Trial Outcomes & Findings for Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy (NCT NCT01353079)
NCT ID: NCT01353079
Last Updated: 2015-02-05
Results Overview
Change in baseline in avg combined daily RSS and medication scores during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Maximum medication score dependent on cumulative rescue medication use. Lower result is more favorable. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.
COMPLETED
PHASE3
429 participants
2011 ragweed pollen season, 8/2011 -10/2011
2015-02-05
Participant Flow
Participant milestones
| Measure |
Short Ragweed Pollen Allergenic Extract
Allergy Immunotherapy: Daily administration of Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season.
Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual
|
Glycero-COCAs
Placebo-Glycero-COCAs sublingual
|
|---|---|---|
|
Overall Study
STARTED
|
218
|
211
|
|
Overall Study
COMPLETED
|
191
|
190
|
|
Overall Study
NOT COMPLETED
|
27
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy
Baseline characteristics by cohort
| Measure |
Ragweed Allergenic Extract
n=218 Participants
Allergy Immunotherapy: Daily administration of Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.
Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual
|
Glycero-COCAs
n=211 Participants
Placebo: Glycero-COCAS sublingual
|
Total
n=429 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
218 Participants
n=93 Participants
|
211 Participants
n=4 Participants
|
429 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=93 Participants
|
117 Participants
n=4 Participants
|
244 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=93 Participants
|
94 Participants
n=4 Participants
|
185 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2011 ragweed pollen season, 8/2011 -10/2011Population: ITT population includes subjects who had at least one post treatment efficacy measurement
Change in baseline in avg combined daily RSS and medication scores during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Maximum medication score dependent on cumulative rescue medication use. Lower result is more favorable. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.
Outcome measures
| Measure |
Ragweed Allergenic Extract
n=196 Participants
Allergy Immunotherapy: Daily sublingual administration of ragweed allergenic extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.
Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual
|
Placebo (Glycero-Cocas)
n=193 Participants
Placebo: Glycero-COCAs sublingual
|
|---|---|---|
|
Scores on a Scale [Net Average Combined Daily Rhinoconjunctivitis Symptom (RSS) and Medication Scores]
|
0.853 Scores on a scale
Standard Deviation 1.64
|
1.687 Scores on a scale
Standard Deviation 2.40
|
SECONDARY outcome
Timeframe: 3 peak weeks of the 2011 ragweed pollen seasonPopulation: ITT population includes subjects who had at least one post treatment efficacy measurement. This analysis includes subjects the met the ITT criteria excluding those subjects that did not have either a combined symptom/medication score or RSS during the three peak weeks of the ragweed pollen season.
Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, watery eyes/tears), nasal (sneezing, itching, runny, stuffy nose), and ears (itching). Avg daily RSS computed by summing 8 individual allergy symptoms recorded in AM and PM; forming daily RSS by summing AM and PM RSS for each day; averaging daily RSS for three peak weeks. Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Max medication score dependent on cumulative rescue medication use. Lower result, more favorable. Three peak weeks of ragweed pollen counts during entire ragweed season was contiguous and calculated using a moving average of ragweed pollen counts for each week. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.
Outcome measures
| Measure |
Ragweed Allergenic Extract
n=192 Participants
Allergy Immunotherapy: Daily sublingual administration of ragweed allergenic extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.
Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual
|
Placebo (Glycero-Cocas)
n=192 Participants
Placebo: Glycero-COCAs sublingual
|
|---|---|---|
|
Scores on a Scale (Net Average Combined Daily Rhinoconjunctivitis Symptom and Medication Scores Reported During the Three Peak Weeks of Ragweed Pollen Season)
|
1.374 Scores on a scale
Standard Deviation 2.10
|
2.231 Scores on a scale
Standard Deviation 3.20
|
SECONDARY outcome
Timeframe: 2011 ragweed pollen season; 8/2011 - 10/2011Population: ITT population includes subjects who had at least one post treatment efficacy measurement
Change in baseline in avg daily RSS during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.
Outcome measures
| Measure |
Ragweed Allergenic Extract
n=196 Participants
Allergy Immunotherapy: Daily sublingual administration of ragweed allergenic extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.
Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual
|
Placebo (Glycero-Cocas)
n=193 Participants
Placebo: Glycero-COCAs sublingual
|
|---|---|---|
|
Scores of a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Entire Ragweed Pollen Season)
|
0.830 Scores on a scale
Standard Deviation 1.56
|
1.601 Scores on a scale
Standard Deviation 2.29
|
SECONDARY outcome
Timeframe: 3 peak weeks of the 2011 ragweed pollen seasonPopulation: ITT population includes subjects who had at least one post treatment efficacy measurement. This analysis includes subjects the met the ITT criteria excluding those subjects that did not have either a combined symptom/medication score or RSS during the three peak weeks of the ragweed pollen season.
Change from baseline in avg daily rhinoconjunctivitis symptom scores during the three peak weeks of ragweed pollen season for the ITT population (netpRSS). Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for three peak weeks of ragweed pollen season.
Outcome measures
| Measure |
Ragweed Allergenic Extract
n=192 Participants
Allergy Immunotherapy: Daily sublingual administration of ragweed allergenic extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.
Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual
|
Placebo (Glycero-Cocas)
n=192 Participants
Placebo: Glycero-COCAs sublingual
|
|---|---|---|
|
Scores on a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Three Peak Weeks of Ragweed Pollen Season)
|
1.318 Scores on a scale
Standard Deviation 1.99
|
2.105 Scores on a scale
Standard Deviation 3.01
|
Adverse Events
Ragweed Allergenic Extract
Glycero-Cocas
Serious adverse events
| Measure |
Ragweed Allergenic Extract
n=218 participants at risk
allergy immunotherapy: Daily administration of ragweed allergenic extract up to 42U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season.
placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual
|
Glycero-Cocas
n=211 participants at risk
placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/218
|
0.47%
1/211 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/218
|
0.47%
1/211 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/218
|
0.47%
1/211 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/218
|
0.47%
1/211 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/218
|
0.47%
1/211 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/218
|
0.47%
1/211
|
|
Surgical and medical procedures
Surgery
|
0.46%
1/218 • Number of events 1
|
0.00%
0/211
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.46%
1/218 • Number of events 1
|
0.00%
0/211
|
Other adverse events
| Measure |
Ragweed Allergenic Extract
n=218 participants at risk
allergy immunotherapy: Daily administration of ragweed allergenic extract up to 42U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season.
placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual
|
Glycero-Cocas
n=211 participants at risk
placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual
|
|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.0%
11/218 • Number of events 11
|
10.4%
22/211 • Number of events 22
|
|
Nervous system disorders
Headache
|
7.8%
17/218 • Number of events 17
|
8.1%
17/211 • Number of events 17
|
Additional Information
Terrance Coyne, M.D., Executive Vice President of Research & Development; Chief Medical Officer
GREER Laboratories, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60