Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00232518
Other study ID # GR076306
Secondary ID
Status Completed
Phase N/A
First received September 30, 2005
Last updated May 4, 2007
Start date September 2005
Est. completion date November 2006

Study information

Verified date April 2005
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Procedure:
Infection with hookworm larvae


Locations

Country Name City State
United Kingdom University of Nottingham Nottingham

Sponsors (1)

Lead Sponsor Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum change from baseline in airway responsiveness to adenosine 5’-monophosphate (AMP) during the lung migration phase of hookworm infection.
Secondary Change from baseline in rhinoconjunctivitis quality of life questionnaire score
Secondary allergen skin wheal response
Secondary mean daily peak flow
Secondary total- and specific serum IgE titres
Secondary acidic mammalian chitinase, cytokine profiles, other inflammatory markers
Secondary occurrence of adverse effects
See also
  Status Clinical Trial Phase
Terminated NCT02032056 - Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period N/A
Completed NCT01842711 - Cumulative Irritation Patch Test N/A
Completed NCT01633840 - New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges N/A
Completed NCT00997971 - Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein Phase 3
Completed NCT00554983 - Efficacy and Safety From a Recombinant Folding Variant of Bet v 1 Phase 3
Completed NCT00331929 - Respiratory Health Study of Children in Kiryat Tivon N/A
Completed NCT00220753 - Air Cleaners for Children and Adolescents With Asthma and Dog Allergy N/A
Completed NCT04046731 - Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation N/A
Completed NCT04126096 - Negative Predictive Value and NIC of Beta-Lactam Antibiotics. N/A
Completed NCT04004351 - Treatment Modalities in Children and Adolescents Suffering From HDM-induced Allergic Rhinitis and/or Asthma
Not yet recruiting NCT05997784 - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Completed NCT04418999 - Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus Early Phase 1
Completed NCT04186949 - Early Origins of Allergy and Asthma
Completed NCT02127801 - Single Ascending-dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Participants Phase 1
Enrolling by invitation NCT05011071 - The Alberta BLOOM Premature Child Study
Not yet recruiting NCT06330974 - Allergy, Asthma, and Atopic Eczema in Finland
Completed NCT02596321 - A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma Phase 3
Completed NCT02306473 - The Leaky Lung Test Early Phase 1
Terminated NCT02601690 - Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America
Completed NCT02293343 - 24 Hrs Histamine Profile in Healthy Persons and Patients With Food Intolerance N/A