HayfeverPhase 4NCT00150514
Effects of Sublingual Immunotherapy on Grasspollen Allergy
A Phase 4 study testing Oralgen, Nasal biopsy and Nasal washing in people with Hayfever, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The objective of the study is to document the objective immunological effects of SLIT on the nasal mucosa. Better understanding of these immunological pathways, in which this widely practised clinical therapy is likely to work, can only benefit the overall outcome of this, more patient friendly, therapy and it will… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hayfever
- What is being tested?
- Oralgen, Nasal biopsy and Nasal washing
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2002to Dec 2006
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and older.
- Patients known in general practice with documented clinical history of grass pollen allergy with moderate disease intensity as retrospectively derived from the use of symptomatic allergy medication during the previous grass pollen season, i.e. regular use of cromoglycates as nasal spray and/or eye drops, and/or regular use of anti histamine tablets or sprays and/or limited use of local acting or systemically administered corticosteroids.
- Positive (ARTU) grass pollen specific skin prick test (despite negative RAST).
Who cannot join
- Clinical history of severe asthmatic symptoms requiring inhalant therapy with daily pulmonary steroids during at least 3 months a year.
- Symptomatic perennial allergic rhinitis. Meaning perennial allergy is allowed if the allergen is not present in patients' daily life (especially one month prior to provocation) and if they have no apparent symptoms of this perennial allergy.
- Other seasonal allergic rhinitis are not allowed unless it is asymptomatic during the period of provocation.
- The intention to subject the patient to surgery of the nasal cavity in the course of the study.
- Previous immunotherapy.
- Negative (ARTU) grass pollen specific skin prick test (despite positive RAST).
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- Contraindications to sublingual immunotherapy, i.e.:
- Malignancies and serious disorders of the oral cavity
- History of status asthmaticus and anaphylactic shock
- Aggressively developing asthmatic symptoms
- Serious chronic inflammations, chronic disorders associated with fever, particularly of the bronchial tubes
- Irreversible, secondary changes in reactive organs (emphysema, bronchiectasis)
- Auto immune diseases and immunodeficiency
- Concurrent therapy involving immunosuppressives
- Systemic and collagen diseases
- Tuberculosis of the lung and tuberculosis
- Serious psychological disorders
- Documented hypersensitivity to glycerol
- Pregnancy
- Serious cardiovascular disease
- Usage of b -blockers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo Controlled, Double-Blind, Randomised Study to Assess Efficacy of Sublingual Immunotherapy in Patients With Grass Pollen Allergy Through Assessment of Its Immunological Effects on the Mucosal Tissue of the Nose.
The objective of the study is to document the objective immunological effects of SLIT on the nasal mucosa. Better understanding of these immunological pathways, in which this widely practised clinical therapy is likely to work, can only benefit the overall outcome of this, more patient friendly, therapy and it will demonstrate the effects of SLIT on the allergic reaction, with objective parameters, in the nasal tissues showing it to be a true etiological treatment of allergy.
Read the detailed description
Double blind placebo controlled evaluation of the immunological effects (decrease of IgE specific cells and the decrease of Th2 mediator release, respectively increase of Th1 mediator release) of SLIT on the nasal mucosal tissue of adult humans with severe rhinocunjunctivitis due to grass pollen allergy.
- Conditions
- Hayfever
- Being tested
- Oralgen, Nasal biopsy, Nasal washing, Peak nasal inspiratory flow
- Keywords
- nasal biopsy grasspollen sublingual immunotherapy
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OralgenDrug
Nasal biopsyProcedure or surgery
Nasal washingProcedure or surgery
Peak nasal inspiratory flowProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Double blind placebo controlled evaluation of the immunological effects of SLIT on the nasal mucosal tissue of adult humans with sever
Secondary outcomes (4)
I. Correlating immunological effects to a retrospective subjective complaint reduction.
II. Rescue medication decrease through SLIT.
III. Determining the effects of SLIT on decongestion.
IV. Assessment of treatment compliance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJan 2002
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HayfeverStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 38 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- K Ingels, MD, Study chair, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150514
- Sponsor's protocol ID
- AB0103
- Status last verified
- Nov 2003
- First submitted
- 7 Sep 2005
- Last updated
- 8 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled, Double-Blind, Randomised Study to Assess Efficacy of Sublingual Immunotherapy in Patients With Grass Pollen Allergy Through Assessment of Its Immunological Effects on the Mucosal Tissue of the Nose.
- ClinicalTrials.gov ID
- NCT00150514
- Acronym / sponsor ID
- AB0103
- Conditions
- Hayfever
- Keywords
- nasal biopsy grasspollen sublingual immunotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Dec 2006
- First posted
- 8 Sep 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.
The objective of the study is to document the objective immunological effects of SLIT on the nasal mucosa. Better understanding of these immunological pathways, in which this widely practised clinical therapy is likely to work, can only benefit the overall outcome of this, more patient friendly, therapy and it will demonstrate the effects of SLIT on the allergic reaction, with objective parameters, in the nasal tissues showing it to be a true etiological treatment of allergy.
Detailed description
Double blind placebo controlled evaluation of the immunological effects (decrease of IgE specific cells and the decrease of Th2 mediator release, respectively increase of Th1 mediator release) of SLIT on the nasal mucosal tissue of adult humans with severe rhinocunjunctivitis due to grass pollen allergy.
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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and older.
- Patients known in general practice with documented clinical history of grass pollen allergy with moderate disease intensity as retrospectively derived from the use of symptomatic allergy medication during the previous grass pollen season, i.e. regular use of cromoglycates as nasal spray and/or eye drops, and/or regular use of anti histamine tablets or sprays and/or limited use of local acting or systemically administered corticosteroids.
- Positive (ARTU) grass pollen specific skin prick test (despite negative RAST).
Key exclusion criteria (21 listed)
- Clinical history of severe asthmatic symptoms requiring inhalant therapy with daily pulmonary steroids during at least 3 months a year.
- Symptomatic perennial allergic rhinitis. Meaning perennial allergy is allowed if the allergen is not present in patients' daily life (especially one month prior to provocation) and if they have no apparent symptoms of this perennial allergy.
- Other seasonal allergic rhinitis are not allowed unless it is asymptomatic during the period of provocation.
- The intention to subject the patient to surgery of the nasal cavity in the course of the study.
- Previous immunotherapy.
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 |
|---|---|---|
| Oralgen | Drug | – |
| Nasal biopsy | Procedure or surgery | – |
| Nasal washing | Procedure or surgery | – |
| Peak nasal inspiratory flow | Procedure or surgery | – |
Primary outcome
Double blind placebo controlled evaluation of the immunological effects of SLIT on the nasal mucosal tissue of adult humans with sever
4 secondary outcomes
I. Correlating immunological effects to a retrospective subjective complaint reduction.
II. Rescue medication decrease through SLIT.
III. Determining the effects of SLIT on decongestion.
IV. Assessment of treatment compliance.
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 8 Sep 2005.
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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.
K Ingels, MD study chair
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oralgen, Nasal biopsy and Nasal washing in people with Hayfever, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 21 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 8 Sep 2005. 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 Netherlands. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Double blind placebo controlled evaluation of the immunological effects of SLIT on the nasal mucosal tissue of adult humans with sever. 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 8 Sep 2005.