Trial Outcomes & Findings for Study of the Inflammation and Airway Changes That Occur After Exposure to Allergen in Asthmatics (NCT NCT02230189)

NCT ID: NCT02230189

Last Updated: 2022-08-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

24 hours

Results posted on

2022-08-16

Participant Flow

Participant milestones

Participant milestones
Measure
Allergic Asthmatics(AA)
Volunteers with both asthma and allergy (as established by skin prick testing)
Allergic Non-Asthmatics(ANA)
Volunteers with allergy (as established by skin prick testing) but without asthma;
Non-Allergic Non-Asthmatics(NANA)
Volunteers with neither asthma nor allergy (as established by skin prick testing)
Overall Study
STARTED
22
2
4
Overall Study
COMPLETED
17
2
3
Overall Study
NOT COMPLETED
5
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Allergic Asthmatics(AA)
Volunteers with both asthma and allergy (as established by skin prick testing)
Allergic Non-Asthmatics(ANA)
Volunteers with allergy (as established by skin prick testing) but without asthma;
Non-Allergic Non-Asthmatics(NANA)
Volunteers with neither asthma nor allergy (as established by skin prick testing)
Overall Study
Physician Decision
1
0
0
Overall Study
Withdrawal by Subject
3
0
1
Overall Study
Lost to Follow-up
1
0
0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Allergic Non-asthmatics(ANA)
n=2 Participants
) Volunteers with allergy (as established by skin prick testing) but without asthma
Non-allergic Non-asthmatics(NANA)
n=3 Participants
Volunteers with neither asthma nor allergy (as established by skin prick testing)
Allergic Asthmatics(AA)
n=17 Participants
Volunteers with both asthma and allergy (as established by skin prick testing)
Total
n=22 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=5 Participants
3 Participants
n=7 Participants
16 Participants
n=5 Participants
21 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Continuous
29.5 years
STANDARD_DEVIATION 2.12 • n=5 Participants
29 years
STANDARD_DEVIATION 5 • n=7 Participants
29.7 years
STANDARD_DEVIATION 7.15 • n=5 Participants
29.5 years
STANDARD_DEVIATION 9.268 • n=4 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
1 Participants
n=7 Participants
11 Participants
n=5 Participants
13 Participants
n=4 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
2 Participants
n=7 Participants
6 Participants
n=5 Participants
9 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
0 Participants
n=7 Participants
4 Participants
n=5 Participants
5 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=5 Participants
3 Participants
n=7 Participants
13 Participants
n=5 Participants
17 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
4 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
3 Participants
n=4 Participants
Race (NIH/OMB)
White
2 Participants
n=5 Participants
1 Participants
n=7 Participants
8 Participants
n=5 Participants
11 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
3 Participants
n=5 Participants
3 Participants
n=4 Participants
Region of Enrollment
United States
2 participants
n=5 Participants
3 participants
n=7 Participants
17 participants
n=5 Participants
22 participants
n=4 Participants
FEV1
4.52 liters
STANDARD_DEVIATION 1.71 • n=5 Participants
4.22 liters
STANDARD_DEVIATION 0.397 • n=7 Participants
3.38 liters
STANDARD_DEVIATION 0.789 • n=5 Participants
3.6 liters
STANDARD_DEVIATION 0.864 • n=4 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Allergen Challenge Subjects
n=12 Participants
Intervention: Segmental airway allergen challenge In this arm, we studied volunteers with both asthma and allergy (as established by skin prick testing) Biological/Vaccine: Segmental airway allergen challenge Procedure/Surgery: Bronchoscopy Diagnostic Test: Methacholine challenge test Diagnostic Test: Spirometry Diagnostic Test: Allergen skin prick test
Diluent Challenge Subjects
n=12 Participants
Intervention: Segmental airway diluent challenge In this arm, we studied volunteers with both asthma and allergy (as established by skin prick testing).
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
miR1248
7.02 Normalized log2 copy number
Standard Deviation 0.31
7.21 Normalized log2 copy number
Standard Deviation 0.48
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
miR944
7.12 Normalized log2 copy number
Standard Deviation 0.19
7.27 Normalized log2 copy number
Standard Deviation 0.36
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
miR6806
6.63 Normalized log2 copy number
Standard Deviation 0.22
6.35 Normalized log2 copy number
Standard Deviation 0.13
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
miR103a
12.05 Normalized log2 copy number
Standard Deviation 0.38
11.7 Normalized log2 copy number
Standard Deviation 0.48
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
miR454-5p
6.77 Normalized log2 copy number
Standard Deviation 0.16
6.57 Normalized log2 copy number
Standard Deviation 0.28
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
miR320e
6.57 Normalized log2 copy number
Standard Deviation 0.16
6.69 Normalized log2 copy number
Standard Deviation 0.24
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
miR4521
7.33 Normalized log2 copy number
Standard Deviation 0.79
6.74 Normalized log2 copy number
Standard Deviation 0.43
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
miR107
9.63 Normalized log2 copy number
Standard Deviation 0.61
9.01 Normalized log2 copy number
Standard Deviation 0.98
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
miR891a
7.02 Normalized log2 copy number
Standard Deviation 0.64
6.56 Normalized log2 copy number
Standard Deviation 0.46
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
miR363
9.55 Normalized log2 copy number
Standard Deviation 1.16
8.77 Normalized log2 copy number
Standard Deviation 1.07
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
miR181a
8.29 Normalized log2 copy number
Standard Deviation 0.33
8.83 Normalized log2 copy number
Standard Deviation 0.86
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
miR130b
6.72 Normalized log2 copy number
Standard Deviation 0.17
6.5 Normalized log2 copy number
Standard Deviation 0.33
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
miR365a
6.4 Normalized log2 copy number
Standard Deviation 0.14
6.55 Normalized log2 copy number
Standard Deviation 0.21
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
miR135b
6.65 Normalized log2 copy number
Standard Deviation 0.22
6.43 Normalized log2 copy number
Standard Deviation 0.19
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
miR1273h
6.53 Normalized log2 copy number
Standard Deviation 0.24
6.62 Normalized log2 copy number
Standard Deviation 0.33
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
miR3177
6.79 Normalized log2 copy number
Standard Deviation 0.26
6.88 Normalized log2 copy number
Standard Deviation 0.27

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Allergen Challenge Subjects
n=4 Participants
Intervention: Segmental airway allergen challenge In this arm, we studied volunteers with both asthma and allergy (as established by skin prick testing) Biological/Vaccine: Segmental airway allergen challenge Procedure/Surgery: Bronchoscopy Diagnostic Test: Methacholine challenge test Diagnostic Test: Spirometry Diagnostic Test: Allergen skin prick test
Diluent Challenge Subjects
n=4 Participants
Intervention: Segmental airway diluent challenge In this arm, we studied volunteers with both asthma and allergy (as established by skin prick testing).
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR877
5.13 Normalized log2 copy number
Standard Deviation 0.42
5.66 Normalized log2 copy number
Standard Deviation 0.39
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR6510
7.74 Normalized log2 copy number
Standard Deviation 0.57
9.2 Normalized log2 copy number
Standard Deviation 0.81
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR3605
5.92 Normalized log2 copy number
Standard Deviation 0.61
6.9 Normalized log2 copy number
Standard Deviation 0.8
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR3912
5.03 Normalized log2 copy number
Standard Deviation 0.53
5.83 Normalized log2 copy number
Standard Deviation 0.61
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR15b
6.76 Normalized log2 copy number
Standard Deviation 0.33
6.09 Normalized log2 copy number
Standard Deviation 0.39
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR127
7.06 Normalized log2 copy number
Standard Deviation 0.8
8.54 Normalized log2 copy number
Standard Deviation 1.73
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR146a
14.14 Normalized log2 copy number
Standard Deviation 1.19
12.73 Normalized log2 copy number
Standard Deviation 0.8
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR449b
9.99 Normalized log2 copy number
Standard Deviation 0.54
8.84 Normalized log2 copy number
Standard Deviation 0.88
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR21-5p
18.02 Normalized log2 copy number
Standard Deviation 0.33
17 Normalized log2 copy number
Standard Deviation 0.82
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR6842
6.83 Normalized log2 copy number
Standard Deviation 0.37
7.67 Normalized log2 copy number
Standard Deviation 0.44
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR142-5p
7.68 Normalized log2 copy number
Standard Deviation 0.38
6.93 Normalized log2 copy number
Standard Deviation 0.66
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR21
7.97 Normalized log2 copy number
Standard Deviation 0.49
6.83 Normalized log2 copy number
Standard Deviation 0.99
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR493
5.03 Normalized log2 copy number
Standard Deviation 0.31
5.66 Normalized log2 copy number
Standard Deviation 0.67
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR193a
6.66 Normalized log2 copy number
Standard Deviation 0.99
7.46 Normalized log2 copy number
Standard Deviation 0.72
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR149
9.98 Normalized log2 copy number
Standard Deviation 0.42
10.95 Normalized log2 copy number
Standard Deviation 0.4
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR449a
12.46 Normalized log2 copy number
Standard Deviation 0.56
11.36 Normalized log2 copy number
Standard Deviation 0.95
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR6511a
5.58 Normalized log2 copy number
Standard Deviation 0.66
6.46 Normalized log2 copy number
Standard Deviation 0.56
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR6843
5.99 Normalized log2 copy number
Standard Deviation 0.11
6.8 Normalized log2 copy number
Standard Deviation 0.67
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR671
8.53 Normalized log2 copy number
Standard Deviation 0.87
9.3 Normalized log2 copy number
Standard Deviation 0.73
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR6503
4.93 Normalized log2 copy number
Standard Deviation 0.19
5.56 Normalized log2 copy number
Standard Deviation 0.59
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR450b
6.05 Normalized log2 copy number
Standard Deviation 0.4
5.35 Normalized log2 copy number
Standard Deviation 0.52
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR485
5.08 Normalized log2 copy number
Standard Deviation 0.62
5.68 Normalized log2 copy number
Standard Deviation 0.72
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR6806
5.22 Normalized log2 copy number
Standard Deviation 0.38
5.85 Normalized log2 copy number
Standard Deviation 0.43
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR3182
5.92 Normalized log2 copy number
Standard Deviation 0.2
5.68 Normalized log2 copy number
Standard Deviation 0.97
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR142-3p
7.58 Normalized log2 copy number
Standard Deviation 0.21
6.72 Normalized log2 copy number
Standard Deviation 0.91
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR320d
6.48 Normalized log2 copy number
Standard Deviation 0.33
7.09 Normalized log2 copy number
Standard Deviation 0.72
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR3928
5.95 Normalized log2 copy number
Standard Deviation 0.3
5.24 Normalized log2 copy number
Standard Deviation 0.49
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR744
5.6 Normalized log2 copy number
Standard Deviation 0.58
5.1 Normalized log2 copy number
Standard Deviation 0.47
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR206
5.67 Normalized log2 copy number
Standard Deviation 1.06
5.18 Normalized log2 copy number
Standard Deviation 0.61
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR30e
11.3 Normalized log2 copy number
Standard Deviation 0.29
10.36 Normalized log2 copy number
Standard Deviation 0.7
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR4500
6.21 Normalized log2 copy number
Standard Deviation 0.41
5.61 Normalized log2 copy number
Standard Deviation 0.22
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR125a
13.66 Normalized log2 copy number
Standard Deviation 1.47
14.55 Normalized log2 copy number
Standard Deviation 1.18
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR99b
13.78 Normalized log2 copy number
Standard Deviation 0.31
14.33 Normalized log2 copy number
Standard Deviation 0.4
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR1
5.86 Normalized log2 copy number
Standard Deviation 0.76
5.17 Normalized log2 copy number
Standard Deviation 0.49
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR146b
14.13 Normalized log2 copy number
Standard Deviation 0.38
14.72 Normalized log2 copy number
Standard Deviation 0.76
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR1255a
5.21 Normalized log2 copy number
Standard Deviation 0.54
5.79 Normalized log2 copy number
Standard Deviation 0.67
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR223
9.9 Normalized log2 copy number
Standard Deviation 0.6
8.9 Normalized log2 copy number
Standard Deviation 1.08
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR642a
7.8 Normalized log2 copy number
Standard Deviation 0.56
8.32 Normalized log2 copy number
Standard Deviation 0.22
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR548ae
5.86 Normalized log2 copy number
Standard Deviation 0.24
5.23 Normalized log2 copy number
Standard Deviation 0.4
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR146b-3p
7.9 Normalized log2 copy number
Standard Deviation 0.35
8.58 Normalized log2 copy number
Standard Deviation 0.31
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR181a
8.25 Normalized log2 copy number
Standard Deviation 0.32
8.74 Normalized log2 copy number
Standard Deviation 0.58
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR4467
5.17 Normalized log2 copy number
Standard Deviation 0.47
5.56 Normalized log2 copy number
Standard Deviation 0.92
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR1249
5.05 Normalized log2 copy number
Standard Deviation 0.35
5.62 Normalized log2 copy number
Standard Deviation 0.44
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR766
5.59 Normalized log2 copy number
Standard Deviation 0.63
4.98 Normalized log2 copy number
Standard Deviation 0.3
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR29c
7.93 Normalized log2 copy number
Standard Deviation 0.56
7.09 Normalized log2 copy number
Standard Deviation 0.78
Difference in Expression of Epithelial miRNAs (in Read Counts) 7 Days After Allergen-challenge as Compared to 7 Days After Diluent Challenge
miR370
5.77 Normalized log2 copy number
Standard Deviation 0.76
6.51 Normalized log2 copy number
Standard Deviation 1

Adverse Events

Allergic Asthmatics(AA)

Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths

Allergic Non-Asthmatics(ANA)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Non-Allergic Non-Asthmatics(NANA)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Allergic Asthmatics(AA)
n=22 participants at risk
Volunteers with both asthma and allergy (as established by skin prick testing)
Allergic Non-Asthmatics(ANA)
n=2 participants at risk
Volunteers with allergy (as established by skin prick testing) but without asthma;
Non-Allergic Non-Asthmatics(NANA)
n=4 participants at risk
Volunteers with neither asthma nor allergy (as established by skin prick testing)
Pregnancy, puerperium and perinatal conditions
Pregnancy identified during study enrollment
4.5%
1/22 • Number of events 1 • Adverse event data were prospectively collected from the first visit until 48 hours after the last study visit in all participants and until the resolution of any potential adverse event reported by a subject after a study procedure, up to 6 months.
0.00%
0/2 • Adverse event data were prospectively collected from the first visit until 48 hours after the last study visit in all participants and until the resolution of any potential adverse event reported by a subject after a study procedure, up to 6 months.
0.00%
0/4 • Adverse event data were prospectively collected from the first visit until 48 hours after the last study visit in all participants and until the resolution of any potential adverse event reported by a subject after a study procedure, up to 6 months.

Other adverse events

Other adverse events
Measure
Allergic Asthmatics(AA)
n=22 participants at risk
Volunteers with both asthma and allergy (as established by skin prick testing)
Allergic Non-Asthmatics(ANA)
n=2 participants at risk
Volunteers with allergy (as established by skin prick testing) but without asthma;
Non-Allergic Non-Asthmatics(NANA)
n=4 participants at risk
Volunteers with neither asthma nor allergy (as established by skin prick testing)
Respiratory, thoracic and mediastinal disorders
Increased systolic blood pressure post-bronchoscopy
4.5%
1/22 • Number of events 1 • Adverse event data were prospectively collected from the first visit until 48 hours after the last study visit in all participants and until the resolution of any potential adverse event reported by a subject after a study procedure, up to 6 months.
0.00%
0/2 • Adverse event data were prospectively collected from the first visit until 48 hours after the last study visit in all participants and until the resolution of any potential adverse event reported by a subject after a study procedure, up to 6 months.
0.00%
0/4 • Adverse event data were prospectively collected from the first visit until 48 hours after the last study visit in all participants and until the resolution of any potential adverse event reported by a subject after a study procedure, up to 6 months.
Respiratory, thoracic and mediastinal disorders
Respiratory infection post-bronchoscopy
4.5%
1/22 • Number of events 1 • Adverse event data were prospectively collected from the first visit until 48 hours after the last study visit in all participants and until the resolution of any potential adverse event reported by a subject after a study procedure, up to 6 months.
0.00%
0/2 • Adverse event data were prospectively collected from the first visit until 48 hours after the last study visit in all participants and until the resolution of any potential adverse event reported by a subject after a study procedure, up to 6 months.
0.00%
0/4 • Adverse event data were prospectively collected from the first visit until 48 hours after the last study visit in all participants and until the resolution of any potential adverse event reported by a subject after a study procedure, up to 6 months.

Additional Information

PI: Prescott G. Woodruff, MD, MPH

University of California, San Francisco

Phone: 415-514-2061

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place