N/A
N=196
Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment
Birch Pollen Allergy
Bottom Line
View on ClinicalTrials.gov: NCT02143583 ↗Enrolled (actual)
196
Serious AEs
1.0%
Results posted
Jun 2015
Primary outcome: Primary: Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season — 0.853; 0.795; 0.959 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Anergis
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season |
0.853; 0.795; 0.959 | — |
| SECONDARY Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season |
1.486; 1.479; 1.767 | — |
Summary
Study aiming to evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50 µg or 100 µg maintenance dose administered in previous study AN004T in reducing symptoms of allergic rhinoconjunctivitis during the 2nd following birch pollen season.
Eligibility Criteria
Inclusion Criteria
- Any subject having been randomized in the AN004T trial and had received at least one injection
- Any subject having been informed and provided signed consent for participating in the trial and willing to follow all planned trial assessments
Exclusion Criteria
- Any subject having received specific immunotherapy against birch pollen or a tree pollen mix including birch pollen at any time since AN004T and before Visit 1
- Any subject intending to travel during the birch pollen season outside of the birch pollination area for more than 7 consecutive days
- Any subject unable or unwilling to record allergy symptoms and medications daily during the following birch pollen season using an electronic diary device
- Any subject not covered by medical insurance
- Any subject having received immunosuppressive medication within 4 weeks prior to inclusion, or planned to be used during the trial period
- Any subject having received systemic or local antihistamines, oral or inhaled corticosteroids or under anti depressant medication with antihistamine effect within 2 weeks prior to inclusion
- Any subject having used any investigational or non-registered drug, vaccine, or medical device within 4 weeks prior to inclusion, or planned to use such treatments during the trial period
Data sourced from ClinicalTrials.gov (NCT02143583). 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.