An Observational Post Marketing study to check the safety and tolerance of Alerfix Total in patients with Asthma

Not Applicable

Completed

• Conditions: Other and unspecified asthma, 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

This is Randomized, Open Label and multicentre study, designed to evaluate the efficacy and safety of study drug Alerfix Total.

This study will include patients with NSRS with asthma by their treating physician in accordance with the respective local prescribing information and routine clinical practice

The patients treated with Alerfix Total will be followed for assessment of safety parameters throughout the study (2 weeks).

Visual analog scale scores will be assessed at baseline (Day 1 before the treatment), day 7 and at end of the treatment (day 14).Quality of life will be assessed at baseline (Day 1 before the treatment), day 7 and at end of the treatment (day 14). Adverse events will be recorded throughout the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-09
• Last Update Posted: 2018-11-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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 “INDICATION & USAGE†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.

Exclusion Criteria

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.	Not Applicable

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (6)

Devi Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Kanoria Hospital & Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Poojan Multispeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Prisha Medical Care; 🇮🇳 Ahmadabad, GUJARAT, India

Sanjivani Super Speciality Hospitals Pvt. Ltd.; 🇮🇳 Ahmadabad, GUJARAT, India

Shri Umiya Multispeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Devi Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Kamlesh Fatania

Principal investigator

09825466788

drkamlesh_fatania@yahoo.co.in