anaphylaxis to cat allergen * Participation in another research study involving a drug or biologic during the past 30 days * Presence of past or current medical problems/other factors that may pose additional risks from participation or influence study results, as determined per study investigator

Design outcomes

Primary

MeasureTime frameDescription
Difference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic Asthma24 hoursFor each participant with Allergic Asthma, a baseline airway epithelial brushing was performed, allergen was instilled into one segment of the lung, and diluent (control) was instilled into another segment. Both segments were brushed for epithelial cells 24 hours later. After processing brushes to RNA and generating RNA sequencing data, the RNA transcript read counts for each gene underwent variance stabilized log normalization. Then we built a regression model which estimated the difference in miRNA read count in the allergen challenged as compared to the baseline sample and the difference in miRNA read count in the diluent challenged segment as compared to baseline for each participant. The change from baseline read count for each miRNA in the allergen samples was compared to the change in the diluent samples and statistical significance was assessed using the unadjusted p-value(\<0.05). The direction of change does not have clinical significance; this was a mechanistic study.
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge7 daysFor each participant with Allergic Asthma, a baseline airway epithelial brushing was performed, allergen was instilled into one segment of the lung, and diluent (control) was instilled into another segment. Both segments were brushed for epithelial cells 7 days later. After processing the brushes to RNA and generating RNA sequencing data, the RNA transcript read counts for each gene underwent variance stabilized log normalization. Then we built a regression model which estimated the difference in miRNA read count in the allergen challenged as compared to the baseline sample and the difference in miRNA read count in the diluent challenged segment as compared to baseline for each participant. The change from baseline read count for each miRNA in the allergen samples was compared to the change in the diluent samples and statistical significance was assessed using the unadjusted p-value(\<0.05). The direction of change does not have clinical significance; this was a mechanistic study.

Countries

United States

Participant flow

Participants by arm

ArmCount
Allergic Non-asthmatics(ANA)
) Volunteers with allergy (as established by skin prick testing) but without asthma
2
Non-allergic Non-asthmatics(NANA)
Volunteers with neither asthma nor allergy (as established by skin prick testing)
3
Allergic Asthmatics(AA)
Volunteers with both asthma and allergy (as established by skin prick testing)
17
Total22

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up100
Overall StudyPhysician Decision100
Overall StudyWithdrawal by Subject301

Baseline characteristics

CharacteristicAllergic Non-asthmatics(ANA)TotalAllergic Asthmatics(AA)Non-allergic Non-asthmatics(NANA)
Age, Categorical
<=18 years
0 Participants1 Participants1 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
2 Participants21 Participants16 Participants3 Participants
Age, Continuous29.5 years
STANDARD_DEVIATION 2.12
29.5 years
STANDARD_DEVIATION 9.268
29.7 years
STANDARD_DEVIATION 7.15
29 years
STANDARD_DEVIATION 5
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants5 Participants4 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants17 Participants13 Participants3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
FEV14.52 liters
STANDARD_DEVIATION 1.71
3.6 liters
STANDARD_DEVIATION 0.864
3.38 liters
STANDARD_DEVIATION 0.789
4.22 liters
STANDARD_DEVIATION 0.397
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants4 Participants3 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants3 Participants2 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants3 Participants3 Participants0 Participants
Race (NIH/OMB)
White
2 Participants11 Participants8 Participants1 Participants
Region of Enrollment
United States
2 participants22 participants17 participants3 participants
Sex: Female, Male
Female
1 Participants13 Participants11 Participants1 Participants
Sex: Female, Male
Male
1 Participants9 Participants6 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 220 / 20 / 4
other
Total, other adverse events
2 / 220 / 20 / 4
serious
Total, serious adverse events
1 / 220 / 20 / 4

Outcome results

Primary

Difference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic Asthma

For each participant with Allergic Asthma, a baseline airway epithelial brushing was performed, allergen was instilled into one segment of the lung, and diluent (control) was instilled into another segment. Both segments were brushed for epithelial cells 24 hours later. After processing brushes to RNA and generating RNA sequencing data, the RNA transcript read counts for each gene underwent variance stabilized log normalization. Then we built a regression model which estimated the difference in miRNA read count in the allergen challenged as compared to the baseline sample and the difference in miRNA read count in the diluent challenged segment as compared to baseline for each participant. The change from baseline read count for each miRNA in the allergen samples was compared to the change in the diluent samples and statistical significance was assessed using the unadjusted p-value(\<0.05). The direction of change does not have clinical significance; this was a mechanistic study.

Time frame: 24 hours

Population: Our pre-specified primary outcome was limited to Allergic Asthmatics only. The rationale for this is that participants without allergy or asthma do not respond to Allergen Challenge and therefore the changes in miRNA are uninformative.

ArmMeasureGroupValue (MEAN)Dispersion
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR45217.33 Normalized log2 copy numberStandard Deviation 0.79
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR1079.63 Normalized log2 copy numberStandard Deviation 0.61
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR891a7.02 Normalized log2 copy numberStandard Deviation 0.64
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR3639.55 Normalized log2 copy numberStandard Deviation 1.16
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR12487.02 Normalized log2 copy numberStandard Deviation 0.31
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR9447.12 Normalized log2 copy numberStandard Deviation 0.19
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR68066.63 Normalized log2 copy numberStandard Deviation 0.22
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR103a12.05 Normalized log2 copy numberStandard Deviation 0.38
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR454-5p6.77 Normalized log2 copy numberStandard Deviation 0.16
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR320e6.57 Normalized log2 copy numberStandard Deviation 0.16
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR181a8.29 Normalized log2 copy numberStandard Deviation 0.33
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR130b6.72 Normalized log2 copy numberStandard Deviation 0.17
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR365a6.4 Normalized log2 copy numberStandard Deviation 0.14
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR135b6.65 Normalized log2 copy numberStandard Deviation 0.22
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR1273h6.53 Normalized log2 copy numberStandard Deviation 0.24
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR31776.79 Normalized log2 copy numberStandard Deviation 0.26
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR31776.88 Normalized log2 copy numberStandard Deviation 0.27
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR45216.74 Normalized log2 copy numberStandard Deviation 0.43
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR454-5p6.57 Normalized log2 copy numberStandard Deviation 0.28
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR1079.01 Normalized log2 copy numberStandard Deviation 0.98
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR365a6.55 Normalized log2 copy numberStandard Deviation 0.21
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR891a6.56 Normalized log2 copy numberStandard Deviation 0.46
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR320e6.69 Normalized log2 copy numberStandard Deviation 0.24
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR3638.77 Normalized log2 copy numberStandard Deviation 1.07
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR1273h6.62 Normalized log2 copy numberStandard Deviation 0.33
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR12487.21 Normalized log2 copy numberStandard Deviation 0.48
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR181a8.83 Normalized log2 copy numberStandard Deviation 0.86
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR9447.27 Normalized log2 copy numberStandard Deviation 0.36
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR135b6.43 Normalized log2 copy numberStandard Deviation 0.19
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR68066.35 Normalized log2 copy numberStandard Deviation 0.13
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR130b6.5 Normalized log2 copy numberStandard Deviation 0.33
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With Allergic AsthmamiR103a11.7 Normalized log2 copy numberStandard Deviation 0.48
Comparison: miR4521p-value: 0.01t-test, 2 sided
Comparison: miR107p-value: 0.01t-test, 2 sided
Comparison: miR-891ap-value: 0.018t-test, 2 sided
Comparison: miR363p-value: 0.021t-test, 2 sided
Comparison: miR1248p-value: 0.028t-test, 2 sided
Comparison: miR944p-value: 0.033t-test, 2 sided
Comparison: miR6806p-value: 0.034t-test, 2 sided
Comparison: miR103ap-value: 0.036t-test, 2 sided
Comparison: miR454p-value: 0.037t-test, 2 sided
Comparison: miR320ep-value: 0.041t-test, 2 sided
Comparison: miR181ap-value: 0.043t-test, 2 sided
Comparison: miR130bp-value: 0.044t-test, 2 sided
Comparison: miR365ap-value: 0.044t-test, 2 sided
Comparison: miR135bp-value: 0.047t-test, 2 sided
Comparison: miR1273hp-value: 0.048t-test, 2 sided
Comparison: miR3177p-value: 0.048t-test, 2 sided
Primary

Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge

For each participant with Allergic Asthma, a baseline airway epithelial brushing was performed, allergen was instilled into one segment of the lung, and diluent (control) was instilled into another segment. Both segments were brushed for epithelial cells 7 days later. After processing the brushes to RNA and generating RNA sequencing data, the RNA transcript read counts for each gene underwent variance stabilized log normalization. Then we built a regression model which estimated the difference in miRNA read count in the allergen challenged as compared to the baseline sample and the difference in miRNA read count in the diluent challenged segment as compared to baseline for each participant. The change from baseline read count for each miRNA in the allergen samples was compared to the change in the diluent samples and statistical significance was assessed using the unadjusted p-value(\<0.05). The direction of change does not have clinical significance; this was a mechanistic study.

Time frame: 7 days

Population: Our pre-specified primary outcome was limited to Allergic Asthmatics only. The rationale for this is that participants without allergy or asthma do not respond to Allergen Challenge and therefore the changes in miRNA are uninformative.

ArmMeasureGroupValue (MEAN)Dispersion
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR193a6.66 Normalized log2 copy numberStandard Deviation 0.99
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR320d6.48 Normalized log2 copy numberStandard Deviation 0.33
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR39285.95 Normalized log2 copy numberStandard Deviation 0.3
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR7445.6 Normalized log2 copy numberStandard Deviation 0.58
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR2065.67 Normalized log2 copy numberStandard Deviation 1.06
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR30e11.3 Normalized log2 copy numberStandard Deviation 0.29
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR45006.21 Normalized log2 copy numberStandard Deviation 0.41
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR125a13.66 Normalized log2 copy numberStandard Deviation 1.47
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR99b13.78 Normalized log2 copy numberStandard Deviation 0.31
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR15.86 Normalized log2 copy numberStandard Deviation 0.76
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR146b14.13 Normalized log2 copy numberStandard Deviation 0.38
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR1255a5.21 Normalized log2 copy numberStandard Deviation 0.54
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR2239.9 Normalized log2 copy numberStandard Deviation 0.6
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR642a7.8 Normalized log2 copy numberStandard Deviation 0.56
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR548ae5.86 Normalized log2 copy numberStandard Deviation 0.24
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR146b-3p7.9 Normalized log2 copy numberStandard Deviation 0.35
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR8775.13 Normalized log2 copy numberStandard Deviation 0.42
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR181a8.25 Normalized log2 copy numberStandard Deviation 0.32
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR44675.17 Normalized log2 copy numberStandard Deviation 0.47
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR12495.05 Normalized log2 copy numberStandard Deviation 0.35
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR7665.59 Normalized log2 copy numberStandard Deviation 0.63
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR29c7.93 Normalized log2 copy numberStandard Deviation 0.56
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR3705.77 Normalized log2 copy numberStandard Deviation 0.76
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR65107.74 Normalized log2 copy numberStandard Deviation 0.57
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR36055.92 Normalized log2 copy numberStandard Deviation 0.61
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR39125.03 Normalized log2 copy numberStandard Deviation 0.53
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR15b6.76 Normalized log2 copy numberStandard Deviation 0.33
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR1277.06 Normalized log2 copy numberStandard Deviation 0.8
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR146a14.14 Normalized log2 copy numberStandard Deviation 1.19
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR449b9.99 Normalized log2 copy numberStandard Deviation 0.54
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR21-5p18.02 Normalized log2 copy numberStandard Deviation 0.33
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR68426.83 Normalized log2 copy numberStandard Deviation 0.37
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR142-5p7.68 Normalized log2 copy numberStandard Deviation 0.38
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR217.97 Normalized log2 copy numberStandard Deviation 0.49
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR4935.03 Normalized log2 copy numberStandard Deviation 0.31
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR1499.98 Normalized log2 copy numberStandard Deviation 0.42
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR449a12.46 Normalized log2 copy numberStandard Deviation 0.56
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR6511a5.58 Normalized log2 copy numberStandard Deviation 0.66
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR68435.99 Normalized log2 copy numberStandard Deviation 0.11
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR6718.53 Normalized log2 copy numberStandard Deviation 0.87
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR65034.93 Normalized log2 copy numberStandard Deviation 0.19
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR450b6.05 Normalized log2 copy numberStandard Deviation 0.4
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR4855.08 Normalized log2 copy numberStandard Deviation 0.62
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR68065.22 Normalized log2 copy numberStandard Deviation 0.38
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR31825.92 Normalized log2 copy numberStandard Deviation 0.2
Allergen Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR142-3p7.58 Normalized log2 copy numberStandard Deviation 0.21
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR65109.2 Normalized log2 copy numberStandard Deviation 0.81
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR193a7.46 Normalized log2 copy numberStandard Deviation 0.72
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR320d7.09 Normalized log2 copy numberStandard Deviation 0.72
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR36056.9 Normalized log2 copy numberStandard Deviation 0.8
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR39285.24 Normalized log2 copy numberStandard Deviation 0.49
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR4855.68 Normalized log2 copy numberStandard Deviation 0.72
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR7445.1 Normalized log2 copy numberStandard Deviation 0.47
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR39125.83 Normalized log2 copy numberStandard Deviation 0.61
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR2065.18 Normalized log2 copy numberStandard Deviation 0.61
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR14910.95 Normalized log2 copy numberStandard Deviation 0.4
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR30e10.36 Normalized log2 copy numberStandard Deviation 0.7
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR15b6.09 Normalized log2 copy numberStandard Deviation 0.39
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR45005.61 Normalized log2 copy numberStandard Deviation 0.22
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR65035.56 Normalized log2 copy numberStandard Deviation 0.59
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR125a14.55 Normalized log2 copy numberStandard Deviation 1.18
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR1278.54 Normalized log2 copy numberStandard Deviation 1.73
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR99b14.33 Normalized log2 copy numberStandard Deviation 0.4
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR449a11.36 Normalized log2 copy numberStandard Deviation 0.95
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR15.17 Normalized log2 copy numberStandard Deviation 0.49
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR146a12.73 Normalized log2 copy numberStandard Deviation 0.8
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR146b14.72 Normalized log2 copy numberStandard Deviation 0.76
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR31825.68 Normalized log2 copy numberStandard Deviation 0.97
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR1255a5.79 Normalized log2 copy numberStandard Deviation 0.67
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR449b8.84 Normalized log2 copy numberStandard Deviation 0.88
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR2238.9 Normalized log2 copy numberStandard Deviation 1.08
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR6511a6.46 Normalized log2 copy numberStandard Deviation 0.56
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR642a8.32 Normalized log2 copy numberStandard Deviation 0.22
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR21-5p17 Normalized log2 copy numberStandard Deviation 0.82
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR548ae5.23 Normalized log2 copy numberStandard Deviation 0.4
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR450b5.35 Normalized log2 copy numberStandard Deviation 0.52
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR146b-3p8.58 Normalized log2 copy numberStandard Deviation 0.31
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR68427.67 Normalized log2 copy numberStandard Deviation 0.44
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR8775.66 Normalized log2 copy numberStandard Deviation 0.39
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR68436.8 Normalized log2 copy numberStandard Deviation 0.67
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR181a8.74 Normalized log2 copy numberStandard Deviation 0.58
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR142-5p6.93 Normalized log2 copy numberStandard Deviation 0.66
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR44675.56 Normalized log2 copy numberStandard Deviation 0.92
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR68065.85 Normalized log2 copy numberStandard Deviation 0.43
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR12495.62 Normalized log2 copy numberStandard Deviation 0.44
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR216.83 Normalized log2 copy numberStandard Deviation 0.99
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR7664.98 Normalized log2 copy numberStandard Deviation 0.3
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR6719.3 Normalized log2 copy numberStandard Deviation 0.73
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR29c7.09 Normalized log2 copy numberStandard Deviation 0.78
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR4935.66 Normalized log2 copy numberStandard Deviation 0.67
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR3706.51 Normalized log2 copy numberStandard Deviation 1
Diluent Challenge SubjectsDifference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent ChallengemiR142-3p6.72 Normalized log2 copy numberStandard Deviation 0.91
Comparison: miR6510p-value: 0t-test, 2 sided
Comparison: miR3605p-value: 0t-test, 2 sided
Comparison: miR3912p-value: 0t-test, 2 sided
Comparison: miR15bp-value: 0t-test, 2 sided
Comparison: miR127p-value: 0t-test, 2 sided
Comparison: miR146ap-value: 0t-test, 2 sided
Comparison: miR449bp-value: 0t-test, 2 sided
Comparison: miR21-5pp-value: 0.01t-test, 2 sided
Comparison: miR6842p-value: 0.01t-test, 2 sided
Comparison: miR142-5pp-value: 0.01t-test, 2 sided
Comparison: miR21p-value: 0.01t-test, 2 sided
Comparison: miR493p-value: 0.01t-test, 2 sided
Comparison: miR193ap-value: 0.01t-test, 2 sided
Comparison: miR149p-value: 0.01t-test, 2 sided
Comparison: miR449ap-value: 0.01t-test, 2 sided
Comparison: miR6511ap-value: 0.01t-test, 2 sided
Comparison: miR6843p-value: 0.01t-test, 2 sided
Comparison: miR671p-value: 0.01t-test, 2 sided
Comparison: miR6503p-value: 0.02t-test, 2 sided
Comparison: miR450bp-value: 0.02t-test, 2 sided
Comparison: miR485p-value: 0.02t-test, 2 sided
Comparison: miR6806p-value: 0.02t-test, 2 sided
Comparison: miR3182p-value: 0.02t-test, 2 sided
Comparison: miR142-3pp-value: 0.02t-test, 2 sided
Comparison: miR320dp-value: 0.02t-test, 2 sided
Comparison: miR3928p-value: 0.02t-test, 2 sided
Comparison: miR744p-value: 0.02t-test, 2 sided
Comparison: miR206p-value: 0.02t-test, 2 sided
Comparison: miR30ep-value: 0.03t-test, 2 sided
Comparison: miR4500p-value: 0.03t-test, 2 sided
Comparison: miR125ap-value: 0.03t-test, 2 sided
Comparison: miR99bp-value: 0.03t-test, 2 sided
Comparison: miR1p-value: 0.03t-test, 2 sided
Comparison: miR146bp-value: 0.03t-test, 2 sided
Comparison: miR1255ap-value: 0.03t-test, 2 sided
Comparison: miR223p-value: 0.03t-test, 2 sided
Comparison: miR642ap-value: 0.03t-test, 2 sided
Comparison: miR548aep-value: 0.4t-test, 2 sided
Comparison: miR146bp-value: 0.04t-test, 2 sided
Comparison: miR877p-value: 0.04t-test, 2 sided
Comparison: miR181ap-value: 0.04t-test, 2 sided
Comparison: miR4467p-value: 0.04t-test, 2 sided
Comparison: miR1249p-value: 0.04t-test, 2 sided
Comparison: miR766p-value: 0.04t-test, 2 sided
Comparison: miR29cp-value: 0.048t-test, 2 sided
Comparison: miR370p-value: -1.75t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026