None listed
Conditions
Brief summary
This study aims to provide proof of concept support for prevalence of aspiration and association with more frequent severe acute exacerbations in chronic obstructive pulmonary disease.
Interventions
Baseline standardised measurements: spirometry, gas transfer, lung volumes by body plethysmography, exhaled nitric oxide (FENO), transcutaneous oximetry, respiratory rate, Airways Questionnaire 20 (AQ20), Eating Assessment Tool-10 (EAT-10), Oral Health Assessment Tool (OHAT), resting pH of unstimulated saliva, auditory perceptual voice evaluation and videofluoroscopy swallowing examination. Radiographic oral barium liquid solution was administered as part of standard videofluoroscopy procedure. Dose of oral barium solution was 100mL, taken twice within a 5-minute period during initial testing. Assessments were delivered individually by an experienced speech pathologist, respiratory scientists and radiographers within 1.5 hours. Measurements performed at 6 months: above measurements repeated excluding OHAT, resting saliva pH, voice evaluation, respiratory rate and videofluoroscopy swallowing examination. Measurements performed at 12 months: AQ20 and EAT-10 via telephone. Measurements performed at 3, 6, 9, 12 months: Episodes of acute exacerbations of COPD (AECOPD) via telephone interviews using structured AECOPD questionnaire and examination of medical records.
Sponsors
Eligibility
Inclusion criteria
Verified diagnosis of COPD made by general practitioner or respiratory physician using international criteria/guidelines. Stable lung disease in the preceding 12 weeks prior to initial/baseline assessments.
Exclusion criteria
Known neurological disease, significant head or neck surgery impacting swallow, history of head or neck cancer, abnormal cranial nerve function on examination, current smokers