NL-OMON38416已完成3 期
A 12-week, multicentre, randomised, 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 Symbicort® 200/6 (budesonide 200 µg plus formoterol 6 µg/actuation), 2 inhalations b.i.d., on parameters of small airway function in patients with Chronic Obstructive Pulmonary Disease. - FAIR
Chiesi Farmaceutici0 个研究点目标入组 170 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria
- •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 severe to very severe COPD and including:
- •a) Smoking history of at least 10 pack years defined as [(number of cigarettes smoked per day) * (number of years of smoking)] / 20, both current and ex-smokers are eligible.
- •b) Regular use of bronchodilators (e.g. β2-agonist, anticholinergics) in the 2 months before visit 1.
- •c) Post-bronchodilator FEV1 < 50% of the predicted normal value at visit 1.
- •d) Post-bronchodilator FEV1/FVC < 0.7 at visit 1.
- •f) Plethysmographic Functional Residual Capacity (FRC) > 120% of the predicted normal value (at visit 1 and visit 2).
- •g) A Baseline Dyspnoea Index (BDI) focal score <=*10 (at visit 1 and at visit 2).
- •3. A cooperative attitude and ability to be trained to the proper use of pMDI and DPI (Turbohaler®, inspiratory flow-driven, multidose powder inhaler) inhalers.
排除标准
- •Exclusion criteria
- •1. Diagnosis of asthma or other clinically or functionally relevant 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 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL 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.
- •Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.
- •3. Clinically 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 and/or symptomatic infection of the airways requiring antibiotic therapy (at least 5 days) in the 2 months prior to screening and during the study period. 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*.
- •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. plethysmography).
- •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.
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