None listed
Conditions
Brief summary
In previous research, we have shown that patients with COPD continue to suffer multiple clinical problems despite tertiary based care. Both airway inflammation (swelling in the airways) (74%), and general body inflammation (60%) are common problems and can lead to other diseases. We have also demonstrated that quality of life impairment escalates as the number of clinical problems increases and that reducing these problems, including airway and general body inflammation, significantly improves health status. We have now developed a novel integrated treatment algorithm that addresses the inflammatory components of the disease. The purpose of this study is to examine the efficacy of this treatment decision algorithm in the management of COPD on the outcomes of quality of life and exacerbations. We will compare this approach to placebo treatment. We hypothesise, in patients with COPD, that individualised anti-inflammatory pharmacotherapy will significantly improve quality of life and lengthen the time to COPD exacerbation. We will also examine whether a panel of protein biomarkers are associated with treatment response and airway inflammation.
Interventions
The intervention will involve inflammation based pharmacotherapy targeted to markers of airway and systemic inflammation. The treatment decisions will be informed using a treatment decision algorithm. Both groups will be treated for 6 months. In the intervention group, neutrophilic inflammation (sputum neutrophils >age correlated absolute) will be treated with oral tablet of azithromycin 250mg daily for 6 months. Systemic inflammation (hs-CRP>3mg/l or WCC>9x10 (9)/L) will be treated with oral ta
The intervention will involve inflammation based pharmacotherapy targeted to markers of airway and systemic inflammation. The treatment decisions will be informed using a treatment decision algorithm. Both groups will be treated for 6 months. In the intervention group, neutrophilic inflammation (sputum neutrophils >age correlated absolute) will be treated with oral tablet of azithromycin 250mg daily for 6 months. Systemic inflammation (hs-CRP>3mg/l or WCC>9x10 (9)/L) will be treated with oral tablet of rosuvastatin 20mg nocte for 6 months. Eosinophilic inflammation will be treated with daily oral tablet of Prednisolone 15mg for 4 weeks and then 5mg for 20 weeks. In the case of a combination of inflammatory processes, participants will be prescribed a combination of treatments according to the algorithm. If the inflammatory process is not detected, the targeted active treatment will be substituted with a matching placebo.
Sponsors
John Hunter Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Adults with COPD, confirmed by incompletely reversible airflow obstruction (post bronchodilator FEV1 <80% predicted and FER <0.7 or physician confirmed COPD in patients with a reduced FVC), and stable disease with no recent respiratory infection, acute exacerbation, or change in maintenance therapy in the previous 4 weeks. Participants will have a history of a prior COPD exacerbation in the past year.
Exclusion criteria
Current smoking (confirmed by history and exhaled carbon monoxide); current treatment with any macrolide, tetracycline or OCS in the preceding month, hypersensitivity to macrolides, pregnancy/breast feeding, inability to attend study visits, impaired liver function at screening as shown by AST, ALT, alkaline phosphatase or total bilirubin greater than the 2 times upper limit of normal. Participants will be excluded if there is prolongation of the QTc interval (480mS) or significant hearing impairment.
Outcome results
None listed