How does treatment of allergic rhinitis with immunotherapy affect the blood cells of the immune system?
- Conditions
- Allergic Rhinitis due to birch or grass pollenMedDRA version: 14.1Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollenSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2012-000594-24-GB
- Lead Sponsor
- Royal Sussex County Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Male or female; age 18 with no upper age limit
History of seasonal rhino-conjunctivitis in the appropriate season, not controlled by optimised standard medical therapy
Positive skin prick test to grass pollen or tree pollen
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
;
Male or female; age 18 with no upper age limit
History of seasonal rhino-conjunctivitis in the appropriate season, not controlled by optimised standard medical therapy
Positive skin prick test to grass pollen or tree pollen
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
Inadequately controlled or moderate to severe asthma (GINA III/IV), i.e. the FEV1 is below 70 % of the target value despite adequate pharmacotherapy
Irreversible changes in the reaction organ (emphysema, bronchiectasis, etc.)
Clinically significant cardiovascular insufficiency (in cardiovascular diseases, there is an elevated risk of adverse reactions to adrenaline)
Local or systemic use of beta blockers
Significant allergic disease to more than one pollen
Diseases of the immune system (autoimmune diseases, immune complex-induced immunopathies, immunodeficiencies etc.)
Malignant disease within the past five years (Patients with previous malignant disease that is considered cured may be included subject to the consent of their oncologist)
Inability to attend regularly for injections and follow-up visits
Severe atopic dermatitis
Previous immunotherapy with pollen extract
Pregnant or not using adequate contraception (post-menopausal, surgically sterilised, long-term abstinent, or barrier methods plus spermicide)
Breast-feeding
Evidence of current drug or alcohol misuse
Hypersensitivity to any of the SIT exipients
Active tuberculosis
Severe mental disorders
Multiple sclerosis
Patients with an acute febrile illness should not be included in the study but they may take part once they have recovered.
Involved in another trial involving investigation of a medicinal product within 4 months
;
Inadequately controlled or moderate to severe asthma (GINA III/IV), i.e. the FEV1 is below 70 % of the target value despite adequate pharmacotherapy
Irreversible changes in the reaction organ (emphysema, bronchiectasis, etc.)
Clinically significant cardiovascular insufficiency (in cardiovascular diseases, there is an elevated risk of adverse reactions to adrenaline)
Local or systemic use of beta blockers
Significant allergic disease to more than one pollen
Diseases of the immune system (autoimmune diseases, immune complex-induced immunopathies, immunodeficiencies etc.)
Malignant disease within the past five years (Patients with previous malignant disease that is considered cured may be included subject to the consent of their oncologist)
Inability to attend regularly for injections and follow-up visits
Severe atopic dermatitis
Previous immunotherapy with pollen extract
Pregnant or not using adequate contraception (post-menopausal, surgically sterilised, long-term abstinent, or barrier methods plus spermicide)
Breast-feeding
Evidence of current drug or alcohol misuse
Hypersensitivity to any of the SIT exipients
Active tuberculosis
Severe mental disorders
Multiple sclerosis
Patients with an acute febrile illness should not be included in the study but they may take part once they have recovered.
Involved in another trial involving investigation of a medicinal product within 4 months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: How does immunotherapy affect the immune system's responses to allergens? ;Secondary Objective: ;Primary end point(s): Modulation of T and B cell responses to pollen allergens by immunotherapy;Timepoint(s) of evaluation of this end point: This will be evaluated around 7 weeks after the first immunotherapy injection. (Each injection is given 1 week apart and starts 7 weeks prior to pollen season.);Main Objective: How does immunotherapy affect the immune system's responses to allergens? ;Secondary Objective: ;Primary end point(s): Modulation of T and B cell responses to pollen allergens by immunotherapy;Timepoint(s) of evaluation of this end point: This will be evaluated around 7 weeks after the first immunotherapy injection. (Each injection is given 1 week apart and starts 7 weeks prior to pollen season.)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): In recruited patients who are birch allergic we will also look at modulation of the IgE epitope diversity directed against Bet v 1, the major birch pollen allergen, by birch pollen immunotherapy.;Timepoint(s) of evaluation of this end point: Blood for this will be taken at the same timepoint as the primary end point but the serum may be frozen for analysis at a later date.;Secondary end point(s): In recruited patients who are birch allergic we will also look at modulation of the IgE epitope diversity directed against Bet v 1, the major birch pollen allergen, by birch pollen immunotherapy.;Timepoint(s) of evaluation of this end point: Blood for this will be taken at the same timepoint as the primary end point but the serum may be frozen for analysis at a later date.