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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Fluticasone

Inhaled Placebo

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring emphysema, CRP, interleukin-8, dynamic hyperinflation

Eligibility Criteria

58 Years - 72 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

Hospital Son Llatzer

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Inhaled Placebo

Inhaled corticosteroids (Fluticasone, 0.5 mg)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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, %

Secondary Outcome Measures

Full Information

NCT ID

NCT02209974

First Posted

July 23, 2014

Last Updated

August 5, 2014

Sponsor

Hospital Son Llatzer

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02209974

Brief Title

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

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Son Llatzer

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

emphysema, CRP, interleukin-8, dynamic hyperinflation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inhaled Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Inhaled corticosteroids (Fluticasone, 0.5 mg)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Fluticasone

Other Intervention Name(s)

Inhaled Corticosteroids

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Inhaled Placebo

Primary Outcome Measure Information:

Title

Differences in response to exercise between healthy and COPD patients

Description

Time Frame

1 month

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

58 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: