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

NCT01186653 | Completed Phase 4

• 1 other identifier: AcadMedCTU030406
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of life

  4 week

Study Arms (2)

Symbicort

EXPERIMENTAL

Symbicort® (budesonide / formoterol, 400 micrograms/9 micrograms one puff bd, dose as per NICE guidelines

Drug: budesonide / formoterol

Seretide

ACTIVE COMPARATOR

fluticasone/salmeterol, 250 micrograms/25 micrograms two puffs bd, dose as per NICE guidelines

Drug: fluticasone/salmeterol

Interventions

budesonide / formoterol DRUG

budesonide / formoterol, 400 micrograms/9 micrograms one IH bd

Also known as: Symbicort

Symbicort

fluticasone/salmeterol DRUG

fluticasone/salmeterol, 250 micrograms/25 micrograms two puffs bd, dose as per NICE guidelines

Also known as: Seretide

Seretide

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Alcohol or drug abuse.(will interfere with assessment)
• Inability to follow study procedures.(self explanatory)

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Respiratory Medicine, Castgle Hill Hospital

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide, Formoterol Fumarate Drug Combination; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Budesonide; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Salmeterol Xinafoate; Albuterol; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes

Study Officials

• Alyn H Morice, Professor

  Hull and East Yorkshire NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 23, 2010
• Study Start: October 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 6, 2010

Record last verified: 2010-08

Locations

GB (1)