A Multicentric, Comparative Controlled, Open Label, Randomized, Parallel-Group, Phase III Study to Evaluate the Safety and Efficacy of FDC containing Montelukast plus Acebrophylline and Montelukast alone in Patients Suffering From Chronic Asthama
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biocon Ltd
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Clinical improvements are the primary end-points and are defined as patients who has:
研究概览
简要总结
This was a Multicentric, Randomized, Parallel-Group Study to compare the efficacy of FDC containing montelukast plus acebrophylline and montelukast alone in Patients Suffering From Chronic Asthama. This study was conducted at three centers in India. 200 patients has taken part in the study.
Efficacyresults: Statistical analysis reveals that the test product is more efficaciousthan the comparator.
Safetyresults: No specific safety concern has emerged from the analysis of the safetydataset submitted for the treatment groups. However, it should be rememberedthat the FDC tablet is intended to be used in chronic asthma patients betweenthe age group of 18 to 64 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 64.00 Year(s)（—）
- 性别
- All
入选标准
- •i) Male and female patients in the age group of 18- 64 years.
- •ii) Patients clinically diagnosed as suffering from mild asthma as indicated by an FEV1 between 60 and 85% of predicted.
- •iii) Requiring inhaled ß2-agonists on an as-needed basis iv) Stable asthma; there should have been no exacerbations or need for any other treatment for one month, and no hospitalizations for asthma should have occurred with-in 3 months of the pre study visit.
- •v) Nonsmokers for at least 1 yr (with a smoking history of no more than 10 pack-yrs) vi) ACT score 19 [18,19] vii)ACQ score 1.5 [20] viii)Subjects or legal representatives willing to give informed consent.
- •ix) Patient must not have received any drug similar to active or comparator group within 2 weeks of commencement of the study.
- •x)Females of childbearing potential should have a negative pregnancy test at the pre study visit and should agree to use contraception during the study.
排除标准
- •i)History of hypersensitivity reaction or any specific groups.
- •ii)Presence of severe hepatic or renal disorders, iii)Pregnancy or lactation iv)Alcoholics and heavy smokers.
- •v)Patients on following medications: Anticonvulsant drugs, Rifampicin, Erythromycin /other macrolides, Ciprofloxacin (not ofloxacin) Cimetidine (not ranitidine).
- •vi)Patients on anti TB drugs and or diagnosed to be suffering from tuberculosis.
- •vii)Patients suffering from HIV infection.
结局指标
主要结局
Clinical improvements are the primary end-points and are defined as patients who has:
时间窗: 28 days
1.Improvement in pulmonary function test (FEV1 & FEV1/ FVC)
时间窗: 28 days
2.Improvement in Asthma Control Tests Score (Appendix IV)
时间窗: 28 days
3.Improvement in Asthma Control Questionnaires Score (Appendix V)
时间窗: 28 days
4.(Reduction in) Number of as-needed ß2-agonist puffs used
时间窗: 28 days
5.Percentage of unscheduled or emergency asthma-related (primary care) consultations during the study period
时间窗: 28 days
次要结局
未报告次要终点