EUCTR2007-005235-29-HU进行中（未招募）不适用
Efficacy and safety of Salmeterol/Fluticasone MDI HEXAL versus SeretideTM EvohalerTM in adolescent and adult patients with moderate-to-severe persistent asthma: A 12-week, multicenter, randomized, double-blind, double-dummy, parallel-group study
适应症
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
- 480
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 also by the parent(s) or by the legal guardian prior to any protocol specific procedures
- •3. Medical history of moderate-to-severe 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 alone or low- to high-dose ICS plus LABA within the 4 weeks immediately prior to Visit -1 (see Appendix V for daily dosages of ICS according to GINA)
- •6. FEV1 =50% 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 beta-2-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 (200 µg salbutamol). Reversibility has to be demonstrated at Visit -1 or needs to be documented by valid spirometric results, obtained with 200-400µg of salbutamol, within 6 months prior to Visit -1
- •8. Ability to read and write and to fill in the patient diary
- •9. Ability to handle correctly the metered-dose inhalers and the peak flow meter
- •At Visit 0:
- •1. FEV1 = 50% and < 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 pre-inhalation 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 for symptomatic relief (not prophylaxis) 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 asthma as defined by GINA
- •2. Evidence of any active concomitant pulmonary disease other than asthma, i.e. chronic bronchitis, COPD
- •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, smokers who stopped smoking less than 6 months before Visit -1 or former smokers with a history of =10 pack-years.
- •11. Overdependence on RABA, i.e. frequency of RABA inhalation not consistent with controlled moderate-to-severe 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, rectal, parenteral or depot corticosteroids within 4 weeks preceding Visit -1
- •16. More than 2 courses of oral corticosteroids within the last 12 weeks
- •17. Theophylline, leukotriene modifiers and anticholinergics within 4 weeks preceding Visit -1
- •18. Long-acting antihistamines within 1 week preceding Visit -1 (astemizole within 12 weeks)
- •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 active and significant pulmonary abnormalities as detected on available chest radiographs
- •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
- •33. Pregnant or nursing women
- •34. Females of childbearing potential (not surgically sterilized / hysterectomized or postmenopausal for at least 1 year), who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices)
- •35. Necessity to use a spacer device for inhalation
- •36. History of non-compliance with asthma management plan
- •37. Suspected alcohol or drug abuse
- •38. Current participation in another investigational drug study, or participation in any clinical study involving an investigational drug
研究者
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