The aim is to investigate whether a melting tablet that contains birch pollen allergen will decrease the hay fever symptoms and may alleviate the need for conventional allergy symptom-suppressing medication. The purpose of this specific study is…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The average daily rhinoconjunctivitis symptom score during the entire BPS
Secondary outcome
The average rhinoconjunctivitis daily medication score (DMS) during the BPS
The combined rhinoconjunctivitis symptom and medication score during the entire
BPS.
The average rhinoconjunctivitis DSS, average rhinoconjunctivitis DMS and
average rhinoconjunctivitis DCS during the entire TPS (hazel, alder and birch)
Well days/symptom and medication free days/Days with severe symptoms in the
entire BPS and the entire TPS
The average daily asthma symptom score during the entire BPS and the entire TPS
Global evaluation in an overall comparison of this BPS compared to the previous
BPS
Background summary
Allergy vaccination or specific immunotherapy is the practice of giving
specific allergens to a person who is allergic to that particular allergen.
When given regular doses of the allergen, the body*s tolerance toward the
allergen increases and you will experience fewer or no symptoms.
Allergy vaccines are normally given as injections under the skin or as drops or
tablets applied under the tongue.
In this trial the trial medication is a dispersible tablet, which means the
tablet will quickly melt and be absorbed by the mucous membrane when placed
under the tongue
Study objective
The aim is to investigate whether a melting tablet that contains birch pollen
allergen will decrease the hay fever symptoms and may alleviate the need for
conventional allergy symptom-suppressing medication. The purpose of this
specific study is finding the right dose, but also finding the best balance
between safety and efficacy of the tablet. ALK the tablet has been studied in a
previous clinical study.
Study design
Randomized double blind placebo study in different centers and different
countries with 6 different doses of birch pollen vaccine tablet being compared
with a placebo tablet (dummy tablet which no active / active substance). The
study will last 6 to 10 months while the participants will visit the clinic
several times for study-related tests
Intervention
Study medication and laboratory assessments
Study burden and risks
Patients may experience side effects from the use of study medication, the most
common side effect of birch pollen allergy tablet are local reactions suchas
tingling in the mouth. Most of these side effects / symptoms are mild to
moderate and usually go on after 30 minutes. A list of the most common
complaints from previous studies is described in the ICF.
Blood samples can cause mild pain, redness, bruising and / or irritation at
the place where blood has been drawn.
Transistorstraat 23-25
Almere 1322 CK
NL
Transistorstraat 23-25
Almere 1322 CK
NL
Listed location countries
Age
Inclusion criteria
1. Written informed consent obtained before entering the trial
2. Male or female aged 18-65 years
3. A documented clinically relevant history of birch pollen induced allergic rhinoconjunctivitis (with or without asthma), with uncontrolled symptoms despite having received symptomatic drug treatment during the birch pollen seasons 2011 and 2012
4. An appropriate minimum level of birch pollen allergic rhinoconjunctivitis symptoms corresponding to moderate to severe, defined as a total DSS score of (retrospective) score of at least >=8 on the worst day in the previous birch pollen season (e.g. 2 (on a scale from 0 to 3) on at least 4 out of 6 symptoms (4 nasal and 2 eye symptoms))
5. Having experienced at least one of the following, due to allergic rhinoconjunctivitis during the previous birch pollen season: sleep disturbance, impairment of daily activities, leisure and/or sport, impairment of school or work, or troublesome symptoms
6. Positive SPT response (wheal diameter >= 3 mm larger than the negative control) to Betula verrucosa
7. Positive specific IgE against Bet v 1 (>= IgE Class 2; >=0.70 kU/L) at screening
8. Female subjects, who are fertile must have a negative pregnancy test and be willing to practise appropriate contraceptive methods until the end of trial
9. Subjects must be willing and able to comply with trial protocol regimens.
Exclusion criteria
1. A clinically relevant history of symptomatic seasonal allergic rhinitis and/or asthma, having received regular medication, due to another allergen source than birch, hazel, and alder, overlapping the birch pollen season
2. A clinically relevant history of perennial allergic rhinitis and/or asthma having received regular medication due to an allergen to which the subject is regularly exposed
3. A clinical history of uncontrolled asthma within 3 months prior to screening
4. Reduced lung function, defined as FEV1 < 70% of predicted value after adequate pharmacologic treatment
5. Previous treatment with immunotherapy with birch pollen allergen (or a cross-reacting allergen (hazel or alder):
a.For immunotherapy without updosing phase: for more than 1 month within the last 5 years
b.For immunotherapy with an updosing phase: treatment which has reached maintenance dose (permitted if discontinued before reaching maintenance)
6. Ongoing immunotherapy with any specific immunotherapy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-000031-59-NL |
| CCMO | NL40557.056.12 |