Trial Outcomes & Findings for Efficacy Study of Sublingual Immunotherapy to Treat Ragweed Allergies (NCT NCT00599872)
NCT ID: NCT00599872
Last Updated: 2015-01-14
Results Overview
Symptom score defined as sum of scores from eight 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). Average daily RSS ranged from 0-48; A lower score was more favorable. The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season.
COMPLETED
PHASE3
430 participants
Ragweed pollen season, 08/01/08 to 10/30/08, approximately 3 months
2015-01-14
Participant Flow
Participant milestones
| Measure |
Active
Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
|
Placebo
Placebo to be administered once daily at 0.0 Units/Amb a 1
|
|---|---|---|
|
Overall Study
STARTED
|
216
|
214
|
|
Overall Study
COMPLETED
|
167
|
181
|
|
Overall Study
NOT COMPLETED
|
49
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Study of Sublingual Immunotherapy to Treat Ragweed Allergies
Baseline characteristics by cohort
| Measure |
Active
n=216 Participants
Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
|
Placebo
n=214 Participants
Placebo to be administered once daily at 0.0 Units/Amb a 1
|
Total
n=430 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
|
216 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
430 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
|
35.8 years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 9.24 • n=7 Participants
|
35.6 years
STANDARD_DEVIATION 9.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
265 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
216 participants
n=5 Participants
|
214 participants
n=7 Participants
|
430 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Ragweed pollen season, 08/01/08 to 10/30/08, approximately 3 monthsPopulation: The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)
Symptom score defined as sum of scores from eight 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). Average daily RSS ranged from 0-48; A lower score was more favorable. The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season.
Outcome measures
| Measure |
Active
n=136 Participants
Ragweed allergenic extract administer once daily at 26.3 to 77.3 Units/Amb a 1.
|
Placebo
n=157 Participants
Placebo to be administered once daily at 0.0 Units/Amb a 1
|
|---|---|---|
|
Scores on a Scale (Average of Daily Rhinoconjunctivitis Symptom Score (RSS) Recorded During the Ragweed Season
|
6.2 Scores on a scale
Standard Deviation 6.2
|
6.5 Scores on a scale
Standard Deviation 5.61
|
SECONDARY outcome
Timeframe: 09/01/2008-09/07/2008Population: The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)
Symptom score defined as sum of scores from eight 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). Average daily RSS ranged from 0-48; A lower score was more favorable. The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season. The highest pollen count week was defined as the 7 contiguous days from the series with the largest average pollen count, and in which the weekly average was computed using at least 4 non-missing daily RSS values (either AM or PM could be present to be considered a valid daily RSS value).
Outcome measures
| Measure |
Active
n=136 Participants
Ragweed allergenic extract administer once daily at 26.3 to 77.3 Units/Amb a 1.
|
Placebo
n=157 Participants
Placebo to be administered once daily at 0.0 Units/Amb a 1
|
|---|---|---|
|
Scores on a Scale (Average Daily RSS During the Highest Pollen Count Week)
|
7.0 scores on a scale
Standard Deviation 6.96
|
7.5 scores on a scale
Standard Deviation 7.03
|
SECONDARY outcome
Timeframe: Ragweed pollen season 08/01/08 to 10/30/08Population: The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)
Symptom score defined as sum of scores from eight 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). Average daily RSS ranged from 0-48; A lower score was more favorable. The average daily RSS (the sum of the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS).
Outcome measures
| Measure |
Active
n=136 Participants
Ragweed allergenic extract administer once daily at 26.3 to 77.3 Units/Amb a 1.
|
Placebo
n=157 Participants
Placebo to be administered once daily at 0.0 Units/Amb a 1
|
|---|---|---|
|
Scores on a Scale (Average Daily AM RSS and the Average Daily PM RSS During the Ragweed Season)
Average Daily AM RSS
|
3.5 Scores on a scale
Standard Deviation 3.64
|
3.8 Scores on a scale
Standard Deviation 3.22
|
|
Scores on a Scale (Average Daily AM RSS and the Average Daily PM RSS During the Ragweed Season)
Average Daily PM RSS
|
3.5 Scores on a scale
Standard Deviation 3.47
|
3.6 Scores on a scale
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: Ragweed pollen season 08/01/08 to 10/30/08Population: The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)
The average daily RSS during the ragweed season for each of the 3 organ systems (ocular, nasal, ears) were separately analyzed to evaluate these individual components of the RSS. Three separate baseline average daily RSS values were computed for this analysis. The modified ITT population was used for this analysis. The range for scores: 0 to 3 for each of eight symptom or a total of 0 to 24 daily RSS. A lower score was more favorable.
Outcome measures
| Measure |
Active
n=136 Participants
Ragweed allergenic extract administer once daily at 26.3 to 77.3 Units/Amb a 1.
|
Placebo
n=157 Participants
Placebo to be administered once daily at 0.0 Units/Amb a 1
|
|---|---|---|
|
Scores on a Scale (Average Daily RSS During the Ragweed Season for Each of the Three Organ) Systems (Ocular, Nasal, Ears);
Ocular
|
1.7 Scores on a scale
Standard Deviation 2.44
|
1.9 Scores on a scale
Standard Deviation 2.12
|
|
Scores on a Scale (Average Daily RSS During the Ragweed Season for Each of the Three Organ) Systems (Ocular, Nasal, Ears);
Nasal
|
4.0 Scores on a scale
Standard Deviation 3.55
|
4.2 Scores on a scale
Standard Deviation 3.41
|
|
Scores on a Scale (Average Daily RSS During the Ragweed Season for Each of the Three Organ) Systems (Ocular, Nasal, Ears);
Ears
|
0.5 Scores on a scale
Standard Deviation 0.94
|
0.5 Scores on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Ragweed pollen season 08/01/08 to 10/30/08Population: The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)
Total allergy relief medication score during the ragweed season for each subject. This score is computed for each subject by summing their individual medication scores (excluding beta-agonist use) for the entire ragweed season. High scores were indicative of poor symptom relief from the study medication. The associated relief medication scores assigned to medication are 0-if no medication taken; 3 for each one antihistamine tablet taken; 1 for each 2 antihistamine eye drop administrations, 1 for each 2 antihistamine nasal spray administrations and 1 for each puff of beta-agonist. The maximum medication score was dependent on the cumulative rescue medication use. The lower result the more favorable.
Outcome measures
| Measure |
Active
n=136 Participants
Ragweed allergenic extract administer once daily at 26.3 to 77.3 Units/Amb a 1.
|
Placebo
n=157 Participants
Placebo to be administered once daily at 0.0 Units/Amb a 1
|
|---|---|---|
|
Scores on a Scale (Total Allergy Relief Medication Score During the Ragweed Season) for Each Subject
|
40.5 Scores on a scale
Standard Deviation 85.59
|
50.1 Scores on a scale
Standard Deviation 137.00
|
SECONDARY outcome
Timeframe: Ragweed pollen season 08/01/08 to 10/30/08Population: The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)
The average combined allergy symptom and medication score during the ragweed season for each subject. This score is computed for each subject by adding their daily relief medication scores (excluding beta-agonist use) and their daily RSS for the entire ragweed season, and then taking the average of the combined scores across days.
Outcome measures
| Measure |
Active
n=136 Participants
Ragweed allergenic extract administer once daily at 26.3 to 77.3 Units/Amb a 1.
|
Placebo
n=157 Participants
Placebo to be administered once daily at 0.0 Units/Amb a 1
|
|---|---|---|
|
Scores on a Scale (The Average Combined Allergy Symptom and Medication Score During the Ragweed Season for Each Subject)
|
6.7 Scores on a scale
Standard Deviation 6.85
|
7.3 Scores on a scale
Standard Deviation 6.69
|
Adverse Events
Ragweed Allergenic Extract
Placebo
Serious adverse events
| Measure |
Ragweed Allergenic Extract
n=216 participants at risk
Ragweed Allergenic extract administered once daily at 77.3 Units/Amb a 1.
|
Placebo
n=214 participants at risk
Placebo be administered once daily at 0.0 Units/Amb a 1
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hernia
|
0.46%
1/216 • Number of events 1 • Approximately 30 weeks
|
0.00%
0/214 • Approximately 30 weeks
|
|
Psychiatric disorders
Stress
|
0.46%
1/216 • Number of events 1 • Approximately 30 weeks
|
0.00%
0/214 • Approximately 30 weeks
|
|
Gastrointestinal disorders
food poisoning
|
0.46%
1/216 • Number of events 1 • Approximately 30 weeks
|
0.00%
0/214 • Approximately 30 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place