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Dyspnea in COPD: Relationship With Exacerbations Frequency (DPE)

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ClinicalTrials.gov Identifier: NCT02113839
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Isabel Blanco, Hospital Clinic of Barcelona

Study Description
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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.


Condition or disease Intervention/treatment Phase
Dyspnea Procedure: Spirometry Procedure: CO Exhaled breath Procedure: P01 Procedure: FeNO Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Breathlessness Perception in COPD: Relationship With Exacerbation Frequency
Study Start Date : April 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Procedure: Spirometry
Before re-breathing (if the patient not performed one 6 months in advance).
Other Names:
  • FEV1
  • FVC
  • FEV1/FVC
  • VC
  • TLC
  • Rwc
  • DLCO
  • DLCO/VA
  • Ventilation (VE)
  • Inspiratory capacity (IC)

Procedure: 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).
Other Names:
  • CO (ppm)
  • COHb (%)

Procedure: 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.

Procedure: FeNO
The measurement of fraction of exhaled nitric oxide during exacerbations of COPD is higher than normal.
Active Comparator: 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
 Procedure: Spirometry
Before re-breathing (if the patient not performed one 6 months in advance).
Other Names:
  • FEV1
  • FVC
  • FEV1/FVC
  • VC
  • TLC
  • Rwc
  • DLCO
  • DLCO/VA
  • Ventilation (VE)
  • Inspiratory capacity (IC)

Procedure: 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).
Other Names:
  • CO (ppm)
  • COHb (%)

Procedure: 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.

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


Outcome Measures
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Primary Outcome Measures :
  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 ) [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Borg scale [ Time Frame: Baseline ]
    10-point subjective scoring system, in which a patient rates his/her effort of exertion.

  2. Fractional exhaled nitric oxide (FeNO) [ Time Frame: Baseline ]
  3. Inspiratory capacity (IC) [ Time Frame: Baseline ]
    The sum of inspiratory reserve volume and tidal volume.

  4. Ventilation at rest [ Time Frame: Baseline ]
  5. CO exhaled test [ Time Frame: Baseline ]
    Testing for Carbon Monoxide in exhaled breath in current smokers.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113839


Locations
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Spain
Hospital Clínic
Barcelona, BCN, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Isabel Blanco Vich, MD, PhD Hospital Clínic
Study Director: Alvar G Agustí, MD, PhD Hospital Clínic
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Isabel Blanco, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02113839    
Other Study ID Numbers: DysPerEx
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: April 2014
Keywords provided by Isabel Blanco, Hospital Clinic of Barcelona:
Dyspnea perception
COPD
Exacerbations
CO2 rebreathing test
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory