NL-OMON55388已完成2 期
The effect of FP-025, a MMP-12 inhibitor, on allergen induced airway responses, airway inflammation and aspects of airway remodeling in subjects with mild eosinophilic House Dust Mite (HDM)-allergic asthma - 160509 Foresee
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
Trial ended prematurely
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. Females or males, between 18 and 55 years of age at Screening, inclusive, on
- •the day of signing the Informed Consent Form (ICF).
- •2. Apart from a clinically stable asthma and HDM-allergy, subjects should be
- •generally healthy with no history of a clinically relevant medical condition
- •that in the opinion of the investigator might interfere with successful study
- •conduct and no clinically relevant abnormalities on medical history, physical
- •exam, vital signs, laboratory parameters or ECG at Screening.
- •3. Subject has a BMI >= 18.0 kg/m2 and <= 32.0 kg/m2 (and weighs >=50 kg).
- •4. Subjects have been diagnosed with asthma cf GINA guidelines.
- •5. Subjects should have established allergy for HDM (serum HDM-specific IgE or
- •positive SPT at Screening or documented within 1 year pre-screening).
- •6. No severe exacerbation of asthma within past 1 year requiring hospital
- •admission and/or treatment with oral corticosteroids; no (never) intensive care
- •admissions for asthma or intubation).
- •7. FEV1 should be >=70% of predicted on Screening Day 2.
- •8. On Screening Day 2, PC20FEV1(Meth) should be <16 mg/mL if methacholine
- •chloride is used (or adjusted by a factor of 1.2 if methacholine bromide is
- •used). If histamine is used, PC20FEV1(Hist) should be <16 mg/mL.
- •9. Baseline blood eosinophils should be >=150 cells/µL at Screening or
- •documented within 3 months before Screening Day 1.
- •10. Subjects should have a documented airway late response to inhaled HDM on
- •Screening Day 3.
- •11. Subjects of childbearing potential must be willing to use adequate
- •contraception (double-barrier) or must refrain from intercourse.
- •12. Female subjects of non-childbearing potential must have had >= 12 months of
- •spontaneous amenorrhea (with follicle-stimulating hormone [FSH] >= 30 mIU/mL).
- •Surgically sterile women are defined as those who have had a hysterectomy,
- •bilateral ovariectomy (for *benign* reasons), or bilateral tubal ligation.
- •13. All female subjects should have a negative pregnancy test at Screening and
- •on Day -1.
- •14. Negative alcohol breath test on Screening Day 1 and Day -1.
- •15. Negative cotinine test on Screening Day 1 and Day -1.
- •16. Negative urine drug screen for recreational and other drugs on Screening
- •Day 1 and Day -1.
- •17. Subjects are non-smokers. A non-smoker is defined as an individual who has
- •abstained from smoking for at least 1 year prior to Screening Day 1. Number of
- •years smoked x number of packs per day should be <5 pack years.
- •18. Subject should be willing and able to perform the lung function tests and
- •other study-related procedures and comply with study protocol requirements.
- •19. Subject should provide a signed and dated informed consent.
排除标准
- •1. Subject has any active and/or chronic (physical or mental) condition
- •requiring maintenance (pharmaco)therapy or which otherwise precludes subject
- •from safe or adequate study participation (ineligibility will be assessed by
- •2. Subject has a history of cancer (exception: localized basalioma or cervix
- •carcinoma in situ).
- •3. Subject had any major (nasal) surgery in the 6 months before Screening Day 1.
- •4. Subject is pregnant or lactating.
- •5. Subject is using immunotherapy that according to the PI may interfere with
- •the study (e.g. in case of immunotherapy with HDM or when subject is in the
- •updosing phase of any immunotherapy).
- •6. Subject regularly used alcohol (intake of >21 units/wk for males and >14
- •units/wk for females) and/or recreational drugs within the last 6 months prior
- •to screening.
- •7. Subject had any respiratory (viral) infections (e.g. common cold) within 3
- •weeks of Screening Day 1 or on Day -1.
- •8. Subject is using maintenance asthma therapy or long-acting bronchodilators
- •or any other anti-asthma or anti-allergic medications (as detailed in the
- •protocol) other than infrequent use of SABA prn only.
- •9. Subject is using prohibited medications as detailed in the protocol.
- •10. Multi-sensitized symptomatic subjects with seasonal (pollen) allergies
- •should be included outside of the relevant allergen season and/or should not be
- •in frequent contact with the relevant allergen during the study.
- •11. Subject has any known allergic response for the medications used or known
- •severe allergic reactions or anaphylaxis (to food/medications/insect venoms).
- •12. Subject participated in medical studies in the past 3 months
- •(non-biologicals) or in the past 6 months (biologicals).
- •13. Subject is anticipated not to comply with study medication or other aspects
- •of the study (at the discretion of the investigator).
研究者
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