NCT00861926已完成3 期
48-week, Multicentre, Multinational, Randomized, Double-blind, 2-arm Parallel Group, Comparing the Efficacy of FOSTER for Maintenance & Reliever Versus Fixed-dose FOSTER for Maintenance + Salbutamol as Reliever in Asthmatics ≥ 18 Years of Age
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,714
- 试验地点
- 207
- 主要终点
- Time to first severe asthma exacerbation
研究概览
简要总结
Primary objective:
The primary objective of the study was to compare the efficacy of Maintenance and Reliever Therapy (MART) with Foster® 100/6 μg (one inhalation bid) plus additional inhalations as needed, with the standard treatment of Foster® 100/6 μg (one inhalation bid) plus salbutamol 100 μg (Ventolin ®) additional inhalations as needed in not fully controlled asthmatic patients.
Secondary objectives:
The secondary objectives of the study were:
- to evaluate the effect of treatments on lung function parameters and on other clinical outcome measures, and
- to assess the safety and the tolerability of Foster® as MART.
详细描述
This was a 48-week phase III, double-blind, randomized, 2-arm parallel group study in asthmatic patients (adults of both sexes) not fully controlled under ICS treatment.
The study plan included:
- A pre-screening visit (V0, 3-10 days before V1) to explain the aim of the study, to sign the informed consent form and to prepare patients for V1;
- A screening visit (V1, week -2) to assess inclusion/exclusion criteria followed by a 2-week run-in period when the patients received Foster® 100/6μg, one inhalation twice a day plus salbutamol for reliever medication;
- A randomization visit (V2, week 0) when patients were allocated to one of the two treatment arms:
A) Foster® 100/6 μg one inhalation bid for maintenance plus additional inhalations as needed; B) Foster® 100/6 μg one inhalation bid for maintenance plus salbutamol as needed.
- And subsequent visits taking place at clinics after 4 (V3), after 12 (V4), after 24 (V5), after 36 (V6) and after 48 weeks (V7) of treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written signed and dated informed consent obtained from patient;
- •Male or female patients aged ≥ 18 years;
- •Clinical diagnosis of asthma for ≥ 6 months;
- •A positive reversibility test, defined as an increase of at least 12% and at least 200 mL from pre-dose in FEV1 30 minutes following 4 puffs (4 × 100 μg) of inhaled salbutamol pMDI. If this could not be achieved, a documented reversibility test to salbutamol within the last 6 months was acceptable for eligibility;
- •Patients who experienced at least one severe exacerbation in the 12 months before entry (but not in the last month), defined as deterioration in asthma resulting in hospitalization or emergency room treatment due to asthma worsening, or the need for systemic steroids for at least 3 days because of asthma;
- •Using inhaled corticosteroids (ICS) in monotherapy or using ICS in a fixed or free combination with long acting β2 agonists (LABA) at a constant dose (changes in doses for less than seven days were accepted) for two months before V
- •If patients were under ICS only, the daily dose had to be ≥ non-extrafine 1000 μg BDP or equivalent.
- •If patients were under ICS + LABA, the ICS daily dose had to be ≥ non-extrafine 500 μg BDP or equivalent. LABA were to be stopped at least 24 hours before V
- •Not fully controlled asthmatics (which means partly controlled or/and uncontrolled patients according to GINA guidelines 2007) (apart from asthma exacerbation criteria) in the last month before V
- •Asthma control was assessed in terms of:
- •Daytime symptoms (more than twice a week);
- •Limitation of activities (any);
- •Nocturnal symptoms/awakening (any);
- •Need for rescue (more than twice a week);
- •Forced expiratory volume in the first second (FEV1) < 80% predicted (or personal best, if known) on any day.
- •Partly controlled patients were those with at least one of the above mentioned symptoms/signs in any week of the last month before V
- •Uncontrolled patients were those with 3 or more features of partly controlled asthma present in any week of the last month before V
- •FEV1 ≥ 60% of predicted for the patient normal value;
- •Non smokers or ex-smokers (defined as those who have stopped smoking for more than one year and with a smoking history of less than 10 pack/years); Pack/year: number of cigarettes smoked per day multiplied by the number of years of smoking/
- •A co-operative attitude and ability to be trained to correctly use the pMDI;
- •Subjects who were willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Not fully controlled asthma (defined according to criterion No. 7) in the last week of the run-in was to be confirmed at Visit 2.
排除标准
- •Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotrophin laboratory test (> 5 mIU/mL). Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precluded intercourse with a male partner and women whose partners had been sterilized by vasectomy or other means, unless they met 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 were using one or more of the following acceptable methods of contraception:
- •Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy);
- •Hormonal contraception (implantable, patch, oral);
- •Double-barrier methods (any double combination of: IUD, male or female condom, diaphragm, sponge, cervical cap).
- •Acceptable methods of contraception could include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensured compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal were not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation;
- •Body Mass Index (BMI) > 34 kg/m2;
- •Patients with lower respiratory tract infections affecting the patient's asthma within 30 days of the screening visit;
- •Use of systemic steroids in the last month;
- •Patients with other lung diseases such as (but not limited to) COPD, cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder;
- •Patients who had an uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that could, in the judgment of the investigator, represent for the patients an undue risk or that could compromise the results or interpretation of the study;
- •History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias;
- •Cancer or any other chronic disease with poor prognosis (less than 2 years) and /or affecting patient status;
- •Clinically relevant laboratory abnormalities such as (but not limited to) hypokaliemia (<3.5 mEq/L), that could compromise patient's safety or compliance, interfere with evaluation, or preclude completion of the study, in the judgment of the investigator. Patients with uncontrolled diabetes, including patients with a history of serum glucose levels consistently out of the normal range (> 140 mg/dl) or HbA1c > 8.0%, were to be excluded from the study;
- •Patients who had an abnormal QTcF interval value in the screening visit ECG test (i.e., > 450 msec in males or > 470 msec in females);
- •Intolerance or contra-indication to treatment with β2-agonists and/or ICS or allergy to any component of the study treatments;
- •Patients treated with slow-release corticosteroids in the 3 months prior to screening visit;
- •Patients unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments;
- •Patients being treated with anti-IgE antibodies;
- •Patients treated with LABA or ICS/LABA fixed combination in the 24 hours before visit 1;
- •Patients having received an investigational drug within 2 months before the screening visit;
- •Inability to comply to study procedures or to study treatment intake;
- •Inability to carry out a valid spirometry;
- •Severe asthma exacerbation in the last month before screening visit;
- •Severe asthma exacerbation during the run-in period.
结局指标
主要结局
Time to first severe asthma exacerbation
时间窗: At each clinic visit
次要结局
- Number of severe asthma exacerbations Number of hospitalization Asthma symptoms Rescue medication LFTs(At each clinic visit)
研究者
研究点 (207)
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