AIRWAY EFFECTS OF TIOTROPIUM IN PATIENTS WITH COPD
Research type
Research Study
Full title
TARGETING OF THE SMALL AIRWAYS IN PATIENTS WITH COPD: AIRWAY EFFECTS OF TIOTROPIUM -Respimat vs. Handihaler
IRAS ID
163666
Contact name
Omar Usmani
Contact email
Sponsor organisation
Imperial College London
Eudract number
2015-001615-13
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
COPD (chronic obstructive pulmonary disease) is a lung disease that involves the large and small airways. It is important for inhaled medication to be delivered throughout the whole airway tree in respiratory disease particularly in COPD where the airflow limitation caused by the disease arises from the small airways. However many drugs do not reach the small airways. Respimat is a novel inhaler platform that has small particles and allows slow inhalation enabling deeper lung drug delivery. Small particle inhaled corticosteroids (ICS) and long acting beta agonists (LABA) combinations have been shown to improve measures of large and small airways that are also now being translated into meaningful improvements in patients with asthma and COPD. Tiotropium is a long-acting inhaled bronchodilator (reliever) that improves lung function, quality of life, and exercise endurance and reduces exacerbations in patients with chronic obstructive pulmonary disease (COPD).
We aim to investigate the effect of tiotropium from different devices using measures of small and large airways in patients with mild-moderate COPD. We will compare Tiotropium Handihaler (18 micrograms once daily) with Tiotropium Respimat (5 micrograms once daily).
There will be two main components to the study:
1) We will be investigating the effect of Inhaler Training with Handihaler on airway function and symptoms. We will train patients in the optimal use of the Handihaler to see if we can improve (i) lung function (large and small airways) and (ii) clinical symptoms.
2) We will investigate whether changing the device from a DPI-Handihaler (Dry Powder Inhaler) to a fine particle SMI-Respimat (Soft Mist Inhaler) gives an added advantage to the patient? Do the properties of the Respimat device with deeper lung deposition (slow velocity and small particles) improve small airway measures (and large airway measures) that might also be related to an improvement in symptoms?REC name
London - Dulwich Research Ethics Committee
REC reference
15/LO/0982
Date of REC Opinion
31 Jul 2015
REC opinion
Further Information Favourable Opinion