Long-term follow-up of desensitization by Specific ImmunoTherapy (SIT) received during the trial AN004T in subjects allergic to birch pollen MedDRA version: 14.1 Level: LLT Classification code 10066093 Term: Birch pollen allergy System Organ Class: 100000004870
Conditions
Sponsors
Anergis SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects satisfying all the following criteria could be included in the trial. 1. Had been randomized in the AN004T trial and had received at least 1 injection 2. Have been informed and provided signed consent for participating in the trial and willing to follow all planned trial assessments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 238 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any subject presenting with one or more of the following criteria will not be included in the trial. These exclusion criteria are valid for each year. 1. Received specific immunotherapy against birch pollen or a tree pollen mix including birch pollen at any time since AN004T and before Visit 1 2. Intending to travel during the birch pollen season outside of the birch pollination area for more than 7 consecutive days 3. Unable or unwilling to record allergy symptoms and medications daily during the following birch pollen season using an electronic diary device 4. Not covered by medical insurance 5. Received immunosuppressive medication within 4 weeks prior to inclusion, or planned to be used during the trial period 6. Received systemic or local antihistamines, oral or inhaled corticosteroids or under anti depressant medication with antihistamine effect within 2 weeks prior to inclusion 7. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50 µg or 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the 2nd following birch pollen season;Secondary Objective: 50 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the 3rd and 4th following birch pollen seasons • To evaluate the maintained efficacy of a 2-month pre-seasonal treatment with an AllerT 100-µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the 3rd and 4th following birch pollen seasons • To compare the effects of a 2-month pre-seasonal treatment with AllerT at maintenance doses of 50 µg and 100 µg during the 2nd to 4th following birch pollen seasons with the effects during the 1st season assessed in Study AN004T.;Primary end point(s): The primary efficacy variable is the average of the combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) obtained daily during the birch pollen season. ;Timepoint(s) of evaluation of this end point: Start day of each birch pollen season until end day of each birch pollen season | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Average quality-of-life total score The average of the total score of the validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) obtained weekly during the birch pollen season. • Average of the Night-time Nasal Symptom Score (NNSS) obtained daily during the birch pollen season. • Average of the combined Rhinoconjunctivitis and Night-time Symptom and Medication Score (RNSMS) obtained daily during the birch pollen season • Percentage of well days during the birch pollen season The percentage of well days over the number of days of the birch pollen season when the daily questionnaires were completed. • Percentage of days with severe symptoms during the birch pollen season The percentage of days with severe symptoms over the number of days of the birch pollen season when the daily questionnaires were completed. • Subject’s global evaluation of treatment efficacy collected at Visit V3 of each year ;Timepoint(s) of evaluation of this end point: Start day of each birch pollen season until end day of each birch pollen season | — |
Countries
Denmark, France, Latvia, Lithuania, Poland, Sweden, Switzerland
Contacts
Public ContactTamara Schärer
Anergis SA
Outcome results
None listed