Effects of Inhaled Corticosteroids in the Systemic Inflammation Induced by Exercise in Patients With COPD

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Inhaled Placebo; Drug: Fluticasone

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Baleares
    • Palma de Mallorca, Baleares, Spain, 07198
      • Hospital Son Llatzer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years to 72 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Inhaled Placebo; Inhaled placebo administered to healthy (n=7) and to a half (n=8) of COPD patients	Drug: Inhaled Placebo
EXPERIMENTAL: Inhaled corticosteroids (Fluticasone, 0.5 mg); 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.; Other Names: Inhaled Corticosteroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, %	1 month

Collaborators and Investigators

• Sponsor: Hospital Son Llatzer
• Collaborators: Sociedad Española de Neumología y Cirugía Torácica; Hospital Clinic of Barcelona; Fundació d'investigació Sanitària de les Illes Balears; Hospital Son Espases; Spanish Research Center for Respiratory Diseases
• Investigators: Principal Investigator: Antonia Fuster, PhD Medicine, Hospital Son Llatzer; Study Chair: Jaume Sauleda, PhD Medicine, Hospital Son Espases; Study Chair: Catalina Balaguer, Medicine, Hospital Son Espases; Study Chair: Bernardí Barceló, PhD Medicine, Hospital Son Espases; Study Chair: Angel Rios, Nursing, FISIB Fundació Investigació de les Illes Balears; Study Chair: Amanda Iglesias, Biology, FISIB Fundació Investigació de les Illes Balears; Study Chair: Aina Noguera, Medicine, Hospital Son Espases; Study Chair: Bernat Togores, Medicine, Hospital Son Espases; Study Chair: Alvar Agustí, PhD Medicine, IDIBAPS Hospital Clínic; Study Chair: Ernest Sala-Llinàs, PhD Medicine, Hospital Son Espases

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): November 1, 2009

Study Registration Dates

• First Submitted: July 23, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (ESTIMATE): August 6, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: emphysema; CRP; interleukin-8; dynamic hyperinflation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Inflammation; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone
• Other Study ID Numbers: IC-COPD-2014