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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust; Hull University Teaching Hospitals NHS Trust
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Salmeterol Xinafoate

Criteria

Inclusion Criteria:

• Patients with a diagnosis of COPD.

• Criteria for treatment with inhaled steroids met as per NICE guidelines.

• Patients on treatment with either Symbicort® or Seretide® at the time of recruitment (on treatment dose as per NICE guidelines).

• Recruited patients are able to understand and co-operate with the study conduct and are willing to give written consent.

Exclusion Criteria:

• Patients with any concomitant disease which may interfere with the study procedure or evaluation.(self explanatory)

• A recent exacerbation of COPD within the last 8 weeks.( will interfere with assessment )

• Use of oral steroids within the last 2 months.(will interfere with assessment)

• Use of ocular, intra-articular, rectal or other steroids during 4 weeks prior to inclusion.(will interfere with assessment)

• Participation in any other study (use of investigational product) within 4 weeks prior to inclusion.(potential to interfere with assessment)

• Alcohol or drug abuse.(will interfere with assessment)

• Inability to follow study procedures.(self explanatory)