Study To evaluate safety and tolerability of FDC of Fluticasone Furoate 100 or 200mcg and Vilanterol Trifenatate 25mcg Dry Powder Inhaler capsules in patients with Asthma.

A Post-Marketing Active Surveillance Of The FDC Of Fluticasone Furoate 100 or 200 mcg and Vilanterol Trifenatate 25mcg Dry Powder Inhaler Capsules In Patients With Asthma. - none

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/10/075840

Enrollment

200

Registered

2024-10-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: J455- Severe persistent asthma

Interventions

Intervention1: FDC of Fluticasone Furoate 100mcg + Vilanterol Trifenatate 25mcg: FDC Fluticasone Furoate 100mcg + Vilanterol Trifenatate 25mcg Dry Powder Inhaler 1 capsules Once daily in patients with

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients/LAR willing and able to provide data sharing consent 2.Patients of either gender of 12 years or above with Asthma where use of combination medicinal product (LABA and ICS) is appropriate as per prescribing information 3.Patients suitable to participate in the PMS as per Investigators discretion

Exclusion criteria

Exclusion criteria: 1. Patients having history of hypersensitivity to fluticasone or vilanterol or any of the excipients. 2. Primary treatment of status asthmaticus or asthma requiring intensive measures. 3. Severe hypersensitivity to milk proteins or any ingredients.

Design outcomes

Primary

Measure	Time frame
Adverse events (serious/ non-serious, expected/ unexpected, related/ non-related)Timepoint: Baseline, Week 4, Week 8 and Week 12	—

Secondary

Measure	Time frame
Adverse events (serious/ non-serious, expected/ unexpected, related/ non-related)Timepoint: Baseline, Week 4, Week 8 and Week 12;Change in PEFRTimepoint: Week 4, Week 8 and Week 12;Change in ACQ-5 scoreTimepoint: Week 4, Week 8 and Week 12	—

Countries

India

Contacts

Public ContactMr Abhijit Vaidya

Cipla Ltd

sandesh.sawant3@cipla.com02223025006

Outcome results

None listed

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