Trial Outcomes & Findings for The Effects of Immunotherapy in the Nose (NCT NCT01985542)
NCT ID: NCT01985542
Last Updated: 2021-06-10
Results Overview
Transcriptomics are evaluated By Next Generation Sequencing. The total number of differentially expressed transcripts are defined from nasal epithelial brushing samples taken at -6 months vs. at +6 months in the two subject groups. The subject groups are the Subcutaneous immunotherapy group and No immunotherapy group.
COMPLETED
NA
16 participants
-6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.
2021-06-10
Participant Flow
Participant milestones
| Measure |
Subcutaneous Immunotherapy
Starts with birch pollen subcutaneous immunotherapy
birch pollen subcutaneous immunotherapy: birch pollen subcutaneous immunotherapy
|
no Immunotherapy
not starting with birch pollen subcutaneous immunotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Immunotherapy in the Nose
Baseline characteristics by cohort
| Measure |
Subcutaneous Immunotherapy
n=3 Participants
Starting with subcutaneuous birch pollen immunotherapy with normal protocol of the Hospital
|
no Immunotherapy
n=3 Participants
Birch pollen allergic subjects that are not starting with immunotherapy
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
40 years
n=99 Participants
|
34 years
n=107 Participants
|
38.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
Finland
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: -6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.Transcriptomics are evaluated By Next Generation Sequencing. The total number of differentially expressed transcripts are defined from nasal epithelial brushing samples taken at -6 months vs. at +6 months in the two subject groups. The subject groups are the Subcutaneous immunotherapy group and No immunotherapy group.
Outcome measures
| Measure |
Subcutaneous Immunotherapy
n=6 nasal brushing sample
Subjects with birch pollen allergic rhinitis.
|
No Immunotherapy
n=6 nasal brushing sample
Subjects with birch pollen allergic rhinitis.
|
|---|---|---|
|
The Total Number of Differentially Expressed Transcripts.
|
119 transcripts
|
49 transcripts
|
SECONDARY outcome
Timeframe: -6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.Population: The subject groups are the Subcutaneous immunotherapy group and No immunotherapy group.
Visual analogue scale (VAS) was measured as 0-100 mm per each symptom question. VAS value 0 (mm) indicates no symptoms, and value 100 (mm) indicates the worst case. Total VAS score = sum of the VAS scores for the 41 symptoms The minimum value of the total VAS score is 0, and the maximum value is 4100. Relative change = \[(measure at time +6 months - measure at time -6 months)\]/measure at time -6 months \* 100%. Measure = total VAS score
Outcome measures
| Measure |
Subcutaneous Immunotherapy
n=3 Participants
Subjects with birch pollen allergic rhinitis.
|
No Immunotherapy
n=3 Participants
Subjects with birch pollen allergic rhinitis.
|
|---|---|---|
|
Percentage Change in Visual Analogue Scale Scores of Symptoms
|
-68 percent change
Interval -76.0 to -7.0
|
91 percent change
Interval -49.0 to 347.0
|
Adverse Events
Subcutaneous Immunotherapy
no Immunotherapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place