Dyspnea in COPD: Relationship With Exacerbations Frequency

Not Applicable

Completed

• Conditions: Dyspnea
• Interventions: Procedure: Spirometry; Procedure: CO Exhaled breath; Procedure: P01; Procedure: FeNO

• Registration Number: NCT02113839
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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.

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 Timeline

• Status Verified: 2014-04
• Study Start: 2014-04
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-14
• Study First Posted: 2014-04-15
• Primary Completion: 2014-08
• Study Completion: 2015-05
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No frequent exacerbators	CO Exhaled breath	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
Frequent exacerbators	Spirometry	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
Frequent exacerbators	P01	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
Frequent exacerbators	FeNO	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
No frequent exacerbators	Spirometry	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
No frequent exacerbators	P01	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
No frequent exacerbators	FeNO	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
Frequent exacerbators	CO Exhaled breath	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

Primary Outcome Measures

Name	Time	Method
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 )	Baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Clínic; 🇪🇸 Barcelona, BCN, Spain