Status:

TERMINATED

Mechanisms of Allergen Immunotherapy

Lead Sponsor:

Royal Sussex County Hospital

Conditions:

Allergic Rhinitis

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 practitio...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2015

Estimated Enrollment :

2 Patients enrolled

Trial Details

Trial ID

NCT01523158

Start Date

April 1 2012

End Date

September 1 2015

Last Update

September 25 2012

Active Locations (1)

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1

Royal Sussex County Hospital

Brighton, United Kingdom, BN2 5BE