Allergic RhinoconjunctivitisNCT01085526
Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Allergic Rhinitis
A study testing Alutard phleum pratense subcutaneous immunotherapy and Alutard phl prat in people with Allergic Rhinoconjunctivitis, run by Aarhus University Hospital.
Trial summary
The trial is randomized prospective study to examine the effects of subcutaneous immunotherapy on the adaptive immune system. The trial includes 30 participants randomized to treatment or control group. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- Alutard phleum pratense subcutaneous immunotherapy and Alutard phl prat
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Sep 2014
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- rhinoconjunctivitis due to grass pollen allergy
- positive skin prick test and nasal allergen challenge test to grass pollen extract
Who cannot join
- severe comorbidity, severe asthma, pregnancy
About this study
Official title: Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Patients With Allergic Rhinitis Due to Grass Pollen Allergy - a Prospective Randomized Controlled Study
The trial is randomized prospective study to examine the effects of subcutaneous immunotherapy on the adaptive immune system. The trial includes 30 participants randomized to treatment or control group. The effect measures are changes in the basophil activity and biology as well as changes in plasma cells during and after treatment. Clinical outcome is assessed by QoL questionnaires and clinical testing.
Hypotheses:
- changes in plasma cells correlate to changes in immunoglobulins and effector cell responses
- the reduction of inflammation due to SCIT has influence on the effector cell responses
- changes in paraclinical measurements can be related to clinical findings
Read the detailed description
The investigators are recruiting 30 participants, which are randomized to receive SCIT (24) or no treatment (6) The following will be measured
- the development of immunoglobulin response
- plasma cells under updosing phase
- changes in basophil activity under updosing and maintenance treatment
- subtyping of allergic sensitization
- clinical outcome and quality of life
- changes in mast cells in the nasal mucosa
- changes in the cell biology of the basophils
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Alutard phleum pratense subcutaneous immunotherapy, Alutard phl prat
- Keywords
- basophil activity, plasma cells, IgE, IgG1, IgG4, mast cells, IgE receptor, allergic rhinoconjunctivitis, grass pollen allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alutard phleum pratense subcutaneous immunotherapyBiological
Also called alutard phleum pratense, subcutaneous immunotherapy
standard regimen of SCIT
Alutard phl pratDrug
Also called Alutard 225, phleum pratense, ALK-abelló
| Study group | Role | What they receive |
|---|---|---|
| alutard phl prat. treatment group | Active comparator | 18 subjects receiving active treatment: basophil activity, plasma cells and immunoglobulins measured Receives: Biological: Alutard phleum pratense subcutaneous immunotherapy; Drug: Alutard phl prat |
| control group | No intervention | control |
| alutard phl.prat., treatment group2 | Active comparator | basophil activity, basophil biology measured Receives: Biological: Alutard phleum pratense subcutaneous immunotherapy; Drug: Alutard phl prat |
What is being measured
The primary outcome is the main question the study is designed to answer.
a significant decrease in basophil activity during and after treatment
Measured: every 3 weeks for 3 months, then 3 monthly for 3 years
Secondary outcomes (4)
reduction in high affinity IgE receptor density on basophils and mast cells
igE receptor density on basophils and mast cells from nasal mucosa
Measured: at inclusion and at the end of study
clinical outcome: reduction in the reaction to allergen challenge tests (skin and nose), significant better outcome in quality of life questionnaires and symptom/medication scores
allergen challenging response
Measured: once yearly for 4 years
a significant increase in the number of plasma cells during up dosing
Measured: 5 times during the first 3 months of the study
a significant shift in specific immunoglobulins from IgE at start to IgG1 and IgG4 after treatment. allergen epitope specific IgE and IgG4
Measured: every 3 months for 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinoconjunctivitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, ALK-Abelló A/S, Lundbeck Foundation
- Responsible party
- Principal investigator, Pia Pedersen, Aarhus University Hospital
- Investigators
- Ronald Dahl, Prof, dr.med, Study chair, Dept. of Respiratory Medicine, Århus University HospitalHans Juergen Hoffmann, assoc prof, Principal investigator, Dept of Respiratory Medicine, Århus University HospitalJohannes M Schmid, MD, Principal investigator, Dept. of Respiratory Medicine, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085526
- Sponsor's protocol ID
- BasoScit
- Status last verified
- Jul 2014
- First submitted
- 10 Mar 2010
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Patients With Allergic Rhinitis Due to Grass Pollen Allergy - a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01085526
- Acronym / sponsor ID
- BasoScit
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- basophil activity, plasma cells, IgE, IgG1, IgG4, mast cells, IgE receptor, allergic rhinoconjunctivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, ALK-Abelló A/S, Lundbeck Foundation
- Study start
- Feb 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Mar 2010 (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 trial is randomized prospective study to examine the effects of subcutaneous immunotherapy on the adaptive immune system. The trial includes 30 participants randomized to treatment or control group. The effect measures are changes in the basophil activity and biology as well as changes in plasma cells during and after treatment. Clinical outcome is assessed by QoL questionnaires and clinical testing.
Hypotheses:
- changes in plasma cells correlate to changes in immunoglobulins and effector cell responses
- the reduction of inflammation due to SCIT has influence on the effector cell responses
- changes in paraclinical measurements can be related to clinical findings
Detailed description
The investigators are recruiting 30 participants, which are randomized to receive SCIT (24) or no treatment (6) The following will be measured
- the development of immunoglobulin response
- plasma cells under updosing phase
- changes in basophil activity under updosing and maintenance treatment
- subtyping of allergic sensitization
- clinical outcome and quality of life
- changes in mast cells in the nasal mucosa
- changes in the cell biology of the basophils
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| alutard phl prat. treatment group | Active comparator | Biological: Alutard phleum pratense subcutaneous immunotherapy, Drug: Alutard phl prat18 subjects receiving active treatment: basophil activity, plasma cells and immunoglobulins measured |
| control group | No intervention | –control |
| alutard phl.prat., treatment group2 | Active comparator | Biological: Alutard phleum pratense subcutaneous immunotherapy, Drug: Alutard phl pratbasophil activity, basophil biology measured |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- rhinoconjunctivitis due to grass pollen allergy
- positive skin prick test and nasal allergen challenge test to grass pollen extract
Key exclusion criteria (1 listed)
- severe comorbidity, severe asthma, 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 |
|---|---|---|
| Alutard phleum pratense subcutaneous immunotherapyAlso: alutard phleum pratense, subcutaneous immunotherapystandard regimen of SCIT | Biological | alutard phl prat. treatment group, alutard phl.prat., treatment group2 |
| Alutard phl pratAlso: Alutard 225, phleum pratense, ALK-abelló | Drug | alutard phl prat. treatment group, alutard phl.prat., treatment group2 |
Primary outcome
a significant decrease in basophil activity during and after treatment
Time frame: every 3 weeks for 3 months, then 3 monthly for 3 years
4 secondary outcomes
reduction in high affinity IgE receptor density on basophils and mast cells
Time frame: at inclusion and at the end of study
clinical outcome: reduction in the reaction to allergen challenge tests (skin and nose), significant better outcome in quality of life questionnaires and symptom/medication scores
Time frame: once yearly for 4 years
a significant increase in the number of plasma cells during up dosing
Time frame: 5 times during the first 3 months of the study
a significant shift in specific immunoglobulins from IgE at start to IgG1 and IgG4 after treatment. allergen epitope specific IgE and IgG4
Time frame: every 3 months for 4 years
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 18 Feb 2015.
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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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.
Ronald Dahl, Prof, dr.med study chair
Dept. of Respiratory Medicine, Århus University Hospital
Hans Juergen Hoffmann, assoc prof principal investigator
Dept of Respiratory Medicine, Århus University Hospital
Johannes M Schmid, MD principal investigator
Dept. of Respiratory Medicine, Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Alutard phleum pratense subcutaneous immunotherapy and Alutard phl prat in people with Allergic Rhinoconjunctivitis, run by Aarhus University Hospital.
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 2 inclusion and 1 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 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
a significant decrease in basophil activity during and after treatment (time frame: every 3 weeks for 3 months, then 3 monthly for 3 years). 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 18 Feb 2015.