Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment

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 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.

Study Overview

• Status: Completed
• Conditions: Birch Pollen Allergy

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).

• Study Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• Denmark
  • Arhus, Denmark, 8000
    • Lungemedicinsk Forskningsafdeling
  • Odense, Denmark, 5000
    • Klinisk Institute
  • Copenhagen
    • Hellerup, Copenhagen, Denmark, 2900
      • Allergiklinikken
• France
  • Strasbourg, France, 67000
    • Hôpitaux Universitaires de Strasbourg
• Latvia
  • Rezekne, Latvia, 4601
    • Viktorija Vevere private practice of Allergology
  • Riga, Latvia, 1003
    • Center of examination and treatment of allergic diseases
• Lithuania
  • Kaunas, Lithuania, 50009
    • Kaunas Clinics University Hospital
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital
  • Vilnius, Lithuania, 08431
    • Allergy Clinic JSC Perspektyvos
  • Vilnius, Lithuania, 10200
    • Antakalnio affiliation of the Vilnius City Allergy Center
• Poland
  • Lodz, Poland, 90153
    • SPZOZ Uniwersytecki Szpital Kliniczny - Allergology
  • Lodz, Poland, 90553
    • Alergologii Centrum
  • Lublin, Poland, 20095
    • Alergotest
  • Tarnow, Poland, 33100
    • Alergo-Med
  • Warszawa, Poland, 01157
    • Centrum Alergologii IRMED
  • Wroclaw, Poland, 50-368
    • Silesian Piasts University of Medicine in Wrocław
  • Wroclaw, Poland, 54203
    • Aler-med
  • Zabrze, Poland, 41800
    • NZOZ Przychodnia Lekarska Hipokrates
• Sweden
  • Lund, Sweden, 22185
    • University hospital Skane
  • Orebro, Sweden, 70185
    • Orebro University Hospital
  • Vasteras, Sweden, 72189
    • Lungavdelningen, Vastmanlands
• Switzerland
  • VD
    • Lausanne, VD, Switzerland, 1005
      • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects with moderate to severe allergic rhiniconjunctivitis to birch pollen

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
AllerT 100 μg; patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
AllerT 50 μg; patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
Placebo; Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; = subject took topical antihistamine; = subject took oral antihistamine; = subject took oral corticosteroids	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Collaborators and Investigators

• Sponsor: Anergis
• Investigators: Principal Investigator: Framçois SPERTINI, MD, University of Lausanne Hospitals

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: May 2, 2014
• First Submitted That Met QC Criteria: May 20, 2014
• First Posted (Estimate): May 21, 2014

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: allergen immunotherapy; desensitization; rhinoconjunctivitis; birch pollen
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis, Allergic; Rhinitis; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: AN005T; 2013-003881-15 (EudraCT Number)