EUCTR2007-000135-26-LT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/50 µg per actuation) versus SeretideTM 50 (25 µg/50 µg per actuation) over a period of 12 weeks in pediatric patients aged 4-11 years 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
- 420
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 children aged 4 to 11 years
- •2. Written informed consent signed according to local requirements by one or by both patient’s parent(s) or legal representative prior to any protocol specific procedures
- •3. Medical history of persistent moderate 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
- •medium- to high-dose ICS or medium-dose ICS plus LABA (children <5 years)
- •high-dose ICS or low- to medium-dose ICS plus LABA (children >=5 years)
- •within the 4 weeks immediately prior to Visit -1
- •6. Ability to perform spirometric maneuvers with a forced expiratory time of at least 1 second
- •7. Patients aged 6-11 years capable of coordinating MDI actuation and inhalation
- •8. 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 RABA and at least 12 hours for LABA
- •9. Reversible and variable airflow limitation: At least 12% increase of FEV1 15-20 min after inhalation of 200 µg salbutamol. Reversibility has to be demonstrated at Visit -1 or needs to be documented by valid spirometric results obtained within 6 months prior to Visit -1
- •10. Ability to read and write and to fill in the patient diary by the patient or by patient’s parent(s) or legal representative
- •11. Ability to handle correctly the peak flow meter and the metered-dose inhalers with/without spacer
- •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 Visit -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) no
- •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
- •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
- •3. Respiratory tract infection (including sinusitis) and middle ear infection 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. Overdependence on RABA, i.e. frequency of RABA inhalation not consistent with persistent moderate asthma
- •11. Patients naive for inhaled corticosteroids
- •12. Change in asthma medication or regimen (other than inhalation of RABA) within 4 weeks preceding Visit -1
- •13. Administration of cromones within 4 weeks preceding Visit -1
- •14. Administration of oral corticosteroids within 4 weeks preceding Visit 1
- •15. More than 2 courses of oral corticosteroids within the last 12 weeks
- •16. Allergen-specific immunotherapy within the last 12 weeks
- •17. Long-acting antihistamines within 1 week preceding Visit -1 (astemizole within 12 weeks)
- •18. Use of beta-blockers or potent inhibitors of the cytochrome P450-3A4 system like ketoconazole, itraconazole, ritonavir within 4 weeks preceding Visit -1
- •19. Vaccination with live-attenuated virus within 2 weeks preceding
- •20. Impaired adrenal cortex function
- •21. Severe renal or hepatic disease
- •22. Hypokalemia uncorrected and/or serum potassium value on Visit -1 less than 3.5 mmol/L
- •23. Acute or history of severe cardiovascular disorders (e.g. heart rhythm abnormalities)
- •24. Untreated or unstable hypertension
- •25. Known diabetes
- •26. Hyperthyroidism not adequately controlled
- •37. Glaucoma
- •28. History of hypersensitivity to one or both of the active ingredients or to any other component of the preparations or reliever medication
- •29. Presence of any other severe decompensated concomitant disease (endocrine, hematological, neurological, immunological)
- •30. Known active and significant pulmonary abnormalities as detected on chest radiographs
- •31. 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.
- •32. Females of childbearing potential, not willing to abstain from sexual activities throughout complete duration of participation in the study
- •33. History of non-compliance with asthma management plan
- •34. Current participation in another investigational drug study, or participation in any clinical study involving an investigational drug within 3 months prior to Visit -1
- •35. Lack of sufficient co-operation or compliance or existing psychosocial problems
- •36. Legal incapacity of the patient’s parent(s) or legal representative or other circumstances rendering the patient’s parent(s) or legal representative unable to understand the nature, scope and possible consequences of the study
- •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 6 actuations
研究者
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