Repeated Nasal Challenge in Skin Prick-puncture Negative and Intradermal Positive Dust Mite Allergic Rhinitis Patients (DUSTMITE)
This study has been completed.
Sponsor:
University of South Florida
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
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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 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 May 21, 2013