None listed
Conditions
Interventions
Intervention1: ACEBROPHYLLINE 200 MG SR + MONTELUKAST 10mg: 200mg &
10mg
Control Intervention1: ACEBROPHYLLINE 200 MG SR: 200mg
Sponsors
Ravenbhel Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: &#9632; All patients with duly filled in ICFs [Informed Consent Forms] &#9632; Ages: > 15 years and < 80 years &#9632; Genders Eligible for Study: both &#9632; The patients who had been prescribed asthma medication for 1 year or more &#9632; The patients with FEV1 of 50% or more of predicted values. &#9632; The patients with a poor asthma control defined by a score of 1.5 or greater on the Asthma Control Questionnaire [ACQ] &#9632; Female patients still menstruating with acceptable mode of contraception
Exclusion criteria
Exclusion criteria: ? Patients unwilling to sign on ICF ? Participation in other trials, ? Patients with a history or showing the presence of other lung disease that would be responsible for bronchial asthma ? Patients having received oral corticosteriods, leukotriene antagonist or Acebrophylline within 28 days of commencement of trial ? Patients having previous or current smoking history of more than 10 cigarrettes per day ? Patients requiring aspirin, corticosteroids, warfarin, ticlopidine or any other drug that affects absorption of the study drugs ? Pregnancy or breast feeding, ? Inadequate contraception, ? Dementia, Depression or any other functional disorder ? Alcohol or drug dependence, ? Concomitant serious medical condition, ? Hypersensitivity to Acebrophylline or Montelukast or any other leukotriene antagonists ? Any other serious diseases having fatal progression. ? Clear diagnosis of kidney or liver disease, abnormal kidney or liver function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main efficacy variable prospectively sought in the protocol will be change from baseline to end point in the combined scores of the following scales: 1. ACQ ? Asthma control questionnaire 2. To establish this, we will be using the standardized Mini-Asthma-Quality-of-Life Questionnaire [Mini AQLQ] comprising of 15 questionsTimepoint: 14,28,42&56 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary variables will be clinical global impression items: o 1 (severity of condition), o 2 (global improvement or deterioration), and o 3 (overall treatment assessment, risk or benefit) and Responder rate, defined as >50% reduction in Episodes of Poor Asthma Control [EPAC] from the baseline. The treatment responders must report >50% reduction in EPAC in at least 2 visits excluding baseline visit.Timepoint: 14,28,42&56 days | — |
Countries
India
Contacts
Public ContactDr. Nitin Rathod
Outcome results
None listed