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

Trial description: Growing evidence indicates that adherence and compliance to inhaled drug treatment remains a challenge for both Chronic obstructive pulmonary disease (COPD) and asthma, as compared to oral therapies. There is currently no robust quantitative or semi-quantitative way of assessing patient compliance for inhaled products used to treat respiratory disease. Human head hair grows at the rate of approximately 1 centimeter/month, offering the potential to detect and monitor drug deposition in the hair as it grows. The aim of this exploratory study is to establish whether human head hair or human sweat samples can be used as a means to detect and if possible to quantify the accumulated inhaled respiratory drug concentrations. This will be a pilot study to assess the concentration of marketed inhaled drug products in head hair and sweat (finger smears and scalp) taken by subjects as part of their prescribed therapy for the treatment of COPD/asthma. No investigational medicinal product is being assessed in this study. It is anticipated that successful detection of inhaled therapies in hair or sweat over time should allow assessment against patient reported adherence to therapy or direct physician assessment of compliance and the rationale will be to apply this methodology to collect adherence data in clinical programmes designed to measure and compare compliance to different dose regimens and treatments. Approximately 200 adult subjects with asthma or COPD, on their current inhaled medication consistently (same strength and dosage interval) for at least 6 weeks prior to the study visit will be enrolled. The study consists of a single visit to a clinical unit for the collection of hair and sweat samples. There will be no additional visits or follow-up.