Allergic RhinitisSIMBANCT05245175
Impact of Carrier Solutions for House Dust Mite Allergen on Allergic Reactions
A study testing Sodium chloride particles, Lactose particles and Clean air in people with Allergic Rhinitis, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
Single-blind, within-block randomized, clean-air-controlled study to assess the effect of lactose and sodium chloride particles in patients with allergic rhinitis on nasal symptoms when challenged in the Fraunhofer Allergen Challenge Chamber Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Sodium chloride particles, Lactose particles and Clean air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- 22 Feb 2022to 13 Apr 2022
- 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
- Able and willing to give written informed consent.
- Male and female subjects, aged 18-65 years. Women will be considered for inclusion if they are:
- Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing.
- Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).
- 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 is complete abstinence from intercourse from two weeks prior to the first allergen challenge until at least 72 hours after the last allergen challenge -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Body mass index between 18 and 32 kg/m2
Show all 12Show fewer
- History of HDM-induced allergic rhinitis with or without conjunctivitis of 1 year or longer in duration at screening.
- Positive skin prick test responses (positive wheal diameter reaction of ≥ 3 mm larger than the negative control and wheal diameter < 2 mm to the sodium chloride/diluent negative control) to D. pteronyssinus at screening or within the past 12 months (if performed and documented at the clinical unit).
- Serum specific IgE level (≥ 0.7 kU/L) to D. pteronyssinus at screening or within the past 12 months (if performed and documented at the clinical unit).
- FEV1 of 80% of predicted value or greater at screening. If subject fails to achieve this value, the assessment may be repeated 2 additional times.
- Total Nasal Symptom Score (TNSS) of ≤ 3 prior to entering the chamber at visit 2.
- Smokers or non-smokers.
Who cannot join
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urine analysis, vital signs, lung function or ECG at screening visit , which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
- Diastolic blood pressure above 95 mmHg.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are 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).
- History of an acute infection at screening that has not resolved four weeks prior to visit 2.
- Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyps).
- Concomitant allergies to seasonal aeroallergens which are anticipated to be or become active (i.e., grass, trees, weeds, rye; defined as IgE ≥ 3.5 kU/L [IgE samples drawn within 12 months prior to screening can be used to assess criteria as long as they are performed and documented at the clinical unit]; OR symptomatic to aeroallergens within the past 2 years or within the past 2 allergy seasons; OR both) through the completion of the study.
Show all 19Show fewer
- Concomitant allergy to an animal dander who has exposure on a regular basis to the respective animal dander.
- History of allergic reactions such as anaphylactic shock, exanthema generalized, angioedema or hypotension caused by HDM and/or any medical products (including vaccine) in the past.
- Known or suspected clinically relevant intolerance to lactose .
- Asthma other than mild asthma which is treated with short acting beta-2-agonists only and which is controlled according to the current GINA guidelines.
- Participation in another clinical trial 30 days prior to enrollment.
- Donation of more than 400 ml of blood the preceding 2 months before screening.
- History of regular drug or alcohol abuse in the past 3 months.
- Risk of non-compliance with study procedures.
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
- Specific Immunotherapy (SIT) within five years prior to the study.
- Treatment with medication that might interfere with rescue medication for anaphylactic reactions (e.g. beta blocker).
- Systemic immunosuppression treatment (e.g. oral steroids, biologics, e.g. dupilumab, JAK-Inhibitors, cyclosporine, azathioprine, Mycophenolat Mofetil (MMF) within 3 months before visit 2
- Treatment with anti-allergic medication or topical steroids (within 2 weeks before visit 2)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Fraunhofer Institute for Toxicology and Experimental Medicine
Hanover, Lower Saxony, 30625
About this study
Official title: Assessment of Impact of Different Carrier Solutions for House Dust Mite Allergen (HDM) Challenge on Allergic Reactions in Patients with HDM Allergic Rhinitis
Single-blind, within-block randomized, clean-air-controlled study to assess the effect of lactose and sodium chloride particles in patients with allergic rhinitis on nasal symptoms when challenged in the Fraunhofer Allergen Challenge Chamber
Read the detailed description
Allergen Challenge Chambers (ACC) are used worldwide since many years to test anti-allergic treatment in early clinical development. ACCs provide the advantage of controlled atmospheres with stable allergen load and highly reproducible symptoms during challenges.
The Fraunhofer ACC has been used since more than 20 years to test a range of different anti-allergic treatments, mostly using pollen challenges.
For house dust mite (HDM) challenges, a carrier solution containing lactose or sodium chloride is reconstituted with commercially available HDM allergen. The solution is spray-dried to create allergen loaded lactose or sodium chloride particles of a determined size. Those particles are distributed in the ACC.
Whether lactose or sodium chloride particles alone could induce nasal irritation during allergen challenges, has not been examined. Should allergen-free carrier solutions contribute to nasal symptoms, study results might be confounded. Even more so, if one carrier solution caused more nasal irritation than the other.
To determine if allergen-free carrier solutions alone irritate the nasal mucosa, we expose subjects with allergic rhinitis and house dust mite allergy to three different atmospheres: (1) lactose particles alone, (2) sodium chloride particles alone, and (3) clean air. Also, we aim to document nasal symptoms during challenges with HDM-containing carrier solutions to decide on the best carrier option for future clinical trials.
- Conditions
- Allergic Rhinitis
- Being tested
- Sodium chloride particles, Lactose particles, Clean air, Sodium chloride particles with house dust mite, Lactose particles with house dust mite
- Keywords
- Allergen Challenge Chamber, House dust mite, Sodium chloride
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium chloride particlesOther
Patients are exposed to sodium chloride particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber.
Lactose particlesOther
Patients are exposed to lactose particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber.
Clean airOther
Patients are exposed to clean air for 4 hours in the Fraunhofer Allergen Challenge Chamber.
Sodium chloride particles with house dust miteOther
Patients are exposed to sodium chloride particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber.
Lactose particles with house dust miteOther
Patients are exposed to lactose particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber.
| Study group | Role | What they receive |
|---|---|---|
| Sodium chloride particles | Experimental | Patients are exposed to sodium chloride particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber. Receives: Other: Sodium chloride particles |
| Lactose particles | Experimental | Patients are exposed to lactose particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber. Receives: Other: Lactose particles |
| Clean air | Placebo comparator | Patients are exposed to clean air for 4 hours in the Fraunhofer Allergen Challenge Chamber. Receives: Other: Clean air |
| Sodium chloride particles with house dust mite | Experimental | Patients are exposed to sodium chloride particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber. Receives: Other: Sodium chloride particles with house dust mite |
| Lactose particles with house dust mite | Experimental | Patients are exposed to lactose particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber. Receives: Other: Lactose particles with house dust mite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mean total nasal symptom score (TNSS) during challenge over 4 hours with either lactose or sodium chloride particles compared to challenges with clean air.
TNSS = Total Nasal Symptom Score (min = 0 = no symptoms; max = 12 = max symptoms)
Measured: Day 1, Day 2, Day 3
Secondary outcomes (2)
Change of mean VAS of symptoms during challenge over 4 hours with either lactose or sodium chloride particles compared to challenges with clean air
VAS = Visual Analogue Scale (min = 0 = no symptoms; max = 10 = max symptoms)
Measured: Day 1, Day 2, Day 3
Difference in nasal secretion weight during challenge over 4 hours with either lactose or sodium chloride particles compared to challenges with clean air
Pre-weighed handkerchief sachets used by subjects during challenge are weighed after use to determine nasal secretion amount
Measured: Day 1, Day 2, Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start22 Feb 2022
- Primary completion13 Apr 2022
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- 18 patients will be exposed 5 times in the Allergen Challenge Chamber. The 5 exposures are divided into 2 blocks. The first block consists of 3 challenges with sodium chloride particles, lactose particles, and clean air to address the primary and secondary objectives. The second block consists of 2 further challenges with D. pteronyssinus coupled with either sodium chloride particles or lactose particles to address exploratory objectives.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 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, MD, Fraunhofer-Institute of Toxicology and Experimental Medicine
- Investigators
- Jens M Hohlfeld, Prof. Dr., Principal investigator, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245175
- Sponsor's protocol ID
- 22-05 SIMBA
- Acronym
- SIMBA
- Status last verified
- Jul 2022
- First submitted
- 26 Jan 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lueer K, Biller H, Casper A, Windt H, Mueller M, Badorrek P, Haefner D, Framke T, Koch A, Ziehr H, Krug N, Koch W, Hohlfeld JM. Safety, efficacy and repeatability of a novel house dust mite allergen challenge technique in the Fraunhofer allergen challenge chamber. Allergy. 2016 Dec;71(12):1693-1700. doi: 10.1111/all.12947. Epub 2016 Jun 23.
PubMed 27255590
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Impact of Different Carrier Solutions for House Dust Mite Allergen (HDM) Challenge on Allergic Reactions in Patients with HDM Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT05245175
- Acronym / sponsor ID
- SIMBA / 22-05 SIMBA
- Conditions
- Allergic Rhinitis
- Keywords
- Allergen Challenge Chamber, House dust mite, Sodium chloride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 17 Feb 2022 (actual)
- 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.
Single-blind, within-block randomized, clean-air-controlled study to assess the effect of lactose and sodium chloride particles in patients with allergic rhinitis on nasal symptoms when challenged in the Fraunhofer Allergen Challenge Chamber
Detailed description
Allergen Challenge Chambers (ACC) are used worldwide since many years to test anti-allergic treatment in early clinical development. ACCs provide the advantage of controlled atmospheres with stable allergen load and highly reproducible symptoms during challenges.
The Fraunhofer ACC has been used since more than 20 years to test a range of different anti-allergic treatments, mostly using pollen challenges.
For house dust mite (HDM) challenges, a carrier solution containing lactose or sodium chloride is reconstituted with commercially available HDM allergen. The solution is spray-dried to create allergen loaded lactose or sodium chloride particles of a determined size. Those particles are distributed in the ACC.
Whether lactose or sodium chloride particles alone could induce nasal irritation during allergen challenges, has not been examined. Should allergen-free carrier solutions contribute to nasal symptoms, study results might be confounded. Even more so, if one carrier solution caused more nasal irritation than the other.
To determine if allergen-free carrier solutions alone irritate the nasal mucosa, we expose subjects with allergic rhinitis and house dust mite allergy to three different atmospheres: (1) lactose particles alone, (2) sodium chloride particles alone, and (3) clean air. Also, we aim to document nasal symptoms during challenges with HDM-containing carrier solutions to decide on the best carrier option for future clinical trials.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- 18 patients will be exposed 5 times in the Allergen Challenge Chamber. The 5 exposures are divided into 2 blocks. The first block consists of 3 challenges with sodium chloride particles, lactose particles, and clean air to address the primary and secondary objectives. The second block consists of 2 further challenges with D. pteronyssinus coupled with either sodium chloride particles or lactose particles to address exploratory objectives.
| Arm | Type | Receives |
|---|---|---|
| Sodium chloride particles | Experimental | Other: Sodium chloride particlesPatients are exposed to sodium chloride particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber. |
| Lactose particles | Experimental | Other: Lactose particlesPatients are exposed to lactose particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber. |
| Clean air | Placebo comparator | Other: Clean airPatients are exposed to clean air for 4 hours in the Fraunhofer Allergen Challenge Chamber. |
| Sodium chloride particles with house dust mite | Experimental | Other: Sodium chloride particles with house dust mitePatients are exposed to sodium chloride particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber. |
| Lactose particles with house dust mite | Experimental | Other: Lactose particles with house dust mitePatients are exposed to lactose particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able and willing to give written informed consent.
- Male and female subjects, aged 18-65 years. Women will be considered for inclusion if they are:
- Body mass index between 18 and 32 kg/m2
- History of HDM-induced allergic rhinitis with or without conjunctivitis of 1 year or longer in duration at screening.
- Positive skin prick test responses (positive wheal diameter reaction of ≥ 3 mm larger than the negative control and wheal diameter < 2 mm to the sodium chloride/diluent negative control) to D. pteronyssinus at screening or within the past 12 months (if performed and documented at the clinical unit).
Key exclusion criteria (19 listed)
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urine analysis, vital signs, lung function or ECG at screening visit , which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
- Diastolic blood pressure above 95 mmHg.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are 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).
- History of an acute infection at screening that has not resolved four weeks prior to visit 2.
- Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyps).
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 |
|---|---|---|
| Sodium chloride particlesPatients are exposed to sodium chloride particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber. | Other | Sodium chloride particles |
| Lactose particlesPatients are exposed to lactose particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber. | Other | Lactose particles |
| Clean airPatients are exposed to clean air for 4 hours in the Fraunhofer Allergen Challenge Chamber. | Other | Clean air |
| Sodium chloride particles with house dust mitePatients are exposed to sodium chloride particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber. | Other | Sodium chloride particles with house dust mite |
| Lactose particles with house dust mitePatients are exposed to lactose particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber. | Other | Lactose particles with house dust mite |
Primary outcome
Change of mean total nasal symptom score (TNSS) during challenge over 4 hours with either lactose or sodium chloride particles compared to challenges with clean air.
Time frame: Day 1, Day 2, Day 3
TNSS = Total Nasal Symptom Score (min = 0 = no symptoms; max = 12 = max symptoms)
2 secondary outcomes
Change of mean VAS of symptoms during challenge over 4 hours with either lactose or sodium chloride particles compared to challenges with clean air
Time frame: Day 1, Day 2, Day 3
Difference in nasal secretion weight during challenge over 4 hours with either lactose or sodium chloride particles compared to challenges with clean air
Time frame: Day 1, Day 2, Day 3
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 15 Oct 2024.
- Background: PubMed 27255590Lueer K, Biller H, Casper A, Windt H, Mueller M, Badorrek P, Haefner D, Framke T, Koch A, Ziehr H, Krug N, Koch W, Hohlfeld JM. Safety, efficacy and repeatability of a novel house dust mite allergen challenge technique in the Fraunhofer allergen challenge chamber. Allergy. 2016 Dec;71(12):1693-1700. doi: 10.1111/all.12947. Epub 2016 Jun 23.
- Individual participant dataSharing planned: No
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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.
Jens M Hohlfeld, Prof. Dr. principal investigator
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium chloride particles, Lactose particles and Clean air in people with Allergic Rhinitis, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
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 12 inclusion and 19 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 15 Oct 2024. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Change of mean total nasal symptom score (TNSS) during challenge over 4 hours with either lactose or sodium chloride particles compared to challenges with clean air. (time frame: Day 1, Day 2, Day 3). 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 NCT05245175, which also lists 1 linked publication.
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 15 Oct 2024.