Randomised Placebo Controlled Study of Effects of Therapeutic Hookworm Infection in Asthma

January 2, 2008 updated by: University of Nottingham

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. In addition, we have recently completed a randomized placebo-controlled clinical trial of hookworm infection in allergic patients with rhinitis which showed that there was no negative effect on bronchial responsiveness during the phase in the lifecycle where the hookworm larvae migrate through the lungs. Consequently, are now proceeding with the definitive randomized placebo-controlled trial of hookworm infection in people with asthma. This study will also provide us with the opportunity to investigate the cellular mechanisms of the effect of hookworm infection on the immune system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. We have also completed a randomized controlled clinical trial of hookworm infection in people with allergic rhinoconjunctivitis and have shown that there is no significant change in airway responsiveness during the lung migration phase of the hookworm life cycle. We are now performing the definitive study which is a randomized placebo-controlled trial of the effects of therapeutic hookworm infection in people with asthma. During this study, we will be monitoring various indicators of asthma control but will also be able to measure a range of relevant immunological parameters to explore the relation between these parameters and expression of the allergic and asthmatic phenotypes

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG5 1PB
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of asthma
  • Use of regular inhaled corticosteroid treatment to a maximum of 1000mcg beclomethasone or equivalent per day
  • Measurable airway responsiveness to AMP
  • Negative hookworm serology
  • Positive skin prick tests to D.pteronyssinum, cat fur or grass pollen

Exclusion Criteria:

  • Possible or planned pregnancy or breastfeeding
  • Use of regular oral corticosteroids or immunosuppressive medication
  • Anemia
  • History of anaphylaxis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline airway responsiveness to adenosine-5-monophosphate (AMP) during the 12 weeks of the study.

Secondary Outcome Measures

Outcome Measure
Change in peak flow variability, asthma symptom scores, asthma medication usage, allergen skin wheal response,total and specific IgE titres, acidic mammalian chitinase, cytokine profiles, other inflammatory markers
occurrence of adverse effects.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: David Pritchard, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

May 4, 2007

First Submitted That Met QC Criteria

May 4, 2007

First Posted (ESTIMATE)

May 7, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2008

Last Update Submitted That Met QC Criteria

January 2, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RB08A3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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