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Assessment of Reactance Parameters Measured by the Forced Oscillation Technique for the Bronchodilator Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Duovent HFA
Sponsored by
Centre Hospitalier Universitaire UCLouvain Namur
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of COPD confirmed by post-bronchodilator (DUOVENT HFA 4 puffs) obstructive airway obstruction (FEV1/Forced Vital Capacity < Percentile 5) persisting after bronchodilatation
  • Former or active smoking > 10 packs/year
  • Age > 40 years
  • Informed consent

Exclusion Criteria:

  • Inability to comply with bronchodilator weaning time :

    6 hours for short-acting bronchodilators ; 12 hours for long-acting bronchodilators ; 24 hours for very long-acting bronchodilators

  • Inability to comply with the 4 hours of smoking cessation before the measurements
  • Inability to perform respiratory function tests
  • Continuous oxygen therapy
  • Close angle glaucoma
  • History of urinary retention (only for patients not usually treated with anticholinergic bronchodilators)
  • Pregnancy
  • Acute illness contraindicating the performance of respiratory tests

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Acute inspiratory capacity increase

    Secondary Outcome Measures

    Full Information

    First Posted
    April 9, 2019
    Last Updated
    April 16, 2019
    Sponsor
    Centre Hospitalier Universitaire UCLouvain Namur
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03910985
    Brief Title
    Assessment of Reactance Parameters Measured by the Forced Oscillation Technique for the Bronchodilator Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
    Official Title
    Assessment of Reactance Parameters Measured by the Forced Oscillation Technique for the Bronchodilator Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 23, 2019 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centre Hospitalier Universitaire UCLouvain Namur

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aims of this study is : to assess the bronchodilator (DUOVENT HFA) response of parameters measured by the forced oscillations (FOT) and in particular the reactance parameters related to the presence of a limitation of expiratory flows to compare the response of the reactance parameters to bronchodilators with the conventional spirometric parameters (FEV1) and inspiratory capacity (IC), and according to the severity of the disease to assess and compare the relationship between the response to bronchodilators in terms of IC on the one hand and on the other hand in terms of FEV1, reactance parameters (measured by FOT), resistance parameters (measured by plethysmography and FOT) Assess and compare the relationship between dyspnea intensity assessed by various scales and conventional respiratory function parameters (spirometry, plethysmography, diffusion indices) and parameters measured by FOT
    Detailed Description
    Different techniques will be used during this study : First, the FOT. The measurements will be performed using a Tremoflo-type (Thorasys Thoracic Medical System Inc.) device that generates an oscillating pressure waveform and measures impedance of the respiratory system and its components (resistance and reactance) as a function of frequency, as well as the respiratory system resonant frequency. Measurements will be performed during tidal breathing, the subjects breathing through the pneumotachograph of the system, with nose occluded, the cheeks supported by the hands (of the subjects or of an operator) to reduce the influence of the compliant upper airways. Three measurements of minimum 20 seconds duration will be recorded in the sitting position. Second, the spirometry. The measurements will be carried out using a Medisoft Exp'air type of equipment. The parameters will be successively measured in the sitting position : The inspiratory capacity (IC) will be measured by maximal inspiratory maneuver starting from the functional residual capacity The thoracic gas volume (TGV), total lung capacity (TLC), as well as the airway resistance will be measured by plethysmography The diffusion indices (CO transfer factor (DL,CO) and CO transfer coefficient (KCO)) will be measured in apnea A spirometry will then be carried out. Three maneuvers with acceptability and reproducibility criteria will be performed All these measurements will be carried out before the administration of the bronchodilator and 30 minutes after the administration of the bronchodilator (4 puffs of DUOVENT HFA, using an inhalation chamber).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease
    Keywords
    COPD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Duovent HFA
    Intervention Description
    bronchodilation
    Primary Outcome Measure Information:
    Title
    Acute inspiratory capacity increase
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of COPD confirmed by post-bronchodilator (DUOVENT HFA 4 puffs) obstructive airway obstruction (FEV1/Forced Vital Capacity < Percentile 5) persisting after bronchodilatation Former or active smoking > 10 packs/year Age > 40 years Informed consent Exclusion Criteria: Inability to comply with bronchodilator weaning time : 6 hours for short-acting bronchodilators ; 12 hours for long-acting bronchodilators ; 24 hours for very long-acting bronchodilators Inability to comply with the 4 hours of smoking cessation before the measurements Inability to perform respiratory function tests Continuous oxygen therapy Close angle glaucoma History of urinary retention (only for patients not usually treated with anticholinergic bronchodilators) Pregnancy Acute illness contraindicating the performance of respiratory tests

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Assessment of Reactance Parameters Measured by the Forced Oscillation Technique for the Bronchodilator Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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