PROTOCOL

A multicentric, retrospective, observational, cross-sectional, survey study to analyse the

role of Fluticasone Furoate and Vilanterol Powder for Inhalation in Asthma.
Doctor:

Address:

Contact: Tel. (Res) Tel. (Off.) Fax: e-Mail:

Contact: Tel. (Res) Tel. (Off.) Fax: e-Mail:

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This document is the property of Sun Pharma Laboratories Limited and is confidential. Therefore, it
may not be photocopied, either in part or in full, or shown to any person not directly associated
either with the trial, or with the concerned ethics committee, or with the concerned regulatory
authority.
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Sun Pharma Laboratories Limited
Sun House, Plot No. 201 B/1
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Western express highway, Goregaon (E),

Mumbai- 400063, Maharashtra. India.
Tel: 43244324/1234
Fax: 43244343
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TABLE OF CONTENTS

INTRODUCTION 3
OBJECTIVES 4
METHODOLOGY 4
STUDY PROCEDURES 4
ADMINISTRATIVE MATTERS 4
REFERENCES 5

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I. INTRODUCTION

Asthma is a very common disease in worldwide population, in which almost 1 in 10 children and 1 in
12 adults are affected. According to Global Asthma Report 2018, 339 million people are affected
worldwide.1 Asthma is a chronic inflammatory disease characterized by bronchial hyper-reactivity
(BHR) which leads to overproduction of mucus, airway narrowing and airway wall remodelling by
reacting to non-specific stimuli (such as exercise and cold air) on smooth muscle cells in people with
asthma.2

According to GINA (Global Initiative for Asthma), the goal of treatment in ASTHMA is to: achieve
total control and to reduce inflammation. 3 Clinicians commonly use various pharmacological
treatments in the management of asthma to relieve symptoms, improve quality of life, enhance
exercise tolerance, prevent and treat exacerbations. The main strategy to be considered in the
pharmacological treatment of asthma are bronchodilators; short-acting bronchodilators (β -agonist
and anti- cholinergics) are given as first-line treatment and long-acting bronchodilators can be given
in more symptomatic patients with greater functional impact. 4

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The Global Initiative for Asthma (GINA) and the National Asthma Education and Prevention Program
(NAEPP) recommend a stepwise approach to achieve sufficient control of asthma, including
reduction in the risk of exacerbations. If control is not achieved, an increase in controller therapy
dose or the introduction of additional maintenance therapies are recommended. 5
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Fluticasone furoate/vilanterol is a once-daily, fixed combination of an inhaled corticosteroid (ICS)
and a long-acting β2-adrenoreceptor agonist (LABA), delivered via a dry powder inhaler. It is
approved for the treatment of asthma and COPD and is the first once-daily ICS/LABA to be available
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for this indication. Fluticasone furoate is an enhanced-affinity glucocorticoid receptor agonist, with
potent anti-inflammatory activity. Vilanterol produces rapid and prolonged bronchodilation. In
phase III trials in adolescents and adults with various levels of asthma uncontrolled on ICS and/or
ICS/LABA, fluticasone furoate/vilanterol 100/25 or 200/25 mcg once daily significantly improved
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pulmonary function compared with placebo or equivalent dosages of fluticasone furoate alone (in
some trials) or fluticasone propionate.

Below enlisted are the advantages of Fluticasone Furoate and Vilanterol in asthma: 5,6
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 First once-daily combination of ultra-long-acting inhaled β2-agonists and inhaled

glucocorticoids
 Vilanterol: Ultra-long acting (ULABA)
 FF is structurally distinct from fluticasone propionate (FP) & has both greater affinity for
glucocorticoid receptor and longer retention in respiratory tissues than FP
 Great potential to improve compliance to long-term regular inhaled therapy
 To improve the natural history and prognosis of asthma patients
There is need for evaluation of safety and efficacy of this combination in real world settings.Hence
this study is designed as a multicentre, retrospective, observational, cross-sectional, survey study to
analyse the role of Fluticasone Furoate and Vilanterol Powder for Inhalation in Asthma
I. OBJECTIVES
This observational, cross-sectional study aims to evaluate the role of Fluticasone Furoate and
Vilanterol Powder for Inhalation in Asthma.

II. METHODOLOGY

1. Design of Study: Multicentric, observational retrospective, cross-sectional survey study

2. Study Population and procedures: Chest physician and consulting physicians (CPs)

3. Study Treatment: As this is a physician’s survey, there is no active intervention required.

4. Variables for analysis

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III. Following data points will be collected:

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Variables
Basic demography Age, height, weight, BMI
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Please refer the data collection form (DCF) for full details

IV. STUDY PROCEDURES:

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DCF will be provided to the doctors across India by trained Sun Pharma personnel
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Doctors will fill in the data

Data collection form will be forwarded for analysis

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Data Analysis

The data from all participating doctors will be pooled for analysis.

V. ADMINISTRATIVE MATTERS

1. Supply of DCFs and Stationery Items

DCF will be provided
2. Source Documents
The data will be collected from physician. No medical records, outpatient registers or other records
which is maintained by the doctor will be accessed to collect data.

3. Collection of DCFs
These will be collected for data entry and analysis.
VI. References:

1.Global Asthma Report 2018, https://www.researchgate.net/publication/3 29424076_ The_

Global_ Asthma_ Report_2018

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2.Lambrecht, BN., & Hammad, H. (2015). The immunology of asthma. Nature immunology, 16(1),

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45.

3.GINA (Global Initiative for Asthma) – global strategy for asthma management and prevention,
revised. (2018). http://www.ginasthma.org. pp. 1–162. STRATEGY FOR PREVENTION, DIAGNOSIS
AND
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4. MANAGEMENT OF COPD: 2022 Report. Available at: https://goldcopd.org/2022-gold-reports-
2Accessed on 05/05/2023

5. O'Byrne PM, et al. Eur Respir J. 2014 Mar;43(3):773-82

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