Dyspnea in COPD: Relationship With Exacerbations Frequency

NCT02113839 | Completed

• 1 other identifier: DysPerEx
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspnea

Keywords

Dyspnea perception; COPD; Exacerbations; CO2 rebreathing test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Borg scale

  Baseline

• Fractional exhaled nitric oxide (FeNO)

  Baseline

• Inspiratory capacity (IC)

  Baseline

• Ventilation at rest

  Baseline

• CO exhaled test

  Baseline

Study Arms (2)

No frequent exacerbators

ACTIVE COMPARATOR

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

Procedure: Spirometry; Procedure: CO Exhaled breath; Procedure: P01; Procedure: FeNO

Frequent exacerbators

ACTIVE COMPARATOR

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

Procedure: Spirometry; Procedure: CO Exhaled breath; Procedure: P01; Procedure: FeNO

Interventions

Spirometry PROCEDURE

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

Also known as: FEV1, FVC, FEV1/FVC, VC, TLC, Rwc, DLCO, DLCO/VA, Ventilation (VE), Inspiratory capacity (IC)

Frequent exacerbators; No frequent exacerbators

CO Exhaled breath PROCEDURE

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).

Also known as: CO (ppm), COHb (%)

Frequent exacerbators; No frequent exacerbators

P01 PROCEDURE

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.

Frequent exacerbators; No frequent exacerbators

FeNO PROCEDURE

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

Frequent exacerbators; No frequent exacerbators

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with diagnosis of COPD (Gold 2 or 3 or 4)
• \>2 months from last exacerbation and no change in therapy

You may not qualify if:

• patients on regular sedative drugs
• patients with neuromuscular diseases
• patients with respiratory failure and/or in long-term oxygen therapy

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic

Barcelona, BCN, 08036, Spain

Location

Related Publications (13)

• 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.

  PMID: 19558002 BACKGROUND

• 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.

  PMID: 16938447 BACKGROUND

• 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.

  PMID: 20831787 BACKGROUND

• 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.

  PMID: 21177668 BACKGROUND

• 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.

  PMID: 22586006 BACKGROUND

• 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.

  PMID: 20843247 BACKGROUND

• 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.

  PMID: 10843984 BACKGROUND

• 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.

  PMID: 10806163 BACKGROUND

• 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.

  PMID: 24041746 BACKGROUND

• 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.

  PMID: 10543270 BACKGROUND

• 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.

  PMID: 20854931 BACKGROUND

• 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.

  PMID: 17507545 BACKGROUND

• 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.

  PMID: 27586869 DERIVED

MeSH Terms

Conditions

Dyspnea; Pulmonary Disease, Chronic Obstructive

Interventions

Ventilation; Inspiratory Capacity; Carboxyhemoglobin

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Hemoglobins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globins; Hemeproteins

Study Officials

• Isabel Blanco Vich, MD, PhD

  Hospital Clínic

  PRINCIPAL INVESTIGATOR

• Alvar G Agustí, MD, PhD

  Hospital Clínic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 15, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: May 1, 2015
• Last Updated: August 20, 2015

Record last verified: 2014-04

Locations

ES (1)