EUCTR2012-001749-42-IT进行中（未招募）不适用
Effects of treatment and withdrawal with inhaled beclomethasone/formoterol on lung inflammation in COPD. - Study 3
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点开始时间: 2012年5月28日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 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
- •-Patient is male or female, at least 40 years of age and no more than 85 years.
- •- Patient has mild, moderate or severe COPD (stage I-III) according to the GOLD guidelines with a FEV1/FVC < 70% and FEV1 > 30% of the predicted value. Diagnosis of COPD will be based on GOLD guideline criteria (16).
- •- Reversibility to short-acting beta-agonists (SABA) (400 ?g equivalent of salbutamol) of less than 200 ml or less than 12% predicted value FEV1.
- •- Patients will be on a constant dose of ICS/LABA (ICS: 1000 ?g/day of fluticasone or equivalent) for at least 8 weeks before study enrolment.
- •- No acute exacerbations in the previous 3 months.
- •- No history of systemic disease or other pulmonary disease.
- •- No treatment with systemic glucocorticoids in the previous 4 weeks.
- •- No history of asthma or atopic disease.
- •- Current treatment for COPD can include SABA alone as needed or long-acting antimuscarinic drugs on regular basis.
- •- Apart from COPD, subjects are in good psycho-physical conditions based on history, physical examimantion and laboratory tests, and are able to complete the study.
- •-Ability to perform reproducible spirometry.
- •-Patient is a nonsmoker and has stopped smoking for at least one year.
- •-Ability of patient to provide informed consent, as evidenced by signing a copy of the consent form approved by the institutional review board of the subject’s respective study institution.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •1.Patient is, in the opinion of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, or cannot read or comprehend written material.
- •2.Patient is hospitalized.
- •3.Patient has undergone any major surgical procedure in the previous four weeks.
- •4.Patient has participated in a clinical trial involving an investigational or marketed drug in the previous four weeks.
- •5.Subjects who were current smokers in the previous year.
- •5.Patient has, in addition to COPD, any active, acute or chronic pulmonary disorder documented by history or physical examination.
- •6.Patient has history of asthma and/or reversibility to short-acting beta-agonists (SABA) (400 ?g equivalent of salbutamol) ? 200 ml or ? 12% predicted value FEV1.
- •7.Patient has ever been intubated for COPD, has required acute COPD therapy treated in an emergency room/urgent care facility/office setting within one month or has been hospitalized for COPD in the previous three months or required 2 or more hospitalizations for COPD in the past year.
- •8.Patient had an upper respiratory tract infection (URI) in the previous three weeks.
- •General Medical
- •4.Patient is hypersensitive to inhaled ?-agonists or their components.
- •5.Patient has a clinically significant, active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or haematological systems, or has uncontrolled hypertension (>160/95), or an immunodeficiency, or an autoimmune disorder.
- •6.Patient has a history of any illness that could be immediately life threatening (ventricular arrhythmia, neoplasia, incompletely cured or treated in the last three months, 'brittle' diabetes mellitus), or would pose restriction on participation in the study.
- •Medications
- •2.Patient has taken the following medications:
- •5)Oral, intravenous, intramuscular, intra-articular corticosteroids in the previous 4 weeks with the exception of nasal or inhaled corticosteroids administered on a continuous basis.
- •6)Antibiotics for ?7 consecutive days in the previous 4 weeks.
- •7)IV gammaglobulin or immunosuppressants in the previous 4 weeks.
- •8)Beta-receptor-blocking agents (including ocular preparations) in individuals known to be sensitive to these compounds in the previous two weeks.
- •3.Patient is unable to perform acceptable, reproducible spirometry, and peak flow measurements.
- •4.Patient is unable or unwilling to comply with the study procedures.
研究者
相似试验
已完成
不适用
Comparison of the therapeutic effect with inhaled corticosteroid in clinical cough variant asthma;subtypes classified by impulse oscillometry systemcough variant asthmaJPRN-UMIN000033583Sugawara internal medicine and respiratory clinic120
已完成
不适用
What is the effect of inhalational anaesthetic agents on blood glucose levels in non diabetic patients?CTRI/2021/12/038579All India Institute of Medical Sciences Raipur105
进行中（未招募）
不适用
EFFICACY And TOLLERABILITY Of TREATMENT for inhalation WITH L-ASA IN PATIENTS WITH MILD Or MODERATED ASTHMA IN COMPARISON WITH CORTICOSTEROID for inhalatioTREATMENT of MILD Or MODERATED ASTHMAMedDRA version: 6.1Level: PTClassification code 10003553EUCTR2005-001808-40-ITMEDESTEA RESEARCH & PRODUCTIO160
进行中（未招募）
不适用
Study HZA106851: A Study of the Effects of Inhaled Fluticasone Furoate/GW642444 versus Placebo on the HPA Axis of Adolescent and Adult AsthmaticsAsthmaMedDRA version: 12.1Level: LLTClassification code 10003553Term: AsthmaEUCTR2009-017669-44-DEGlaxoSmithKline Research & Development Ltd185
已完成
不适用
The effect of Lavender Essense on Cesarean post operative pain reliefPain.pain,unspecifiedR 52.9IRCT201204249552N1Jundishapur University of Medical Sciences,Vice Chancellor for Research and Technology60