EUCTR2013-005293-22-SK进行中（未招募）1 期
A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group,Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI80/2.25 ug, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 ug,2 Actuations Twice Daily, Compared with Budesonide pMDI 80 ug,2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 279
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
- •For inclusion in the study, patients should fulfill the following criteria at Visit 1:
- •1. Provision of a signed and dated (by the parent or legal guardian) written Informed Consent form (and assent form, per Institutional Review Board [IRB]/Ethics Committee [EC] requirements) prior to undergoing any study-related procedures including being asked to withdraw regularly used medications
- •2. Be between the ages of 6 and <12 years (not having reached his/her 12th birthday at the time of Visit 1)
- •3. Have a documented clinical diagnosis of asthma as defined by the ATS (ie, a disease characterized by increased responsiveness of the trachea and bronchi to various stimuli and manifested by widespread narrowing of the airway that changes in severity either spontaneously or as a result of therapy) for at least 6 months prior to Visit 2.
- •4. If receiving immunotherapy injections, a patient must have been on a stable maintenance regimen for at least 6 weeks and be expected to remain on immunotherapy throughout the study.
- •5. Require and be prescribed treatment with a consistent daily dose of ICS within the corresponding dosage range listed below for at least 4 weeks prior to Visit 1. If the patient is not under the care of the investigator, documentation of ICS use by pharmacy records or copies of the prescribing health care provider’s records are required to verify ICS use.
- •- Budesonide 320 µg to 540 µg/day
- •- Beclomethasone HFA: 160 to 320 µg/day
- •- Budesonide (nebulized): 1000 µg/day
- •- Flunisolide: 1000 to 1250 µg/day
- •- Flunisolide HFA: 320 µg/day
- •- Flunisolide HFA pMDI: 176 to 352 µg/day
- •- Fluticasone DPI: 200 to 400 µg/day
- •- Triamcinolone acetonide: 600 to 900 µg/day
- •- Ciclesonide: 160 to 320 µg/day
- •- Mometasone: 110 to 220 µg/day
- •- OR on a fixed combination of ICS and LABA
- •Note: Other non-steroidal asthma medications (eg, leukotriene modifiers, mast cell stabilizers) could have been used in combination with any of the above and would not impact a patient’s eligibility. These medications must be discontinued at or before Visit 2. After providing written informed consent for the study, potential patients maintained on a fixed combination of ICS and LABA should be switched
- •to a comparable dose of ICS without the addition of LABA at least 48 hours prior to Visit 2. This change will not be considered a change in the dose of maintenance ICS.
- •For inclusion in the study, patients should fulfill the following criteria at Visit 2:
- •6. Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after the last dose of inhaled LABA of 60% to 100% of predicted normal. Polgar predicted normal standards will be used for all patients. Race correction will be applied as appropriate. If the patient is
- •taking a fixed combination of ICS/LABA, the patient is to be placed on a comparable dose of ICS monotherapy, without LABA, at least 48 hours prior to Visit 2.
- •7. Demonstrate reversibility of clinic FEV1 of =12% from pre- albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol (albuterol/salbutamol pMDI, 90/100 µg per inhalation, 2 to 4 actuations, with or without a spacer, or up to 2.5 mg of nebulized
- •albuterol/salbutamol). For patients who fail to demonstrate reversibility at Visit 2, but meet all of the other inclusion criteria and none of the exclusion criteria, the assessment can be repeated once, after Visit 2,
排除标准
- •1. Have been hospitalized at least once or required emergency treatment more than once for an asthma-related condition during the 6 months prior to Visit 1
- •2. Have required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 6 weeks prior to Visit 1
- •3. Have any significant disease or disorder (eg, cardiovascular, pulmonary [other than asthma], gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) or other disease or
- •condition generally affecting lung function (eg, prematurity, congenital lung anomalies, tracheoesophageal fistula, bronchiectasis, chronic sinusitis) which, in the opinion of the investigator, could place the patient at risk if participating in the study, or could influence the results of the study or the patient's ability to participate in the study
- •4. Have participated in another investigational drug study during the 4 weeks prior to Visit 1
- •5. Receiving treatment withß-blocker (including eye drops)
- •6. Have taken omalizumab (Xolair®, Genentech/Novartis) or any other monoclonal or polyclonal antibody therapy, for any reason within the 6 months prior to Visit 2
- •7. Have a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide, or formoterol, and/or their excipients and/or have a severe hypersensitivity to milk proteins
- •8. Have any clinically relevant abnormal findings in physical examination or vital signs at Visit 2, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study
- •9. Have a planned hospitalization at any time during the study
- •10. Have a positive pregnancy test at any time during study
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