Rhinitis, Allergic, PerennialNCT00232518
Randomised Controlled Clinical Trials of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis
A study testing Infection with hookworm larvae in people with Rhinitis, Allergic, Perennial and Hayfever, run by University of Nottingham at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial, Hayfever, Allergy
- What is being tested?
- Infection with hookworm larvae
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2005to Nov 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of allergic rhinitis
- Measurable airway responsiveness to AMP
- Negative hookworm serology
- Positive skin prick tests to D.pteronyssinum, cat fur or grass pollen
Who cannot join
- History of asthma
- History of anaemia
- History of severe allergic reaction or anaphylaxis
- Possible or planned pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Clinical Trial of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis
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.
Read the 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.
- Conditions
- Rhinitis, Allergic, Perennial, Hayfever, Allergy
- Being tested
- Infection with hookworm larvae
- Keywords
- immune system, infection, allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, Hypersensitivity, Infections, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infection with hookworm larvaeProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum change from baseline in airway responsiveness to adenosine 5'-monophosphate (AMP) during the lung migration phase of hookworm infection.
Secondary outcomes (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startSep 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Investigators
- John Britton, Principal investigator, University of NottinghamDavid Prichard, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232518
- Sponsor's protocol ID
- GR076306
- Status last verified
- Apr 2005
- First submitted
- 30 Sep 2005
- Last updated
- 7 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Clinical Trial of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT00232518
- Acronym / sponsor ID
- GR076306
- Conditions
- Rhinitis, Allergic, Perennial, Hayfever, Allergy
- Keywords
- immune system, infection, allergic rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 4 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptoms of allergic rhinitis
- Measurable airway responsiveness to AMP
- Negative hookworm serology
- Positive skin prick tests to D.pteronyssinum, cat fur or grass pollen
Key exclusion criteria (4 listed)
- History of asthma
- History of anaemia
- History of severe allergic reaction or anaphylaxis
- Possible or planned pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infection with hookworm larvae | Procedure or surgery | – |
Primary outcome
Maximum change from baseline in airway responsiveness to adenosine 5'-monophosphate (AMP) during the lung migration phase of hookworm infection.
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Britton principal investigator
University of Nottingham
David Prichard principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infection with hookworm larvae in people with Rhinitis, Allergic, Perennial and Hayfever, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum change from baseline in airway responsiveness to adenosine 5'-monophosphate (AMP) during the lung migration phase of hookworm infection.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2007.