Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Imperial College London.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
ALK-Abelló A/S
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00135629
First received: August 25, 2005
Last updated: November 22, 2010
Last verified: November 2010
  Purpose

The purpose of this study is to determine at which point in the dosing regime grass pollen immunotherapy causes a significant reduction in the late skin response to allergen challenge. A once weekly cluster regimen of 2 injections per visit was employed during the up-dosing phase, followed by monthly maintenance injections of 100,000 SQ units. Symptom scores and need of rescue medication were recorded by patients during the study period. The size of early and late cutaneous response to allergen challenge was recorded and measured by a physician.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Biological: Sublingual Alutard SQ grass pollen tablets (Phleum pratense)
Procedure: Venepuncture: 100ml blood sample taken on 12 separate visits
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever: A Pilot Study. (Up-dosing Study)

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Symptom and medication score recorded by subjects
  • Adverse events

Secondary Outcome Measures:
  • Rhinoconjunctivitis Quality of Life Questionnaire
  • Intradermal allergen challenge

Estimated Enrollment: 18
Study Start Date: October 2002
Estimated Study Completion Date: February 2004
Detailed Description:

This was a single centre, randomised, double-blind placebo controlled trial of grass pollen injection immunotherapy (Alutard SQ, ALK Abello, Denmark) in adults with severe summer hayfever unresponsive to antihistamines and topical steroids. The main aim was to determine at which point in the dosing regime grass pollen immunotherapy causes a significant reduction in the late skin response to allergen challenge. A once weekly cluster regimen of 2 injections per visit was employed during the up-dosing phase, followed by monthly maintenance injections of 100,000 SQ units. Twelve patients received active treatment (mean age 31, 7 male) whilst 6 were given placebo (mean age 37, 2 male). The 24 hour skin response (size of swelling, (mm)) to intradermal allergen challenge (0.1, 1, 10 BU) was determined on alternate weeks during the 8 week up-dosing phase and then monthly up to 6 months and 3 monthly up to 11-13 months following initiation of treatment.

Results:

At the end of the up-dosing phase (approximately 8 weeks) there was a significant reduction in the size of the late phase response which was evident with all three intradermal doses (p=0.02 for 0.1 & 1 BU and p=0.04 for 10 BU). This reduction was sustained throughout the maintenance phase (p=0.04 for 0.1 BU and 0.01 for 1& 10BU).

Conclusion:

The up-dosing phase of grass pollen immunotherapy alone is sufficient to dampen the late skin response to allergen challenge. Whether or not this may be predictive of the clinical response to immunotherapy remains to be determined.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female 18-65 years of age
  • Written informed consent obtained before entering the trial
  • A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
  • A clinical history of severe rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep), which remain troublesome despite treatment with anti-allergic drugs during the grass pollen season
  • Positive Skin Prick Test (SPT) response (wheal diameter ≥ 3 mm) to Phleum pratense
  • Positive specific IgE against Phleum pratense (≥ IgE Class 2)
  • Physical examination with no clinically relevant findings
  • If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the trial
  • Willingness to comply with this protocol

Exclusion Criteria:

  • FEV1 < 70% of predicted value
  • A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of - and potentially overlapping - the grass pollen season
  • A clinical history of significant symptomatic perennial allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed
  • A clinical history of significant recurrent acute sinusitis (defined as 2 episodes per year for the last two years all of which required antibiotic treatment) or chronic sinusitis
  • At randomisation, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (serous otitis media is not an exclusion criterion)
  • History of emergency visit or admission for asthma in the previous 12 months
  • Use of an investigational drug within 30 days prior to screening
  • Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
  • History of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
  • History of angioedema
  • Any of the following underlying conditions known or suspected to be present:

    • Cystic fibrosis
    • Malignancy
    • Insulin-dependent diabetes
    • Malabsorption or malnutrition
    • Renal or hepatic insufficiency
    • Chronic infection
    • Drug dependency or alcoholism
    • Ischemic heart disease or angina requiring current daily medication or with any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric, endocrine, or other major systemic disease)
  • Immunosuppressive treatment
  • History of hypersensitivity to the excipients of the trial medications
  • History of allergy, hypersensitivity or intolerance to trial medications or rescue medications
  • A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude
  • Unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the grass pollen season
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135629

Locations
United Kingdom
Royal Brompton Hospital, NHLI Imperial College
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
Imperial College London
ALK-Abelló A/S
Investigators
Principal Investigator: Stephen R Durham, Professor Royal Brompton Hospital, Imperial College, National Heart & Lung Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00135629     History of Changes
Other Study ID Numbers: DHRG-UpDosing
Study First Received: August 25, 2005
Last Updated: November 22, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Hayfever
Sublingual Immunotherapy
Grass pollen immunotherapy
Late cutaneous response
Intradermal allergen challenge
Seasonal Allergic Rhinoconjunctivitis

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 01, 2014