Skip to main content
Clinical Trials/NCT02209974
NCT02209974
Completed
Phase 4

Inhaled Corticosteroids do Not Modify the Systemic Inflammation Induced by Exercise in Patients With Chronic Obstructive Pulmonary Disease

Hospital Son Llatzer1 site in 1 country23 target enrollmentFebruary 2004

Overview

Phase
Phase 4
Intervention
Inhaled Placebo
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Hospital Son Llatzer
Enrollment
23
Locations
1
Primary Endpoint
Differences in response to exercise between healthy and COPD patients
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is controversial.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 2004
End Date
November 2009
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Hospital Son Llatzer
Responsible Party
Principal Investigator
Principal Investigator

Antonia Fuster

Medicine PhD

Hospital Son Llatzer

Eligibility Criteria

Inclusion Criteria

  • ex-smokers (\> 10 packets-year) with moderate-severe COPD patients

Exclusion Criteria

  • Not provided

Arms & Interventions

Inhaled Placebo

Inhaled placebo administered to healthy (n=7) and to a half (n=8) of COPD patients

Intervention: Inhaled Placebo

Inhaled corticosteroids (Fluticasone, 0.5 mg)

Inhaled corticosteroids administered to the other half (n=8) of COPD patients

Intervention: Fluticasone

Outcomes

Primary Outcomes

Differences in response to exercise between healthy and COPD patients

Time Frame: 1 month

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, %

Study Sites (1)

Loading locations...

Similar Trials