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Evaluation of a Nasal Allergen Challenge Procedure Using Dust Mite Extract | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

Evaluation of a Nasal Allergen Challenge Procedure Using Dust Mite Extract

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

NCT00927329•University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Specific allergy to house dust mite Dermatophagoides farinae confirmed by positive immediate skin test response.
•2. 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.
•3. Ability to withhold antihistamine medications for one week prior to screening visit and one week prior to nasal allergen challenge visit.
•4. Subjects must be able and willing to give informed consent.

Exclusion Criteria

•1. 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.
•2. Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
•3. Use of systemic steroid therapy within the preceding 12 months for treatment of an asthma exacerbation.
•4. 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).
•5. Use of allergen immunotherapy.
•6. Use of daily theophylline within the past month.
•7. 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.
•8. Pregnancy or nursing a baby.
•9. Cigarette smoking within the past 12 months.
•10. 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.
+9 more criteria

Key Dates

Start Date

January 1, 2009

Primary Completion Date

April 1, 2017

Completion Date

April 1, 2017

Last Updated

May 5, 2017

Conditions

Dermatophagoides Farinae AllergyAsthmaHealthy

Interventions

dust mite inhalation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 5, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Evaluation of a Nasal Allergen Challenge Procedure Using Dust Mite Extract

Inclusion Criteria

Exclusion Criteria

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