STIFLE

• Research type

  Research Study

• Full title

  A 24-week Randomised Exploratory Open-Label Study Aiming To Characterise Changes In Airway Inflammation, Symptoms, Lung Function,And Reliever Use In Asthma Patients Using SABA (Salbutamol) Or Anti-Inflammatory Reliever (SYMBICORT®1) As Rescue Medication In Addition To SYMBICORT As Daily Asthma Controller

• IRAS ID

  250245

• Contact name

  Jessica Bainbridge

• Contact email

  jessica.bainbridge@parexel.com

• Sponsor organisation

  Astra Zeneca AB

• Eudract number

  2018-003467-64

• Duration of Study in the UK

  1 years, 5 months, 1 days

• Research summary

  Asthma is a common lung condition that causes occasional breathing difficulties. It affects people of all ages and often starts in childhood, although it can also develop for the first time in adults.

  Asthma is usually treated using an inhaler, which is a small device that lets the patient breathe in the asthma medicine.

  The main types of inhalers are:
  • preventer – used every day to prevent asthma symptoms from occurring
  • reliever – used when needed to quickly relieve asthma symptoms

  In addition, some people also take other medication to control their asthma.

  AstraZeneca AB is doing this research using medications called Symbicort® and Ventolin®. None of the medications that will be used in this study are new. All of them have been approved for use in clinical practice by European and UK Health Authorities, based on their proven safety and efficacy profile. Therefore, the risks involved in taking any of the medications is the same as if they were prescribed by the family doctor outside of the study.

  Studies have shown that the use of Symbicort® as both preventer treatment (morning and evening doses) and as a reliever treatment provides good control of asthma and reduces asthma attacks. When Symbicort® is used in this way the mechanism behind the benefit is not understood.

  The purpose of this exploratory study is to better understand the daily changes in inflammation, asthma symptoms, lung function tests and use of asthma medication measured daily at home and at a few clinical visits.

  The study is planned to go on for approximately 17 months and include around 60 to 80 patients with asthma from the United Kingdom.

• REC name

  HSC REC A

• REC reference

  18/NI/0233

• Date of REC Opinion

  24 Dec 2018

• REC opinion

  Favourable Opinion