Clinical trial NCT02143583: Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment
Official title: Long-term Follow-up of a Multicentre, Randomized, Double-blind, Placebo-controlled Trial (AN004T) Assessing the Efficacy and Tolerability of 2 Dosing Regimens of AllerT in Adult Subjects Allergic to Birch Pollen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birch Pollen Allergy
Keywords: rhinoconjunctivitis
birch pollen
desensitization
allergen immunotherapy
Lead sponsor: Anergis
Sponsor class: INDUSTRY
First posted: 2014-05-21
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with moderate to severe allergic rhiniconjunctivitis to birch pollen

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).

Eligibility criteria: 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

Primary outcomes:
measure: Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season
timeFrame: 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
Secondary outcomes:
measure: Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season
timeFrame: 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
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Allergiklinikken
state: Copenhagen
city: Arhus
country: Denmark
facility: Lungemedicinsk Forskningsafdeling
city: Odense
country: Denmark
facility: Klinisk Institute
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg
city: Rezekne
country: Latvia
facility: Viktorija Vevere private practice of Allergology
city: Riga
country: Latvia
facility: Center of examination and treatment of allergic diseases
city: Kaunas
country: Lithuania
facility: Kaunas Clinics University Hospital
city: Vilnius
country: Lithuania
facility: Allergy Clinic JSC Perspektyvos
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital
city: Vilnius
country: Lithuania
facility: Antakalnio affiliation of the Vilnius City Allergy Center
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny - Allergology
city: Lodz
country: Poland
facility: Alergologii Centrum
city: Lublin
country: Poland
facility: Alergotest
city: Tarnow
country: Poland
facility: Alergo-Med
city: Warszawa
country: Poland
facility: Centrum Alergologii IRMED
city: Wroclaw
country: Poland
facility: Silesian Piasts University of Medicine in Wrocław
city: Wroclaw
country: Poland
facility: Aler-med
city: Zabrze
country: Poland
facility: NZOZ Przychodnia Lekarska Hipokrates
city: Lund
country: Sweden
facility: University hospital Skane
city: Orebro
country: Sweden
facility: Orebro University Hospital
city: Vasteras
country: Sweden
facility: Lungavdelningen, Vastmanlands
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: VD
Study officials:
affiliation: University of Lausanne Hospitals
name: Framçois SPERTINI, MD
role: PRINCIPAL_INVESTIGATOR
References: