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

NCT ID: NCT02209974

Last Updated: 2014-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2009-11-30

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Inhaled corticosteroids (Fluticasone, 0.5 mg)

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

Group Type: EXPERIMENTAL

Fluticasone

Intervention Type: DRUG

Administration of inhaled corticosteroids (fluticasone, 0.5 mg) each 12 hours to 8 of the 16 COPD patients versus placebo.

Inhaled Placebo

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

Group Type: PLACEBO_COMPARATOR

Inhaled Placebo

Intervention Type: DRUG

Interventions

Fluticasone

Administration of inhaled corticosteroids (fluticasone, 0.5 mg) each 12 hours to 8 of the 16 COPD patients versus placebo.

Intervention Type: DRUG

Inhaled Placebo

Intervention Type: DRUG

Other Intervention Names

Inhaled Corticosteroids

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 58 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role: collaborator

Hospital Son Espases

OTHER

Sponsor Role: collaborator

Spanish Research Center for Respiratory Diseases

OTHER

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: collaborator

Fundació d'investigació Sanitària de les Illes Balears

OTHER_GOV

Sponsor Role: collaborator

Hospital Son Llatzer

OTHER

Sponsor Role: lead

Responsible Party

Antonia Fuster

Medicine PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonia Fuster, PhD Medicine

Role: PRINCIPAL_INVESTIGATOR

Hospital Son Llatzer

Jaume Sauleda, PhD Medicine

Role: STUDY_CHAIR

Hospital Son Espases

Catalina Balaguer, Medicine

Role: STUDY_CHAIR

Hospital Son Espases

Bernardí Barceló, PhD Medicine

Role: STUDY_CHAIR

Hospital Son Espases

Angel Rios, Nursing

Role: STUDY_CHAIR

FISIB Fundació Investigació de les Illes Balears

Amanda Iglesias, Biology

Role: STUDY_CHAIR

FISIB Fundació Investigació de les Illes Balears

Aina Noguera, Medicine

Role: STUDY_CHAIR

Hospital Son Espases

Bernat Togores, Medicine

Role: STUDY_CHAIR

Hospital Son Espases

Alvar Agustí, PhD Medicine

Role: STUDY_CHAIR

IDIBAPS Hospital Clínic

Ernest Sala-Llinàs, PhD Medicine

Role: STUDY_CHAIR

Hospital Son Espases

Locations

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Countries

Spain

Other Identifiers

IC-COPD-2014

Identifier Type: -

Identifier Source: org_study_id