Allergy Clinical Trial
Official title:
Randomised Controlled Clinical Trial of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis
Verified date | April 2005 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
There has been considerable debate over the last 30 years about the interaction between
asthma and parasitic infection. It has been suggested that at least part of the reason for
the increasing prevalence of asthma in the developed world is a decrease in parasite
infections resulting from improved living conditions with economic development. Our previous
studies in Ethiopia suggest that hookworm infection may be particularly important in this
process.
To establish definitively whether parasites can protect against allergic disease, and
specifically asthma, ultimately requires a randomised clinical trial of parasite infection
in patients with asthma. We, the researchers at the University of Nottingham, have completed
a study in normal volunteers to establish the dose of hookworms necessary to generate
infection at the level shown to be protective in population surveys, and shown that
infection is well tolerated. We now propose two randomised placebo-controlled double blind
clinical trials. The first will test the effectiveness of hookworm infection in reducing
symptoms in allergic patients with rhinitis, and will also serve to allow us to check the
likely safety of hookworm infection in asthma. Assuming that the results of this study are
favourable, we will then carry out a trial of hookworm infection in asthma. We will also
take the opportunity during both of these studies to investigate the cellular mechanisms of
the effect of hookworm infection on the immune system.
Status | Completed |
Enrollment | 30 |
Est. completion date | November 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Symptoms of allergic rhinitis - Measurable airway responsiveness to AMP - Negative hookworm serology - Positive skin prick tests to D.pteronyssinum, cat fur or grass pollen Exclusion Criteria: - History of asthma - History of anaemia - History of severe allergic reaction or anaphylaxis - Possible or planned pregnancy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Nottingham | Nottingham |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum change from baseline in airway responsiveness to adenosine 5’-monophosphate (AMP) during the lung migration phase of hookworm infection. | |||
Secondary | Change from baseline in rhinoconjunctivitis quality of life questionnaire score | |||
Secondary | allergen skin wheal response | |||
Secondary | mean daily peak flow | |||
Secondary | total- and specific serum IgE titres | |||
Secondary | acidic mammalian chitinase, cytokine profiles, other inflammatory markers | |||
Secondary | occurrence of adverse effects |
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