EUCTR2007-000134-39-HU进行中（未招募）不适用
Double-blind, double-dummy, multi-center, randomized parallel group trial to demonstrate therapeutic equivalence of Salmeterol/Fluticasone MDI HEXAL (25 µg/125 µg per actuation) versus SeretideTM 125 (25 µg/125 µg per actuation) over a period of 12 weeks in adolescent and adult patients with persistent moderate asthma
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Hexal AG
- 入组人数
- 426
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
- •At Visit -1:
- •1. Male or female patients aged 12 to 65 years
- •2. Written informed consent signed by the patient or for patients younger than 18 years (adolescents) signed by the parent(s) or by the legal guardian prior to any protocol specific procedures
- •3. Medical history of moderate persistent asthma (according to GINA) of at least 6 months duration
- •4. Regular use of ICS or ICS plus LABA over the 6 months immediately prior to Visit -1
- •5. Regular treatment with high-dose ICS or low- to medium-dose ICS plus LABA within the 4 weeks immediately prior to Visit -1
- •6. FEV1 greater than 60% of the predicted value by the European Community for Coal and Steel (ECCS) after a washout period of at least 6 hours for rapid-acting beta2-agonists (RABA) and at least 12 hours for LABA
- •7. Reversible and variable airflow limitation: At least 15% increase of FEV1 15-20 min after RABA inhalation (400 µg salbutamol)
- •8. Ability to read and write and to fill in the patient diary
- •9. Ability to handle correctly the metered-dose inhalers and a peak flow meter
- •At visit 0:
- •1. FEV1 greater than 60% and less than 80% of the predicted value by the European Community for Coal and Steel (ECCS) after a washout period of at least 6 hours for RABA (reliever medication)
- •2. FEV1 within +/- 15% of the value obtained at V-1
- •3. At least 2 of the following criteria fulfilled during the last 7 days of the run-in period:
- •3.1. Nighttime symptom score (diary card rating of asthma symptoms) is at least 1 on at least 1 day
- •3.2. Daytime symptom score (diary card rating of asthma symptoms) is at least 1 on at least 3 days
- •3.3. Use of RABA on at least 4 days
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •At Visit -1:
- •1. Intermittent or persistent mild or severe asthma as defined by GINA
- •2. Evidence of any active concomitant pulmonary disease other than asthma, i.e. chronic bronchitis, chronic obstructive pulmonary disease
- •3. Respiratory tract infection (including sinusitis) within 4 weeks prior to Visit -1
- •4. Acute asthma exacerbation within 4 weeks preceding Visit -1
- •5. Acute asthma exacerbation requiring hospitalization or emergency room visit within 12 weeks preceding Visit -1
- •6. History of life-threatening acute attacks or intubation for asthma
- •7. History of seasonal asthma exacerbation
- •8. History of paradoxical bronchospasm after inhaled asthma therapy
- •9. Active or inactive lung tuberculosis
- •10. Smoking habits: current smokers or previous smokers who stopped smoking less than 6 months before Visit -1.
- •11. Overdependence on RABA, i.e. frequency of RABA inhalation not consistent with moderate persistent asthma
- •12. Patients naive for inhaled corticosteroids
- •13. Change in asthma medication or regimen (other than inhalation of RABA) within 4 weeks preceding Visit -1
- •14. Administration of cromones within 4 weeks preceding Visit -1
- •15. Administration of oral corticosteroids within 4 weeks preceding Visit -1
- •16. More than 2 courses of oral corticosteroids within the last 3 months
- •17. Desensitization therapy within the last 3 months
- •18. Long-acting antihistamines within 1 week preceding Visit -1 (astemizole within 3 months)
- •19. Use of beta-blockers, non-potassium sparing diuretics or potent inhibitors of the cytochrome P450-3A4 system like ketoconazole, itraconazole, ritonavir within 4 weeks preceding Visit -1
- •20. Vaccination with live-attenuated virus within 2 weeks preceding
- •21. Impaired adrenal cortex function
- •22. Severe renal or hepatic disease
- •23. Hypokalemia uncorrected and/or serum potassium value on Visit -1 less than 3.5 mmol/L
- •24. Acute or history of severe cardiovascular disorders (New York Heart Association class II-IV heart failure, heart rhythm abnormalities)
- •25. Untreated or unstable hypertension
- •26. Known diabetes of all types
- •27. Hyperthyroidism not adequately controlled
- •28. Glaucoma
- •29. History of hypersensitivity to one or both of the active ingredients or to any other component of the preparations or reliever medication
- •30. Presence of any other severe decompensated concomitant disease (endocrine, hematological, neurological, immunological)
- •31. Known abnormal chest radiography
- •32. Other relevant medical condition, ECG abnormality, or laboratory profile that might compromise the patient’s safety, compliance, or interfere with the evaluation or preclude completion as judged by the investigator or other contraindication to test drug.
- •At Visit 0:
- •1. Acute respiratory tract infection during run-in period
- •2. Severe asthma exacerbation during run-in period
- •3. Any intake of asthma medication other than the inhalation of the supplied reliever medication during run-in period
- •4. Use of more than 12 actuations of reliever medication on any single day during the run-in period
研究者
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