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

NCT00469989 | Completed DMC

• 1 other identifier: RB08A3
• 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. 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.

Conditions

Asthma

Keywords

immune system; allergy; hookworm infection; parasite infection; asthma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• 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.

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:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Hypersensitivity; Hookworm Infections; Parasitic Diseases

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Strongylida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Infections

Study Officials

• John Britton

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• David Pritchard

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2007
• First Posted: May 7, 2007
• Study Start: January 1, 2007
• Study Completion: October 1, 2007
• Last Updated: January 11, 2008

Record last verified: 2008-01

Locations

GB (1)