Rhinitis, Allergic, SeasonalBirch11NCT01985542
The Effects of Immunotherapy in the Nose
A study testing birch pollen subcutaneous immunotherapy in people with Rhinitis, Allergic, Seasonal, run by Helsinki University Central Hospital.
Trial summary
Allergic rhinitis might be caused by decreased resistance of nasal barrier to allergens and other environmental insults. About 20 % of the European population suffers from pollen allergies. Read more about this study
- Who is it for?
- Ages 12 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- birch pollen subcutaneous immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- allergic rhinoconjunctivitis of birch pollen OR healthy controls
Who cannot join
- smoking, asthma, any other disease than allergic rhinoconjunctivitis, requiring constant medication
About this study
Official title: The Molecular Biological Effects of Immunotherapy in the Nose
Allergic rhinitis might be caused by decreased resistance of nasal barrier to allergens and other environmental insults. About 20 % of the European population suffers from pollen allergies. Birch pollen allergic rhinitis is the most common allergic disease in the Scandinavia and it exists widely also in the Central Europe. Suffering and high costs of pollen allergies may be reduced by understanding the molecular biology of the nasal barriers during allergic response. Our aim is to observe the effect of season and birch pollen immunotherapy on the molecular biology of nasal epithelium and the microbiome.
Read the detailed description
This is a controlled study with an intervention arm, and a control group of healthy volunteers. The population is composed of nonsmoking healthy adults and patients having birch or timothy pollen allergy with rhinoconjuctivitis symptoms and without other diseases. The diagnosis of pollen allergy is verified with positive history, skin prick test, and allergen specific IgE antibodies. Subjects undergo a spirometry with a bronchodilatator test and a histamine challenge. Quality of life and patient history data is collected by questionnaires. Four peripheral blood samples, as well as nasal cell swabs from nasal mucosa without local anesthesia are collected from each patient; in spring and winter before the group of the intervention arm starts with birch pollen subcutaneous immunotherapy; and during the first spring and winter when a subgroups has received the birch pollen immunotherapy. We plan to perform the following analyses for the nasal specimens: transcriptomics and their regulators, sequencing of 16SrRNA and RT-qPCR for assessing mucosal microbiome, mass spectrometry for analyses of proteins and protein-protein complexes, immunohistochemistry for tissue level localization and quantitation of proteins, in silico analyses for the data mining, integration and display. In addition we observe the alterations in inflammatory mediators after in vitro allergen activation of purified peripheral blood leukocytes by ELISA and real time qPCR.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- birch pollen subcutaneous 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.
birch pollen subcutaneous immunotherapyDrug
birch pollen subcutaneous immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| subcutaneous immunotherapy | Active comparator | Starts with birch pollen subcutaneous immunotherapy Receives: Drug: birch pollen subcutaneous immunotherapy |
| no immunotherapy | No intervention | not starting with birch pollen subcutaneous immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Total Number of Differentially Expressed Transcripts.
Transcriptomics are evaluated By Next Generation Sequencing. The total number of differentially expressed transcripts are defined from nasal epithelial brushing samples taken at -6 months vs. at +6 months in the two subject groups.
The subject groups are the Subcutaneous immunotherapy group and No immunotherapy group.
Measured: -6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.
Secondary outcomes (1)
Percentage Change in Visual Analogue Scale Scores of Symptoms
Visual analogue scale (VAS) was measured as 0-100 mm per each symptom question. VAS value 0 (mm) indicates no symptoms, and value 100 (mm) indicates the worst case.
Total VAS score = sum of the VAS scores for the 41 symptoms The minimum value of the total VAS score is 0, and the maximum value is 4100. Relative change = [(measure at time +6 months - measure at time -6 months)]/measure at time -6 months * 100%.
Measure = total VAS score
Measured: -6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startMay 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Finnish Institute of Occupational Health
- Responsible party
- Principal investigator, Sanna Salmi, Helsinki University Central Hospital
- Investigators
- Sanna K Salmi, MD PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985542
- Sponsor's protocol ID
- The effects of immunotherapy
- Acronym
- Birch11
- Status last verified
- May 2021
- First submitted
- 4 Nov 2013
- Last updated
- 10 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: The individual participant data is not shared.
Publications
Mattila P, Renkonen J, Toppila-Salmi S, Parviainen V, Joenvaara S, Alff-Tuomala S, Nicorici D, Renkonen R. Time-series nasal epithelial transcriptomics during natural pollen exposure in healthy subjects and allergic patients. Allergy. 2010 Feb;65(2):175-83. doi: 10.1111/j.1398-9995.2009.02181.x. Epub 2009 Oct 5.
PubMed 19804444Joenvaara S, Mattila P, Renkonen J, Makitie A, Toppila-Salmi S, Lehtonen M, Salmi P, Lehti S, Makinen J, Sormunen R, Paavonen T, Renkonen R. Caveolar transport through nasal epithelium of birch pollen allergen Bet v 1 in allergic patients. J Allergy Clin Immunol. 2009 Jul;124(1):135-142.e1-21. doi: 10.1016/j.jaci.2008.11.048. Epub 2009 Apr 2.
PubMed 19344938
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Molecular Biological Effects of Immunotherapy in the Nose
- ClinicalTrials.gov ID
- NCT01985542
- Acronym / sponsor ID
- Birch11 / The effects of immunotherapy
- Conditions
- Rhinitis, Allergic, Seasonal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki, Finnish Institute of Occupational Health
- Study start
- May 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Posted 20 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Allergic rhinitis might be caused by decreased resistance of nasal barrier to allergens and other environmental insults. About 20 % of the European population suffers from pollen allergies. Birch pollen allergic rhinitis is the most common allergic disease in the Scandinavia and it exists widely also in the Central Europe. Suffering and high costs of pollen allergies may be reduced by understanding the molecular biology of the nasal barriers during allergic response. Our aim is to observe the effect of season and birch pollen immunotherapy on the molecular biology of nasal epithelium and the microbiome.
Detailed description
This is a controlled study with an intervention arm, and a control group of healthy volunteers. The population is composed of nonsmoking healthy adults and patients having birch or timothy pollen allergy with rhinoconjuctivitis symptoms and without other diseases. The diagnosis of pollen allergy is verified with positive history, skin prick test, and allergen specific IgE antibodies. Subjects undergo a spirometry with a bronchodilatator test and a histamine challenge. Quality of life and patient history data is collected by questionnaires. Four peripheral blood samples, as well as nasal cell swabs from nasal mucosa without local anesthesia are collected from each patient; in spring and winter before the group of the intervention arm starts with birch pollen subcutaneous immunotherapy; and during the first spring and winter when a subgroups has received the birch pollen immunotherapy. We plan to perform the following analyses for the nasal specimens: transcriptomics and their regulators, sequencing of 16SrRNA and RT-qPCR for assessing mucosal microbiome, mass spectrometry for analyses of proteins and protein-protein complexes, immunohistochemistry for tissue level localization and quantitation of proteins, in silico analyses for the data mining, integration and display. In addition we observe the alterations in inflammatory mediators after in vitro allergen activation of purified peripheral blood leukocytes by ELISA and real time qPCR.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subcutaneous immunotherapy | Active comparator | Drug: birch pollen subcutaneous immunotherapyStarts with birch pollen subcutaneous immunotherapy |
| no immunotherapy | No intervention | –not starting with birch pollen subcutaneous immunotherapy |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- allergic rhinoconjunctivitis of birch pollen OR healthy controls
Key exclusion criteria (1 listed)
- smoking, asthma, any other disease than allergic rhinoconjunctivitis, requiring constant medication
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 |
|---|---|---|
| birch pollen subcutaneous immunotherapybirch pollen subcutaneous immunotherapy | Drug | subcutaneous immunotherapy |
Primary outcome
The Total Number of Differentially Expressed Transcripts.
Time frame: -6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.
Transcriptomics are evaluated By Next Generation Sequencing. The total number of differentially expressed transcripts are defined from nasal epithelial brushing samples taken at -6 months vs. at +6 months in the two subject groups. The subject groups are the Subcutaneous immunotherapy group and No immunotherapy group.
1 secondary outcome
Percentage Change in Visual Analogue Scale Scores of Symptoms
Time frame: -6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19804444Mattila P, Renkonen J, Toppila-Salmi S, Parviainen V, Joenvaara S, Alff-Tuomala S, Nicorici D, Renkonen R. Time-series nasal epithelial transcriptomics during natural pollen exposure in healthy subjects and allergic patients. Allergy. 2010 Feb;65(2):175-83. doi: 10.1111/j.1398-9995.2009.02181.x. Epub 2009 Oct 5.
- Background: PubMed 19344938Joenvaara S, Mattila P, Renkonen J, Makitie A, Toppila-Salmi S, Lehtonen M, Salmi P, Lehti S, Makinen J, Sormunen R, Paavonen T, Renkonen R. Caveolar transport through nasal epithelium of birch pollen allergen Bet v 1 in allergic patients. J Allergy Clin Immunol. 2009 Jul;124(1):135-142.e1-21. doi: 10.1016/j.jaci.2008.11.048. Epub 2009 Apr 2.
- Individual participant dataSharing planned: No. The individual participant data is not shared.
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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.
Sanna K Salmi, MD PhD principal investigator
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
A study testing birch pollen subcutaneous immunotherapy in people with Rhinitis, Allergic, Seasonal, run by Helsinki University Central 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 1 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 10 Jun 2021. 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?
Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Total Number of Differentially Expressed Transcripts. (time frame: -6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01985542, which also lists 2 linked publications.
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 10 Jun 2021.