Dyspnea in COPD: Relationship With Exacerbations Frequency
NCT ID: NCT02113839
Last Updated: 2015-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2014-04-30
2015-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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No frequent exacerbators
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
Spirometry
Before re-breathing (if the patient not performed one 6 months in advance).
CO 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).
P01
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.
FeNO
The measurement of fraction of exhaled nitric oxide during exacerbations of COPD is higher than normal.
Frequent exacerbators
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
Spirometry
Before re-breathing (if the patient not performed one 6 months in advance).
CO 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).
P01
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.
FeNO
The measurement of fraction of exhaled nitric oxide during exacerbations of COPD is higher than normal.
Interventions
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Spirometry
Before re-breathing (if the patient not performed one 6 months in advance).
CO 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).
P01
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.
FeNO
The measurement of fraction of exhaled nitric oxide during exacerbations of COPD is higher than normal.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \>2 months from last exacerbation and no change in therapy
Exclusion Criteria
* patients with neuromuscular diseases
* patients with respiratory failure and/or in long-term oxygen therapy
18 Years
80 Years
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Isabel Blanco
MD, PhD
Principal Investigators
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Isabel Blanco Vich, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínic
Alvar G Agustí, MD, PhD
Role: STUDY_DIRECTOR
Hospital Clínic
Locations
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Hospital Clínic
Barcelona, BCN, Spain
Countries
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References
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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.
Miravitlles M, Anzueto A, Legnani D, Forstmeier L, Fargel M. Patient's perception of exacerbations of COPD--the PERCEIVE study. Respir Med. 2007 Mar;101(3):453-60. doi: 10.1016/j.rmed.2006.07.010. Epub 2006 Aug 30.
Agusti A, Calverley PM, Celli B, Coxson HO, Edwards LD, Lomas DA, MacNee W, Miller BE, Rennard S, Silverman EK, Tal-Singer R, Wouters E, Yates JC, Vestbo J; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) investigators. Characterisation of COPD heterogeneity in the ECLIPSE cohort. Respir Res. 2010 Sep 10;11(1):122. doi: 10.1186/1465-9921-11-122.
Garcia-Aymerich J, Gomez FP, Benet M, Farrero E, Basagana X, Gayete A, Pare C, Freixa X, Ferrer J, Ferrer A, Roca J, Galdiz JB, Sauleda J, Monso E, Gea J, Barbera JA, Agusti A, Anto JM; PAC-COPD Study Group. Identification and prospective validation of clinically relevant chronic obstructive pulmonary disease (COPD) subtypes. Thorax. 2011 May;66(5):430-7. doi: 10.1136/thx.2010.154484. Epub 2010 Dec 21.
Fan VS, Gaziano JM, Lew R, Bourbeau J, Adams SG, Leatherman S, Thwin SS, Huang GD, Robbins R, Sriram PS, Sharafkhaneh A, Mador MJ, Sarosi G, Panos RJ, Rastogi P, Wagner TH, Mazzuca SA, Shannon C, Colling C, Liang MH, Stoller JK, Fiore L, Niewoehner DE. A comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations: a randomized, controlled trial. Ann Intern Med. 2012 May 15;156(10):673-83. doi: 10.7326/0003-4819-156-10-201205150-00003.
Hurst JR, Vestbo J, Anzueto A, Locantore N, Mullerova H, Tal-Singer R, Miller B, Lomas DA, Agusti A, Macnee W, Calverley P, Rennard S, Wouters EF, Wedzicha JA; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010 Sep 16;363(12):1128-38. doi: 10.1056/NEJMoa0909883.
Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest. 2000 May;117(5 Suppl 2):398S-401S. doi: 10.1378/chest.117.5_suppl_2.398s.
Seemungal TA, Donaldson GC, Bhowmik A, Jeffries DJ, Wedzicha JA. Time course and recovery of exacerbations in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2000 May;161(5):1608-13. doi: 10.1164/ajrccm.161.5.9908022.
Jones PW, Nadeau G, Small M, Adamek L. Characteristics of a COPD population categorised using the GOLD framework by health status and exacerbations. Respir Med. 2014 Jan;108(1):129-35. doi: 10.1016/j.rmed.2013.08.015. Epub 2013 Aug 30.
Agusti AG, Villaverde JM, Togores B, Bosch M. Serial measurements of exhaled nitric oxide during exacerbations of chronic obstructive pulmonary disease. Eur Respir J. 1999 Sep;14(3):523-8. doi: 10.1034/j.1399-3003.1999.14c08.x.
Parker J, Wolansky LJ, Khatry D, Geba GP, Molfino NA. Brain magnetic resonance imaging in adults with asthma. Contemp Clin Trials. 2011 Jan;32(1):86-9. doi: 10.1016/j.cct.2010.09.006. Epub 2010 Sep 18.
Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
Scioscia G, Blanco I, Arismendi E, Burgos F, Gistau C, Foschino Barbaro MP, Celli B, O'Donnell DE, Agusti A. Different dyspnoea perception in COPD patients with frequent and infrequent exacerbations. Thorax. 2017 Feb;72(2):117-121. doi: 10.1136/thoraxjnl-2016-208332. Epub 2016 Sep 1.
Other Identifiers
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DysPerEx
Identifier Type: -
Identifier Source: org_study_id
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