Dermatophagoides Farinae AllergyPhase 1DustyNCT00927329
Evaluation of a Nasal Allergen Challenge Procedure Using Dust Mite Extract
A Phase 1 study testing dust mite inhalation in people with Dermatophagoides Farinae Allergy and Asthma, run by University of North Carolina, Chapel Hill.
Trial summary
The purpose of this study is to serve as a pilot safety study for nasal allergen challenges. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatophagoides Farinae Allergy, Asthma, Healthy
- What is being tested?
- dust mite inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Apr 2017
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Specific allergy to house dust mite Dermatophagoides farinae confirmed by positive immediate skin test response.
- Subjects may be enrolled with mild asthma if they have an FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without the use of bronchodilating medications for 12 hours). This is consistent with lung function of persons with mild episodic or mild persistent asthma. For the purpose of this protocol, an asthmatic individual will be defined as having: a) a positive methacholine challenge with a provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) with less than or equal to 10 mg/ml by the method used; OR b) physician diagnosed asthma with symptoms and chronic daily therapy consistent with mild asthma.
- Ability to withhold antihistamine medications for one week prior to screening visit and one week prior to nasal allergen challenge visit.
- Subjects must be able and willing to give informed consent.
Who cannot join
- Any chronic medical condition considered by the PI as a contraindication to the allergen challenge study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease.
- Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
- Use of systemic steroid therapy within the preceding 12 months for treatment of an asthma exacerbation.
- Use of inhaled or nasal steroids, cromolyn, or leukotriene inhibitors (Montelukast or Zafirlukast) within the past month (except for use of cromolyn exclusively prior to exercise).
- Use of allergen immunotherapy.
- Use of daily theophylline within the past month.
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- Use of nasal medications that might alter the response to nasal allergen challenge including anti-inflammatory and anti-histamine agents within one week of challenge.
- Pregnancy or nursing a baby.
- Cigarette smoking within the past 12 months.
- Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
- Exacerbation of asthma more than 2x/week which would be characteristic of a person with moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
- Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise).
- Vitamin or herbal supplementation considered by the PI as having anti-inflammatory and/or anti-oxidant properties must be stopped 7 days prior to entrance into the study.
- A history of nasal or sinus surgery within the last 5 years.
- Viral URI within four weeks of challenge.
- Acute infection requiring the use of antibiotics within the last four weeks. Must be off antibiotics for at least two weeks prior to study.
- Participation in an allergen challenge study within two weeks of this challenge or use of an investigational agent within the last 30 days.
- Use of tricyclic antidepressants, beta-blockers, monoamine oxidase inhibitors or other drugs that may interfere with the treatment of anaphylaxis.
- Subjects with history of immunologic disease or on immune suppression for cancer or other disease.
About this study
Official title: Evaluation of the Safety and Effect of an Allergen Challenge Procedure on Nasal Airway Inflammation in Allergic Individuals Using a Dermatophagoides Farinae Extract Nasal Allergen Challenge Protocol
The purpose of this study is to serve as a pilot safety study for nasal allergen challenges.
Read the detailed description
The purpose of this study is to serve as a pilot safety study for the implementation of a new technique for nasal allergen challenges. The new technique consists of having patients maximally inhale to total lung capacity. A nasal metered dose pump will be used to deliver the Dermatophagoides farinae allergen to the nasal mucosa. The patient will not sniff after allergen delivery as in the previous study but instead exhale through the mouth. The investigators propose that this technique will inhibit large amounts of allergen reaching airway mucosa beyond the nasal site of introduction thus limiting serious adverse events.
- Conditions
- Dermatophagoides Farinae Allergy, Asthma, Healthy
- Being tested
- dust mite inhalation
- Keywords
- Dermatophagoides, farinae, allergen, dust, allergic, mite, allergy
- Medical subject headings
- Dust Mite Allergy, Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dust mite inhalationBiological
Also called allergy, allergic, Dermatophagoides, farinae
Nasal allergen challenge will be provided in a graded dose fashion of 0 AU, 100 AU, 500 AU, and 1000 AU separated by 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| dust mite | Experimental | Not described Receives: Biological: dust mite inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful nasal allergen challenge without serious adverse event.
Measured: Immediate
Secondary outcomes (1)
analyze and compare cells of the airway and serum for a variety of inflammatory markers relevant to innate immunity.
Measured: 4 hr post exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startJan 2009 (estimated)
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Original PI left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatophagoides Farinae AllergyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- David Peden, MD, Principal investigator, University of North Carolina, Chapel HillMichelle Hernandez, MD, Study director, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927329
- Sponsor's protocol ID
- 09-0196
- Other IDs
- 59719
- Acronym
- Dusty
- Status last verified
- May 2017
- First submitted
- 22 Jun 2009
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effect of an Allergen Challenge Procedure on Nasal Airway Inflammation in Allergic Individuals Using a Dermatophagoides Farinae Extract Nasal Allergen Challenge Protocol
- ClinicalTrials.gov ID
- NCT00927329
- Acronym / sponsor ID
- Dusty / 09-0196
- Conditions
- Dermatophagoides Farinae Allergy, Asthma, Healthy
- Keywords
- Dermatophagoides, farinae, allergen, dust, allergic, mite, allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Original PI left institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2009 (estimated)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 24 Jun 2009 (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 purpose of this study is to serve as a pilot safety study for nasal allergen challenges.
Detailed description
The purpose of this study is to serve as a pilot safety study for the implementation of a new technique for nasal allergen challenges. The new technique consists of having patients maximally inhale to total lung capacity. A nasal metered dose pump will be used to deliver the Dermatophagoides farinae allergen to the nasal mucosa. The patient will not sniff after allergen delivery as in the previous study but instead exhale through the mouth. The investigators propose that this technique will inhibit large amounts of allergen reaching airway mucosa beyond the nasal site of introduction thus limiting serious adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dust mite | Experimental | Biological: dust mite inhalation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Specific allergy to house dust mite Dermatophagoides farinae confirmed by positive immediate skin test response.
- Subjects may be enrolled with mild asthma if they have an FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without the use of bronchodilating medications for 12 hours). This is consistent with lung function of persons with mild episodic or mild persistent asthma. For the purpose of this protocol, an asthmatic individual will be defined as having: a) a positive methacholine challenge with a provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) with less than or equal to 10 mg/ml by the method used; OR b) physician diagnosed asthma with symptoms and chronic daily therapy consistent with mild asthma.
- Ability to withhold antihistamine medications for one week prior to screening visit and one week prior to nasal allergen challenge visit.
- Subjects must be able and willing to give informed consent.
Key exclusion criteria (19 listed)
- Any chronic medical condition considered by the PI as a contraindication to the allergen challenge study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease.
- Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
- Use of systemic steroid therapy within the preceding 12 months for treatment of an asthma exacerbation.
- Use of inhaled or nasal steroids, cromolyn, or leukotriene inhibitors (Montelukast or Zafirlukast) within the past month (except for use of cromolyn exclusively prior to exercise).
- Use of allergen immunotherapy.
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 |
|---|---|---|
| dust mite inhalationAlso: allergy, allergic, Dermatophagoides, farinaeNasal allergen challenge will be provided in a graded dose fashion of 0 AU, 100 AU, 500 AU, and 1000 AU separated by 20 minutes. | Biological | dust mite |
Primary outcome
Successful nasal allergen challenge without serious adverse event.
Time frame: Immediate
1 secondary outcome
analyze and compare cells of the airway and serum for a variety of inflammatory markers relevant to innate immunity.
Time frame: 4 hr post exposure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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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.
David Peden, MD principal investigator
University of North Carolina, Chapel Hill
Michelle Hernandez, MD study director
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dust mite inhalation in people with Dermatophagoides Farinae Allergy and Asthma, run by University of North Carolina, Chapel Hill.
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 4 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: withdrawn, as of the sponsor's last update on 5 May 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Successful nasal allergen challenge without serious adverse event. (time frame: Immediate). 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 5 May 2017.