EUCTR2006-001193-25-GB进行中（未招募）1 期
A 4 week randomised, double blind, placebo controlled, parallel group, phase II, PoP study to assess the efficacy and safety of AZD1981 in adult patients with asthma.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
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 ICF (Informed Consent Form) could be obtained at an information
- •visit prior to Visit 1 or at Visit 1 (according to local regulations), but before any
- •study related procedures has been performed.
- •2. Men and post menopausal or surgically sterilized women, aged 18-60 years.
- •Women will be considered post menopausal if they have been amenorrheic for at
- •least 12 months, and an FSH plasma concentration within the post menopausal
- •range as defined by the laboratory.
- •3. Minimum of 6 month’s documented history of asthma according to the ATS
- •definition (ATS 1987).
- •4. Daily use of =400 µg inhaled GCS during 30 days prior to Visit 1.
- •5. FEV1 =60 - <100% of predicted normal value pre-bronchodilator.
- •6. Reversible airway obstruction either according to the reversibility test performed
- •at Visit 1, or as historic data found in medical record (not older than 2 years)
- •Reversibility is defined as an increase in FEV1 of =12% relative baseline and
- •=200 mL after an inhalation of in total 1 mg Bricanyl Turbuhaler. If not fulfilled at
- •Visit 1, criterion No 11 should be fulfilled at Visit 2.
- •7. The patient must not have had a clinically important asthma exacerbation, as
- •judged by the investigator, one month before Visit 1.
- •8. A positive skin prick test to airway allergens (at least one) such as: pollen from
- •birch, grass, or mugwort, animal fur for example dog, cat, horse, or house dust
- •mite at Visit 1 or as historic data found in medical records not older than 2 years.
- •9. Able to read and write and use electronic devices.
- •10. Use of as-needed medication at least 4 times during the last week of the run-in
- •11. If the reversibility criterion is not met at Visit 1 (either from historic data or
- •from the spirometry measurement) the patient must either show an increase in
- •FEV1 of =12% relative baseline and =200 mL after an inhalation of in total 1 mg
- •Bricanyl Turbuhaler or show a variation in PEF of at least 20% on at least 2 days
- •during the run-in period. This should be calculated as follows: (max PEF - min
- •PEF) / max PEF (all values from the same day).
- •12. The patient must not have taken more than 12 inhalations of as-needed medication
- •on any single day during the run-in period.
- •13. The patient must not have had a clinically important asthma exacerbation, as
- •judged by the investigator, during the run-in period.
- •14. Patients must not have used 8 inhalations or more of as-needed medication/24
- •hours on more than 2 days/week (any 7 days period) during the run-in period.
- •15. The patient must not have used iGCS during the run-in period.
- •16. No clinical relevant abnormal findings in clinical chemistry, haematology, FSH
- •(females only), urinalysis, which, in the opinion of the investigator, may put
- •patient at risk because of his/her participation in the study.
- •17. Provision of informed consent for pharmacogen
排除标准
- •1. Inability to tolerate withdrawal of asthma therapy as required for the study.
- •2. Hospitalisation for asthma within the last 2 years prior to Visit 1.
- •3. Respiratory infection significantly affecting the asthma, as judged by the
- •investigator, within 30 days prior to Visit 1.
- •4. Any of the following:
- •- current smoker,
- •- patient with a history of smoking for more than 10 pack years (one pack year= 1
- •pack (20 cigarettes) per day for 1 year or equivalent),
- •- ex-smoker since less than 1 year.
- •5. Body Mass Index (BMI) <18 kg/m 2 and body weight <50 kg.
- •6. A history of additional risk factors for Torsade de pointes (eg, heart failure,
- •hypokalemia, family history of Long QT syndrome).
- •7. Use of concomitant medications that prolong the QT/QTc interval other than
- •terbutaline or albuterol.
- •8. Use of ß -blocker medication (including eye-drops)
- •9. Pregnancy or breast feeding.
- •10. Any significant disorder (eg, cardiovascular, pulmonary (other than asthma),
- •gastrointestinal, hepatic, renal, neurological, musculosceletal, infectious,
- •endocrine, metabolic, malignant, psychiatric, major physical impairment) which,
- •in the opinion of the investigator, either put the patient at risk because of
- •participating in the study or may influence the results of the study, or the patients
- •ability to participate in the study.
- •11. Any clinical relevant abnormal findings in physical examination, pulse, blood
- •pressure or ECG at Visit 1, which, in the opinion of the investigator, may put
- •patient at risk because of his/her participation in the study.
- •12. Previous randomisation of treatment into the present study, see Section 3.5.
- •13. Planned hospitalisation during the course of the study.
- •14. Suspected poor capability to follow instructions of the study, as judged by the
- •investigator.
- •15. Past or present alcohol or drug abuse.
- •16. Involvement in the planning and conduct of the study (applies to both AstraZeneca
- •staff and staff at the study site).
- •17. Patients currently on immunotherapy, or who have had a course within the last
- •18. Participation in another clinical study involving an investigational product within
- •3 months before Visit 1.
研究者
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