Mechanisms of Allergen Immunotherapy

Allergic Rhinitis Clinical Trial

Official title:

An Open Study to Investigate the Effects of Injection Immunotherapy on Allergen-specific T and B Cell Responses in Adult Patients With Seasonal Allergic Rhinitis.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01523158
• Other study ID #: 12/014/TAR
• Status: Terminated
• Phase: N/A
• First received: January 27, 2012
• Last updated: September 21, 2012
• Start date: April 2012
• Est. completion date: September 2015

Study information

• Verified date: September 2012
• Source: Royal Sussex County Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

Hay fever (seasonal allergic rhinitis) results from allergy to grass and tree pollen. The majority of affected individuals manage well with medication from the Pharmacy or from their general practitioner (GP), but for some severely affected people it severely impacts on quality of life. Less than 40% of those affected in UK general practice feel that these medications achieve good symptomatic control.

Specific immunotherapy or desensitisation is the practice of administering small amounts of allergen to allergic patients in increasing doses. This treatment is highly effective in these patients and furthermore is truly disease-modifying, with benefits persisting long-term, even when the treatment has been completed. Desensitisation is a routine treatment in the UK, Europe and North America. The exact immune mechanisms that underlie this symptomatic improvement are not entirely clear. Dr Tarzi, Professor Frew and Professor Kern have recently developed new methods for the investigation of immune responses to allergens. These methods require relatively small blood samples and may provide useful information about how immunotherapy exerts its effects. In addition to improving the investigators basic understanding of this treatment, such knowledge may drive improvements in the treatment and could be useful for monitoring patients for response. The investigators study proposes to investigate changes in the immune responses to pollen allergens during immunotherapy. Blood will be taken just prior to the first immunotherapy injection and again just prior to the final injection. In this way the investigators will be able to compare the immune responses to pollen allergen before and after treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

• 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 (immunotherapy product) excipients

• Active tuberculosis

• Severe mental disorders

• Multiple sclerosis

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Biological:
• Allergovit grass or birch
subcutaneous injection of immunotherapy once weekly for 7 weeks prior to birch pollen season.

Locations

Country	Name	City	State
United Kingdom	Royal Sussex County Hospital	Brighton

Sponsors (1)

Lead Sponsor	Collaborator
Royal Sussex County Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	What are the changes in T cells associated with immunotherapy?	How does the T cell response change after immunotherapy	6 months	No