MedTrace Logo

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

NCT01179282 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2013-02-01

No results posted yet for this study

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 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.

Conditions

  • ALLERGIC RHINITIS

Interventions

BIOLOGICAL

dust mite extract or placebo

intervention will be to stop study drug or placebo

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01179282 on ClinicalTrials.gov