To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This effect will be primarily measured by means of the clinical index score (a
combination of symptom score and use of medication). When the mean CIS in the
SUBLIVAC® Grasses group is a minimum of 30% lower than the mean CIS from the
placebo group, SUBLIVAC® Grasses is considered clinically effective. A minimal
reduction in symptoms of 30% is considered clinically relevant according to the
Malling criterion.
Secondary outcome
Secondary parameters include CIS derived variables.
Secondary objectives are to determine if a deviation in mast-cell serum
tryptase level at screening is predictive for the occurrence of adverse
reactions to IT and/or (lack of) efficacy and if a present oral allergy
syndrome improves through SUBLIVAC® Grasses therapy.
With the 'rhinoconjunctivitis quality of life questionnaire" it is expected
that the SUBLIVAC® Grasses treated patients score better than the placebo group.
With the quantitative skin prick test it is expected that the SUBLIVAC® Grasses
treated patients will react less sensitive than the placebo treated patients.
IgG is determined sinceit is considered an indicator for the efficacy.
Background summary
Allergen specific immunotherapy is the only causial treament of IgE mediated
allergies. Sublingual treatment is especially considered patient friendly alsoe
because of the low incidence and mostly mild side effects. Ifficacy od specific
immunotharpy has been prooven in multiple double-blind, placeobo controlled
clinical studies.
Sublivac is a sublingual allergen extract which has been marketed since 1997.
Sublivac is indicated for the treatment of allergic rhinitis, allergic
conjuntivitis and allergic astma caused by allergens from e.g. house dust mite
and grasspollen. Diagnosis needs to be confirmed by skin prick test or specific
serum IgE test (RAST). Sublivac is intended for treatment of both adults as
well as children of five years and above. So far, Sublivac has been produced
patient specific.
In this study it will be determined if Sublivac Grasses can reduce symtpoms
and/or use of symptomatic medication and is safe to use. Sublivac grassen
consists of allergen extract of Lolium perenne, Phleum pratense en Poa
pratensis pollen.
Study objective
To show that treatment with SUBLIVAC® Grasses is clinically effective by means
of reduction in allergic symptoms and/or use of allergic symptomatic medication
in subjects suffering from IgE mediated allergic complaints triggered by grass
pollen.
Study design
Double-blind, block randomised, placebo-controlled, multi-centre,
international, parallel groups.
Intervention
Start with two drops daily of SUBLIVAC® Grasses 10.00 AU/ml or placebo and
increase by two drops daily, until the maintenance dose of 10 drops SUBLIVAC®
Grasses is reached.
Study burden and risks
Some subjects developed local side effects, mostly within the first few days
after starting with sublingual immunotherapy, such as itching and swelling of
the oral mucous membrane. These side effects mostly resolve quickly and without
further treatment. Also mild systemic reactions might occur like itching eyes,
sneezing, coughing and worsening of atopic eczema. Diarrhea and abdominal pain
might occur some time after medication in take. Intensified systemic reactions
(shortness of breath, generalized urticaria and Quincke*s Oedema) might also
occur. Life-threatening side effects have never been reported with the
sublingual immunotherapy we will use in this study.
The extra burden for the aptients consists ofapproximately four extra visits
and:
2x rhinoconjunctivitis questionnaire
During the first two week of therapy a daily diary concerning medication intake
and side effects.
During the three moneths of the pollen season a daily diary on allergy symptoms
and medication use.
9x examination of eyes, nose and mouth
1x skin prick test series
2x quantitative skin prick test
1x collection of two tubes blood
2x collection of three tubes blood
The results of this study are needed to find out if and after how long
SUBLIVAC® Grasses can reduce allergy symptoms and/or the use of anti-allergy
medication. This information will benefit other patients with a grass pollen
allergy so they will receive medication which effectively reduces allergy
symptoms or the use of anti-allergy medication.
The benefit for you is that you receive three years of immunotherapy and
antihistaminics treatment during the study free-of-charge. Visits to the doctor
during the study will not be charged and the patient will receive a travel cost
reimbursement of ¤ 25 per visit. For the visits when a quantitative skin prick
is done, an extra ¤ 25 reimbursement will be given for the inconvenience.
Given the low risk, low (time)burden and the offer of oral antihistamines
during the pollen season inclusion of patients in this study is justified.
Parklaan 125
2011 KT Haarlem
Nederland
Parklaan 125
2011 KT Haarlem
Nederland
Listed location countries
Age
Inclusion criteria
Subjects with allergic rhinoconjunctivitis with or without mild asthma (FEV1 >= 70%) for at least 2 years. Their allergic symptoms should be related to grass pollen
Use of anti-allergy symptomatic medication in the last pollen season (or, in case of a low pollen season, in one of the two previous years)
A positive skin prick test (>3 mm) for grasses and specific serum IgE-test
(>1 U/ml) for grass pollen (Lolium perenne, Phleum pratense and Poa pratensis).
Age 12 years or older.
Subjects (and their parents if required) shall give a written informed consent
Exclusion criteria
A positive SPT for perennial allergens of house dust mite
Symptoms related to concomitant sensitisation to perennial allergens of pets
Chronic asthma or emphysema, particularly with a FEV1 < 70 % of predicted value or use of inhalation corticosteroids outside grass and tree pollen season for more than two episodes and/or longer than fourteen days
Use of symptomatic medication for more than three episodes and/or longer than three days outside the tree- or grasspollen season
Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV)
Inflammation and infection of the target organ
Severe atopic dermatitis requiring systemic immuno-suppressive medication
Allergen specific immuno-therapy treatment within the last 5 years for a period longer than three months
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 | EUCTR2005-005175-16-NL |
| CCMO | NL12128.100.06 |