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

This study has been completed.
Sponsor:
Information provided by:
University of Nottingham
ClinicalTrials.gov Identifier:
NCT00232518
First received: September 30, 2005
Last updated: May 4, 2007
Last verified: April 2005
  Purpose

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.


Condition Intervention
Rhinitis, Allergic, Perennial
Hayfever
Allergy
Procedure: Infection with hookworm larvae

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomised Controlled Clinical Trial of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

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

Secondary Outcome Measures:
  • 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
  • occurrence of adverse effects

Estimated Enrollment: 30
Study Start Date: September 2005
Study Completion Date: November 2006
Detailed Description:

Epidemiological evidence suggests that human hookworm infection is associated with a reduced risk of asthma and allergic disease. This association is potentially important not only to understanding the aetiology of asthma and allergic disease, but also because it suggests that hookworms or their products might be therapeutically effective in these conditions. To test the hypothesis that hookworms protect against asthma ultimately requires a clinical trial.

We have carried out a dose-ranging study to establish the dose of hookworm larvae necessary to generate infection at the intensity shown to be protective in epidemiological studies, with acceptable side effects, and now propose to test the effect of 12 weeks of hookworm infection at this level of intensity in two randomised placebo controlled clinical trials. The first will be in patients with allergic rhinoconjunctivitis, to determine whether hookworm infection improves rhinitis symptoms and also, because these patients will have measurable airway responsiveness, to determine whether airway responsiveness changes during the lung migration phase of the hookworm life cycle. If this study confirms that hookworm infection does not increase airway responsiveness, we will proceed to a similar trial in patients with asthma.

In both studies we will also measure a range of relevant immunological parameters to explore the relation between these parameters and expression of the allergic and asthmatic phenotypes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00232518

Locations
United Kingdom
University of Nottingham
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: John Britton University of Nottingham
Principal Investigator: David Prichard University of Nottingham
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00232518     History of Changes
Other Study ID Numbers: GR076306
Study First Received: September 30, 2005
Last Updated: May 4, 2007
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
immune system
infection
allergic rhinitis

Additional relevant MeSH terms:
Hookworm Infections
Ancylostomiasis
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Conjunctivitis, Allergic
Conjunctivitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Strongylida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Respiratory Tract Infections
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014