An observational study in Birch Pollen Allergy, sponsored by Anergis. Completed at 22 sites in 7 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-06-24.
Sponsored by Anergis · Observational
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.
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).
392 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 25 are open to participants now.
This study's enrollment of 196 is above the median of 96 across 30 observational studies indexed under Rhinitis, Allergic, Seasonal.
Browse Rhinitis, Allergic, Seasonal studies →Anergis is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects with moderate to severe allergic rhiniconjunctivitis to birch pollen
Exclusion Criteria:
patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
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
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
| Milestone | AllerT 100 μg | AllerT 50 μg | Placebo |
|---|---|---|---|
| Started | 62 | 66 | 68 |
| Completed | 61 | 66 | 66 |
| Not completed | 1 | 0 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 | 1 |
| Withdrew: Husband illness | 0 | 0 | 1 |
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
| units on a scale | AllerT 100 μg | AllerT 50 μg | Placebo |
|---|---|---|---|
| Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season | 0.853 ± 0.524 | 0.795 ± 0.421 | 0.959 ± 0.487 |
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
| units on a scale | AllerT 100 μg | AllerT 50 μg | Placebo |
|---|---|---|---|
| Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season | 1.486 ± 1.017 | 1.479 ± 0.879 | 1.767 ± 1.054 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AllerT 100 μg | — | 0/62 (0%) | 2/62 (3.2%) |
| AllerT 50 μg | — | 2/66 (3%) | 1/66 (1.5%) |
| Placebo | — | 0/68 (0%) | 4/68 (5.9%) |
| Event | AllerT 100 μg | AllerT 50 μg | Placebo |
|---|---|---|---|
| AngioedemaSkin and subcutaneous tissue disorders | 0/62 | 1/66 | 0/68 |
| Rash generalisedSkin and subcutaneous tissue disorders | 0/62 | 1/66 | 0/68 |
| Threatened laborPregnancy, puerperium and perinatal conditions | 0/62 | 1/66 | 0/68 |
| Event | AllerT 100 μg | AllerT 50 μg | Placebo |
|---|---|---|---|
| NasopharyngitisRespiratory, thoracic and mediastinal disorders | 2/62 | 1/66 | 4/68 |
Safety set : subjects having received at least one injection of AllerT or placebo in AN004T and successfully screened in AN005T
| Age, Continuous(years) | AllerT 100 μg | AllerT 50 μg | Placebo | Total |
|---|---|---|---|---|
| Mean | 39.0 ± 9.0 | 37.9 ± 9.4 | 35.5 ± 9.3 | 37.4 ± 9.3 |
| Sex: Female, Male(Participants) | AllerT 100 μg | AllerT 50 μg | Placebo | Total |
|---|---|---|---|---|
| Female | 30 | 37 | 34 | 101 |
| Male | 32 | 29 | 34 | 95 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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