Clinical trial NCT02209974: Effects of Inhaled Corticosteroids in the Systemic Inflammation Induced by Exercise in Patients With COPD
Official title: Inhaled Corticosteroids do Not Modify the Systemic Inflammation Induced by Exercise in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: emphysema
CRP
interleukin-8
dynamic hyperinflation
Lead sponsor: Hospital Son Llatzer
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Neumología y Cirugía Torácica
name: Hospital Son Espases
name: Spanish Research Center for Respiratory Diseases
name: Hospital Clinic of Barcelona
name: Fundació d'investigació Sanitària de les Illes Balears
First posted: 2014-08-06
Enrollment: 23
Sex: MALE
Minimum age (years): 58
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Differences in response to exercise between healthy and COPD patients
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Baleares
Study officials:
affiliation: Hospital Son Llatzer
name: Antonia Fuster, PhD Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Son Espases
name: Jaume Sauleda, PhD Medicine
role: STUDY_CHAIR
affiliation: Hospital Son Espases
name: Catalina Balaguer, Medicine
role: STUDY_CHAIR
affiliation: Hospital Son Espases
name: Bernardí Barceló, PhD Medicine
role: STUDY_CHAIR
affiliation: FISIB Fundació Investigació de les Illes Balears
name: Angel Rios, Nursing
role: STUDY_CHAIR
affiliation: FISIB Fundació Investigació de les Illes Balears
name: Amanda Iglesias, Biology
role: STUDY_CHAIR
affiliation: Hospital Son Espases
name: Aina Noguera, Medicine
role: STUDY_CHAIR
affiliation: Hospital Son Espases
name: Bernat Togores, Medicine
role: STUDY_CHAIR
affiliation: IDIBAPS Hospital Clínic
name: Alvar Agustí, PhD Medicine
role: STUDY_CHAIR
affiliation: Hospital Son Espases
name: Ernest Sala-Llinàs, PhD Medicine
role: STUDY_CHAIR
References: