An Observational Post Marketing study to check the safety and tolerance of Alerfix Total in patients with Asthma
- Conditions
- Health Condition 1: J459- Other and unspecified asthmaHealth Condition 2: null- Patients with Cough and/or wheeze and/or chronic dyspnoea with asthma.
- Registration Number
- CTRI/2017/09/009643
- Lead Sponsor
- Eris Life sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Men or Women, between 18 to 80 years of age (both inclusive).
2.The patient experiencing Cough and/or wheeze and/or chronic dyspnoea or any other symptoms of NSRS with asthma
3.Patient indication and disease condition according to the â??INDICATION & USAGEâ?? as mentioned in the package insert available with Alerfix Total
4.Women of childbearing potential using an acceptable method of birth control.
5.Willing to give written informed consent for participation in the study and to comply with the study procedures
1.Evidence of active liver disease or SGPT > 2.5 times upper limit of normal (ULN)
2.Evidence of renal impairment (Serum creatinine levels more than 2.0 mg /dl)
3.Pregnancy
4.Malignancy
5.Contraindication as mentioned in package insert
6.Patients with medical conditions that preclude the follow-up as defined in the protocol or otherwise limits participation in this study
7.Patients with known history of hypersensitivity to the study drug
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To explore the overall safety profile of Alerfix total, as measured by adverse events and Questionnaires, in patients with NSRS and asthma under conditions of routine medical practice.Timepoint: Not Applicable
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable