Phase 3
Completed N=429
Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy
Source: ClinicalTrials.gov NCT01353079 ↗Enrolled (actual)
429
Serious AEs
1.2%
Results posted
Feb 2015
Primary outcomePrimary: Scores on a Scale [Net Average Combined Daily Rhinoconjunctivitis Symptom (RSS) and Medication Scores] — 0.853; 1.687 Scores on a scale — p=<0.05
Summary
The primary objective of this study is to demonstrate that SLIT administered pre-and co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short ragweed pollen season.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Scores on a Scale [Net Average Combined Daily Rhinoconjunctivitis Symptom (RSS) and Medication Scores] |
0.853; 1.687 | <0.05 sig |
| SECONDARY 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; 2.231 | <0.05 sig |
| SECONDARY Scores of a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Entire Ragweed Pollen Season) |
0.830; 1.601 | <0.05 sig |
| SECONDARY Scores on a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Three Peak Weeks of Ragweed Pollen Season) |
1.318; 2.105 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- allergic to ragweed
Exclusion Criteria
- not allergic to ragweed
- history of anaphylaxis
- subject with chronic sinusitis, unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunological disease
- Asthmatic subjects with FEV1 or PEF less than or equal to 80% predicted
- Subjects who have received experimental drug within 30 days prior to study admission
- Subjects who have received anit-IgE medications in the last 12 months
- Subjects who have received ragweed immunotherapy in the last 3 years
- Subjects who are currently users of inhaled, intramuscular, or intravenous corticosteroids, tricyclic anti-depressants, beta blockers, and MAO inhibitors
- Subjects refusing to sign epi-pen training form
- Females who are pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT01353079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.