Levels of inhaled medicines in asthma and COPD patients, v1

  • Research type

    Research Study

  • Full title

    An investigation of drug concentrations in hair and sweat of subjects with respiratory diseases following the exposure of inhaled chronic respiratory therapies as a future means of assessing treatment related compliance (15-503).

  • IRAS ID

    188346

  • Contact name

    Adeep Puri

  • Contact email

    rec@hmrlondon.com

  • Sponsor organisation

    GSK

  • Eudract number

    2000-123456-78

  • Duration of Study in the UK

    1 years, 0 months, 0 days

  • Research summary

    Many treatments for asthma and chronic obstructive pulmonary disease (COPD) need to be inhaled. Studies have shown that, often, people don’t take inhaled medicines as prescribed by their doctor. If asthmatics or people with COPD don’t take their medication as prescribed, they may increase their risk of having an asthma attack or a severe episode of COPD.

    A simple and accurate method for measuring levels of inhaled medicines would help doctors better understand how regularly patients take their medication. We’re doing this study to collect samples of head hair and sweat from people with asthma or COPD, who take an inhaled medicine. We aim to find out if inhaled medicines can be detected in hair and sweat, if the levels of those medicines in hair and sweat vary with dose and if hair samples can be used to monitor patients' use of inhaled medicines. This is not a study of a medicine.

    We'll take hair and sweat samples from 200 adults with asthma or COPD who have been taking an inhaled medicine, as prescribed by their doctor, for at least 6 weeks. Participants will make 1 outpatient visit to HMR.

    A pharmaceutical company GlaxoSmithKline is funding the study.

    The study will take place at 1 centre in London.

  • REC name

    East Midlands - Derby Research Ethics Committee

  • REC reference

    15/EM/0462

  • Date of REC Opinion

    15 Oct 2015

  • REC opinion

    Further Information Favourable Opinion