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

Completed

• Conditions: Birch Pollen Allergy

• Registration Number: NCT02143583
• Lead Sponsor: Anergis

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).

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-05-02
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-21
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2015-03-23
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-22
• Last Update Submitted: 2015-06-22
• Results First Posted: 2015-06-24
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season	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	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

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (22)

Allergiklinikken; 🇩🇰 Hellerup, Copenhagen, Denmark

Lungemedicinsk Forskningsafdeling; 🇩🇰 Arhus, Denmark

Klinisk Institute; 🇩🇰 Odense, Denmark

Hopitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Viktorija Vevere private practice of Allergology; 🇱🇻 Rezekne, Latvia

Center of examination and treatment of allergic diseases; 🇱🇻 Riga, Latvia

Kaunas Clinics University Hospital; 🇱🇹 Kaunas, Lithuania

Allergy Clinic JSC Perspektyvos; 🇱🇹 Vilnius, Lithuania

Vilnius University Hospital; 🇱🇹 Vilnius, Lithuania

Antakalnio affiliation of the Vilnius City Allergy Center; 🇱🇹 Vilnius, Lithuania

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