None listed
Conditions
Brief summary
Firstly, we will examine the optimal way to determine personal-best exhaled nitric oxide levels in COPD patients. Our hypothesis is that lower exhaled nitric oxide levels can be achieved on oral compared with inhaled steroid. To test this, we will measure levels of exhaled nitric oxide in COPD patients on high-dose inhaled and oral steroid. Secondly, we will examine the effect of inhaled steroid dose on exhaled nitric oxide levels and markers of TH2/eosinophilic airway inflammation in COPD. Our hypothesis is that, as inhaled steroid dose is decreased, any increase in FENO from baseline will be associated with a change in other markers of TH2/eosinophilic airway inflammation. To test this, we will measure exhaled nitric oxide levels and take measures of blood and sputum markers of TH2/eosinophilic airway inflammation in COPD patients on a step-wise reducing course from high-dose to low-dose inhaled steroid and then to placebo. Thirdly, we will examine measures of health status (lung function, quality of life and functional status) in patients with COPD. Our hypothesis is that any decrease in health status on a reducing course of inhaled steroid is associated with an increase in exhaled nitric oxide level. To test this, we will measure exhaled nitric oxide levels and take measures of health status in COPD patients on a step-wise reducing course from high-dose to low-dose inhaled steroid and then to placebo.
Interventions
Exhaled nitric oxide will be measured in COPD patients following a course of oral steroid (prednisolone 30mg once daily for three weeks) and then, without 'wash-out' between courses, a course of high-dose inhaled corticosteroid (budesonide 800mcg twice daily for six weeks). The dose of inhaled budesonide will then be reduced to budesonide 400mcg twice daily for four weeks then budesonide 200mcg twice daily for four weeks then placebo inhaled for four weeks then stopped. Exhaled nitric oxide lev
Exhaled nitric oxide will be measured in COPD patients following a course of oral steroid (prednisolone 30mg once daily for three weeks) and then, without 'wash-out' between courses, a course of high-dose inhaled corticosteroid (budesonide 800mcg twice daily for six weeks). The dose of inhaled budesonide will then be reduced to budesonide 400mcg twice daily for four weeks then budesonide 200mcg twice daily for four weeks then placebo inhaled for four weeks then stopped. Exhaled nitric oxide level will be monitored as the inhaled steroid dose is reduced. Participants will be blinded to whether they are taking oral or high-dose inhaled steroid in the first nine weeks of the study: oral liquid prednisolone vs. oral liquid placebo once daily, and budesonide dry powder inhaler twice daily vs. placebo dry powder inhaler twice daily. Participants will then be blinded to the dose of inhaled steroid during dose reduction for the remainder of the study (budesonide dry powder inhaler twice daily vs. placebo dry powder inhaler twice daily) Adherence to oral steroid will be monitored by drug return. Adherence to inhaled steroid will be monitored by Smartinhaler (Nexus6).
Sponsors
Dr Jack Dummer
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of COPD with post-bronchodilator FEV1 <80%. Smoking history of >10 pack years.
Exclusion criteria
Bronchiectasis, lung cancer, diabetes. Other co-morbidity likely to affect completion of the study. Unable to undergo induced sputum test. Current smokers.
Outcome results
None listed