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
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
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
Sites / Locations
Outcomes
Primary Outcome Measures
Acute inspiratory capacity increase
Secondary Outcome Measures
Full Information
NCT ID
NCT03910985
First Posted
April 9, 2019
Last Updated
April 16, 2019
Sponsor
Centre Hospitalier Universitaire UCLouvain Namur
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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