A Phase 4 interventional study of tiotropium in Chronic Obstructive Pulmonary Disease, sponsored by Royal Free and University College Medical School. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2006-11-29.
Sponsored by Royal Free and University College Medical School · Phase 4, Interventional, and Treatment
Patients with COPD experience exacerbations that are a major cause of morbidity. Exacerbations are associated with increased airway and systemic inflammation and those experiencing frequent exacerbations demonstrate increased inflammation in the stable state. Tiotropium has been shown to reduce exacerbation frequency and it might be postulated that this is due to a reduction in inflammation. The study will compare airway inflammation and exacerbation frequency in patients with COPD on tiotropium or placebo.
Patients with COPD will be randomised to tiotropium or placebo in addition to their usual medication. They will be followed prospectively over 1 year and provide sputum for quantification of IL-6 and IL-8 at baseline and at 3 monthly intervals.Serum IL-6 will also be quantified at baseline and over the year. Changes in inflammatory markers will be assessed by analysis of area under the curve of log transformed data. Exacerbation frequency will be calculated from patient diary cards using a previously validated symptom-based exacerbation definition.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 220 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Royal Free and University College Medical School is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
sputum IL-6
sputum IL-8
sputum MPO
serum IL-6
serum CRP
exacerbation frequency
FEV1
FVC
This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.
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Royal Free and University College Medical School