A study to assess the control of asthma and ease of use of inhaler device (Synchrobreathe) with the medicine (Seroflo-Salmetrol/Fluticasone FDC) in routine clinical practice

Phase 4

Completed

• Conditions: Health Condition 1: J709- Respiratory conditions due to unspecified external agent

• Registration Number: CTRI/2018/12/016629
• Lead Sponsor: Cipla Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-04-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 490

Inclusion Criteria

1.A voluntarily given, written signed dated informed data sharing consent from patients and/or legally acceptable representative

2.Patients of either gender of age 12 years and above

3.Subjects with documented diagnosis of asthma who are treatment naïve or uncontrolled due to poor inhaler technique

4.Able and willing to comply with all study requirements

5.Patients suitable for study as per Investigator and eligible to start treatment with Salmeterol/Fluticasone FDC administered through Synchrobreathe

Exclusion Criteria

1.Hypersensitivity to study drug and/or its components

2.Acute episode of asthma where intensive measures were used or primary treatment of status asthmaticus

3.Patients experienced with the use of Synchrobreathe device

Study & Design

• Study Type: Observational
• Study Design: Not specified