Asthma Control Assessment Via ACT and DRC in Asthmatics Treated With Seretide (50/250) Over 12 Weeks
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Percentage of Well Controlled Participants as Per Gaining Optimal Asthma Control (GOAL) Criteria After 12 Week Compared to Percentage of Participants With Asthma Control Test (ACT) Score of 20-25 for Week 9 to Week 12
研究概览
简要总结
The majority of asthma patients are not well controlled, despite the availability of asthma medication that could effectively treat the disease. In this study uncontrolled patients who are steroid-naive or on low dose inhaled corticosteroids will be treated with Seretide (salmeterol/fluticasone combination, SFC) 50/250 µg twice daily. The asthma control test (ACT) will be used to detect differences in the level of asthma control during treatment. The study aims to show a correlation between improvements of ACT und the level of asthma control which will be reached by the patients.
The aim of the study is to show that most of symptomatic asthma patients can reach 'well controlled asthma' with SFC. We get information about ACT in daily practice and physicians are trained to use the asthma control test as a screening tool and for follow up of asthma management. Correlations are expected between the improvements in ACT, Quality of Life and asthma control according to the Gaining Optimal Asthma controL (GOAL) criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SFC 50/250 mcg
Participants received the combination product, fluticasone 250 microgram (mcg) plus salmeterol 50 mcg (SFC 50/250 mcg) for 12 weeks. Study treatment was received using DISKUS™ powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
干预措施: Salmeterol/Fluticasone 50/250 mcg (Drug)
SFC 50/250 mcg
Participants received the combination product, fluticasone 250 microgram (mcg) plus salmeterol 50 mcg (SFC 50/250 mcg) for 12 weeks. Study treatment was received using DISKUS™ powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
干预措施: Salbutamol 100 mcg (Drug)
SFC 50/250 mcg
Participants received the combination product, fluticasone 250 microgram (mcg) plus salmeterol 50 mcg (SFC 50/250 mcg) for 12 weeks. Study treatment was received using DISKUS™ powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
干预措施: DISKUS™ powder inhalers (Device)
结局指标
主要结局
Percentage of Well Controlled Participants as Per Gaining Optimal Asthma Control (GOAL) Criteria After 12 Week Compared to Percentage of Participants With Asthma Control Test (ACT) Score of 20-25 for Week 9 to Week 12
时间窗: Week 9 to Week 12
A week with well controlled asthma, when two or more of the criteria were fulfilled (diary entries): At most 2 days per week with 24-hour symptom score \>1 (Range: 0= None to 5= severe), rescue salbutamol use on \<= 2 days and at most 4 occasions per week, and a morning peak flow \>= 80% of the predicted value on each day per week. All of the criteria which includes no night-time awakenings due to asthma (diary entry), no emergency visits (diary entry), no exacerbations and no treatment-related adverse events leading to treatment change are fulfilled. The total ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms are not under control.
次要结局
- Change From Baseline in Percentage of Participants With ACT Score of 20-25 at Week 12(Baseline (Visit 3) and Week 12)
- Change From Baseline in Mean ACT Score at Visit 6(Baseline (Viait 3) and Week 12)
- Number of Participants With Well Controlled and Totally Controlled Asthma at Week 12(Week 12)
- Change From Baseline in Quality of Life Using the Asthma Quality of Life Questionnaire (AQLQ)(Baseline (Visit 3) up to Week 12)
- Correlation of Change in AQLQ Score and Change in ACT Score(Week 12)
- Change From Baseline in Forced Expiratory Volume (FEV1) to Week 12(Baseline (Visit 3) up to Week 12)
- Change From Baseline in Mean Morning Percent Predicted Peak Expiratory Flow (PEF) at Week 12(Baseline (Visit 3) and Week 12)
- Change From Baseline in Mean 24-hour Symptom Score at Week 12(Baseline (Visit 3) and Week 12)
- Change From Baseline in Number of Additional Usage of Salbutamol at Week 12(Baseline (Visit 3) and week 12)
- Percent Change From Baseline in Number of Nights With no Nocturnal Awakening at Week 12(Baseline (Visit 3) and week 12)
- Number of Participants With Emergency Visits Due to Asthma(Up to week 12)
- Number of Participants With Adverse Events (AE) Leading to a Change in Asthma Treatment(Up to Week 12)
- Assessment of Tolerability by Change From Baseline of Pulse Rate(Baseline (Visit 3) up to Week 12)
- Assessment of Tolerability by Number of Participants With at Least One Treatment Emergent Serious and, Non-serious AE(Up to Week 12)
- Assessment of Tolerability by Change From Baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)(Baseline (Visit 3) up to Week 12)
- Number of Participants With Occurrence of (Near-) Incidents Associated With Peak Flow Measurements(Up to Week 12)