EUCTR2006-005097-52-IE进行中（未招募）1 期
A Single-Centre, Randomised, double-blind, two month Interventional Parallel group Study Assessing the in vivo synergy of salmeterol xinafoate/fluticasone propionate (50/250 µg twice daily) via a single Diskus inhaler (combination) versus salmeterol xinafoate (50 µg twice daily) and fluticasone propionate (250µg twice daily) via separate Diskus inhalers (concurrent treatment) on eosinophilic inflammation in the lungs of adult subjects > 18 years old who have moderate bronchial asthma. - Synergy 2006
Adelaide & Meath Hospital0 个研究点开始时间: 2006年12月5日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •1. Gender: Male or Female.
- •A female is eligible to enter this study if she is of:
- •- Non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal), or
- •- Child-bearing potential, has a negative urinary pregnancy test at screening and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study. Acceptable methods of contraception are:
- •--Male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female subject
- •--Implants of levonorgesterel
- •--Injectable progestogen
- •--Oral contraceptive (either combined or progestogen)
- •--Any intrauterine device (IUD) with a documented failure rate of less than 1% per year.
- •2. Age: Greater than or equal to 18 years of age.
- •3. Respiratory Disease Qualification:
- •Each subject must have been previously diagnosed or treated for bronchial asthma, or have a history and finding suggestive of bronchial asthmas as defined by the GINA guidelines:
- •Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role. The chronic inflammation causes an associated increase in airway hyper responsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning. These episodes are usually associated with widespread but variable airflow obstruction that is often reversible either spontaneously or with treatment
- •Percentage of eosinophils in induced sputum =3%.
- •4. Informed Consent: Subjects are willing to give their written informed consent to participate in the study.
- •Are the trial subjects under 18? no
- •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
- •1. Smoking history: Pack-years > 10 years
- •2. Known or suspected Chronic Obstructive Pulmonary Disease
- •3. Other Medication for Asthma: Use of oral, depot or parenteral corticosteroids within 4 weeks of the screening visit or concomitant medication with antileukotriene and/or theophylline drugs
- •4. Other Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease likely (in the opinion of the investigator) to interfere with the study. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation, or would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- •5. Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy.
- •6. Infections: Upper or lower respiratory tract infections within four weeks immediately preceding Visit 1.
- •7. Questionable Compliance with Medications or Visits: Any infirmity, disability, or geographic location which would limit compliance for scheduled visits.
- •8. Inability to read and understand English: Due to the fiscal constraints of an investigator led study, it will be impossible to provide translation services, therefore, subjects will not be eligible if s/he is not able to read and understand English.
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