Status:
COMPLETED
Repeated Nasal Challenge in Skin Prick-puncture Negative and Intradermal Positive Dust Mite Allergic Rhinitis Patients
Lead Sponsor:
University of South Florida
Conditions:
ALLERGIC RHINITIS
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Subjects who have a clinical history of perennial rhinitis symptoms associated with dust exposure or not associated with other perennial allergens, will have a positive challenge with Dermatophagoides...
Detailed Description
All patients will be seen in the outpatient setting. After skin testing, subjects meeting established criteria will be placed in the study. Subjects will use dust mite Dermatophagoides pteronyssinus e...
Eligibility Criteria
Inclusion
- Gender: Male or female
- Females are eligible to participate only if they are currently non-pregnant and non-lactating. Female subjects should not be enrolled if they plan to become pregnant during the time of the study.
- Age: 18-65 years of age at enrollment
- Literacy: The subject must be able to read, comprehend, and record information in English.
- Consent: The subject must have the ability to give informed consent.
- Type of subject: The subject must be seen in the outpatient setting.
- Skin test: The subject must be ppt negative and intradermal positive to Dp dust mite allergen defined by an orthogonal wheal 6 mm or greater than the saline negative control.
- Rhinitis: The subject must have a history consistent with allergic rhinitis symptoms for at least 1 year.
Exclusion
- Ppt positive to major seasonal allergens; oak, cypress, cedar, Australian pine, or bayberry tree pollens.
- Respiratory Instability: Hospitalization for respiratory disease within the last 6 months prior to entry into the study.
- Respiratory Disease: Current diagnosis of asthma, cystic fibrosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, or any other lower respiratory abnormalities.
- Respiratory Tract Infections: Confirmed or suspected infection of the nose, sinus, middle ear, oropharynx, upper respiratory tract, or lower respiratory tract within 28 days prior to testing.
- Other Concurrent Conditions/Diseases: Any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbates during the study. The list of conditions/diseases that will result in exclusion if determined to be clinically significant includes, but is not limited to: cardiac arrhythmia; congestive heart failure; coronary artery disease; Addison's disease; diabetes mellitus; dyspnea; uncontrolled hypertension; hematological, hepatic, neurological, thyroid, peptic ulcer, or renal disease; immunologic compromise; current malignancy; or tuberculosis.
- Physical Exam: Subjects who have nasal polyps, sinusitis, significant anatomic abnormality or infection of the upper airway will be excluded.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01179282
Start Date
June 1 2009
End Date
December 1 2012
Last Update
February 1 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Usf Asthma Allergy and Immunology Cru
Tampa, Florida, United States, 33613