drugset / Trial / NCT01186653

Effect on Adrenal Function of Budesonide Versus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD)

NCT01186653

Phase 4 Completed 22 enrolled Hull University Teaching Hospitals NHS Trust
RandomizedCrossoverOpen-labelTreatment

Summary

National Institute for Clinical Excellence (NICE) guidelines recommend high dose inhaled steroids for patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD, a common chronic disease related to smoking) who are having two or more exacerbations requiring treatment with antibiotics or oral steroids in a 12 month period. The preparations licensed for this indication commercially available are Symbicort® and Seretide®. High dose inhaled steroids (contained in both) can cause suppression of the adrenal glands. The investigators want to assess adrenal suppression caused by the two preparations and compare. The results could guide investigators in prescribing these preparations.

Timeline

Start
2007-10
Primary completion
2010-05
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 400 ug Inhaled
Comparator Fluticasone Other / unclassified 250 ug Inhaled
Subject Formoterol Other / unclassified 9 ug Inhaled
Comparator Salmeterol Other / unclassified 25 ug Inhaled