Trial Outcomes & Findings for The Impact of Grass SLIT Treatment on Birch Pollen Induced Allergic Rhinitis - a Pilot Evaluation (NCT NCT02394600)
NCT ID: NCT02394600
Last Updated: 2018-01-29
Results Overview
To determine the effect of 4 months of treatment with Grastek® on the symptoms of birch pollen induced AR in participants with both timothy grass pollen-induced and birch pollen-induced allergen rhinitis (AR) TNSS is comprised of the sum of 4 symptoms: runny nose, itchy nose sneezing and nasal congestion. Each of these symptoms are evaluated based on a 4 point Likert scale from 0-3. 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. TNSS can therefore have a range from 0 to 12.
COMPLETED
PHASE4
93 participants
4 months
2018-01-29
Participant Flow
Participant milestones
| Measure |
Grastek
4 months of once per day Grastek sublingual immunotherapy
|
Placebo
4 months of once per day matching placebo sublingual tablet
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
|
Overall Study
COMPLETED
|
43
|
44
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Grastek
4 months of once per day Grastek sublingual immunotherapy
|
Placebo
4 months of once per day matching placebo sublingual tablet
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
The Impact of Grass SLIT Treatment on Birch Pollen Induced Allergic Rhinitis - a Pilot Evaluation
Baseline characteristics by cohort
| Measure |
Grastek
n=47 Participants
4 months of once per day Grastek sublingual immunotherapy
|
Placebo
n=46 Participants
4 months of once per day matching placebo sublingual tablet
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
37.89 years
n=5 Participants
|
38.17 years
n=7 Participants
|
38.03 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: 93 participants were randomized into this study. The final number of participants that completed and were included for analysis are listed above.
To determine the effect of 4 months of treatment with Grastek® on the symptoms of birch pollen induced AR in participants with both timothy grass pollen-induced and birch pollen-induced allergen rhinitis (AR) TNSS is comprised of the sum of 4 symptoms: runny nose, itchy nose sneezing and nasal congestion. Each of these symptoms are evaluated based on a 4 point Likert scale from 0-3. 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. TNSS can therefore have a range from 0 to 12.
Outcome measures
| Measure |
Grastek
n=43 Participants
4 months of once per day Grastek sublingual immunotherapy
|
Placebo
n=44 Participants
4 months of once per matching placebo sublingual tablet
|
|---|---|---|
|
Change in Total Nasal Symptom Score (TNSS) From Baseline to Post-treatment.
|
2.3 Scores on a scale
Interval 1.5 to 3.1
|
2.2 Scores on a scale
Interval 1.4 to 3.0
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: As the primary outcome showed that there was no significant difference between Grastek and placebo this outcome was not able to be completed.
To determine potential biomarkers predictive of clinical efficacy for birch pollen-induced AR following treatment with Grastek®
Outcome measures
Outcome data not reported
Adverse Events
Grastek®
Placebo
Serious adverse events
| Measure |
Grastek®
n=47 participants at risk
4 months of once per day Grastek sublingual immunotherapy
|
Placebo
n=46 participants at risk
4 months of once per day matching placebo sublingual tablet
|
|---|---|---|
|
Gastrointestinal disorders
Worsening of ulcer
|
0.00%
0/47
|
2.2%
1/46 • Number of events 1
|
Other adverse events
| Measure |
Grastek®
n=47 participants at risk
4 months of once per day Grastek sublingual immunotherapy
|
Placebo
n=46 participants at risk
4 months of once per day matching placebo sublingual tablet
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
31.9%
15/47
|
23.9%
11/46
|
|
Gastrointestinal disorders
Nausea
|
8.5%
4/47
|
4.3%
2/46
|
|
General disorders
Headache
|
14.9%
7/47
|
26.1%
12/46
|
|
Ear and labyrinth disorders
Ear pruritus
|
17.0%
8/47
|
0.00%
0/46
|
|
General disorders
Palate pruritus
|
8.5%
4/47
|
2.2%
1/46
|
|
General disorders
Sublingual pruritus
|
14.9%
7/47
|
0.00%
0/46
|
|
General disorders
Throat pruritus
|
23.4%
11/47
|
2.2%
1/46
|
|
General disorders
Tongue pruritus
|
12.8%
6/47
|
0.00%
0/46
|
|
General disorders
Nasal congestion
|
8.5%
4/47
|
2.2%
1/46
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place