Clinical trial NCT02113839: Dyspnea in COPD: Relationship With Exacerbations Frequency
Official title: Breathlessness Perception in COPD: Relationship With Exacerbation Frequency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnea
Keywords: Dyspnea perception
COPD
Exacerbations
CO2 rebreathing test
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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 )
timeFrame: Baseline
Secondary outcomes:
measure: Borg scale
timeFrame: Baseline
measure: Fractional exhaled nitric oxide (FeNO)
timeFrame: Baseline
measure: Inspiratory capacity (IC)
timeFrame: Baseline
measure: Ventilation at rest
timeFrame: Baseline
measure: CO exhaled test
timeFrame: Baseline
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic
state: BCN
Study officials:
affiliation: Hospital Clínic
name: Isabel Blanco Vich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínic
name: Alvar G Agustí, MD, PhD
role: STUDY_DIRECTOR
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