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

Phase 4

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

• Registration Number: CTRI/2024/04/066334
• Lead Sponsor: Central Research And Publication Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Age: 18 – 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

Acute exacerbations of asthma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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