Airway Effects of Tiotropium in Patients With COPD (NCT02683668) | Clinical Trial Compass
CompletedPhase 3
Airway Effects of Tiotropium in Patients With COPD
United Kingdom44 participantsStarted 2016-02-01
Plain-language summary
The aim of the study is to investigate the effect of tiotropium from different devices on a panel of small (IOS, MBNW, DLCO, FVC) and large airway (FEV1, PEF) responses in patients with mild-moderate COPD. Comparisons will be made between Tiotropium Handihaler 18 micrograms once daily and Tiotropium Respimat 5 micrograms once daily
Who can participate
Age range30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
ā. Aged 30 years onwards - there is no upper age limit as we do not want to exclude elderly patients as COPD is primarily a disease in the elderly population.
ā. Have on-going symptoms or exercise limitation (determined by CAT score)
ā. Stable COPD (no chest infection requiring antibiotics and/or oral steroids in the past 2 months).
ā. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion criteria
ā. Subjects who lack the capacity to consent will not be recruited.
ā. Current or past diagnosis of asthma.
ā. Patients on concurrent oral bronchodilators (theophylline, PDE4 inhibitors) will not be included.
ā. Patients on other LAMAs will not be included
ā. History of any chronic respiratory diseases other than COPD.
ā. History of another medical condition, which in the opinion of the Unit Physician, contraindicates his/her participation in the study.
. Clinical evidence of heart failure (NYHA class III-IV).
ā. Unstable respiratory disease in the last four weeks prior to the screening visit (indicated by any change in their maintenance inhaled therapy or who have had a lower respiratory tract infection in the previous four weeks).