A Phase 4 interventional study of Fluticasone and Inhaled Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Hospital Son Llatzer. Completed at 1 site in Spain. Open to male participants aged 58 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-06.
Sponsored by Hospital Son Llatzer · Phase 4, Interventional, and Treatment
Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is controversial.
Physical exercise produces a systemic inflammatory response, both in the healthy individual and in the COPD patient (Rabinovitch et al ERJ 2003; van Helvoort et al Respir Med 2005; Davidson WJ et al. J Appl Physiol). Nevertheless, although it has been described that some of the systemic biomarkers related with COPD (Protein C-Reactive (PCR), interleukin [IL]-8) are associated with a lower tolerance to exercise in COPD patients (García-Río et al. Respir Res 2010), the role of IC on systemic inflammation triggered by exercise in COPD patients remains unknown.
This study explores the hypothesis that the inflammatory response induced by exercise in COPD patients could be with IC treatment.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 23 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Hospital Son Llatzer is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
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Inclusion Criteria:
Inhaled placebo administered to healthy (n=7) and to a half (n=8) of COPD patients
Drug: Inhaled Placebo
Inhaled corticosteroids administered to the other half (n=8) of COPD patients
Drug: Fluticasone
Administration of inhaled corticosteroids (fluticasone, 0.5 mg) each 12 hours to 8 of the 16 COPD patients versus placebo.
Also known as: Inhaled Corticosteroids
Differences in response to exercise between healthy and COPD patients
16 COPD patients were compared with 7 healthy, sedentary and nonsmoker controls. All of them carried out an incremental cycle exercise test (ICET) limited by symptoms. 1 month later, ICET was repeated only by COPD patients. Venous blood samples were obtained at rest and during peak exercise. Anthropometric, functional and response characteristics to exercise: Age, years BMI, m2.kg-1 FEV1/FVC, % FEV1, % reference Peak charge, watts VO2 peak, mL.min-1 Respiratory quotient VE peak, L.min-1 Fc peak, lpm Lactic acid peak, mmol.L-1 SaO2 basal, % SaO2 peak, %
Time frame: 1 month
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Hospital Son Llatzer