Dyspnea in COPD: Relationship With Exacerbations Frequency

Dyspnea Clinical Trial

— DPE  

Official title:

Breathlessness Perception in COPD: Relationship With Exacerbation Frequency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113839
• Other study ID #: DysPerEx
• Status: Completed
• Phase: N/A
• First received: April 4, 2014
• Last updated: August 19, 2015
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: April 2014
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dyspnea

Intervention

Procedure:
• 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 ?rst 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.

Locations

Country	Name	City	State
Spain	Hospital Clínic	Barcelona	BCN

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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;11:122. doi: 10.1186/1465-9921-11-122. — View Citation

Agustí 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. — View 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. — View 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. — View Citation

Garcia-Aymerich J, Gómez FP, Benet M, Farrero E, Basagaña X, Gayete À, Paré C, Freixa X, Ferrer J, Ferrer A, Roca J, Gáldiz JB, Sauleda J, Monsó E, Gea J, Barberà JA, Agustí À, Antó 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. — View Citation

Hurst JR, Vestbo J, Anzueto A, Locantore N, Müllerova 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. — View 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. — View 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. Epub 2006 Aug 30. — View 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. — View 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. Epub 2007 May 16. Review. — View Citation

Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest. 2000 May;117(5 Suppl 2):398S-401S. Review. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The negative airway pressure generated during the ?rst 100 ms of an occluded inspiration, which is an estimation of the neuromuscular drive to breathe. (P01 )		Baseline	No
Secondary	Borg scale	10-point subjective scoring system, in which a patient rates his/her effort of exertion.	Baseline	No
Secondary	Fractional exhaled nitric oxide (FeNO)		Baseline	No
Secondary	Inspiratory capacity (IC)	The sum of inspiratory reserve volume and tidal volume.	Baseline	No
Secondary	Ventilation at rest		Baseline	No
Secondary	CO exhaled test	Testing for Carbon Monoxide in exhaled breath in current smokers.	Baseline	No