EUCTR2018-002477-22-FR进行中（未招募）1 期
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY IN CAT-ALLERGIC PATIENTS WITH ASTHMA TO EVALUATE THE EFFICACY OF A SINGLE DOSE OF REGN1908-1909 TO REDUCE BRONCHOCONSTRICTION UPON CAT ALLERGEN CHALLENGE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Generally healthy men and women between the ages of 18 and 65 inclusive at the time of screening.
- •2. Documented history (for at least 2 years) of symptomatic cat hair-triggered asthma with rhinitis with or without conjunctivitis as defined by all of the following criteria:
- •a. Positive skin prick test (SPT) with cat hair extract (mean wheal diameter at least 5 mm greater than a negative control) at screening
- •b. Positive allergen-specific IgE (sIgE) tests for cat hair and Fel d 1 (> 0.35 kAU/l at screening)
- •c. History of asthma GINA 1
- •d. Screening FEV1 = 70% predicted after withholding long-acting ß2-agonists for > 36 hours and short-acting ß2-agonists for > 6 hours
- •e. Screening asthma control test (ACT) = 20 at all screening visits
- •f. Demonstrated = 20% fall in FEV1 within 2 hours during Cat Allergen Challenge in EEU and ability to withstand exposure for at least 10 minutes during screening
- •3. Willing and able to comply with clinic visits and study-related procedures
- •4. Provide informed consent signed by study patient or legally acceptable representative
- •5. Patients covered by health social identification number
- •6. Able to understand and complete study related questionnaires
- •7. No cat exposure at home for the past year and must continue having no exposure at home during the study; cat exposure outside of the home shall be avoided for at least one week prior to any Cat Allergen Challenge and during the defined follow-up period.
- •8. Less than 10 pack-years of smoking history
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 57
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Patients who experience a = 10% fall in FEV1 at 3 consecutive spirometry measurements during the placebo challenge
- •2. History of significant multiple and/or severe allergies (including latex gloves) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
- •3. History of severe anaphylactic or severe asthmatic reactions to cat exposure
- •4. Active lung disease other than asthma
- •5. Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening
- •6. Use of systemic corticosteroids within 8 weeks prior to screening visit 1
- •7. Use of anti-IgE or other biological therapy within 6 months prior to screening visit 1
- •8. History of SIT with cat allergen or vaccines against cat allergy within 5 years of screening visit 1
- •9. SIT with any allergen within 6 months prior to screening visit 1
- •10. Significant rhinitis (causing TNSS>2), or sinusitis, due to daily contact with other allergens causing symptoms that are expected to coincide with the baseline or the final cat allergen exposure unit assessments as assessed by the investigator, before each exposure
- •11. Patients who anticipate major changes in allergen exposure in their home or work environments that are expected to coincide with the baseline or the final cat allergen exposure assessments as assessed by the investigator
- •12. History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures
- •13. Treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment more than twice within 12 months or once within 3 months prior to screening or has been hospitalized or has attended the ER/Urgent Care facility for asthma more than twice in prior 12 months before screening.
- •14. Pregnant or breastfeeding women
研究者
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