Randomised Controlled Clinical Trials of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis

NCT00232518 | Completed

• 1 other identifier: GR076306
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rhinitis, Allergic, Perennial; Hayfever; Allergy

Keywords

immune system; infection; allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• Maximum change from baseline in airway responsiveness to adenosine 5'-monophosphate (AMP) during the lung migration phase of hookworm infection.

Secondary Outcomes (6)

• Change from baseline in rhinoconjunctivitis quality of life questionnaire score

• allergen skin wheal response

• mean daily peak flow

• total- and specific serum IgE titres

• acidic mammalian chitinase, cytokine profiles, other inflammatory markers

Interventions

Infection with hookworm larvae PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms of allergic rhinitis
• Measurable airway responsiveness to AMP
• Negative hookworm serology
• Positive skin prick tests to D.pteronyssinum, cat fur or grass pollen

You may not qualify if:

• History of asthma
• History of anaemia
• History of severe allergic reaction or anaphylaxis
• Possible or planned pregnancy

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Hypersensitivity; Infections; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• John Britton

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• David Prichard

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: September 1, 2005
• Study Completion: November 1, 2006
• Last Updated: May 7, 2007

Record last verified: 2005-04

Locations

GB (1)