EUCTR2009-013705-34-GB进行中（未招募）1 期
A double-blind, placebo controlled, randomised, parallel group, single centre, phase IIa study to investigate the efficacy, tolerability and safety of 8 doses of AZD8848 administered intranasally once weekly in mild to moderate allergic asthma patients challenged with an inhaled allergen.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •1. Provision of informed consent prior to any study specific procedures
- •2. Male or female patients aged 18 to 55 years (inclusive). Females must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue on the chosen contraceptive method, with additional use of a condom, until Visit 19. Women must be non-lactating and must have a date of menstruation consistent with non-pregnancy (see section 4.1.2 for more details)
- •3. A minimum of 6 months documented history of asthma defined according to the
- •GINA guidelines (Global Initiative for Asthma 2008) prior to Visit 1
- •4. The presence of allergic sensitivity (grass, house dust mite, cat) verified by a
- •positive skin prick test documented within the previous 24 months or at Visit 1
- •5. FEV1 (forced expiratory volume in 1 second) >70% of predicted normal value,
- •prebronchodilator
- •6. The presence of an Early Asthmatic Response corresponding to = 20% FEV1
- •decrease within 2 hours post-allergen challenge as verified and documented within
- •the previous 12 months or at screening. The inhaled allergen will be one of those giving a positive response in the skin prick test (see section 6.2.1).
- •7. Methacholine PC20 (the provocative concentration of methacholine causing a 20%
- •fall in FEV1) <16 mg/mL as verified and documented within the previous 12
- •months or at screening (Visit 1)
- •8. Body mass index between 19 and 33 kg/m2
- •9. Non- or ex-smokers who are expected to not smoke for the duration of the trial up
- •to Visit 12 (an ex-smoker being defined as someone who <10 pack-year history and
- •who has completely stopped smoking for at least 6 months before Visit 1)
- •10. Ability to metabolise AZD8848 (an in vitro screening assay will determine esterase metabolic activity in a blood sample taken at Visit 1 using a pre-defined limit)
- •For inclusion in the main part, note the additional criteria for LAR:
- •6. Early Asthmatic Response corresponding to =20% FEV1 decrease within 2 hours
- •and Late Asthmatic Response corresponding to =15 % FEV1 decrease between 4-10
- •hours post-allergen challenge on two consecutive occasions. The inhaled allergen
- •will be the one of those giving a positive response in the skin prick test (see section 6.2.1).
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any clinically relevant disease and/or abnormality (past or present), which, in the
- •opinion of the Investigator, may either put the patient at risk because of
- •participation in the study, or influence the results of the study, or the patient’s
- •ability to participate in the study. Includes pregnant or lactating females.
- •2. Symptomatic allergic rhinitis (those with a history of allergic rhinitis may
- •participate if asymptomatic at screening and if, in the opinion of the Investigator, it
- •is unlikely that disease exacerbation will occur during the course of the study)
- •3. Any clinical relevant abnormal findings in physical examination, clinical chemistry,
- •haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the
- •investigator, may put the patient at risk because of participation in the study
- •4. QTcF >450ms, confirmed with repeated measurements at Visit 1
- •5. Rhythm, conduction (eg intermittent or constant Bundle branch block;
- •Intraventricular conduction disturbance with repolarisation changes: intermittent or
- •constant AV block (including 1st degree AV block with PR interval >220msec, 2nd
- •or 3rd degree AV block)); or morphologic changes affecting repolirization (eg, flat,
- •biphasic or inverted T waves in primary lead V2), that may limit ability to measure
- •QTc and assess changes in QTc intervals or QTc morphology
- •6. History of additional risk factors for Torsade de pointes (eg heart failure,
- •hypokaelamia, family history of Long QT syndrome, or sudden death)
- •7. Medical history suggesting or confirming abnormal immune function, except for
- •8. Family history (parent or sibling) of autoimmune disease including but not limited
- •to Wegener’s granulomatosis, system lupus erythematosus, rheumatoid arthritis,
- •Sjögren’s syndrome, multiple sclerosis, autoimmune thrombocytopenia, primary
- •biliary cirrhosis or any other autoimmune disease considered clinically relevant by
- •the investigator
- •9. Any detection of anti-PR3 autoantibodies in the blood
- •10. History of or ongoing immunotherapy
- •11. Topical or inhaled glucocorticosteroid +/- Long-Acting ß-Agonists (LABAs)
- •treatment within 4 weeks prior to Visit 1
- •12. Systemic glucocorticosteroid therapy for any reason within 6 weeks prior to Visit 1
- •13. Antihistamine treatment within 1 week prior to Visit 1. This period should be extended for antihistamines with a long half-life (see exclusion criteria 14)
- •14. Use of any medication (including vaccinations, over the counter drugs and herbal medicines such as St John's Wort) or therapy within 2 weeks prior to Visit 1 which may potentially expose the patient to any significant systemic exposure
- •that may interfere with the objectives of the study or the safety of the patients as
- •judged by the investigator, except for inhaled short-acting ß2 agonists for treatment
- •of asthma symptoms and occasional intake of paracetamol
- •15. An exacerbation of asthm
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