Allergy to House Dust MiteNCT01275456
Validation of an Environmental Exposure Chamber for Inhalation Studies With House Dust Mite Allergen in Patients With Allergic Rhinitis
A study testing Exposure to house dust mite in people with Allergy to House Dust Mite, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
This clinical validation study is aimed at testing the efficacy of a new environmental challenge chamber (ECC) to induce symptoms of allergic rhinitis in patients allergic to house dust mite. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergy to House Dust Mite
- What is being tested?
- Exposure to house dust mite
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to May 2011
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female subjects aged 18-55 years.
- Non smokers or ex-smokers with a history of less than 10 pack years, having been nonsmokers for at least the last 12 months.
- History of allergic rhinitis to house dust mite. Subjects with mild intermittent asthma that is controlled with occasional use of as-needed short-acting beta-agonists may be included.
- Normal lung function (FEV1 ≥ 80 % pred)
- Positive skin prick test for dermatophagoides pteronyssinus.
- 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:
- 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 meet 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 dose of study medication until at least 72 hours after treatment -, 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).
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, 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).
- Any structural nasal abnormalities or nasal polyps on examination, history of frequent nose bleeding or recent nasal surgery.
- Conditions or factors, which would make the subject unlikely to be able to stay in the Fraunhofer ECC for four to six 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)
- Intolerance to any excipients especially lactose and/or milk products
- History of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
Fraunhofer-Institute for Toxicology and Experimental Medicine
Hanover, 30625
About this study
This clinical validation study is aimed at testing the efficacy of a new environmental challenge chamber (ECC) to induce symptoms of allergic rhinitis in patients allergic to house dust mite. The symptoms will be recorded on a validated symptom score as Total Nasal Symptom Score (TNSS), allowing for determine whether the challenge is dose dependent and reproducible.
Read the detailed description
At Fraunhofer ITEM, a novel technique to create an atmosphere loaded with allergenic particles was recently developed. In brief, particles are produced in a combined process of nebulization and drying of a solution containing soluble allergenic extracts and lactose. The particle size distribution is regulated by the droplet size distribution and the lactose concentration in the solution, while the allergen content can be chosen independently. Thus, the Fraunhofer scientists have created a universal tool which provides them with the possibility to create atmospheres containing allergenic particles of arbitrary sizes containing a variety of different allergens. By choosing particle sizes preferentially depositing in the nose (above 10 µm) or the lungs (5 to 10 µm), and selecting allergen concentrations commonly found in the environment, it is possible to build up challenge atmospheres for a large variety of indications.
The first clinical application of this new method will be to create an atmosphere simulating the natural exposure to house dust mite allergens. The challenge aerosol will be composed of lactose as carrier material and the two major allergens Der p1 and Der p2 of house dust mites originating from a licenced allergen extract for inhaled challenge.
- Conditions
- Allergy to House Dust Mite
- Being tested
- Exposure to house dust mite
- Keywords
- allergen provocation, environmental challenge, allergen chamber, house dust mite, immunotherapy
- Medical subject headings
- Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to house dust miteProcedure or surgery
0 SQE/qm for 4 hours 250 SQE/qm for 4 hours 500 SQE/qm for 4 hours 1000 SQE/qm for 4 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
Total nasal symptom score (TNSS)
To assess the effect of a 4 hour-environmental allergen challenge with house dust mite extract in an ECC on the total nasal symptom score (TNSS), defined as the sum of obstruction, rhinorrhea, itch, and sneeze, each of which has been scored on a scale from 0 to 3.
Measured: During 4 hours of challenge
Secondary outcomes (5)
Rhinomanometry
To assess the effect of a 4-hour-environmental allergen challenge with house dust mite extract.
Measured: During 4 hours of challenge
visual analogue scale (VAS) for total nasal symptoms
To assess the effect of a 4-hour-environmental allergen challenge with house dust mite extract
Measured: During 4 hours of challenge
Nasal secretion
To assess the effect of a 4-hour-environmental allergen challenge with house dust mite extract.
Measured: during 4 hours of challenge
Exhaled Nitric Oxide (NO)
To assess the effect of a 4-hour-environmental allergen challenge with house dust mite extract.
Measured: during and up to 24 hours after challenge
FEV1
To assess the effect of a 4-hour-environmental allergen challenge with house dust mite extract.
Measured: during and up to 24 hours after challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy to House Dust MiteStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275456
- Sponsor's protocol ID
- 09/01 Valex1
- Status last verified
- Jul 2011
- First submitted
- 10 Jan 2011
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Environmental Exposure Chamber for Inhalation Studies With House Dust Mite Allergen in Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01275456
- Acronym / sponsor ID
- 09/01 Valex1
- Conditions
- Allergy to House Dust Mite
- Keywords
- allergen provocation, environmental challenge, allergen chamber, house dust mite, immunotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 Jan 2011 (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 testing the efficacy of a new environmental challenge chamber (ECC) to induce symptoms of allergic rhinitis in patients allergic to house dust mite. The symptoms will be recorded on a validated symptom score as Total Nasal Symptom Score (TNSS), allowing for determine whether the challenge is dose dependent and reproducible.
Detailed description
At Fraunhofer ITEM, a novel technique to create an atmosphere loaded with allergenic particles was recently developed. In brief, particles are produced in a combined process of nebulization and drying of a solution containing soluble allergenic extracts and lactose. The particle size distribution is regulated by the droplet size distribution and the lactose concentration in the solution, while the allergen content can be chosen independently. Thus, the Fraunhofer scientists have created a universal tool which provides them with the possibility to create atmospheres containing allergenic particles of arbitrary sizes containing a variety of different allergens. By choosing particle sizes preferentially depositing in the nose (above 10 µm) or the lungs (5 to 10 µm), and selecting allergen concentrations commonly found in the environment, it is possible to build up challenge atmospheres for a large variety of indications.
The first clinical application of this new method will be to create an atmosphere simulating the natural exposure to house dust mite allergens. The challenge aerosol will be composed of lactose as carrier material and the two major allergens Der p1 and Der p2 of house dust mites originating from a licenced allergen extract for inhaled challenge.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male and female subjects aged 18-55 years.
- Non smokers or ex-smokers with a history of less than 10 pack years, having been nonsmokers for at least the last 12 months.
- History of allergic rhinitis to house dust mite. Subjects with mild intermittent asthma that is controlled with occasional use of as-needed short-acting beta-agonists may be included.
- Normal lung function (FEV1 ≥ 80 % pred)
- Positive skin prick test for dermatophagoides pteronyssinus.
Key exclusion criteria (12 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, 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).
- 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 house dust mite0 SQE/qm for 4 hours 250 SQE/qm for 4 hours 500 SQE/qm for 4 hours 1000 SQE/qm for 4 hours | Procedure or surgery | – |
Primary outcome
Total nasal symptom score (TNSS)
Time frame: During 4 hours of challenge
To assess the effect of a 4 hour-environmental allergen challenge with house dust mite extract in an ECC on the total nasal symptom score (TNSS), defined as the sum of obstruction, rhinorrhea, itch, and sneeze, each of which has been scored on a scale from 0 to 3.
5 secondary outcomes
Rhinomanometry
Time frame: During 4 hours of challenge
visual analogue scale (VAS) for total nasal symptoms
Time frame: During 4 hours of challenge
Nasal secretion
Time frame: during 4 hours of challenge
Exhaled Nitric Oxide (NO)
Time frame: during and up to 24 hours after challenge
FEV1
Time frame: during and up to 24 hours after challenge
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 6 Jul 2011.
- Sponsor's homepageLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to house dust mite in people with Allergy to House Dust Mite, 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 11 inclusion and 12 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 6 Jul 2011. 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. 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: During 4 hours of challenge). 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 6 Jul 2011.