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

NCT01179282 | Completed

• 1 other identifier: intradermal positive dust mite
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 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

Keywords

DUST MITE ALLERGIES

Outcome Measures

Primary Outcomes (1)

• Mean Symptom score increase by greater than or equal to 2 from baseline

  at last study visit

Secondary Outcomes (1)

• Mean increase in nasal lavage PGD2 and ECP by greater than 15 percent

  last study visit

Study Arms (2)

PLACEBO

PLACEBO COMPARATOR

PLACEBO NASAL SPRAY

Biological: dust mite extract or placebo

DUST MITE ALLERGEN

ACTIVE COMPARATOR

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

Interventions

dust mite extract or placebo BIOLOGICAL

intervention will be to stop study drug or placebo

DUST MITE ALLERGEN; PLACEBO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• Physical Exam: Subjects who have nasal polyps, sinusitis, significant anatomic abnormality or infection of the upper airway will be excluded.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Usf Asthma Allergy and Immunology Cru

Tampa, Florida, 33613, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 11, 2010
• Study Start: June 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 1, 2013

Record last verified: 2013-01

Locations

US (1)