Health Condition 1: null- Bronchial Asthma
Conditions
Interventions
Intervention1: Seratrodast 80 mg: Seratrodast 80 mg once in a day orally is New proposed treatment for asthma for 28 days
Control Intervention1: Monteleukast 10 mg: Monteleukast 10 mg once in a day or
Sponsors
Zuventus Healthcare Ltd
Genelife Clinical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1 Non-smoking male or female patients between 18 and 65 years of age. 2 Patients with active bronchial asthma, of mild to moderate severity, as defined by the National Asthma Education and Prevention Program. a FEV1 60% of predicted normal value. b. Morning PEF 60% of predicted value. c. FEV1 and PEF requirements of items a and b are achieved with the lowest dose of an inhaled steroid as monotherapy. 3. Patients should be expectorating sputum of 20 g/d for at least 2 weeks prior to study. 4. Patients willing to give written informed consent and willing to comply with trial protocol.
Exclusion criteria
Exclusion criteria: 1 Patients with a known history of hypersensitivity to study medications 2 Patients receiving a course of oral or inhaled high dose corticosteroids or any other anti inflammatory drugs such as sodium cromoglycate or nedocromil sodium during the previous 4 weeks 3 Patients receiving either a short acting or a long acting beta2 agonists either as monotherapy inhaler puffs or in combination with an corticosteroid as inhaler puffs 4 Patients receiving a course of antibiotics or mucolytic agents during the previous 4 weeks 5 Patients showing evidences of pulmonary infection on chest radiograph and sputum bacteriology bacteria more than 107 per mL 6 Females that are pregnant breast-feeding or not using birth control and are sexually active 7 Serious systemic disorders incompatible with the study either acute or chronic affecting any other target organ in the human body 8 Patients with history of poorly controlled associated disease such as: heart disease thyroid disorders coagulation disorders and hematologic problems etc. 9 Historyof cancer 10 Patients who are otherwise judged inappropriate for inclusion in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients showing an improvement in the severity of asthma clinical symptomsTimepoint: Proportion of patients showing an improvement in the severity of asthma clinical symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in the muco ciliary clearanceTimepoint: 4 Week;Mean change from baseline in the sputum parameters quantity viscolasticity and eiosinophil cationic proteinTimepoint: 4 Week;Mean change from baseline in the various lung function parametersTimepoint: 4 Week;Proportion of patients with adverse events associated to the drugTimepoint: 4 Week | — |
Countries
India
Contacts
Public ContactDr Ashish Indani
Genelife Clinical Research
Outcome results
None listed