Allergic RhinitisPhase 1/2NCT00290381
The Effects of OC000459 on Nasal Mediators
A Phase 1/2 study testing Oxagen OC000459 in people with Allergic Rhinitis, run by Trevor Hansel at 1 site in United Kingdom.
Trial summary
This is the first proof of concept study for OC000459 and is undertaken to assess the effects of the compound on the development of inflammatory cytokines in a model (nasal allergen challenge model) that is validated and clinically safe and easy to conduct. OC000459 will be compared with placebo in the study. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Oxagen OC000459
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento 1 Feb 2005
- Phase
- Phase 1/2
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
Who cannot join
- 1. Medical conditions likely to affect the outcome of the study.
- 2 History of immunotherapy in the past 3 years or currently on an immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.
- 3. Any infirmity, disability, or geographic location which, in the opinion of the principal investigator, would limit compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Heart & Lung Institute Clinical Studies Unit
London, SW3 6HP
About this study
Official title: The Effects of OC000459 on Nasal Th2 Cytokine Release, Eosinophil Responses, and Nasal Symptoms After Nasal Allergen Challenge (NAC) With Timothy Grass Pollen in Subjects With Allergic Rhinitis Out of Season
This is the first proof of concept study for OC000459 and is undertaken to assess the effects of the compound on the development of inflammatory cytokines in a model (nasal allergen challenge model) that is validated and clinically safe and easy to conduct. OC000459 will be compared with placebo in the study.
The study will be a randomised, double blind, placebo controlled, crossover evaluation of the effect of OC000459 on cytokine secretion induced by nasal allergen challenge. Male subjects with a known history of allergic rhinitis and screening positive to allergen will be included. After dosing with OC000459 or placebo, nasal allergen challenge will be performed and measurements made in the nasal fluids. Nasal symptom scores will also be recorded. Safety parameters will be monitored throughout.
- Conditions
- Allergic Rhinitis
- Being tested
- Oxagen OC000459
- Keywords
- Allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxagen OC000459Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Placebo followed by Drug (OC000459) | Experimental | Placebo and Drug are followed by Nasal Allergen Challenge Receives: Procedure: Oxagen OC000459 |
| Drug (OC000459) followed by Placebo | Experimental | Drug and Placebo are followed by Nasal Allergen Challenge Receives: Procedure: Oxagen OC000459 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of OC000459 on Nasal Filter Paper Levels of IL-4, IL-5, IL-13
Measured: 1 to 9 hours after nasal allergen challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Primary completion1 Feb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Nasal Allergen Challenge Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trevor Hansel
- Sponsor type
- University, hospital or other
- Collaborators
- Oxagen Ltd
- Responsible party
- Sponsor-investigator, Trevor Hansel, Imperial College London
- Investigators
- Trevor T Hansel, FRCPath, Principal investigator, National Heart & Lung Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290381
- Sponsor's protocol ID
- OC000459/005/05
- Status last verified
- Oct 2023
- First submitted
- 10 Feb 2006
- Last updated
- 30 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of OC000459 on Nasal Th2 Cytokine Release, Eosinophil Responses, and Nasal Symptoms After Nasal Allergen Challenge (NAC) With Timothy Grass Pollen in Subjects With Allergic Rhinitis Out of Season
- ClinicalTrials.gov ID
- NCT00290381
- Acronym / sponsor ID
- OC000459/005/05
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Trevor HanselUniversity, hospital or other
- Collaborators
- Oxagen Ltd
- Primary completion
- 1 Feb 2005 (actual)
- First posted
- 13 Feb 2006 (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.
This is the first proof of concept study for OC000459 and is undertaken to assess the effects of the compound on the development of inflammatory cytokines in a model (nasal allergen challenge model) that is validated and clinically safe and easy to conduct. OC000459 will be compared with placebo in the study.
The study will be a randomised, double blind, placebo controlled, crossover evaluation of the effect of OC000459 on cytokine secretion induced by nasal allergen challenge. Male subjects with a known history of allergic rhinitis and screening positive to allergen will be included. After dosing with OC000459 or placebo, nasal allergen challenge will be performed and measurements made in the nasal fluids. Nasal symptom scores will also be recorded. Safety parameters will be monitored throughout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Nasal Allergen Challenge Study
| Arm | Type | Receives |
|---|---|---|
| Placebo followed by Drug (OC000459) | Experimental | Procedure: Oxagen OC000459Placebo and Drug are followed by Nasal Allergen Challenge |
| Drug (OC000459) followed by Placebo | Experimental | Procedure: Oxagen OC000459Drug and Placebo are followed by Nasal Allergen Challenge |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
Key exclusion criteria (3 listed)
- 1. Medical conditions likely to affect the outcome of the study.
- 2 History of immunotherapy in the past 3 years or currently on an immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.
- 3. Any infirmity, disability, or geographic location which, in the opinion of the principal investigator, would limit compliance with the protocol.
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 |
|---|---|---|
| Oxagen OC000459 | Procedure or surgery | Drug (OC000459) followed by Placebo, Placebo followed by Drug (OC000459) |
Primary outcome
The Effect of OC000459 on Nasal Filter Paper Levels of IL-4, IL-5, IL-13
Time frame: 1 to 9 hours after nasal allergen challenge
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 30 Oct 2023.
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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.
Trevor T Hansel, FRCPath principal investigator
National Heart & Lung Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oxagen OC000459 in people with Allergic Rhinitis, run by Trevor Hansel 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 1 inclusion and 3 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 30 Oct 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The Effect of OC000459 on Nasal Filter Paper Levels of IL-4, IL-5, IL-13 (time frame: 1 to 9 hours after nasal allergen challenge). 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 30 Oct 2023.