Repeated Nasal Challenge in Skin Prick-puncture Negative and Intradermal Positive Dust Mite Allergic Rhinitis Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Mean Symptom score increase by greater than or equal to 2 from baseline
研究概览
简要总结
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.
详细描述
All patients will be seen in the outpatient setting. After skin testing, subjects meeting established criteria will be placed in the study. Subjects will use dust mite Dermatophagoides pteronyssinus 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. Both patients and investigators will be blinded as to which spray is being used. Subjects will monitor symptoms using a symptom score card and return to the research unit after the first and second week of challenge for review of symptoms and clinical assessment. If symptoms increase sufficiently to make the subject uncomfortable, they will return earlier. Testing will consist of peak nasal inspiratory flow rate and nasal lavage for PGD2 and ECP. Subjects will have these tests performed at the beginning of the study, and at the end of weeks 1 and 2.
One group of subjects will have a clinical history of perennial rhinitis symptoms associated with dust exposure or not associated with other perennial allergens. These subjects will be ppt negative and intradermal skin test positive to Dp. The other group of subjects will be the control group. They will be healthy with no history of rhinitis or rhinitis symptoms. They will be skin test negative. This group will also perform the same nasal challenge with placebo or Dp extract three times daily each for 2 weeks. This group will also perform the same tests as the rhinitis group.
In this study the research design is a prospective randomized double blind placebo controlled study. One addition is that both the experimental and control groups will use both types of nasal sprays, the Dp extract and the placebo during the nasal challenge. Each group will use one type of spray and then crossover to the other spray.
Study Population 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Mean Symptom score increase by greater than or equal to 2 from baseline
时间窗: at last study visit
次要结局
- Mean increase in nasal lavage PGD2 and ECP by greater than 15 percent(last study visit)
研究者
Richard Lockey
Principal Investigator
University of South Florida