Birch Pollen Allergy
Conditions
Keywords
rhinoconjunctivitis, birch pollen, desensitization, allergen immunotherapy
Brief 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.
Detailed description
Multicenter, international, parallel-group follow-up study of subjects randomized and treated in Study AN004T (AllerT 100 µg, AllerT 50 µg, placebo) and followed over the 2nd, and if appropriate, the 3rd and 4th birch pollen seasons in this study (still double-blind during the 1st year, open-label in the 2nd and 3rd years).
Interventions
None listed
Sponsors
Anergis
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Any subject having been randomized in the AN004T trial and had received at least one injection 2. Any subject having been informed and provided signed consent for participating in the trial and willing to follow all planned trial assessments
Exclusion criteria
1. 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 2. Any subject intending to travel during the birch pollen season outside of the birch pollination area for more than 7 consecutive days 3. Any subject unable or unwilling to record allergy symptoms and medications daily during the following birch pollen season using an electronic diary device 4. Any subject not covered by medical insurance 5. Any subject having received immunosuppressive medication within 4 weeks prior to inclusion, or planned to be used during the trial period 6. 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 7. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season | from the first of 3 consecutive days with a regional pollen count > 10 grains/m3 to the earliest between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3 | The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2 The Rhinoconjunctivitis Symptom Score (RSS) comprises 6 different symptoms from the nose and eyes. The sum of the 6 symptom scores divided by 6 will be used as the RSS (scale of 0 to 3). The daily Rhinoconjunctivitis Medication Score (RMS) will be determined by assigning daily scores as follows: 0 = no medication 1. = subject took topical antihistamine 2. = subject took oral antihistamine 3. = subject took oral corticosteroids |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season | between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3 | The Mini-RQLQ will be used. This evaluation tool includes 14 questions assessing 5 domains (activity limitation, practical problems, nose symptoms, eye symptoms, and non-nose/eye symptoms). For each question the answer is quoted from 0: no troubled to 6: extremely troubled; then the average of the score for the 14 questions is calculated resulting in a scale from 0 to 6, 0 being the best case and 6 the worst case |
Countries
Denmark, France, Latvia, Lithuania, Poland, Sweden, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AllerT 100 μg patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T | 62 |
| AllerT 50 μg patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T | 66 |
| Placebo Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T | 68 |
| Total | 196 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | husband illness | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | AllerT 100 μg | AllerT 50 μg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 39.0 years STANDARD_DEVIATION 9 | 37.9 years STANDARD_DEVIATION 9.4 | 35.5 years STANDARD_DEVIATION 9.3 | 37.4 years STANDARD_DEVIATION 9.3 |
| Sex: Female, Male Female | 30 Participants | 37 Participants | 34 Participants | 101 Participants |
| Sex: Female, Male Male | 32 Participants | 29 Participants | 34 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 62 | 1 / 66 | 4 / 68 |
| serious Total, serious adverse events | 0 / 62 | 2 / 66 | 0 / 68 |
Outcome results
Primary
Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season
The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2 The Rhinoconjunctivitis Symptom Score (RSS) comprises 6 different symptoms from the nose and eyes. The sum of the 6 symptom scores divided by 6 will be used as the RSS (scale of 0 to 3). The daily Rhinoconjunctivitis Medication Score (RMS) will be determined by assigning daily scores as follows: 0 = no medication 1. = subject took topical antihistamine 2. = subject took oral antihistamine 3. = subject took oral corticosteroids
Time frame: from the first of 3 consecutive days with a regional pollen count > 10 grains/m3 to the earliest between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3
Population: Modified-ITT analysis set : participants having received at least 4 injections of AllerT or placebo in AN004T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AllerT 100 μg | Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season | 0.853 units on a scale | Standard Deviation 0.524 |
| AllerT 50 μg | Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season | 0.795 units on a scale | Standard Deviation 0.421 |
| Placebo | Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season | 0.959 units on a scale | Standard Deviation 0.487 |
Secondary
Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season
The Mini-RQLQ will be used. This evaluation tool includes 14 questions assessing 5 domains (activity limitation, practical problems, nose symptoms, eye symptoms, and non-nose/eye symptoms). For each question the answer is quoted from 0: no troubled to 6: extremely troubled; then the average of the score for the 14 questions is calculated resulting in a scale from 0 to 6, 0 being the best case and 6 the worst case
Time frame: between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3
Population: Modified-ITT analysis set : patients having received at least 4 injections of AllerT or placebo in AN004T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AllerT 100 μg | 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 units on a scale | Standard Deviation 1.017 |
| AllerT 50 μg | Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season | 1.479 units on a scale | Standard Deviation 0.879 |
| Placebo | Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season | 1.767 units on a scale | Standard Deviation 1.054 |