EUCTR2006-001248-30-LV进行中（未招募）不适用
A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ciclesonide metered-dose inhaler at a daily dose of 160 µg administered either in a once-daily in the morning regimen (160 µg qd AM) for 16 weeks or in a 160 µg qd AM regimen for 12 weeks preceded by a twice-daily regimen (80 µg bid) for 4 weeks, or in an 80 µg bid regimen for 16 weeks, in adults and adolescents with mild to moderate persistent asthma not treated with steroids. - NA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 700
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
- •Males or females = 12 years of age;
- •History of persistent bronchial asthma for at least 6 months prior to screening;
- •Asthma therapy limited to bronchodilators only such as short-acting ß2-agonists or methylxanthines for at least one month prior to screening;
- •At screening and immediately prior to randomization, after an albuterol withhold of at least 6 hours, FEV1 = 60% and = 85% of predicted normal (see Appendix A of the protocol) and have a morning peak expiratory flow of (AM PEF) = 95% of predicted normal (see Appendix B of the protocol);
- •In subjects using methylxanthines: discontinuation of methylxanthines from at least 24 hours prior to the screening visit onwards;
- •Evidence during the last 7 days (with non-missing measurements) of the screening period prior to randomization for all of the following signs for lack of asthma control:
- •- Daytime asthma symptom score >1 (see Section 7.3.1.3 of the protocol) on 3 or more days,
- •- Albuterol use on 3 or more days,
- •- AM PEF <80% of predicted normal on 3 or more days;
- •At screening or immediately prior to randomization, reversibility of FEV1 by at least 12% (relative to the pre-bronchodilator value in liters) after inhalation of 180 µg albuterol (ex-actuator);
- •FEV1 at randomization within 15% of the FEV1 value (in liters) at screening;
- •Non-smoker for at least 6 months prior to screening, with less than a 10 pack-year smoking history if previous smoker;
- •Able to demonstrate acceptable oral inhaler technique with MDI (seeAppendix C of the protocol).
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any use of injectable or oral corticosteroids within 6 months prior to screening;
- •Any use of an inhaled corticosteroid (ICS) within 30 days prior to screening;
- •Use of ß2-adrenergic blocking agents for any reason;
- •Upper or lower respiratory tract infection within within 30 days prior to screening;
- •History of chronic bronchitis, chronic obstructive pulmonary disease, or emphysema;
- •History of life-threatening asthma, including a history of significant hypercarbia (pCO2 >45 mmHg), prior intubation, respiratory arrest, or seizures as a result of an exacerbation of asthma;
- •More than 2 in-patient hospitalization or emergency care visits due to asthma exacerbations in the year prior to screening;
- •Subjects on maintenance immunotherapy who either began their immunotherapy regimen or had a clinically relevant change in their immunotherapy regimen within 30 days prior to screening;
- •Pregnancy. There are no specific studies of ciclesonide in pregnant women. Therefore pregnant women should be excluded from this study;
- •Breast feeding;
- •Female subjects of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) unless practicing an adequate method of birth control, or unless sexual abstinence is confirmed at informed consent, or unless premenarchal and prepared to accept counseling on reproductive issues in case of becoming menarchal;
- •Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol;
- •Treatment with any investigational product within 30 days prior to screening;
- •Previous randomization in this study;
- •Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult;
- •Any clinically relevant deviation from normal in laboratory parameters that would limit participation in the study or interfere with interpretation of study results;
- •History of hypersensitivity to the study drug(s) or to drugs with a similar chemical structure;
- •ntolerance to albuterol or to excipients in MDI (HFA-134a and ethanol);
- •History of drug or alcohol abuse;
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study; Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study;
- •Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
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