Randomised Placebo Controlled Study of Effects of Therapeutic Hookworm Infection in Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Infection with hookworm larvae
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring immune system, allergy, hookworm infection, parasite infection, asthma
Eligibility Criteria
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
Sites / Locations
- University of Nottingham
Outcomes
Primary Outcome Measures
Change from baseline airway responsiveness to adenosine-5-monophosphate (AMP) during the 12 weeks of the study.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00469989
Brief Title
Randomised Placebo Controlled Study of Effects of Therapeutic Hookworm Infection in Asthma
Official Title
Randomised Placebo Controlled Study of Effects of Therapeutic Hookworm Infection in Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Nottingham
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
immune system, allergy, hookworm infection, parasite infection, asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Infection with hookworm larvae
Primary Outcome Measure Information:
Title
Change from baseline airway responsiveness to adenosine-5-monophosphate (AMP) during the 12 weeks of the study.
Secondary Outcome Measure Information:
Title
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
Title
occurrence of adverse effects.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Britton
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Pritchard
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nottingham
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Randomised Placebo Controlled Study of Effects of Therapeutic Hookworm Infection in Asthma
We'll reach out to this number within 24 hrs