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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Lockey, University of South Florida
ClinicalTrials.gov Identifier:
NCT01179282
First received: August 9, 2010
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
ALLERGIC RHINITIS
Biological: dust mite extract or placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Repeated Nasal Challenge in Skin Prick-puncture Negative and Intradermal Positive Dust Mite Allergic Rhinitis Patients.

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Mean Symptom score increase by greater than or equal to 2 from baseline [ Time Frame: at last study visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean increase in nasal lavage PGD2 and ECP by greater than 15 percent [ Time Frame: last study visit ] [ Designated as safety issue: No ]
    Mean increase in nasal lavage PGD2 and ECP by greater than 15 percent from baseline levels. Correlation between the orthogonol diameter of the wheal and flare of the intradermal skin test and the degree of symptom worse


Enrollment: 42
Study Start Date: June 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: PLACEBO
PLACEBO NASAL SPRAY
Biological: dust mite extract or placebo
intervention will be to stop study drug or placebo
Active Comparator: DUST MITE ALLERGEN
Subjects will use dust mite Dermatophagoides pteronyssinus (Dp) extract or placebo nasal spray at home for 2 weeks, with a 1 month washout period followed by 2 weeks of the other nasal spray.
Biological: dust mite extract or placebo
intervention will be to stop study drug or placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01179282

Locations
United States, Florida
Usf Asthma Allergy and Immunology Cru
Tampa, Florida, United States, 33613
Sponsors and Collaborators
University of South Florida
  More Information

No publications provided

Responsible Party: Richard Lockey, Principal Investigator, University of South Florida
ClinicalTrials.gov Identifier: NCT01179282     History of Changes
Other Study ID Numbers: intradermal positive dust mite
Study First Received: August 9, 2010
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of South Florida:
DUST MITE ALLERGIES

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014