Effects of Inhaled Corticosteroids in the Systemic Inflammation Induced by Exercise in Patients With COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Inhaled Placebo
- Registration Number
- NCT02209974
- Lead Sponsor
- Hospital Son Llatzer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 23
- ex-smokers (> 10 packets-year) with moderate-severe COPD patients
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhaled Placebo Inhaled Placebo Inhaled placebo administered to healthy (n=7) and to a half (n=8) of COPD patients Inhaled corticosteroids (Fluticasone, 0.5 mg) Fluticasone Inhaled corticosteroids administered to the other half (n=8) of COPD patients
- Primary Outcome Measures
Name Time Method Differences in response to exercise between healthy and COPD patients 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, %
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital Son Llatzer
🇪🇸Palma de Mallorca, Baleares, Spain