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NCT Number: NCT02209974

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

Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is controversial.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Emphysema Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

58 year–72 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 07198, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Fluticasone

Drug

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

Other names: Inhaled Corticosteroids

Inhaled placebo

Drug

Primary outcomes

  1. Differences in response to exercise between healthy and COPD patients

    Time frame: 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, %

Sponsors and collaborators

Lead sponsor

Hospital Son Llatzer

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Aug 6, 2014
Registry last updated
Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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