NL-OMON41599已完成不适用
A Dose-Finding and Longitudinal Biomarker Study of Rhinovirus Challenge in Healthy Volunteers and Mild-Moderate Asthmatics to Evaluate the Safety and Use of a Human Rhinovirus Preparation in Developing High Dimensionality Phenotypes (*Handprints*) for Asthma - MK0000-218
Merck Sharp & Dohme (MSD)0 个研究点目标入组 49 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. be willing to give written informed consent for the study - including future
- •biomedical research on collected samples;
- •2. be able to read, comprehend, and write at a sufficient level to complete study
- •3. be willing to complete the study and all measurements;
- •4. be male or female, aged 18 to 55 years of age (inclusive) at the pre-trial (screening)
- •5. have a Body Mass Index (BMI) * 35 kg/m2 and > 17 kg/m2. BMI <= weight
- •(kg)/height (m)2.
- •6. for the purpose of safe participation, be judged to be in good health (except for
- •allowable asthma) based on medical history, physical examination, vital signs, and
- •laboratory safety tests (Section 7.1.3.1) performed at the pre-trial (screening) visit
- •and/or prior to the rhinoviral challenge.
- •7. if a female subject, be one of the below:
- •- of childbearing potential and must demonstrate a serum *-hCG level consistent
- •with the nongravid state at the pre-trial (screening) visit and agree to use (and/or
- •have their partner use) two (2) acceptable methods of birth control beginning at
- •the pre-trial visit throughout the trial and until 10 days after the last study visit.
- •- of non-childbearing potential: a female who is postmenopausal without menses
- •for at least 1 year and an FSH level in the postmenopausal range at the pre-trial
- •(screening) visit and/or a female who is status-post hysterectomy, status-post
- •bilateral oophorectomy, or status-post bilateral tubal ligation without reversal
- •based on the subject*s recall of their medical history. Information must be
- •captured appropriately within the site's source documents.
- •8. be a nonsmoker or has not smoked in the past 12 months with a smoking history of
- •* 10 pack-years;
- •9. be willing to comply with the trial restrictions (see Section 5.7 for a complete
- •summary of trial restrictions).
- •10. have anti-hRV16 titers * 1:4 at the screening visit;
- •11. have negative nasal lavage rhinovirus PCR results prior to virus challenge;
- •12. be one of the following:
- •a. For healthy panels: healthy subject (may have out-of-season seasonal
- •b. For asthmatic panels: mild-moderate asthmatic with the below** criteria
- •13. have a diagnosis of mild-moderate asthma with the below** criteria.
- •** Inclusion Criteria for Mild-Moderate Asthmatics
- •(must be documented within the past five (5) years)
- •-- Diagnosis of asthma based on one or more of:
- •. Methacholine PC20 < 8 mg/mL
- •. Improvement in FEV1 after inhalation of 400mcg salbutamol of *12% of
- •predicted value, and/or 200mL.
- •. diurnal variation in peak expiratory flow (PEF) >8% of mean of twice-daily
- •. decrease in prebronchodilator FEV1 *12% of predicted FEV1 and/or 200mL after
- •tapering off of inhaled corticosteroids (ICS), oral glucocorticoids, long-acting
- •bronchodilator, or regular short-acting bronchodilator.;Note: in cases where either FEV1 or %FEV1 (but not both) changed by the amount specified above, admission of the candidate requires assent of the Sponsor.;AND
- •. a history of spontaneous or exertional wheezing
- •-- Controlled disease based on:
- •. pre-bronchodilator FEV1 * 80% predicted (may be established at screening)
- •AND having all the below for >4 weeks prior to screening
- •. daytime symptoms twice weekly or less
- •. no activity limitation
- •. no nocturnal symptoms
- •. use of relie
排除标准
- •1. is mentally or legally institutionalized / incapacitated, has significant emotional
- •problems at the time of pre-trial (screening) visit or expected during the conduct of
- •the trial or has a history of clinically significant psychiatric disorder of the last 3
- •years. Subjects who have had situational depression may be enrolled in the trial at the
- •discretion of the investigator;
- •2. has a history of clinically significant endocrine, gastrointestinal, cardiovascular,
- •hematological, hepatic, immunological, renal, respiratory, genitourinary or major
- •neurological (including stroke and chronic seizures) abnormalities or diseases;
- •-- Asthma as defined in the inclusion criteria for some participants in Part 1 and all
- •participants in Part 2 is allowed.
- •-- Subjects with a history of uncomplicated (spontaneously evacuated, without
- •infection) kidney stones, cholecystectomy or childhood asthma (the latter only for the
- •healthy volunteer panels) may be enrolled in the trial at the discretion of the
- •investigator.
- •3. has a history of cancer (malignancy) with the exception of uncomplicated basal cell
- •carcinoma of the skin or cervical intraepithelial neoplasia - resolved for at least 5
- •years and not having required chemotherapy or immunomodulation;
- •4. has a history of severe or difficult to manage allergies (e.g. food, drug, latex allergy),
- •or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription
- •drugs or food, that in the opinion of the investigator would pose an undue
- •risk to the subject;
- •5. has (or is expected to have) symptomatic seasonal or perennial rhinitis or sinusitis
- •during the duration of the study (Can defer assessment until end of allergy season for
- •seasonal allergies.);
- •6. has a history of ICU admission or intubation for asthma-related ventilatory failure in
- •adolescence (after approximately age 11) or adulthood;
- •7. is positive for hepatitis B surface antigen, hepatitis C antibodies or HIV;
- •8. has clinically significant abnormalities in screening laboratory tests or ECG;
- •9. has significant nasal septal deviation, nasal polyps, or other nasal anatomical
- •abnormality;
- •Note: History of nasal corrective surgery is allowed if it occurred > 5 years prior to
- •the pre-trial (screening) visit and healed normally.
- •10. shares the same household or has intimate contact with an infant, a pregnant or
- •lactating woman, or an immunosuppressed individual;
- •11. has a history or current evidence of any upper or lower respiratory tract infection or
- •symptoms of such within 6 weeks of baseline assessment (Can defer assessment until
- •appropriate time has passed.);
- •12. had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4
- •weeks prior to the pre-trial (screening) visit;
- •13. has participated in another investigational trial within 10 weeks prior to the pre-trial
- •(screening) visit. The 10 week window will be derived from the date of the last trial
- •medication and / or blood collection in a previous trial and/or AE related to trial drug
- •to the pre-trial/screening visit of the current trial;
- •14. is pregnant or is a nursing mother;
- •15. is unable to refrain from or anticipates the use of prescription and/or non-prescription
- •medications** or herbal remedies (such as St. John*s Wort [Hypericum perforatum])
- •beginning 2 weeks (o
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