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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209974
• Other study ID #: IC-COPD-2014
• Status: Completed
• Phase: Phase 4
• First received: July 23, 2014
• Last updated: August 5, 2014
• Start date: February 2004
• Est. completion date: November 2009

Study information

• Verified date: August 2014
• Source: Hospital Son Llatzer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 58 Years to 72 Years

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Fluticasone
Administration of inhaled corticosteroids (fluticasone, 0.5 mg) each 12 hours to 8 of the 16 COPD patients versus placebo.
• Inhaled Placebo

Locations

Country	Name	City	State
Spain	Hospital Son Llatzer	Palma de Mallorca	Baleares

Sponsors (6)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No