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

NCT02143583 | Completed Results

• 2 other identifiers: AN005T2013-003881-15
• Study Type: observational
• Target: 196
• Locations: 7 countries
• Sites: 22

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.

Conditions

Birch Pollen Allergy

Keywords

rhinoconjunctivitis; birch pollen; desensitization; allergen immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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

  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 (1)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects with moderate to severe allergic rhiniconjunctivitis to birch pollen

You may qualify if:

• Any subject having been randomized in the AN004T trial and had received at least one injection
• Any subject having been informed and provided signed consent for participating in the trial and willing to follow all planned trial assessments

You may not qualify if:

• 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
• Any subject intending to travel during the birch pollen season outside of the birch pollination area for more than 7 consecutive days
• Any subject unable or unwilling to record allergy symptoms and medications daily during the following birch pollen season using an electronic diary device
• Any subject not covered by medical insurance

Sponsors & Collaborators

• Anergis: lead

Study Sites (22)

Allergiklinikken

Hellerup, Copenhagen, 2900, Denmark

Location

Lungemedicinsk Forskningsafdeling

Aarhus, 8000, Denmark

Location

Klinisk Institute

Odense, 5000, Denmark

Location

Hopitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

Viktorija Vevere private practice of Allergology

Rēzekne, 4601, Latvia

Location

Center of examination and treatment of allergic diseases

Riga, 1003, Latvia

Location

Kaunas Clinics University Hospital

Kaunas, 50009, Lithuania

Location

Allergy Clinic JSC Perspektyvos

Vilnius, 08431, Lithuania

Location

Vilnius University Hospital

Vilnius, 08661, Lithuania

Location

Antakalnio affiliation of the Vilnius City Allergy Center

Vilnius, 10200, Lithuania

Location

SPZOZ Uniwersytecki Szpital Kliniczny - Allergology

Lodz, 90153, Poland

Location

Alergologii Centrum

Lodz, 90553, Poland

Location

Alergotest

Lublin, 20095, Poland

Location

Alergo-Med

Tarnów, 33100, Poland

Location

Centrum Alergologii IRMED

Warsaw, 01157, Poland

Location

Silesian Piasts University of Medicine in Wrocław

Wroclaw, 50-368, Poland

Location

Aler-med

Wroclaw, 54203, Poland

Location

NZOZ Przychodnia Lekarska Hipokrates

Zabrze, 41800, Poland

Location

University hospital Skane

Lund, 22185, Sweden

Location

Orebro University Hospital

Örebro, 70185, Sweden

Location

Lungavdelningen, Vastmanlands

Västerås, 72189, Sweden

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1005, Switzerland

Location

Results Point of Contact

• Title: G. DELLA CORTE Clinical Development Director
• Organization: ANERGIS SA

gilles.dellacorte@anergis.ch

+41 21 651 92 30

Study Officials

• Framçois SPERTINI, MD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 21, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 24, 2015
• Results First Posted: June 24, 2015

Record last verified: 2015-06

Locations

DK (3); CH (1); LA (2); PL (8); FR (1); LI (4); SE (3)