RESPO STUDY

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RESPO STUDY

Introduction

The goal of asthma treatment is to achieve and maintain control of asthma and reduce the future risk of exacerbations. Inhaled corticosteroids (ICS) are considered the most effective anti-inflammatory treatment for all severities of persistent asthma. More specifically, for children less than 5 years of age and for adolescents with uncontrolled asthma, low-dose ICS and add-on long-acting beta-agonist (LABA) therapy are considered effective.

Purpose

The goal of asthma treatment is to achieve and maintain control of asthma and reduce the future risk of exacerbations. Inhaled corticosteroids (ICS) are considered the most effective anti-inflammatory treatment for all severities of persistent asthma. More specifically, for children less than 5 years of age and for adolescents with uncontrolled asthma, low-dose ICS and add-on long-acting beta-agonist (LABA) therapy are considered effective.

Actions

  • The study will be conducted for a total duration of approximately 29 weeks: a 4-week run-in period, a 24-week double-blind treatment period and a 1-week follow-up period.
  • Subjects will be randomized to receive FF / VI or FF administered via ELLIPTA® dry powder inhaler (DPI). The dose of FF / VI and FF alone will be selected based on the age of the subjects. A total of 870 subjects will be randomized, of which 652 will be aged between 5 and 11 years (cohort A) and 218 will be aged between 12 and 17 years (cohort B).

Primary objectives:

  • Cohort A: change from baseline (PEF) determined in a pre-dose phase (average) in weeks 1-12 of the treatment period
  • Cohort A and B: Change from baseline in FEV1 at week 12

Secondary objectives:

    • Cohort A and B: Change from baseline in asthma control (ACQ-5) at week 24
    • Cohort A and B: Number of subjects with incidence of exacerbations over the 24-week treatment period
    • Cohort A and B: number of subjects with adverse events and serious adverse events up to week 25
    • Cohort A and B: number of subjects with abnormal ECGs
  • Cohort A and B: Number of subjects with abnormal fasting blood glucose levels.

CNR STAFF

Stefania La Grutta Research Director

Velia Malizia Researcher

Giovanna Cilluffo Researcher

 

Partners involved:

 

 

Funded and coordinated by :      
Sponsored by: