NCT00862394已完成3 期
A 12-week, Multinational, Randomised, Double Blind, Double Dummy, 4-arm Parallel-group Study Comparing the Efficacy and Safety of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation, Via HFA Pressurised Inhalation Solution, in Moderate to Severe Symptomatic Asthmatic Patients Aged ≥ 12 Years Under Treatment With Inhaled Corticosteroids
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 783
- 试验地点
- 1
- 主要终点
- Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic
研究概览
简要总结
To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Outpatients of both sexes, aged > 12 years
- •Moderate to severe symptomatic asthma
- •Forced expiratory volume in the first second (FEV1) > 40% and < 80% of the predicted normal values
- •Reversibility test
- •"Partly controlled" asthma (GINA revised 2006)
- •Patients free of long-acting beta2-agonists (LABAs) treatment
- •Under inhaled corticosteroids (ICS) treatment
- •A minimum inspiratory flow ≥ 40 L/min
- •Non-smokers or ex smokers
- •Asthma Control Questionnaire ACQ score ≥ 1.5
排除标准
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential, UNLESS they are menopausal or have acceptable methods of contraception
- •Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer
- •History of near fatal asthma
- •Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit
- •Diagnosis COPD
- •History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency
- •Diagnosis of restrictive lung disease
- •Patients treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids)
- •Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids
- •Allergy to any component of the study treatments
- •Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit
- •Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ;
- •Patients with abnormal QTc
研究组 & 干预措施
1
Experimental
CHF 1535 Next DPI : BDP/Formoterol : 200/12 µg
干预措施: BDP/Formoterol Next DPI (Drug)
2
Active Comparator
CHF 1535 HFA pMDI : BDP/Formoterol : 200/12 µg
干预措施: Foster (Drug)
3
Experimental
CHF 1535 Next DPI : BDP/Formoterol : 400/24 µg
干预措施: BDP/Formoterol Next DPI (Drug)
4
Active Comparator
CHF 1535 HFA pMDI : BDP/Formoterol : 400/24 µg
干预措施: Foster (Drug)
结局指标
主要结局
Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic
时间窗: 3 month period
次要结局
- Post-dose FEV1 AUC 0-8 h(3 month period)
- Morning and evening asthma clinical symptoms scores(every day)
- Moderate and severe exacerbations(every month)
- Sputum(3 month period)
- Pre-dose FEV1(every month)
- FVC and FEF 25-75%(every month)
- PEF(every day)
- Rescue medication(every day)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)Pulmonary Disease, Chronic ObstructiveNCT00929851Chiesi Farmaceutici S.p.A.1,199
已完成
2 期
A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.AsthmaNCT01191424Chiesi Farmaceutici S.p.A.57
已完成
3 期
Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPDChronic Obstructive Pulmonary DiseaseNCT00476099Chiesi Farmaceutici S.p.A.828
已完成
2 期
Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary DiseaseNCT03590379Chiesi Farmaceutici S.p.A.366
已完成
3 期
Study of an Investigational Nasal Aerosol or Placebo in Children (Ages 4 to 11) With Perennial Allergic Rhinitis (PAR)Allergic RhinitisNCT01783548Teva Branded Pharmaceutical Products R&D, Inc.547