Phase III Therapeutic Evaluation Study Comparing the Efficacy and Safety of the Fluticasone/Salmeterol (500/50 μg) Combination Administered With Elpenhaler® (Rolenium®) Versus the Innovative One (Seretide Diskus®) in Patients With Asthma.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 5
- 主要终点
- The primary variable will be the 12-hour average FEV1 [area under the FEV1 versus time curve divided by 12 (FEV1 AUC0-12/12)].
研究概览
简要总结
The aim of this study is to establish the therapeutic equivalence between the test (Fluticasone/Salmeterol administered with Elpenhaler®, Rolenium®) and the reference formulation (Seretide®, administered with Diskus®), both containing 500/50μg of the Fluticasone/Salmeterol combination.
The study will be conducted in a randomized, double-blind, double-dummy, 2x2 crossover fashion.
详细描述
In case of inhaled products, it is not possible to follow the classic scheme, based on similarity of plasma concentration-time behavior of parent drug in assessing bioequivalence.
For this reason, a pharmacodynamic study was designed in order to assess the therapeutic equivalence of the new formulation of Fluticasone/Salmeterol with the innovative one. The test and reference Fluticasone/Salmeterol formulations will be compared in terms of their bronchodilator effects in lung function. Forced Expiratory Volume in 1 second (FEV1) will be the primary efficacy measure and will be measured in such a way that a similar time-dependent increase in pulmonary function can be demonstrated for both Fluticasone/Salmeterol formulations in patients with asthma. In terms of safety comparison, repeated measurements of adverse events, vital signs, heart rate, blood hematology and biochemistry as well as ECG changes will enable the establishment of the similar safety profile of the test and reference Fluticasone/Salmeterol combinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-65 years,
- •diagnosis of asthma of 6 months,
- •FEV1 ≥ 50% and ≤ 80% predicted,
- •reversibility of at least 12%,
- •stable asthma for at least 4 weeks,
- •inhaled steroids (ICS) at a stable dose within the previous 30 days,
- •PIF 30 - 90 lt/min and
- •informed consent.
排除标准
- •history of other pulmonary disease,
- •asthma exacerbation or respiratory infection within the previous 4 weeks,
- •hospitalization for acute asthmatic symptoms requiring parenteral steroids or oral steroid dose increase, within the previous 30 days,
- •heavy smokers,
- •change of asthma medication within the previous 4 weeks,
- •seasonal asthma alone,
- •history of severe heart disease,
- •pregnancy or lactation,
- •use of a β-blocker, of a NSAID or an antiallergic/antihistaminic medication within 2 weeks prior to screening visit.
研究组 & 干预措施
Elpenhaler Active - Diskus Placebo
Patients on treatment with both devices, Elpenhaler and Diskus, first active substance, second placebo.
干预措施: Elpenhaler active - Diskus placebo (Drug)
结局指标
主要结局
The primary variable will be the 12-hour average FEV1 [area under the FEV1 versus time curve divided by 12 (FEV1 AUC0-12/12)].
时间窗: 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days)
To establish the therapeutic equivalence between the Fluticasone/Salmeterol combination administered with Elpenhaler® (Rolenium®) and the innovative one (Seretide Diskus®) in terms of their bronchodilator effect in lung function.
次要结局
- Time to peak FEV1(0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days))
- The FEV1 values over time for the 12-hour observation period(0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days))
- Time to peak FEV1 maximum value(same as FEV1)