Adverse effects of long-acting beta-agonists in asthma (MAELABA) V4.0

  • Research type

    Research Study

  • Full title

    Mechanisms of adverse effects of long-acting beta-agonists in asthma

  • IRAS ID

    255755

  • Contact name

    Sebastian L Johnston

  • Contact email

    s.johnston@imperial.ac.uk

  • Sponsor organisation

    Imperial College London

  • Eudract number

    2019-003036-23

  • Duration of Study in the UK

    1 years, 0 months, 0 days

  • Research summary

    Asthma is a chronic condition that continues to cause severe illness and a significant number of deaths worldwide. Beta-agonists, which are a type of drug commonly used in the treatment of asthma, help to improve asthma symptoms by relaxing and opening the narrowed airways of asthmatic patients. Recent laboratory studies have suggested that beta-agonists may also have a negative effect in asthma as they can increase the levels of molecules that cause inflammation. The proposed research study will investigate whether the beta-agonist salmeterol causes an increase in the amount of inflammation in the lungs of asthmatic patients and whether using salmeterol combined with the inhaled corticosteroid (ICS) fluticasone causes the inflammation in the airways to decrease. The findings may have important implications for the way in which we prescribe and administer these medications for asthma patients.

    Adults with mild asthma who are not on any regular asthma treatment will be eligible for the study. Patients will be recruited over 12 months and will be enrolled in the study for approximately 7 weeks. The aim is to recruit 24 patients. As part of the study, they will undergo treatment with inhaled salmeterol for 2 weeks and treatment with inhaled salmeterol/fluticasone combined for 2 weeks. At various time intervals, participants will undergo the following tests: bronchoscopy, histamine challenge, exhaled nitric oxide, sputum induction, spirometry, full lung function testing, blood tests. Initial testing will also include a chest x-ray, electrocardiogram, urine pregnancy test for female participants and skin-prick testing. The study will be conducted by a research team from Imperial College London and will take place in St Mary’s Hospital, Imperial College Healthcare NHS Trust, London, UK.

  • REC name

    London - Fulham Research Ethics Committee

  • REC reference

    19/LO/1677

  • Date of REC Opinion

    2 Dec 2019

  • REC opinion

    Further Information Favourable Opinion