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?
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.
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
Start Date: April 2014
Completed Date: May 2015
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
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.