Allergic RhinitisNCT01523158
Mechanisms of Allergen Immunotherapy
A study testing Allergovit grass or birch in people with Allergic Rhinitis, run by Royal Sussex County Hospital at 1 site in United Kingdom.
Trial summary
Hay fever (seasonal allergic rhinitis) results from allergy to grass and tree pollen. The majority of affected individuals manage well with medication from the Pharmacy or from their general practitioner (GP), but for some severely affected people it severely impacts on quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Allergovit grass or birch
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Sep 2015
- 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
- Male or female
- Age 18 with no upper age limit
- History of seasonal rhino-conjunctivitis in the appropriate season, not controlled by optimised standard medical therapy
- Positive skin prick test to grass pollen or tree pollen
Who cannot join
- Inadequately controlled or moderate to severe asthma (GINA III/IV), i.e. the FEV1 is below 70 % of the target value despite adequate pharmacotherapy
- Irreversible changes in the reaction organ (emphysema, bronchiectasis, etc.)
- Clinically significant cardiovascular insufficiency (in cardiovascular diseases, there is an elevated risk of adverse reactions to adrenaline)
- Local or systemic use of beta blockers
- Diseases of the immune system (autoimmune diseases, immune complex-induced immunopathies, immunodeficiencies etc.)
- Malignant disease within the past five years (Patients with previous malignant disease that is considered cured may be included subject to the consent of their oncologist)
Show all 15Show fewer
- Inability to attend regularly for injections and follow-up visits
- Severe atopic dermatitis
- Pregnant or not using adequate contraception (post-menopausal, surgically sterilised, long-term abstinent, or barrier methods plus spermicide)
- Breast-feeding
- Evidence of current drug or alcohol misuse
- Hypersensitivity to any of the SIT (immunotherapy product) excipients
- Active tuberculosis
- Severe mental disorders
- Multiple sclerosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Study to Investigate the Effects of Injection Immunotherapy on Allergen-specific T and B Cell Responses in Adult Patients With Seasonal Allergic Rhinitis.
Hay fever (seasonal allergic rhinitis) results from allergy to grass and tree pollen. The majority of affected individuals manage well with medication from the Pharmacy or from their general practitioner (GP), but for some severely affected people it severely impacts on quality of life. Less than 40% of those affected in UK general practice feel that these medications achieve good symptomatic control.
Specific immunotherapy or desensitisation is the practice of administering small amounts of allergen to allergic patients in increasing doses. This treatment is highly effective in these patients and furthermore is truly disease-modifying, with benefits persisting long-term, even when the treatment has been completed. Desensitisation is a routine treatment in the UK, Europe and North America. The exact immune mechanisms that underlie this symptomatic improvement are not entirely clear. Dr Tarzi, Professor Frew and Professor Kern have recently developed new methods for the investigation of immune responses to allergens. These methods require relatively small blood samples and may provide useful information about how immunotherapy exerts its effects. In addition to improving the investigators basic understanding of this treatment, such knowledge may drive improvements in the treatment and could be useful for monitoring patients for response. The investigators study proposes to investigate changes in the immune responses to pollen allergens during immunotherapy. Blood will be taken just prior to the first immunotherapy injection and again just prior to the final injection. In this way the investigators will be able to compare the immune responses to pollen allergen before and after treatment.
- Conditions
- Allergic Rhinitis
- Being tested
- Allergovit grass or birch
- Keywords
- Allergic Rhinitis, Immunotherapy
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergovit grass or birchBiological
subcutaneous injection of immunotherapy once weekly for 7 weeks prior to birch pollen season.
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy | Other | Open label study of changes to cellular responses following immunotherapy Receives: Biological: Allergovit grass or birch |
What is being measured
The primary outcome is the main question the study is designed to answer.
What are the changes in T cells associated with immunotherapy?
How does the T cell response change after immunotherapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2015 (estimated)
- Study completionSep 2015 (estimated)
Why it stopped: R and D approval not forthcoming
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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Sussex County Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Gray, Royal Sussex County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523158
- Sponsor's protocol ID
- 12/014/TAR
- Status last verified
- Sep 2012
- First submitted
- 27 Jan 2012
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study to Investigate the Effects of Injection Immunotherapy on Allergen-specific T and B Cell Responses in Adult Patients With Seasonal Allergic Rhinitis.
- ClinicalTrials.gov ID
- NCT01523158
- Acronym / sponsor ID
- 12/014/TAR
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, Immunotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: R and D approval not forthcoming
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Royal Sussex County HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 1 Feb 2012 (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.
Hay fever (seasonal allergic rhinitis) results from allergy to grass and tree pollen. The majority of affected individuals manage well with medication from the Pharmacy or from their general practitioner (GP), but for some severely affected people it severely impacts on quality of life. Less than 40% of those affected in UK general practice feel that these medications achieve good symptomatic control.
Specific immunotherapy or desensitisation is the practice of administering small amounts of allergen to allergic patients in increasing doses. This treatment is highly effective in these patients and furthermore is truly disease-modifying, with benefits persisting long-term, even when the treatment has been completed. Desensitisation is a routine treatment in the UK, Europe and North America. The exact immune mechanisms that underlie this symptomatic improvement are not entirely clear. Dr Tarzi, Professor Frew and Professor Kern have recently developed new methods for the investigation of immune responses to allergens. These methods require relatively small blood samples and may provide useful information about how immunotherapy exerts its effects. In addition to improving the investigators basic understanding of this treatment, such knowledge may drive improvements in the treatment and could be useful for monitoring patients for response. The investigators study proposes to investigate changes in the immune responses to pollen allergens during immunotherapy. Blood will be taken just prior to the first immunotherapy injection and again just prior to the final injection. In this way the investigators will be able to compare the immune responses to pollen allergen before and after treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy | Other | Biological: Allergovit grass or birchOpen label study of changes to cellular responses following immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female
- Age 18 with no upper age limit
- History of seasonal rhino-conjunctivitis in the appropriate season, not controlled by optimised standard medical therapy
- Positive skin prick test to grass pollen or tree pollen
Key exclusion criteria (15 listed)
- Inadequately controlled or moderate to severe asthma (GINA III/IV), i.e. the FEV1 is below 70 % of the target value despite adequate pharmacotherapy
- Irreversible changes in the reaction organ (emphysema, bronchiectasis, etc.)
- Clinically significant cardiovascular insufficiency (in cardiovascular diseases, there is an elevated risk of adverse reactions to adrenaline)
- Local or systemic use of beta blockers
- Diseases of the immune system (autoimmune diseases, immune complex-induced immunopathies, immunodeficiencies etc.)
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 |
|---|---|---|
| Allergovit grass or birchsubcutaneous injection of immunotherapy once weekly for 7 weeks prior to birch pollen season. | Biological | Immunotherapy |
Primary outcome
What are the changes in T cells associated with immunotherapy?
Time frame: 6 months
How does the T cell response change after immunotherapy
Results and safety
The study was stopped early (reason given: R and D approval not forthcoming). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allergovit grass or birch in people with Allergic Rhinitis, run by Royal Sussex County Hospital 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 15 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: stopped early, as of the sponsor's last update on 25 Sep 2012. 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 was stopped early (reason given: R and D approval not forthcoming). Results are not available in the source record.
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?
What are the changes in T cells associated with immunotherapy? (time frame: 6 months). 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 25 Sep 2012.