search
Back to results

Dyspnea in COPD: Relationship With Exacerbations Frequency (DPE)

Primary Purpose

Dyspnea

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Spirometry
CO Exhaled breath
P01
FeNO
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dyspnea focused on measuring Dyspnea perception, COPD, Exacerbations, CO2 rebreathing test

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clínic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

No frequent exacerbators

Frequent exacerbators

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 Measures

Borg scale
10-point subjective scoring system, in which a patient rates his/her effort of exertion.
Fractional exhaled nitric oxide (FeNO)
Inspiratory capacity (IC)
The sum of inspiratory reserve volume and tidal volume.
Ventilation at rest
CO exhaled test
Testing for Carbon Monoxide in exhaled breath in current smokers.

Full Information

First Posted
April 4, 2014
Last Updated
August 19, 2015
Sponsor
Hospital Clinic of Barcelona
search

1. Study Identification

Unique Protocol Identification Number
NCT02113839
Brief Title
Dyspnea in COPD: Relationship With Exacerbations Frequency
Acronym
DPE
Official Title
Breathlessness Perception in COPD: Relationship With Exacerbation Frequency
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea
Keywords
Dyspnea perception, COPD, Exacerbations, CO2 rebreathing test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No frequent exacerbators
Arm Type
Active Comparator
Arm Description
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
Arm Title
Frequent exacerbators
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Spirometry
Other Intervention Name(s)
FEV1, FVC, FEV1/FVC, VC, TLC, Rwc, DLCO, DLCO/VA, Ventilation (VE), Inspiratory capacity (IC)
Intervention Description
Before re-breathing (if the patient not performed one 6 months in advance).
Intervention Type
Procedure
Intervention Name(s)
CO Exhaled breath
Other Intervention Name(s)
CO (ppm), COHb (%)
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
P01
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
FeNO
Intervention Description
The measurement of fraction of exhaled nitric oxide during exacerbations of COPD is higher than normal.
Primary Outcome Measure Information:
Title
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 )
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Borg scale
Description
10-point subjective scoring system, in which a patient rates his/her effort of exertion.
Time Frame
Baseline
Title
Fractional exhaled nitric oxide (FeNO)
Time Frame
Baseline
Title
Inspiratory capacity (IC)
Description
The sum of inspiratory reserve volume and tidal volume.
Time Frame
Baseline
Title
Ventilation at rest
Time Frame
Baseline
Title
CO exhaled test
Description
Testing for Carbon Monoxide in exhaled breath in current smokers.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel Blanco Vich, MD, PhD
Organizational Affiliation
Hospital Clínic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alvar G Agustí, MD, PhD
Organizational Affiliation
Hospital Clínic
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clínic
City
Barcelona
State/Province
BCN
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19558002
Citation
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.
Results Reference
background
PubMed Identifier
16938447
Citation
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.
Results Reference
background
PubMed Identifier
20831787
Citation
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.
Results Reference
background
PubMed Identifier
21177668
Citation
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.
Results Reference
background
PubMed Identifier
22586006
Citation
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.
Results Reference
background
PubMed Identifier
20843247
Citation
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.
Results Reference
background
PubMed Identifier
10843984
Citation
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.
Results Reference
background
PubMed Identifier
10806163
Citation
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.
Results Reference
background
PubMed Identifier
24041746
Citation
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.
Results Reference
background
PubMed Identifier
10543270
Citation
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.
Results Reference
background
PubMed Identifier
20854931
Citation
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.
Results Reference
background
PubMed Identifier
17507545
Citation
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.
Results Reference
background
PubMed Identifier
27586869
Citation
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.
Results Reference
derived

Learn more about this trial

Dyspnea in COPD: Relationship With Exacerbations Frequency

We'll reach out to this number within 24 hrs