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

Biocon Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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.

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