A clinical trial to study the effects of Seratrodast in patients with Asthma
- Conditions
- Health Condition 1: null- Bronchial Asthma
- Registration Number
- CTRI/2013/03/003504
- Lead Sponsor
- Zuventus Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
aFEV1 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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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