Safety and Efficacy of Fluticasone Furoate and Vilanterol Powder in the treatment of Patients with Asthma

A Multi-Centric, Active Post Marketing Surveillance Study to Assess the Safety and Efficacy of Fluticasone Furoate and Vilanterol Powder for Inhalation for the Treatment of Patients with Asthma - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/08/073060

Enrollment

325

Registered

2024-08-29

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: J454- Moderate persistent asthma

Interventions

Intervention1: Fluticasone Furoate and Vilanterol Powder for Inhalation (200 mcg + 25 mcg).: Capsules are to be used through Octahaler for inhalation once daily for 12 weeks treatment duration. Capsul

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either gender, aged between greater than or equal to 12 to lesser than or equal to 84 years 2. Patients with confirmed diagnosis of asthma at least 12 weeks prior to enrollment of the surveillance 3. Patients with asthma where use of a combination medicinal product [long-acting beta2-agonist (LABA) and inhaled corticosteroid (ICS)] is appropriate in opinion of treating physician based on prescribing information (PI) and inadequately controlled on combination of low to medium dose ICS and LABA 4. Patients/Legally acceptable representatives (LAR) are willing to provide informed consent (and assent for patients aged greater than or equal to 12 years and lesser than 18 years) to collect the surveillance data

Exclusion criteria

Exclusion criteria: Exclusion of patients from surveillance will be done as per below listed criteria and prescribing information: 1. Patients with history of intolerance or hypersensitivity to any of the components of Fluticasone Furoate and Vilanterol Powder for Inhalation 2. Patient with history of moderate to severe hepatic impairment, cardiac arrhythmias, pulmonary tuberculosis, and ocular disorder (such as cataract, glaucoma etc.) 3. Patient with any clinically significant disorder that, in the opinion of the treating physician would result in jeopardizing patient safety or his/ her inability to understand and comply with the requirements of the surveillance 4. Pregnant women and nursing mothers

Design outcomes

Primary

Measure	Time frame
1.Proportion of patients with Treatment Emergent Adverse Events (TEAEs)Timepoint: Throughout the study period	—

Secondary

Measure	Time frame
1. Change from Baseline in forced expiratory volume in 1 second (FEV1)Timepoint: Baseline, Weeks 4, 8 and 12;2. Change from Baseline in forced vital capacity (FVC)Timepoint: Baseline, Weeks 4, 8 and 12	—

Countries

India

Contacts

Public ContactDigambar Tornale

Sun Pharma Laboratories Limited

shruti.saha@sunpharma.com02243244324

Outcome results

None listed

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