CTRI/2015/11/006380已完成未知
International, multicentre, open-label, randomized, comparative research of effectiveness and drug safety of Flusal, aerosol for inhalation metered dose and Seretide®, inhalation aerosol metered dose in patients with uncontrolled and partially controlled bronchial asthma
OOO Rus Biopharm0 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
- 未知
- 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.Men and women from 18 to 70 years old;
- •2.Availability of written informed consent obtained from the patient before any procedures related to research;
- •3.Diagnosis of persistent bronchial asthma, according to the guidelines established by GINA 2009 version, at least 6 months prior to the screening visit;
- •4.Partially controlled and uncontrolled BA (GINA, 2009).
- •5.Patients who the combination long-acting β2-adrenergic agonists and glucocorticosteroids in form of inhalation is prescribed.
- •6.day symptoms BA > once a day;
- •7.night symptoms BA > once a week;
- •8.indicators of forced expiratory volume per 1 second (FEV1) and peak expiratory flow rate (PEF) from 60 to 80% range for age;
- •10.daily lability of bronchi > 30%;
- •11.Patients should get during, at least, 3 months prior to the screening visit a stable basic therapy of bronchial asthma with inhalation glucocorticosteroids + long-acting beta 2 â?? agonists. Average stable dose of inhalation glucocorticosteroids is defined as the dose of budesonide from >= 400mcg to <= 800mcg or equivalent drug
- •12.Daily requirement in short-acting beta 2 â?? agonists is not more than 8 inhalations per day during 2 consecutive days. As a part of the study combination drugs, containing M-cholinoblockers and short-acting beta 2 â?? agonists (for example, burodual), should be replaced by short-acting beta 2 â?? agonists;
- •13.Patients with performance of Asthma control test by questionnaire ACT 19 or less points;
- •14.Patients with performance of total score by questionnaire ACQ more than 1.5.
- •15.Willingness to cooperate during trial procedures.
- •16.Negative pregnancy test. Urine pregnancy test will be carried out during screening for women of child-bearing potential.
排除标准
- •1.Pregnant or lactating women, or all women physiologically capable of becoming pregnant, EXCEPT those who fall under the following definition of postmenopause: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with already documented level of FSH in a blood serum of > 40 mIU/ml, or use one or more of the following acceptable methods of contraception; surgical sterilization (for example, bilateral tubal ligation, hysterectomy), hormonal contraception (implant, patch, oral), double-barrier methods (any dual combination of the following methods: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap).
- •2.Significant seasonal variations of bronchial asthma or bronchial asthma that occurs only during periodic exposure of allergens or chemical sensibilizators;
- •3.A history of bronchial asthma with almost fatal accidents (for example, unstable bronchial asthma, hospitalization for acute bronchial asthma in the intensive care unit with the use of intubation);
- •4.The diagnosis of COPD, established according to the current version of the manual GOLD, version 2009;
- •5.Exacerbation of bronchial asthma during the 4 weeks prior to the screening visit, requiring the use of systemic glucocorticosteroids and hospitalization (more than 24-hour hospital stay);
- •6.Frequent exacerbations of bronchial asthma: more than 4 exacerbations over 52 weeks before study entry;
- •7.Frequent night awakening: more than 3 times a week;
- •8.Great need for short-acting beta 2 - agonists: more than 8 inhalations per day for two consecutive days;
- •9.The use for the bronchial asthma therapy of mast cell stabilizers, anticholinergics, methylxanthines, antileukotriene and anti-IgE - drugs;
- •10.Lower respiratory tract infection within 1 month prior to the screening visit;
- •11.A history of cystic fibrosis, bronchiectasis or deficiency of alpha-1 antitrypsin;
- •12.The diagnosis of restrictive pulmonary process;
- •13.Patients treated with oral or parenteral glucocorticosteroids in the previous 2 months before the screening visit (3 months for parenteral long-acting corticosteroids);
- •14.The identified or suspected QTÑ? interval elongation (QT corrected) > 0.44 sec;
- •15.Participation in other clinical trials;
- •16.The patients incapable to observe conditions of study management and/or not causing trust;
- •17.Intolerance or contraindication to treatment of beta 2-agonists and / or inhalation corticosteroids or allergy to any component of the study drug therapy;
- •18.Obtaining of the study medication within 1 month prior to the screening visit;
- •19.The presence of significant medical history and / or treatment of cardiac, renal, neurologic, hepatic, endocrine diseases or the presence of any abnormalities in laboratory parameters, which can be an indicator of significant disease that can affect patient safety, compliance, or evaluation of study, require the use of prohibited drugs, according to the researcher.
- •20.A cancer or a history of cancer within 5 years;
- •21.Smoking patients or former smokers who smoked more than 10 pack years and stopped smoking less than 1 year before the study entry. (Pack-year: the number of cigarettes smoked per day, multiplied by the number of years of smoking / 20);
- •22.Conditions requiring the use of systemic corticosteroids
研究者
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