Comparison of inhalational new drug vilanterol fluticasone furoate combination with salmeterol fluticasone furoate combination for reversible respiratory obstructive disease.

A randomized controlled trial to compare safety and efficacy of inhalational long acting Î²2 agonist Vilanterol with fluticasone furoate against Salmeterol with fluticasone furoate in adult patients with reversible obstructive airway disease. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066334

Enrollment

Registered

2024-04-25

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified

Interventions

Intervention1: 1.Vilanterol with Fluticasone Furoate 2.Salmeterol with Fluticasone Furoate: 1.Vilanterol with Fluticasone Furoate OD for 4 weeks 2.Salmeterol with Fluticasone Furoate BD for 4 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Age: 18 â?? 60 years of age. Clinically diagnosed patients of chronic obstructive airway disease with FEV 1 between 40% to 85% of the predicted normal value.

Exclusion criteria

Exclusion criteria: Acute exacerbations of asthma.

Design outcomes

Primary

Measure	Time frame
To compare efficacy of once daily VI/FF against twice daily SAL/FF in adult patients with chronic obstructive airway disease.Timepoint: At Baseline then at 7 days and then at end of 4 Weeks	—

Secondary

Measure	Time frame
1. To assess the safety & tolerability of FF/VI compared to FP/SAL by analyzing adverse events, serious adverse events during 4 weeks. 2.To investigate the impact of FF/VI vs. FP/SAL on health outcomes, such as Asthma Quality of Life Timepoint: At beginning then after 7 days & finally at the end of 4 weeks.	—

Countries

India

Contacts

Public ContactDr Jayshree Shriram Dawane

Bharati Vidyapeeth DTU Pune

jayshree.dawane@bharatividyapeeth.edu9850817154

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026