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Dyspnea in COPD: Relationship With Exacerbations Frequency

Breathlessness Perception in COPD: Relationship With Exacerbation Frequency

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02113839
Acronym
DPE
Enrollment
34
Registered
2014-04-15
Start date
2014-04-30
Completion date
2015-05-31
Last updated
2015-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea

Keywords

Dyspnea perception, COPD, Exacerbations, CO2 rebreathing test

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.

Interventions

PROCEDURESpirometry

Before re-breathing (if the patient not performed one 6 months in advance).

PROCEDURECO 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).

PROCEDUREP01

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.

PROCEDUREFeNO

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

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 )Baseline

Secondary

MeasureTime frameDescription
Borg scaleBaseline10-point subjective scoring system, in which a patient rates his/her effort of exertion.
Fractional exhaled nitric oxide (FeNO)Baseline
Inspiratory capacity (IC)BaselineThe sum of inspiratory reserve volume and tidal volume.
Ventilation at restBaseline
CO exhaled testBaselineTesting for Carbon Monoxide in exhaled breath in current smokers.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026