NCT02209974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_4 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

5.8 years

First QC Date

July 23, 2014

Last Update Submit

August 5, 2014

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

emphysemaCRPinterleukin-8dynamic hyperinflation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Inhaled Placebo

PLACEBO COMPARATOR

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

Drug: Inhaled Placebo

Inhaled corticosteroids (Fluticasone, 0.5 mg)

EXPERIMENTAL

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

Drug: Fluticasone

Interventions

FluticasoneDRUG

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

Also known as: Inhaled Corticosteroids
Inhaled corticosteroids (Fluticasone, 0.5 mg)
Inhaled PlaceboDRUG
Inhaled Placebo

Eligibility Criteria

Age58 Years - 72 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysema

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Antonia Fuster, PhD Medicine

    Hospital Son Llatzer

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medicine PhD

Study Record Dates

First Submitted

July 23, 2014

First Posted

August 6, 2014

Study Start

February 1, 2004

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations

ES(1)