Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effect of High Dose Inhaled Budesonide and Fluticasone on Adrenal Function in Patients With Moderate to Severe COPD
Verified date | August 2010 |
Source | Hull and East Yorkshire Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Respiratory Medicine, Castgle Hill Hospital | Cottingham | East Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Hull and East Yorkshire Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overnight urinary cortisol:creatinine ratio | The primary objective of the study is to determine any change in overnight urinary cortisol:creatinine ratio from that measured after 4 weeks treatment with high dose Symbicort® (budesonide / formoterol, 400 micrograms/9 micrograms one puff bd, dose as per NICE guidelines) to that following 4 weeks treatment with Seretide® (fluticasone/salmeterol, 250 micrograms/25 micrograms two puffs bd, dose as per NICE guidelines) | 12 hr | |
Secondary | Quality of life | Secondary objective is to compare quality of life as measured with a modified St Georges respiratory Questionnaire with high dose Symbicort® (budesonide / formoterol, 400 micrograms/9 micrograms one puff bd, dose as per NICE guidelines) and Seretide® (fluticasone/salmeterol, 250 micrograms/25 micrograms two puffs bd, dose as per NICE guidelines) | 4 week |
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