EUCTR2013-004474-96-HU进行中（未招募）1 期
A 52-week, double-blind, randomised, multi-centre, parallel-group,Phase III study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort® (budesonide/formoterol) Turbuhaler® 160/4.5 µg ‘as needed’ compared with terbutaline Turbuhaler® 0.4 mg ‘as needed’ and with Pulmicort® (budesonide) Turbuhaler® 200 µg twice daily plus terbutaline Turbuhaler® 0.4 mg ‘as needed’
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,750
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
- •For inclusion in the study patients should fulfil the following criteria:
- •1. Provision of informed consent prior to any study specific procedures. For patients
- •under-age, signed informed consent from both the patient and the patient’s
- •parent/legal guardian is required
- •2. Outpatients of either gender aged =12 years at Visit 1
- •3. Diagnosis of asthma according to GINA criteria based on symptoms with a
- •documented history of at least 6 months prior to Visit 1. Lung function and
- •reversibility tests performed as part of Visit 2 and 3 can be used as a confirmation
- •of asthma diagnosis according to GINA criteria if there is no measure of lung
- •function available before Visit 1.
- •4. Patients who are in need of GINA (2012) step 2 treatment:
- •- uncontrolled on inhaled short-acting bronchodilator(s) ‘as needed’ (SABA
- •and/or short acting anticholinergic agent) as judged by the investigator for the
- •last 30 days before Visit 2, or
- •- controlled on mono-maintenance therapy - with low stable dose ICS (= 400 µg
- •budesonide per day or corresponding dose of other ICS) (see Appendix E for
- •conversion) or LTRA - in addition to 'as needed' use of inhaled short-acting
- •bronchodilator(s) (SABA and/or short acting anticholinergic agent), as judged
- •by the investigator for the last 30 days prior to Visit 2
- •5. Based on lung function tests (see Section 5.1.2) at Visit 2, patients pre-treated with
- •? an inhaled short acting bronchodilator only should have pre-bronchodilator
- •FEV1 = 60 % of predicted normal (PN) and post-bronchodilator FEV1 = 80 %
- •PN according to the European Respiratory Society (ERS) guidelines (Quanjer
- •et al 2012)
- •- low dose ICS or LTRA medication in addition to inhaled short-acting
- •bronchodilator(s) should have pre-bronchodilator FEV1 =80 % PN according to
- •the ERS guidelines
- •6. Reversible airway obstruction according to a reversibility test (see Section 5.1.2.2)
- •performed at Visit 2 defined as an increase in FEV1 =12% and 200 ml relative to
- •baseline, after inhalation of 1 mg Bricanyl Turbuhaler. The test can be repeated at
- •Visit 3 in case the patients fail at Visit 2. If patients fail at both occasions, they can
- •still be included if they have a documented historical reversibility within the last 12
- •months prior to Visit 3, with an increase in FEV1 =12% and 200 ml relative to
- •baseline after administration of a rapid acting ß2-agonist
- •For randomisation at Visit 3, patients should fulfil the following criteria:
- •7. Use of Bricanyl Turbuhaler ‘as needed’ due to asthma symptoms on at least
- •3 separate days during the last week of the run-in period
- •8. Ability to use Turbuhaler correctly and to complete the eDiary correctly. Morning
- •and evening data must be
- •Are the trial subjects under 18? yes
- •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 3375
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- •1. Involvement in the planning and/or conduct of the study (applies to both
- •AstraZeneca staff and/or staff at the study site)
- •2. Previous randomisation in the present study
- •3. Participation in another clinical study with a non-biologic investigational product or
- •new formulation of a marketed non-biologic drug during the last 30 days prior to
- •4. Participation in another clinical trial with any marketed or investigational biologic
- •drug within 4 months or 5 half-lives whichever is longer, prior to Visit 1
- •5. Any asthma worsening requiring change in asthma treatment other than inhaled
- •short-acting bronchodilator(s) (SABA and/or short acting anticholinergic agent)
- •within 30 days prior to Visit 1
- •6. Use of oral, rectal or parenteral GCS within 30 days and/or depot parenteral GCS
- •within 12 weeks prior to Visit 1
- •7. Use of any ß-blocking agent including eye-drops
- •8. Known or suspected hypersensitivity to study drugs or excipient
- •9. Smoker (current or previous) with a smoking history of = 10 pack years
- •10. Medical history of life- threatening asthma including intubation and intensive care
- •unit admission
- •11. Any significant disease or disorder (e.g., cardiovascular, pulmonary other than
- •asthma, gastrointestinal, hepatic, 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 patient’s ability to participate
- •in the study
- •12. Any clinically relevant abnormal findings in physical examination and/or vital signs
- •at Visit 2, which, in the opinion of the investigator, may put the patient at risk if
- •participating in the study
- •13. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women
- •not using acceptable contraceptive measures, as judged by the investigator
- •14. Planned hospitalisation during the study
- •15. Suspected poor capability, as judged by the investigator, of following instructions
- •of the study.
- •For randomisation at Visit 3, patients should not fulfil any of the following criteria:
- •16. Use of = 6 Bricanyl Turbuhaler ‘as needed’ inhalations per day, for a certain
- •number of days depending on the actual length of run-in: for = 2 days out of 14
- •days; for =3 days out of 15-21 days; for = 4 days out of 22 or more days of run-in.
- •17. Any asthma worsening requiring change in asthma treatment other than inhaled
- •short-acting bronchodilator(s) (SABA and/or short acting anticholinergic agent)
- •from Visit 1 until Visit 2 and/or requiring any asthma treatment other than run-in
- •study medication from Visit 2 until randomisation
研究者
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