To compare the efficacy of FOSTER vs FOSTER plus SALBUTAMOL

• Research type

  Research Study

• Full title

  A 48-week, multicentre, multinational, randomized, double-blind, 2-arm parallel group study, comparing the efficacy of FOSTERTM for maintenance and reliever versus fixed-dose FOSTERTM for maintenance + salbutamol as reliever in asthmatics =18 years of age.

• IRAS ID

  11427

• Sponsor organisation

  Chiesi Farmaceutici S.p.A

• Eudract number

  2008-004671-22

• Clinicaltrials.gov Identifier

  00861926

• Research summary

  The aim of asthma treatment is to control inflammation of the respiratory tract and to relieve the symptoms related to asthma. Hence asthma treatment commonly involves inhaled corticosteroids (which are drugs that control the inflammation of the airways) and inhaled bronchodilators (which are drugs that open the airways and make breathing easier).A new asthma management approach consists of taking a maintenance dose of a fixed combination of an inhaled corticosteroid (ICS) plus a long acting ǟ÷2-agonist (LABA) for asthma control. Additional doses of the same combination are taken if symptoms occur, without the need to take a separate short acting ǟ÷2-agonist, for example, salbutamol. This management approach is referred to as Maintenance And Reliever Therapy (MART). This approach makes it possible to give the patients both a rapid symptom relief and an anti-inflammatory effect through a drug which tapes the inflammation burden as soon as it starts.The aim of this study is to support the use of FosterTM as rescue medication in case of asthma worsening by comparing the efficacy of MART approach (FosterTM 100/6æg, (one inhalation twice a day) plus additional inhalations as needed), with FosterTM 100/6æg, (one inhalation twice a day) plus salbutamol (100 æg/inhalation as needed).Asthma is a serious, sometimes life-threatening respiratory disease that affects the quality of life for millions of people. Although there is no cure for asthma yet, asthma can be controlled through medical treatment. The management of asthma is currently focused on achieving optimal asthma control and reducing exacerbations. Up until now, people with asthma may have taken medication from one or two inhalers every day for prevention and control of their asthma, and another inhaler to relieve symptoms such as cough and wheeze. Current asthma maintenance therapies, such as inhaled corticosteroid (ICS) and long acting ǟ÷2-agonist (LABA) combination products are generally prescribed on a fixed-dose basis. It is common clinical practice to administer combination therapy once or twice daily at a dose that is related to the severity of asthma and to use a short-acting ǟ÷2-agonist (SABA), such as salbutamol or terbutaline, as required to relieve any breakthrough symptoms.A new asthma management approach consists of taking a maintenance dose of a fixed combination of ICS/LABA for asthma control and additional doses of the same combination are taken if symptoms occur, without the need to take a separate SABA. This management approach is called Maintenance And Reliever Therapy (MART). MART studies demonstrated that patients using this new approach took no extra inhaled steroids, needed less oral steroids compared to other traditional asthma treatment approaches and also experienced fewer asthma attacks.In this study, the efficacy of MART approach with FOSTERTM 100/6 æg, (one inhalation bid) plus additional inhalations as needed, will be compared with the traditional way of asthma treatment: FOSTERTM 100/6 æg, (one inhalation bid) plus salbutamol 100 as reliever (100 æg/inhalation as needed) in not fully controlled asthmatics.

• REC name

  West of Scotland REC 1

• REC reference

  09/S0703/1

• Date of REC Opinion

  7 Jan 2009

• REC opinion

  Favourable Opinion