A 12-week, multicentre, multinational, randomized, double-blind, double-dummy, 2-arm parallel group study comparing the efficacy and safety of Foster® 100/6 (beclomethasone dipropionate 100 µg plus formoterol 6 µg/actuation), 2 puffs b.i.d., versus Seretide® 500/50 (fluticasone 500 µg plus salmeterol 50 µg/actuation), 1 inhalation b.i.d., in patients with Chronic Obstructive Pulmonary Disease.

Chiesi Farmaceutici SpA0 个研究点目标入组 506 人开始时间: 2011年1月14日最近更新: 2017年4月3日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 506

研究概览入排标准研究者记录与标识符相似试验

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. Male or female patients aged = 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or when applicable written informed consent obtained by legal representative.
•2. Outpatients with a clinical diagnosis of moderate to severe COPD and including:
•a) Smoking history of at least 10 pack years defined as [(number of cigarettes smoked per day) x (number of years of smoking)] / 20, both current and ex-smokers are eligible.
•b) Regular use of bronchodilators (e.g. ß2-agonist, anticholinergics) in the 2 months before visit 1.
•c) Post-bronchodilator FEV1 < 60% of the predicted normal value at visit 1.
•d) Post-bronchodilator FEV1/FVC < 0.7 at visit 1.
•e) An increase in FEV1 = 5% from baseline following administration of 400 µg of salbutamol at visit 1.
•f) A Baseline Dyspnoea Index (BDI) focal score < or = 10 (at visit 1 and at visit 2).
•3. History of no more than one COPD exacerbation in the previous 12 months (without considering the last 2 months) to visit 1.
•COPD exacerbation will be defined according to the following: A sustained worsening of the patient’s condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD that includes prescriptions of systemic corticosteroids (at least 3 days) and/or antibiotics (at least 5 days), or need for a visit to an emergency department or hospitalization”.
•4. A cooperative attitude and ability to be trained to the proper use of pMDI and DPI (Accuhaler®, circular moulded plastic inhaler) inhalers.
•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. Diagnosis of asthma or other respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator’s opinion.
•2. Pregnant or lactating women. Females of childbearing potential without an efficient contraception UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or are using one or more of the following acceptable methods of contraception:
•a) surgical sterilization (e.g. bilateral tubal ligation, hysterectomy);
•b) hormonal contraception (implantable, patch, oral, injectable);
•c) barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
•d) Continuous abstinence (e.g. nuns).
•Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.
•3. Clinical or functional unstable concurrent disease: e.g. hyperthyroidism, diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. coronary artery disease, hypertension, heart failure); gastrointestinal disease (e.g. active peptic ulcer); neurological disease; haematological disease; autoimmune disorders, or other which may impact the evaluation of the results of the study according to investigator’s judgement.
•4. Patient with narrow-angle glaucoma.
•5. Clinically significant laboratory and ECG abnormalities indicating a significant or unstable concomitant disease which may impact the evaluation of the results of the study and the safety of the patient according to investigator’s judgement.
•6. Patients with COPD exacerbation (see previous at inclusion criteria no. 3) in the 2 months prior to screening and during the study period.
•7. Patients requiring long term (> 12 hours daily) oxygen therapy for chronic hypoxemia.
•8. Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period.
•9. Patients with known allergy, sensitivity or intolerance to sympathomimetic drugs or inhaled corticosteroids or to any of the excipients contained in the study drugs.
•10. Patients who have evidence of alcohol or drug abuse, not compliant with the study protocol or not compliant with the study treatments according to investigator’s judgement.
•11. Major surgery in the previous 3 months and during the trial which may affect patient’s compliance in study procedures (e.g. spirometry).
•12. Participation in another clinical trial with an investigational drug in the 2 months preceding visit 1.
•13. Patients requiring chronic mechanical ventilation for COPD.

研究者

发起方

Chiesi Farmaceutici SpA

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