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临床试验/EUCTR2006-002412-10-DE
EUCTR2006-002412-10-DE进行中（未招募）不适用

A randomized, double-blind, double-dummy, two-way cross-overstudy evaluating systemic bioavailability and airway clearance ofSymbicort® Turbuhaler® 320/9µg/inhalation versus Seretide™ Diskus™50/500µg/inhalation after single inhalations in patients with ChronicObstructive Pulmonary Disease (COPD) and healthy volunteers - Airway clearance

AstraZeneca AB0 个研究点目标入组 54 人开始时间: 2007年4月18日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
54
研究概览入排标准研究者记录与标识符相似试验

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

  • •COPD patients:
  • •1. Provision of written informed consent obtained prior to study procedures
  • •2. Outpatients, men or women = 40 years of age
  • •3. A clinical diagnosis of COPD with symptoms for more than 1 year
  • •4. A current or previous smoker with a smoking history equivalent to 10 or more
  • •pack years (1 pack year = 20 cigarettes smoked per day for one year)
  • •5. Pre-bronchodilatory FEV1 = 55% of predicted normal value
  • •6. Pre-bronchodilatory FEV1 / VC = 70%
  • •7. Stable symptoms without signs of infection and COPD exacerbation within 1
  • •month prior to the study
  • •8. Productive cough with expectoration two times or more before noon on most days
  • •9. Ability to inhale from Turbuhaler and Diskus according to given instructions, as
  • •judged by the investigator or study nurse
  • •10. Body Mass Index (BMI) between 18 and 32 kg/m2
  • •Healthy volunteers:
  • •1. Provision of written informed consent obtained prior to study procedures
  • •2. Men or women =18 years of age
  • •3. Body Mass Index (BMI) between 18 and 32 kg/m2
  • •4. Healthy, as judged by the investigator after medical history, physical examination,
  • •vital signs, electrocardiogram (ECG), and laboratory tests
  • •5. Pre-bronchodilatory FEV1 > 80% of predicted normal value
  • •6. Pre-bronchodilatory FEV1 / VC > 70%
  • •7. Ability to inhale from Turbuhaler and Diskus according to given instructions, as
  • •judged by the investigator or study nurse
  • •8. Non-smoker, have never been regular smoker
  • •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) yes
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •COPD patients:
  • •1. A history of asthma and/or seasonal allergic rhinitis before 40 years of age
  • •2. Any current respiratory tract disorder other than COPD for example bronchiectasis,
  • •which is considered by the investigator to be clinically significant
  • •3. Any clinically relevant abnormal findings in physical examination and vital signs,
  • •which in the opinion of the investigator, may put the patient at risk because of
  • •his/her participation in the study
  • •4. Any significant disease or disorder (e.g. gastrointestinal, liver, renal, neurological,
  • •musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical
  • •impairment) which, in the opinion of the investigator, may either put the patient
  • •at risk because of participation in the study, or may influence the results of the
  • •study, or the patients ability to participate in the study
  • •5. Patients with significant or unstable ischemic heart disease, arrhythmia,
  • •cardiomyopathy, heart failure, uncontrolled hypertension as defined by the
  • •investigator, or any other relevant cardiovascular disorder as judged by the
  • •investigator
  • •6. Use of oral or ophthalmic non-cardio selective ß-blocking agents
  • •7. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women
  • •not using acceptable contraceptive measures, as judged by the investigator.
  • •8. Known or suspected hypersensitivity to study therapy or excipients of the
  • •investigational products.
  • •9. Patients with a history of chronic alcohol or drug abuse or any condition associated
  • •with poor compliance
  • •10. Blood donation within 3 months prior to enrolment
  • •11. Planned hospitalization during the study
  • •12. Previously enrolled in the present study
  • •13. Participation in another clinical study within 90 days preceding enrolment
  • •14. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
  • •Healthy volunteers:
  • •1. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women
  • •not using an acceptable contraceptive, as judged by the investigator. All women
  • •must show a negative pregnancy urine test result at Visit 1.
  • •2. Known or suspected hypersensitivity to glucocorticosteroids, ß2-adrenergic
  • •agonists, inhaled lactose, or other excipients in study drugs
  • •3. History and/or evidence of any significant disease or disorder (e.g. respiratory,
  • •cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal,
  • •endocrine, metabolic, malignant, psychiatric, major physical impairment) which,
  • •in the opinion of the investigator, may either put the subject at risk because of
  • •participation in the study, or may influence the results of the study, or the subject’s
  • •ability to participate in the study. Evidence of HIV or hepatitis B or C-infection.
  • •4. Significant illness as judged by the investigator or intake of any prescribed
  • •medication within two weeks prior to enrolment .
  • •5. Use of any regular medication or therapy, including over-the-counter remedies,
  • •herbal preparations, vitamins, and mineral supplements 2 weeks prior to enrolment.
  • •6. Blood donation within 3 months prior to enrolment
  • •7. Planned in-patient hospitalization
  • •8. Abuse of drugs or alcohol or any other condition associated with poor compliance
  • •9. Previously enrolled in the present study
  • •10. Participation in another clinical study within 90 days preceding enrolment
  • •11. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at t

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