A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease
|ClinicalTrials.gov Identifier: NCT00995475|
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : October 15, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|COPD||Drug: Fluticasone propionate Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
|Experimental: Inhaled corticosteroid||Drug: Fluticasone propionate|
|Placebo Comparator: Placebo control||Drug: Placebo|
- CRP [ Time Frame: 4 weeks ]
- Alveolar nitric oxide [ Time Frame: 4 weeks ]
- OUCC [ Time Frame: 4 weeks ]