Dyspnea in COPD: Relationship With Exacerbations Frequency (DPE)

Hospital Clinic of Barcelona

Status: Completed

Conditions: Dyspnea

Treatments: Procedure: CO Exhaled breath; Procedure: Spirometry; Procedure: P01; Procedure: FeNO

Study type: Interventional

Funder types: Other

Identifiers

NCT02113839

DysPerEx

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

No frequent exacerbators

Active Comparator group

Description:

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

Treatment:

Procedure: P01

Procedure: Spirometry

Procedure: CO Exhaled breath

Procedure: FeNO

Frequent exacerbators

Active Comparator group

Description:

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

Treatment:

Procedure: P01

Procedure: Spirometry

Procedure: CO Exhaled breath

Procedure: FeNO