Seasonal Allergic RhinitisNCT01983865
Monocenter 6-period Study in Patients With Seasonal Allergic Rhinitis to Birch Pollen to Establish a Challenge Model With Natural Birch Pollen in an Environmental Challenge Chamber (ECC)
A study testing Exposure to birch pollen in people with Seasonal Allergic Rhinitis, run by Fraunhofer-Institute of Toxicology and Experimental Medicine.
Trial summary
This clinical validation study is aimed at establishing a birch pollen challenge in the Fraunhofer ECC in patients allergic to birch pollen. The symptoms will be recorded on a validated symptom score as Total Nasal Symptom Score (TNSS), allowing to determine whether the challenge is dose dependent and reproducible. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Exposure to birch pollen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Feb 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18-65 years.
- Non smokers or ex-smokers with a history of less than 10 pack years, having been non-smokers for at least the last 12 months.
- History of allergic rhinitis to birch pollen. Subjects with mild intermittent asthma controlled with occasional use of as-needed short-acting beta-agonists can be included.
- Normal lung function (FEV1 ≥ 80 % predicted)
- Positive skin prick test for birch
- Able and willing to give written informed consent to take part in the study.
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- Available to complete all study measurements
- Women will be considered for inclusion if they are:
- O Not pregnant, as confirmed by pregnancy test (see flow chart) and not nursing.
- O Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who were pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or met clinical criteria for menopause and had been amenorrhoeic for more than 1 year prior to the screening visit).
- O Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there was complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contracep-tives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
Who cannot join
- History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening.
- Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
- Administration of oral, injectable or dermal corticosteroids within 8 weeks or intranasal and/or inhaled corticosteroids 4 weeks prior to enrollment.
- Past or present disease, which as judged by the investigator, might have affected the outcome of this study. These diseases included, but were not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Any structural nasal abnormalities or nasal polyps on examination, history of frequent nose bleeding or recent nasal surgery.
- Conditions or factors, which made the subject unlikely to be able to stay in the Fraunhofer ECC for four hours.
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- Specific Immunotherapy (SIT) within the last two years prior to screening
- Risk of non-compliance with study procedures
- Participation in another clinical trial 30 days prior to enrolment
- Any contraindication for adrenalin use (e.g. use of local and systemic beta-blockers)
- History of drug or alcohol abuse
About this study
This clinical validation study is aimed at establishing a birch pollen challenge in the Fraunhofer ECC in patients allergic to birch pollen. The symptoms will be recorded on a validated symptom score as Total Nasal Symptom Score (TNSS), allowing to determine whether the challenge is dose dependent and reproducible.
Read the detailed description
This is a mono-center, single-blind, placebo controlled study assessing nasal symptoms in patients with allergic rhinitis upon exposure to birch pollen in an environmental challenge chamber during a 4 hour challenge period with different concentrations of birch pollen versus placebo.
Subjects with allergic rhinitis to birch pollen will be recruited from the Fraunhofer ITEM database or the surrounding communities. After the screening evaluation eligible subjects will undergo six challenge sessions in the environmental challenge chamber at intervals of at least one week. In order to determine dose response, the concentration of birch pollen in the atmosphere of the challenge chamber will be varied from 1000 birch pollen/m³ in the first period, 2000 birch pollen/m³ in the second period, 4000 birch pollen/m³ in the third period, 8000 birch pollen/m³in the fourth period to 0 birch pollen/m³ (only air) in the fifth period. In order to investigate reproducibility in addition to dose response, a challenge with one concentration previously used will be repeated in period six. The dose will be chosen by the Investigator according to the observed nasal symptoms. According to previous experience with grass pollen (Dactylis glomerata) the target symptom level for TNSS is around 6. Therefore, the dose to study reproducibility will be chosen where the average mean TNSS of the last two hours will be closest to six. If two doses are equally close, the higher dose will be chosen because this will allow to optimize the particle monitoring technique. In this regard, it is better to have a high particle concentration in order to separate specific particles from unspecific particles (originating from the subjects themselves).
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Exposure to birch pollen
- 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.
Exposure to birch pollenOther
| Study group | Role | What they receive |
|---|---|---|
| Exposure to birch pollen | Other | Not described Receives: Other: Exposure to birch pollen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS)
TNSS measured every 20 minutes over 4 hours of birch pollen challenge in the ECC
Measured: every 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Jens Hohlfeld, Fraunhofer-Institute of Toxicology and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983865
- Sponsor's protocol ID
- 13-11 Grabi Pilot
- Status last verified
- Feb 2014
- First submitted
- 7 Nov 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocenter 6-period Study in Patients With Seasonal Allergic Rhinitis to Birch Pollen to Establish a Challenge Model With Natural Birch Pollen in an Environmental Challenge Chamber (ECC)
- ClinicalTrials.gov ID
- NCT01983865
- Acronym / sponsor ID
- 13-11 Grabi Pilot
- Conditions
- Seasonal Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Nov 2013 (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 clinical validation study is aimed at establishing a birch pollen challenge in the Fraunhofer ECC in patients allergic to birch pollen. The symptoms will be recorded on a validated symptom score as Total Nasal Symptom Score (TNSS), allowing to determine whether the challenge is dose dependent and reproducible.
Detailed description
This is a mono-center, single-blind, placebo controlled study assessing nasal symptoms in patients with allergic rhinitis upon exposure to birch pollen in an environmental challenge chamber during a 4 hour challenge period with different concentrations of birch pollen versus placebo.
Subjects with allergic rhinitis to birch pollen will be recruited from the Fraunhofer ITEM database or the surrounding communities. After the screening evaluation eligible subjects will undergo six challenge sessions in the environmental challenge chamber at intervals of at least one week. In order to determine dose response, the concentration of birch pollen in the atmosphere of the challenge chamber will be varied from 1000 birch pollen/m³ in the first period, 2000 birch pollen/m³ in the second period, 4000 birch pollen/m³ in the third period, 8000 birch pollen/m³in the fourth period to 0 birch pollen/m³ (only air) in the fifth period. In order to investigate reproducibility in addition to dose response, a challenge with one concentration previously used will be repeated in period six. The dose will be chosen by the Investigator according to the observed nasal symptoms. According to previous experience with grass pollen (Dactylis glomerata) the target symptom level for TNSS is around 6. Therefore, the dose to study reproducibility will be chosen where the average mean TNSS of the last two hours will be closest to six. If two doses are equally close, the higher dose will be chosen because this will allow to optimize the particle monitoring technique. In this regard, it is better to have a high particle concentration in order to separate specific particles from unspecific particles (originating from the subjects themselves).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposure to birch pollen | Other | Other: Exposure to birch pollen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and female subjects aged 18-65 years.
- Non smokers or ex-smokers with a history of less than 10 pack years, having been non-smokers for at least the last 12 months.
- History of allergic rhinitis to birch pollen. Subjects with mild intermittent asthma controlled with occasional use of as-needed short-acting beta-agonists can be included.
- Normal lung function (FEV1 ≥ 80 % predicted)
- Positive skin prick test for birch
Key exclusion criteria (11 listed)
- History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening.
- Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
- Administration of oral, injectable or dermal corticosteroids within 8 weeks or intranasal and/or inhaled corticosteroids 4 weeks prior to enrollment.
- Past or present disease, which as judged by the investigator, might have affected the outcome of this study. These diseases included, but were not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Any structural nasal abnormalities or nasal polyps on examination, history of frequent nose bleeding or recent nasal surgery.
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 |
|---|---|---|
| Exposure to birch pollen | Other | Exposure to birch pollen |
Primary outcome
Total Nasal Symptom Score (TNSS)
Time frame: every 20 minutes
TNSS measured every 20 minutes over 4 hours of birch pollen challenge in the ECC
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 19 Feb 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to birch pollen in people with Seasonal Allergic Rhinitis, run by Fraunhofer-Institute of Toxicology and Experimental Medicine.
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 11 inclusion and 11 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 19 Feb 2014. 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?
Total Nasal Symptom Score (TNSS) (time frame: every 20 minutes). 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 19 Feb 2014.