CTRI/2016/02/006600已完成3 期
International multicenter open label randomized comparative study on the efficacy and safety of Fluzon 250 HFA metered dose aerosol for inhalation (Midas Care Pharmaceutical Pvt. Ltd., India) and Flixotide®, metered dose aerosol for inhalation (GlaxoSmithKline Pharmaceuticals S.A., Spain/Poland) in patients with mild and moderate persistent bronchial asthma - Fluzon
Rus Biopharm LLC0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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
入选标准
- •1 Male and female patients, aged from 18 to 70 years;
- •2 Written informed consent, obtained from the patient before any procedure related to the study;
- •3 Diagnosis of persistent asthma, established according to the GINA guidelines, version 2011, at least 6 months prior to the screening visit;
- •4 Partially controlled bronchial asthma (GINA 2011)
- •5 Patients, who demonstrates the use of iGCS in the form of inhalations.
- •6 daytime symptoms of BA > 1 times a day
- •7 night symptoms of BA > 1 times per week
- •8.forced expiratory volumes per 1 sec (FEV1) and peak expiratory flowrates (PEFR) in the range of 60 to 80% of age norms;
- •9 reversibility of obstruction in tests with short-acting β2agonists >= 12% and >= 200 ml compared to baseline, through 15 to30 minutes after the administration of 400 µg salbutamol;
- •10 daily bronchial lability > 30%
- •11 Patients should have used stable background therapy of bronchial asthma with inhaled iGCS (except for fluticasone, cromones, or leukotriene-receptor antagonists) for at least 4 weeks before the screening visit. The average stable dose of inhaled glucocorticosteroids is defined as the dose of budesonide or equivalent product from >= 500 μg to <= 1000 µg
- •12 Daily requirement in short-acting β8agonists of not more than 2 inhalations per day for 3 consecutive days, 3 to 7 times per week During the study combined preparations, containing M cholinoblockers and short-acting β2-agonists (e.g., berodual), must be replaced with short-acting β2-agonists
- •13 Patients with total scores under the Asthma Control Questionnaire (ACQ) of more than 0.75
- •14 Willingness to cooperate when performing study procedures.
- •15Negative pregnancy test
- •For women of child-bearing potential urine test for pregnancy will be performed at screening
排除标准
- •1.Pregnant or lactating women or all women physiologically capable of becoming pregnant, except those that fall under the following definition of postmenopausal women: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with the documented serum FSH level > 40 mIU/ml, or using one or more of the following acceptable methods of contraception; surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), hormonal contraception (implant, patch, oral), double barrier methods (any dual combination of the following methods: intrauterine device, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap).
- •2.Significant seasonal variation of bronchial asthma or bronchial asthma that occurs only during periodic exposure to allergens or chemical sensitizers;
- •3.History of bronchial asthma with almost fatal outcome (e.g., unstable bronchial asthma, hospitalizations due to asthma exacerbation in the intensive therapy unit with the application of intubation);
- •4.Diagnosis of COPD, established under the current version of GOLD guidelines, version 2009;
- •5. Exacerbation of bronchial asthma within 4 weeks prior to the screening visit, requiring the use of system glucocorticosteroids and hospitalizations (more than 24-hour hospital stay);
- •6.Frequent exacerbations of asthma: over 4 exacerbations 52 weeks before inclusion in the study;
- •7.Frequent night awakenings: more than 3 times a week;
- •8.Large requirement in short-acting β2-agonists (SABA) of not more than 2 inhalations per day for 2 consecutive days;
- •9.The use of fluticasone or fixed combination of iGCS and long- acting β2-agonists (LABA) for the treatment of bronchial asthma;
- •10.Lower respiratory tract infection within 1 month before screening visit;
- •11.History of mucoviscidosis, bronchiectasis or alpha-1 antitrypsin deficiency;
- •12.Diagnosis of restrictive pulmonary process;
- •13.Glaucoma, cataract;
- •14.Intolerance or contraindications to the treatment with ï?¢2-agonists and/or inhalation corticosteroids or allergy to any component of the investigated pharmacotherapy;
- •15.The presence of significant medical history and/or treatment of cardiac, renal, neurologic, hepatic, endocrine diseases or the presence of any abnormalities in laboratory indicators that can serve as an indicators of a significant disease that may affect patientâ??s safety, compliance, or assessment of the study, require the use of banned drugs, according to the investigator.
- •16.Cancer or a history of cancer within 5 years;
- •17.Smoking patients or ex-smokers, who smoked more than 10 pack-years and quitted smoking less than 1 year prior to inclusion in the study. (Pack-year: number of cigarettes, smoked per day, multiplied by the number of years of smoking/20);
- •18.Conditions, requiring the use of systemic glucocorticosteroids
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