Trial Outcomes & Findings for A Novel Biologic Therapy for Perennial Allergic Rhinitis (NCT NCT03360071)
NCT ID: NCT03360071
Last Updated: 2019-09-04
Results Overview
Change in baseline. TNSS (Total Nasal Symptoms Score) + medication rescue score. TNSS is a scale of 0-12 with 12 being severe. Medication score is also 0-12 with 12 being highest use of medications. Thus DCS ranges from 0-24 (severe).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Change from baseline at 10 weeks
Results posted on
2019-09-04
Participant Flow
Participant milestones
| Measure |
Allergen Immunotherapy Group
Allergen Immunotherapy Extract: Allergen Immunotherapy treatment mixture to be delivered subcutaneously
|
Control Group
Allergen Immunotherapy Control: Allergen Immunotherapy Control Solution to be delivered subcutaneously
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
14
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Allergen Immunotherapy Group
Allergen Immunotherapy Extract: Allergen Immunotherapy treatment mixture to be delivered subcutaneously
|
Control Group
Allergen Immunotherapy Control: Allergen Immunotherapy Control Solution to be delivered subcutaneously
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Novel Biologic Therapy for Perennial Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
Allergen Immunotherapy Group
n=17 Participants
Allergen Immunotherapy Extract: Allergen Immunotherapy treatment mixture to be delivered subcutaneously
|
Control Group
n=14 Participants
Allergen Immunotherapy Control: Allergen Immunotherapy Control Solution to be delivered subcutaneously
|
Total
n=31 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
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 1 • n=5 Participants
|
39 years
STANDARD_DEVIATION 1 • n=7 Participants
|
36.8 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
14 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline at 10 weeksChange in baseline. TNSS (Total Nasal Symptoms Score) + medication rescue score. TNSS is a scale of 0-12 with 12 being severe. Medication score is also 0-12 with 12 being highest use of medications. Thus DCS ranges from 0-24 (severe).
Outcome measures
| Measure |
Allergen Immunotherapy Group
n=17 Participants
Allergen Immunotherapy Extract: Allergen Immunotherapy treatment mixture to be delivered subcutaneously
|
Control Group
n=14 Participants
Allergen Immunotherapy Control: Allergen Immunotherapy Control Solution to be delivered subcutaneously
|
|---|---|---|
|
Daily Combined Score (DCS)
|
-4.41 DCS (daily combined score)
Standard Deviation 4.5
|
-1.61 DCS (daily combined score)
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Change from baseline at 10 weeksmini-RQLQ (mini-Rhinoconjunctivitis Quality of Life Questionnaire) is to measure a the level of severity of a set of symptoms of functional impairments due to rhinoconjunctivitis from baseline. 14 questions each range 0-6 (6 is most severe). Total range 0-84 (higher value is more severe symptoms).
Outcome measures
| Measure |
Allergen Immunotherapy Group
n=17 Participants
Allergen Immunotherapy Extract: Allergen Immunotherapy treatment mixture to be delivered subcutaneously
|
Control Group
n=14 Participants
Allergen Immunotherapy Control: Allergen Immunotherapy Control Solution to be delivered subcutaneously
|
|---|---|---|
|
Mini RQLQ
|
-34.9 score on a scale
Standard Deviation 28.4
|
-17.6 score on a scale
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Duration of intervention plus followup (12 weeks)Use of epinephrine during intervention for a total of 8 weeks through followup and study completion (4 more weeks). Thus total number of times epinephrine is required per patient during entire 12 week period.
Outcome measures
| Measure |
Allergen Immunotherapy Group
n=17 Participants
Allergen Immunotherapy Extract: Allergen Immunotherapy treatment mixture to be delivered subcutaneously
|
Control Group
n=14 Participants
Allergen Immunotherapy Control: Allergen Immunotherapy Control Solution to be delivered subcutaneously
|
|---|---|---|
|
Rescue Medication Use
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: continuous review of safety up to 14 weekSafety and adverse events (AES) will be followed. We will measure and report systemic reactions.
Outcome measures
| Measure |
Allergen Immunotherapy Group
n=17 Participants
Allergen Immunotherapy Extract: Allergen Immunotherapy treatment mixture to be delivered subcutaneously
|
Control Group
n=14 Participants
Allergen Immunotherapy Control: Allergen Immunotherapy Control Solution to be delivered subcutaneously
|
|---|---|---|
|
Safety Assessment
|
3 Participants
|
0 Participants
|
Adverse Events
Allergen Immunotherapy Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control Group
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 |
Allergen Immunotherapy Group
n=17 participants at risk
Allergen Immunotherapy Extract: Allergen Immunotherapy treatment mixture to be delivered subcutaneously
|
Control Group
n=14 participants at risk
Allergen Immunotherapy Control: Allergen Immunotherapy Control Solution to be delivered subcutaneously
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
systemic reaction
|
17.6%
3/17 • Number of events 3 • From start of therapy until one month after therapy was completed (12 weeks total).
We look at all adverse events but particularly systemic reaction rates including anaphylaxis and use of epinephrine (12 weeks total)
|
0.00%
0/14 • From start of therapy until one month after therapy was completed (12 weeks total).
We look at all adverse events but particularly systemic reaction rates including anaphylaxis and use of epinephrine (12 weeks total)
|
Additional Information
Jody Tversky, MD
John Hopkins University School of Medicine
Phone: 410-550-2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publication must be approved by sponsor within first 10 years after completion.
- Publication restrictions are in place
Restriction type: OTHER