PER-035-14招募中未知
A 52-WEEK, DOUBLE-BLIND, RANDOMISED, MULTI-CENTRE, PARALLEL-GROUP,PHASE IIISTUDY IN PATIENTS 12 YEARS AND OLDER WITH ASTHMA, EVALUATING THE EFFICACY ANDSAFETY OF SYMBICORT® (BUDESONIDE/FORMOTEROL) TURBUHALER® 160/4.5 μG ‘ASNEEDED’ COMPARED WITH TERBUTALINE TURBUHALER® 0.4 MG ‘AS NEEDED’ AND WITHPULMICORT® (BUDESONIDE) TURBUHALER® 200 μG TWICE DAILY PLUS TERBUTALINETURBUHALER® 0.4 MG ‘AS NEEDED’
ASTRAZENECA - PERU,0 个研究点目标入组 287 人开始时间: 2014年9月12日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 287
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 75（—）
- 性别
- All
入选标准
- •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 with a documented history of at
- •least 6 months prior to Visit 1
- •4. Patients who are in need for GINA step 2 treatment:
- •− uncontrolled on SABA ‘as needed’ 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 LTRAs 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
- •− a SABA 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 LTRAs medication 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 on low dose
- •ICS or LTRAs 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 β2-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 recorded for at least 8 days (any 8) of the last
- •10 days of the run-in period
排除标准
- •Involvement in the planning and/or conduct of the study (applies to both
- •AstraZeneca staff and/or staff at the study site)
- •2. Previous enrolment 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
- •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 SABA
- •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 β-blocking agent including eye-drops
- •8. Known or suspected hypersensitivity to study drugs or excipient
- •9. Current or previous smoker 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 runin.
- •17. Any asthma worsening requiring change in treatment other than SABA from
- •Visit 1 until randomisati
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