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

Sponsor

Hospital Son Llatzer (Other)

Overall Status

Completed

CT.gov ID

NCT02209974

Collaborator

Sociedad Española de Neumología y Cirugía Torácica (Other), Hospital Son Espases (Other), Spanish Research Center for Respiratory Diseases (Other), Hospital Clinic of Barcelona (Other), Fundació d'investigació Sanitària de les Illes Balears (Other)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Fluticasone Drug: Inhaled Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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, %

Eligibility Criteria

Criteria

Ages Eligible for Study:

58 Years to 72 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Son Llatzer	Palma de Mallorca	Baleares	Spain	07198

Sponsors and Collaborators

Hospital Son Llatzer
Sociedad Española de Neumología y Cirugía Torácica
Hospital Son Espases
Spanish Research Center for Respiratory Diseases
Hospital Clinic of Barcelona
Fundació d'investigació Sanitària de les Illes Balears

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