Trial Outcomes & Findings for Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers (NCT NCT05122143)
NCT ID: NCT05122143
Last Updated: 2024-09-19
Results Overview
Total Nasal Symptom Score (TNSS) average from 20 - 180 minutes will be compared between treated and non-treated subjects. Data from all three visits are combined. Scale for a single symptom is from 0 - 3, 0 meaning no symptoms and 3 severe symptoms. Assessed symptoms are: nasal congestion, runny nose, nasal itching and sneezing. TNSS is the sum of the rating of all 4 symptoms and ranges from 0-12.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
Day 8 to Day 22
Results posted on
2024-09-19
Participant Flow
The study was conducted from November 10, 2021 (first subject first screening) to April 04, 2022 (last subject telephone call). Details on treatment sequences: Subjects that qualified for randomization, could enter the treatment period where they received a treatment before entering the chamber. This treatment could be either A - one spray of AM-301 per nostril, B - two sprays of AM-301 per nostril or C - no treatment at all. The order of the treatments was different \> sequences (ABC, xxx).
Patients with house dust mite (HDM) allergy as assessed by their medical history and a positive skin prick test for Dermatophagoides pteronyssinus (der p) allergen were enrolled into the screening phase. 173 patients were screened and out of those, 37 patients were randomized into the prophylactic treatment phase with AM-301. Subjects that could not be enrolled mainly failed to show sufficient proof for HDM allergy.
Participant milestones
| Measure |
Sequence 1
Treatment sequence for the 3 treatment visits: ABC.
|
Sequence 2
Treatment sequence for the 3 treatment visits: BCA.
|
Sequence 3
Treatment sequence for the 3 treatment visits: CAB.
|
Sequence 4
Treatment sequence for the 3 treatment visits: ACB.
|
Sequence 5
Treatment sequence for the 3 treatment visits: BAC.
|
Sequence 6
Treatment sequence for the 3 treatment visits: CBA.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
7
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
5
|
6
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
Treatment sequence for the 3 treatment visits: ABC.
|
Sequence 2
Treatment sequence for the 3 treatment visits: BCA.
|
Sequence 3
Treatment sequence for the 3 treatment visits: CAB.
|
Sequence 4
Treatment sequence for the 3 treatment visits: ACB.
|
Sequence 5
Treatment sequence for the 3 treatment visits: BAC.
|
Sequence 6
Treatment sequence for the 3 treatment visits: CBA.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol non-compliance
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Covid contact
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers
Baseline characteristics by cohort
| Measure |
Sequence 1
n=6 Participants
Treatment sequence for the 3 treatment visits: ABC.
|
Sequence 2
n=6 Participants
Treatment sequence for the 3 treatment visits: BCA.
|
Sequence 3
n=6 Participants
Treatment sequence for the 3 treatment visits:CAB.
|
Sequence 4
n=6 Participants
Treatment sequence for the 3 treatment visits: ACB.
|
Sequence 5
n=7 Participants
Treatment sequence for the 3 treatment visits: BAC.
|
Sequence 6
n=6 Participants
Treatment sequence for the 3 treatment visits: CBA.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
37 Participants
n=115 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Continuous
|
33.5 years
STANDARD_DEVIATION 8.34 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 14.44 • n=7 Participants
|
28.3 years
STANDARD_DEVIATION 4.84 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 9.54 • n=4 Participants
|
35.4 years
STANDARD_DEVIATION 10.45 • n=21 Participants
|
31.7 years
STANDARD_DEVIATION 6.74 • n=10 Participants
|
35.7 years
STANDARD_DEVIATION 10.47 • n=115 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
27 Participants
n=115 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
7 participants
n=21 Participants
|
6 participants
n=10 Participants
|
37 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 8 to Day 22Population: All participants received all three treatments in a different order (sequence). Therefore, data are available for each treatment for all participants. In the ITT population, all participants of the safety population with at least one TNSS assessment are included.
Total Nasal Symptom Score (TNSS) average from 20 - 180 minutes will be compared between treated and non-treated subjects. Data from all three visits are combined. Scale for a single symptom is from 0 - 3, 0 meaning no symptoms and 3 severe symptoms. Assessed symptoms are: nasal congestion, runny nose, nasal itching and sneezing. TNSS is the sum of the rating of all 4 symptoms and ranges from 0-12.
Outcome measures
| Measure |
Treatment A
n=36 Participants
Participants received one spray of AM-301 per nostril before they entered the environmental exposure chamber (EEC).
|
Treatment B
n=36 Participants
Participants received two sprays of AM-301 per nostril before they entered the environmental exposure chamber (EEC).
|
Treatment C
n=34 Participants
Participants received no treatment before they entered the environmental exposure chamber (EEC).
|
|---|---|---|---|
|
Overall Change From Baseline in TNSS at Visits 3, 4 and 5
|
3.9 TNSS score (0-12)
Standard Deviation 2.59
|
4.1 TNSS score (0-12)
Standard Deviation 2.93
|
5.2 TNSS score (0-12)
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Day 8 to Day 22Total Nasal Symptom Score (TNSS) average from 20 - 180 min was compared between treated and non-treated subjects. Scale for a single symptom is from 0 - 3, 0 meaning no symptoms and 3 severe symptoms. Assessed symptoms are: nasal congestion, runny nose, nasal itching and sneezing. TNSS is the sum of the rating of all 4 symptoms and ranges from 0-12. This descriptive endpoint was not corrected for baseline.
Outcome measures
| Measure |
Treatment A
n=36 Participants
Participants received one spray of AM-301 per nostril before they entered the environmental exposure chamber (EEC).
|
Treatment B
n=36 Participants
Participants received two sprays of AM-301 per nostril before they entered the environmental exposure chamber (EEC).
|
Treatment C
n=34 Participants
Participants received no treatment before they entered the environmental exposure chamber (EEC).
|
|---|---|---|---|
|
Difference of Total Nasal Symptom Score (TNSS) at Individual Timepoints During House Dust Mite Challenge in the EEC (0-180 Min) Between Single and Double Application of AM-301 and no Treatment.
100 min in chamber
|
4.2 TNSS (0-12)
Standard Deviation 2.99
|
4.7 TNSS (0-12)
Standard Deviation 3.40
|
6.5 TNSS (0-12)
Standard Deviation 3.08
|
|
Difference of Total Nasal Symptom Score (TNSS) at Individual Timepoints During House Dust Mite Challenge in the EEC (0-180 Min) Between Single and Double Application of AM-301 and no Treatment.
140 min in chamber
|
4.4 TNSS (0-12)
Standard Deviation 3.00
|
5.1 TNSS (0-12)
Standard Deviation 3.69
|
6.3 TNSS (0-12)
Standard Deviation 2.96
|
|
Difference of Total Nasal Symptom Score (TNSS) at Individual Timepoints During House Dust Mite Challenge in the EEC (0-180 Min) Between Single and Double Application of AM-301 and no Treatment.
Pre-chamber
|
0.1 TNSS (0-12)
Standard Deviation 0.35
|
0.1 TNSS (0-12)
Standard Deviation 0.49
|
0.2 TNSS (0-12)
Standard Deviation 0.39
|
|
Difference of Total Nasal Symptom Score (TNSS) at Individual Timepoints During House Dust Mite Challenge in the EEC (0-180 Min) Between Single and Double Application of AM-301 and no Treatment.
20 min in chamber
|
2.3 TNSS (0-12)
Standard Deviation 2.42
|
2.4 TNSS (0-12)
Standard Deviation 2.64
|
2.3 TNSS (0-12)
Standard Deviation 2.25
|
|
Difference of Total Nasal Symptom Score (TNSS) at Individual Timepoints During House Dust Mite Challenge in the EEC (0-180 Min) Between Single and Double Application of AM-301 and no Treatment.
40 min in chamber
|
3.6 TNSS (0-12)
Standard Deviation 2.71
|
3.6 TNSS (0-12)
Standard Deviation 2.85
|
4.2 TNSS (0-12)
Standard Deviation 3.09
|
|
Difference of Total Nasal Symptom Score (TNSS) at Individual Timepoints During House Dust Mite Challenge in the EEC (0-180 Min) Between Single and Double Application of AM-301 and no Treatment.
60 min in chamber
|
4.6 TNSS (0-12)
Standard Deviation 2.79
|
3.6 TNSS (0-12)
Standard Deviation 3.04
|
4.8 TNSS (0-12)
Standard Deviation 3.42
|
|
Difference of Total Nasal Symptom Score (TNSS) at Individual Timepoints During House Dust Mite Challenge in the EEC (0-180 Min) Between Single and Double Application of AM-301 and no Treatment.
80 min in chamber
|
4.3 TNSS (0-12)
Standard Deviation 3.05
|
4.3 TNSS (0-12)
Standard Deviation 3.18
|
5.6 TNSS (0-12)
Standard Deviation 2.77
|
|
Difference of Total Nasal Symptom Score (TNSS) at Individual Timepoints During House Dust Mite Challenge in the EEC (0-180 Min) Between Single and Double Application of AM-301 and no Treatment.
120 min in chamber
|
4.5 TNSS (0-12)
Standard Deviation 3.06
|
4.8 TNSS (0-12)
Standard Deviation 3.67
|
6.2 TNSS (0-12)
Standard Deviation 3.32
|
|
Difference of Total Nasal Symptom Score (TNSS) at Individual Timepoints During House Dust Mite Challenge in the EEC (0-180 Min) Between Single and Double Application of AM-301 and no Treatment.
160 min in chamber
|
4.1 TNSS (0-12)
Standard Deviation 3.33
|
4.9 TNSS (0-12)
Standard Deviation 3.80
|
6.3 TNSS (0-12)
Standard Deviation 3.03
|
|
Difference of Total Nasal Symptom Score (TNSS) at Individual Timepoints During House Dust Mite Challenge in the EEC (0-180 Min) Between Single and Double Application of AM-301 and no Treatment.
180 min in chamber
|
4.3 TNSS (0-12)
Standard Deviation 3.51
|
5.1 TNSS (0-12)
Standard Deviation 3.81
|
6.2 TNSS (0-12)
Standard Deviation 3.32
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=36 participants at risk
Participants received one spray of AM-301 per nostril before they entered the environmental exposure chamber (EEC).
|
Treatment B
n=37 participants at risk
Participants received two sprays of AM-301 per nostril before they entered the environmental exposure chamber (EEC).
|
Treatment C
n=36 participants at risk
Participants received no treatment before they entered the environmental exposure chamber (EEC).
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
2.8%
1/36 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 65 (last follow-up call).
|
0.00%
0/37 • For each participant, adverse event data were collected from day 0 to day 65 (last follow-up call).
|
0.00%
0/36 • For each participant, adverse event data were collected from day 0 to day 65 (last follow-up call).
|
|
Nervous system disorders
Taste disorder
|
2.8%
1/36 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 65 (last follow-up call).
|
0.00%
0/37 • For each participant, adverse event data were collected from day 0 to day 65 (last follow-up call).
|
0.00%
0/36 • For each participant, adverse event data were collected from day 0 to day 65 (last follow-up call).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.8%
1/36 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 65 (last follow-up call).
|
0.00%
0/37 • For each participant, adverse event data were collected from day 0 to day 65 (last follow-up call).
|
0.00%
0/36 • For each participant, adverse event data were collected from day 0 to day 65 (last follow-up call).
|
|
Immune system disorders
Type I hypersensitivity
|
2.8%
1/36 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 65 (last follow-up call).
|
0.00%
0/37 • For each participant, adverse event data were collected from day 0 to day 65 (last follow-up call).
|
0.00%
0/36 • For each participant, adverse event data were collected from day 0 to day 65 (last follow-up call).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place