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Real world evidence on Asthama Inhaler

To compare and assess the safety and effectiveness of Fluticasone furoate + Vilanterol (MDI) with usual care (other ICS + LABA MDI) in patients with asthma in real-world setting.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/06/053990
Enrollment
1000
Registered
2023-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J459- Other and unspecified asthma

Interventions

None listed

Sponsors

Zydus Healthcare Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients eligible for medication

Exclusion criteria

Exclusion criteria: Hypersensitivity to active substance Primary treatment of status asthmatics or acute episodes of asthma where intensive measures are required Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception

Design outcomes

Primary

MeasureTime frame
Spirometry changes Quality of Life Questionnaire Number of rescue medication-free days during the treatment period Global impression of change in the disease condition by the patients at 12 weeks Modified Physician’s Global Evaluation of Treatment Effectiveness (mGETE) at 12 weeks Adverse and Serious adverse events reported during the study duration Asthma exacerbations reported during the study durationTimepoint: Baseline, 4 weeks & 12 weeks—

Secondary

MeasureTime frame
NATimepoint: NA—

Countries

India

Contacts

Public ContactDr Shwetal Sanghvi

Insignia Communications Pvt. Ltd.

drshwetal@insigniacom.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026