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Dyspnea | Dyspnea in COPD: Relationship With Exacerbations Frequency

Dyspnea research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dyspnea

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Procedure:CO Exhaled breathIn 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).

Procedure:P01P01 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.

Procedure:FeNOThe measurement of fraction of exhaled nitric oxide during exacerbations of COPD is higher than normal.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

No frequent exacerbatorsPatients 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 exacerbatorsPatients 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

Study Status

Completed

Start Date: April 2014

Completed Date: May 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: 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 )

Secondary Outcome: Borg scale

Study sponsors, principal investigator, and references

Principal Investigator: Isabel Blanco Vich, MD, PhD

Lead Sponsor: Hospital Clinic of Barcelona

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02113839

Davis SQ, Permutt Z, Permutt S, Naureckas ET, Bilderback AL, Rand CS, Stein BD, Krishnan JA. Perception of airflow obstruction in patients hospitalized for acute asthma. Ann Allergy Asthma Immunol. 2009 Jun;102(6):455-61. doi: 10.1016/S1081-1206(10)60117-2.

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