Assessment of inhalation profiles in patients affected by lung disease
Research type
Research Study
Full title
Assessment of inhalation profiles in asthma and chronic obstructive pulmonary disease patients
IRAS ID
122645
Contact name
Irene Parisini
Contact email
Sponsor organisation
Univeristy of Hertfordshire
Research summary
This study will investigate the inhalation profiles of asthmatic and chronic obstructive pulmonary disease (COPD) patients using an airflow-restricting device that mimics the resistance to airflow of marketed inhalation devices. This will enable the measurement and assessment of the airflow that patients generate when they inhale through marketed devices, without exposing them to any active pharmaceutical ingredients. The airflow-restricting device consists of a disk containing five holes (each with a different diameter) within a sealed mouthpiece. By rotating the disk each aperture diameter is selected in turn, thereby providing a range of resistances through which the patient will inhale.
With informed patient consent, full lung function tests of the patients will be performed in order to assess the severity of the patient’s disease. In addition, the historical patient data will be analysed to assess for any longitudinal decline in lung function. The patient will inhale through the airflow-restricting device, and the inhaled volume will be recorded as a function of inhalation time using spirometry. The recorded profiles will be retained for analysis and used for in vitro studies. In these laboratory studies, the aerosol that would be inhaled by the patient with a given flow profile from the corresponding marketed device will be measured. Consequently, laboratory data will be generated which will support development of a new diagnostic tool to guide clinicians in the appropriate choice of inhalation device for asthmatic and COPD patients.
REC name
London - Dulwich Research Ethics Committee
REC reference
13/LO/0970
Date of REC Opinion
15 Aug 2013
REC opinion
Further Information Favourable Opinion