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Completed

NCT Number: NCT02113839

Dyspnea in COPD: Relationship With Exacerbations 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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic

Barcelona, BCN, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Spirometry

Procedure

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)

CO Exhaled breath

Procedure

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 (%)

P01

Procedure

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.

FeNO

Procedure

The measurement of fraction of exhaled nitric oxide during exacerbations of COPD is higher than normal.

Primary outcomes

  1. 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

Secondary outcomes

  1. Borg scale

    Time frame: Baseline

    10-point subjective scoring system, in which a patient rates his/her effort of exertion.

  2. Fractional exhaled nitric oxide (FeNO)

    Time frame: Baseline

  3. Inspiratory capacity (IC)

    Time frame: Baseline

    The sum of inspiratory reserve volume and tidal volume.

  4. Ventilation at rest

    Time frame: Baseline

  5. CO exhaled test

    Time frame: Baseline

    Testing for Carbon Monoxide in exhaled breath in current smokers.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Breathlessness Perception in COPD: Relationship With Exacerbation Frequency

Acronym: DPE

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Apr 15, 2014
Registry last updated
Aug 20, 2015

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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