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

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.

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Key information

Conditions

Birch Pollen Allergy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Allergiklinikken, Hellerup, Copenhagen, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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
Any subject having received immunosuppressive medication within 4 weeks prior to inclusion, or planned to be used during the trial period
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
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

Treatment and study plan

Primary outcomes

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

Time frame: 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
- = subject took topical antihistamine
- = subject took oral antihistamine
- = subject took oral corticosteroids

Secondary outcomes

Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season

Time frame: 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

Sponsors and collaborators

Lead sponsor

Anergis

Industry

Registry information

Official study 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

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: May 21, 2014
Registry last updated: Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed