A multi-centric, placebo controlled, randomized, double-blind clinical trial to evaluate the efficacy and safety of Fenspiride in treatment of moderate persistent asthma as an add on therapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Primary Outcome
研究概览
简要总结
Title:
A multi-centric, placebo controlled, randomized, double-blind clinicaltrial to evaluate the efficacy and safety of Fenspiride in treatment of moderatepersistent asthma as an add on therapy.
Study Phase: Phase III
Objectives:
The aim of this clinical study is to investigate the efficacyand safety of a 2 week treatment with fenspiride for therapy of moderatepersistent asthma in adult patients receiving regular inhaled corticosteroid.
Primary Objective
The primary objective is to assess the efficacy of fenspiridein resolution of the clinical symptoms in patients with moderate persistent asthmareceiving regular inhaled corticosteroid.
Secondary Objective
The secondary objectives of this trial include :
1. To assess theefficacy of fenspiride in improvement of pulmonary parameters in patients withmoderate persistent asthma.
2. To evaluate the safety of the investigational drug
Study Design:
Prospective, Multi-centric, Randomized, Double Blind,placebo controlled, parallel-group study
Estimated Sample Size: 120
Study endpoints:
Primary Outcome
Theprimary outcomes in the study include:
- Proportion of patients showing an improvement in the severity of clinical symptoms of asthma at the end of the study
Secondary Outcome
Thevarious secondary outcomes of this study include
- Improvement in the Lung function parameters at the end of the study (mean change from the baseline)
- Decrease in the use of short acting β2 agonist at the end of the treatment phase.
- Assessment of therapy by investigator and patients at the end of the treatment period.
- Adverse events reported by the patients during thetreatment period.
| Test Product : |
Fenspiride (80 mg)
|Comparator:
Placebo
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant Inclusion Criteria 1.Male or female patients aged 18 years or older.
- •2.Diagnosed of moderate persistent asthma which is characterized by a forced expiratory volume in 1 second (FEV1) within prediction of 60 % to 80%.
- •3.Reversibility in the measurement of peak expiratory flow rate (PEFR) 4.FEV1 > 12% after inhalation of 400 µg salbutamol, and current therapy with inhaled corticosteroid (budesonide 400 µg/day) 5.Ability to perform Spirometry.
- •6.Patients willing to give written informed consent and willing to comply with trial protocol.
排除标准
- •Participant Exclusion Criteria 1.History of other significant respiratory disease or hospitalization due to asthma within 3 months prior to enrollment in the study 2.History of smoking during 6 months preceding enrollment 3.Use of long acting anti histamines, aspirin, barbiturates, analgesics, opioid analgesics, tranquilizers, MAO inhibitors, long acting β2 agonist and alcohol during a week before enrollment in the study 4.Evidences of pulmonary infection on chest radiograph 5.Pregnancy or lactation 6.Any other clinically significant medical condition that may endanger the safety of participant or jeopardize the protocol.
- •7.Illness severe enough to require hospitalization 8.History of allergy to Fenspiride or similar compounds 9.Current or a History of Cancer.
结局指标
主要结局
Primary Outcome
时间窗: Primary Outcome | •Proportion of patients showing an improvement in the severity of clinical symptoms of asthma at the end of the study
•Proportion of patients showing an improvement in the severity of clinical symptoms of asthma at the end of the study
时间窗: Primary Outcome | •Proportion of patients showing an improvement in the severity of clinical symptoms of asthma at the end of the study
次要结局
- Secondary Outcome(•Improvement in the Lung function parameters at the end of the study (mean change from the baseline))