Birch Pollen AllergyNCT02143583
Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment
An observational study of Birch Pollen Allergy, run by Anergis at 22 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Birch Pollen Allergy
- How many people
- 196 participants
- Where
- 22 sitesin 7 countries
- Study dates
- Feb 2014to Jul 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects with moderate to severe allergic rhiniconjunctivitis to birch pollen
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
Poland8 sites
SPZOZ Uniwersytecki Szpital Kliniczny - Allergology
Lodz, 90153
Alergologii Centrum
Lodz, 90553
Alergotest
Lublin, 20095
Alergo-Med
Tarnów, 33100
Centrum Alergologii IRMED
Warsaw, 01157
Silesian Piasts University of Medicine in Wrocław
Wroclaw, 50-368
Aler-med
Wroclaw, 54203
NZOZ Przychodnia Lekarska Hipokrates
Zabrze, 41800
Lithuania4 sites
Kaunas Clinics University Hospital
Kaunas, 50009
Allergy Clinic JSC Perspektyvos
Vilnius, 08431
Vilnius University Hospital
Vilnius, 08661
Antakalnio affiliation of the Vilnius City Allergy Center
Vilnius, 10200
Denmark3 sites
Lungemedicinsk Forskningsafdeling
Aarhus, 8000
Allergiklinikken
Hellerup, Copenhagen, 2900
Klinisk Institute
Odense, 5000
Sweden3 sites
University hospital Skane
Lund, 22185
Orebro University Hospital
Örebro, 70185
Lungavdelningen, Vastmanlands
Västerås, 72189
Latvia2 sites
Viktorija Vevere private practice of Allergology
Rēzekne, 4601
Center of examination and treatment of allergic diseases
Riga, 1003
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1005
About this study
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
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.
Read the 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).
- Conditions
- Birch Pollen Allergy
- Keywords
- rhinoconjunctivitis, birch pollen, desensitization, allergen immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Birch Pollen AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anergis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Framçois SPERTINI, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143583
- Sponsor's protocol ID
- AN005T
- Other IDs
- 2013-003881-15
- Status last verified
- Jun 2015
- First submitted
- 2 May 2014
- Last updated
- 24 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02143583
- Acronym / sponsor ID
- AN005T
- Conditions
- Birch Pollen Allergy
- Keywords
- rhinoconjunctivitis, birch pollen, desensitization, allergen immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- AnergisIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Posted 24 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects with moderate to severe allergic rhiniconjunctivitis to birch pollen
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 1. = subject took topical antihistamine 2. = subject took oral antihistamine 3. = subject took oral corticosteroids
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Framçois SPERTINI, MD principal investigator
University of Lausanne Hospitals
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Birch Pollen Allergy, run by Anergis at 22 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Poland, Lithuania, Denmark, Sweden, Latvia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.