A study to compare the Safety and Efficacy of fixed dose combination containing montelukast and acebrophylline and montelukast alone in Patients Suffering From Chronic Asthma

Phase 3

Completed

Conditions: Health Condition 1: null- Patients Suffering From Chronic Asthama

Registration Number: CTRI/2011/10/002054

Lead Sponsor: Biocon Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical improvements are the primary end-points and are defined as patients who has: <br/ ><br> <br/ ><br>1.Improvement in pulmonary function test (FEV1 & FEV1/ FVC) <br/ ><br>2.Improvement in Asthma Control Tests Score (Appendix IV) <br/ ><br>3.Improvement in Asthma Control Questionnaires Score (Appendix V) <br/ ><br>4.(Reduction in) Number of as-needed ß2-agonist puffs used <br/ ><br>5.Percentage of unscheduled or emergency asthma-related (primary care) consultations during the study periodTimepoint: 28 days

Secondary Outcome Measures