Repeated Nasal Challenge in Skin Prick-puncture Negative and Intradermal Positive Dust Mite Allergic Rhinitis Patients

Completed · Not applicable · Has a placebo group

Conditions studied: ALLERGIC RHINITIS

In brief

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 pteronyssinus. Subjects will be ppt negative and intradermal skin test positive to Dust p Challenges will be performed with placebo or Dp extract three times daily each for 2 weeks. Primary endpoint after nasal challenge with Dust p Mean Symptom score increase by greater than or equal to 2 from baseline. Secondary Outcomes Mean decrease in PNIF by greater than 15percent from baseline. Mean increase in nasal lavage PGD2 and ECP by greater than 15percent from baseline levels. Correlation between the orthogonol diameter of the wheal and flare of the intradermal skin test and the degree of symptom worsening during the nasal challenge. These results will provide evidence for the continued use of the intradermal skin test in evaluating allergic rhinitis.

Key facts

Study ID

NCT01179282

Run by

University of South Florida

People needed

42

Starts

2009-06-01

Expected to finish

2012-12-01

Last updated by the study team

2013-02-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Usf Asthma Allergy and Immunology Cru — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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