Dyspnea in COPD: Relationship With Exacerbations Frequency (DPE)

August 19, 2015 updated by: Isabel Blanco, Hospital Clinic of Barcelona

Breathlessness Perception in COPD: Relationship With Exacerbation Frequency

The perception of breathlessness varies significantly among COPD patients with similar severity of airflow limitation; those with poorer perception report less exacerbations as compared to those with frequent exacerbations.

Cross-sectional comparison of breathlessness perception in COPD patients with frequent exacerbations or without frequent exacerbations.

To assess "Breathlessness Perception" the investigators will increase the ventilatory demand of the patients by CO2-rebreathing method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The perception of breathlessness varies between individuals. This is a well-established concept in asthma, but mostly unexplored in COPD; the relationship between airflow limitation (FEV1, % ref.) and breathlessness (mMRC) is weak.

The perception of breathlessness varies significantly among COPD patients with similar severity of airflow limitation; those with poorer perception report less exacerbations as compared to those with frequent exacerbations.

It is a cross-sectional comparison of breathlessness perception in COPD patients with frequent exacerbations (≥2 or ≥1 with hospitalization in the previous year) or without frequent exacerbations (0 or 1 without hospitalization in the previous year).

To assess "Breathlessness Perception" the investigators will increase the ventilatory demand of the patients by CO2-rebreathing method. CO2 rebreathing test will be conducted to evaluate the acute ventilatory response to CO2 inhalation used to estimate central chemoreceptor responsiveness in patients with the obstructive pulmonary disease.

Simple descriptive statistics (unpaired T-test) and correlation analysis (bivariate and multivariate) will be used to analyze results.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • BCN
      • Barcelona, BCN, Spain, 08036
        • Hospital Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with diagnosis of COPD (Gold 2 or 3 or 4)
  • >2 months from last exacerbation and no change in therapy

Exclusion Criteria:

  • patients on regular sedative drugs
  • patients with neuromuscular diseases
  • patients with respiratory failure and/or in long-term oxygen therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: No frequent exacerbators

Patients without exacerbations: 0 or 1 that did not required hospitalization in the previous year.

Interventions:

  • Spirometry
  • Emogas analysis
  • Modified Borg Dyspnea Scale
  • CO Exhaled breath
  • P01
  • FeNO
Procedure: Spirometry
Before re-breathing (if the patient not performed one 6 months in advance).
Other Names:
  • FEV1
  • FVC
  • FEV1/FVC
  • VC
  • TLC
  • Rwc
  • DLCO
  • DLCO/VA
  • Ventilation (VE)
  • Inspiratory capacity (IC)
Procedure: CO Exhaled breath
In current smokers of both arms to confirm that the patient has not smoked in the past three hours and to asses the smoking status (heavy, moderate, light).
Other Names:
  • CO (ppm)
  • COHb (%)
Procedure: P01
P01 is the negative airway pressure generated during the first 100 ms of an occluded inspiration. It's an estimation of the neuromuscular drive to breathe.
Procedure: FeNO
The measurement of fraction of exhaled nitric oxide during exacerbations of COPD is higher than normal.
Active Comparator: Frequent exacerbators

Patients with frequent exacerbations: ≥2 or ≥1 if it required hospitalization in the previous year.

Interventions:

  • Spirometry
  • Emogas analysis
  • Modified Borg Dyspnea Scale
  • CO Exhaled breath
  • P01
  • FeNO
Procedure: Spirometry
Before re-breathing (if the patient not performed one 6 months in advance).
Other Names:
  • FEV1
  • FVC
  • FEV1/FVC
  • VC
  • TLC
  • Rwc
  • DLCO
  • DLCO/VA
  • Ventilation (VE)
  • Inspiratory capacity (IC)
Procedure: CO Exhaled breath
In current smokers of both arms to confirm that the patient has not smoked in the past three hours and to asses the smoking status (heavy, moderate, light).
Other Names:
  • CO (ppm)
  • COHb (%)
Procedure: P01
P01 is the negative airway pressure generated during the first 100 ms of an occluded inspiration. It's an estimation of the neuromuscular drive to breathe.
Procedure: FeNO
The measurement of fraction of exhaled nitric oxide during exacerbations of COPD is higher than normal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The negative airway pressure generated during the first 100 ms of an occluded inspiration, which is an estimation of the neuromuscular drive to breathe. (P01 )
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Borg scale
Time Frame: Baseline
10-point subjective scoring system, in which a patient rates his/her effort of exertion.
Baseline
Fractional exhaled nitric oxide (FeNO)
Time Frame: Baseline
Baseline
Inspiratory capacity (IC)
Time Frame: Baseline
The sum of inspiratory reserve volume and tidal volume.
Baseline
Ventilation at rest
Time Frame: Baseline
Baseline
CO exhaled test
Time Frame: Baseline
Testing for Carbon Monoxide in exhaled breath in current smokers.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Isabel Blanco Vich, MD, PhD, Hospital Clinic
  • Study Director: Alvar G Agustí, MD, PhD, Hospital Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Estimate)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DysPerEx

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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