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

Birch Pollen Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143583
• Other study ID #: AN005T
• Secondary ID: 2013-003881-15
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2014
• Last updated: June 22, 2015
• Start date: February 2014
• Est. completion date: July 2014

Study information

• Verified date: June 2015
• Source: Anergis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyFrance: Agence Nationale de Sécurité du Médicament et des produits de santéLithuania: State Medicine Control Agency - Ministry of HealthLatvia: State Agency of MedicinesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSweden: Medical Products AgencySwitzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Birch Pollen Allergy
• Rhinitis, Allergic, Seasonal

Locations

Country	Name	City	State
Denmark	Lungemedicinsk Forskningsafdeling	Arhus
Denmark	Allergiklinikken	Hellerup	Copenhagen
Denmark	Klinisk Institute	Odense
France	Hopitaux Universitaires de Strasbourg	Strasbourg
Latvia	Viktorija Vevere private practice of Allergology	Rezekne
Latvia	Center of examination and treatment of allergic diseases	Riga
Lithuania	Kaunas Clinics University Hospital	Kaunas
Lithuania	Allergy Clinic JSC Perspektyvos	Vilnius
Lithuania	Antakalnio affiliation of the Vilnius City Allergy Center	Vilnius
Lithuania	Vilnius University Hospital	Vilnius
Poland	Alergologii Centrum	Lodz
Poland	SPZOZ Uniwersytecki Szpital Kliniczny - Allergology	Lodz
Poland	Alergotest	Lublin
Poland	Alergo-Med	Tarnow
Poland	Centrum Alergologii IRMED	Warszawa
Poland	Aler-med	Wroclaw
Poland	Silesian Piasts University of Medicine in Wroclaw	Wroclaw
Poland	NZOZ Przychodnia Lekarska Hipokrates	Zabrze
Sweden	University hospital Skane	Lund
Sweden	Orebro University Hospital	Orebro
Sweden	Lungavdelningen, Vastmanlands	Vasteras
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	VD

Sponsors (1)

Lead Sponsor	Collaborator
Anergis

Countries where clinical trial is conducted

Denmark,  France,  Latvia,  Lithuania,  Poland,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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; = 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	No
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	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	No