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Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers are now an established treatment for COPD. Inhaled steroids can have a number of bad effects including suppression of the adrenal glands because of absorption. A previous study in patients with COPD.
C-reactive Protein (CRP) is a peptide produced in the liver in response to inflammation. Elevated circulating levels of CRP are associated with heart conditions. High levels of CRP have also been found in patients with COPD. In some studies, steroid inhalers have reduced CRP levels, and that of other inflammatory mediators, in patients with COPD. It is unknown whether this reflects a reduction in lung inflammation or an effect of systemically absorbed corticosteroid.
It is proposed to investigate the link between inhaled corticosteroid and serum CRP, lung inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled corticosteroid, Then placebo | Experimental | FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. After a washout period of 2 weeks, they then received FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. |
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| Placebo control, Then inhaled corticosteroid | Placebo Comparator | FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. After a washout period of 2 weeks, they then received FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| CRP | C-reactive protein | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Alveolar Nitric Oxide | 4 weeks | |
| OUCC | Overnight urinary cortisol creatinine ratio | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21205715 | Result | Williamson PA, Menzies D, Clearie KL, Vaidyanathan S, Lipworth BJ. Dose-response for inhaled fluticasone on airway and systemic inflammation in COPD. Eur Respir J. 2011 Jan;37(1):206-9. doi: 10.1183/09031936.00062210. No abstract available. |
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This is a randomised, double blind placebo controlled cross over trial design will be used. Following a two-week steroid tapering process and a two-week run in period, two randomised treatment periods will follow. Each will be one month in duration and will be separated by a two-week wash-out period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Corticosteroid One Month | FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. Then two-week washout before placebo. Fluticasone propionate |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
|
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| Drug |
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| Placebo Control One Month |
FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. Then two-week washout before FP. Placebo |
| COMPLETED |
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| NOT COMPLETED |
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| Wash-out Two Week |
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| Second Intervention |
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This is a cross over trial in which 18 participants completed the trials.
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Corticosteroid, Then Placebo or Vice Versa | FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. Then 2 weeks of wash-out. Then followed by FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CRP | C-reactive protein | Posted | Geometric Mean | 95% Confidence Interval | mg/L | 4 weeks |
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| Secondary | Alveolar Nitric Oxide | Posted | Geometric Mean | 95% Confidence Interval | ppb | 4 weeks |
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| Secondary | OUCC | Overnight urinary cortisol creatinine ratio | Posted | Geometric Mean | 95% Confidence Interval | nmol/mmol | 4 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inhaled Corticosteroid | FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. Fluticasone propionate | 0 | 18 | 0 | 18 | 0 | 18 |
| EG001 | Placebo Control | FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. Placebo | 0 | 18 | 0 | 18 | 0 | 18 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Brian J Lipworth | University of Dundee | +44 1382 383188 | b.j.lipworth@dundee.ac.uk |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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