Back to resultsEvaluation of the Reversibility of the Bronchial Obstruction by Impulse Oscillometry Technique in Chronic Obstructive Pulmonary Disease (COPD): Correlation With Functional Features Measured by Plethysmography and Dyspnoea (OSCILLOREVERS)
Primary Purpose
COPD
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
COPD
COPD
Sponsored by
About this trial
This is an interventional diagnostic trial for COPD focused on measuring Resistance, Forced oscillations, Dyspnea
Eligibility Criteria
Inclusion Criteria:
- COPD with dyspnoea with Medical Research Council scale (MRC) >1,
- No exacerbation for 6 weeks
- No bronchodilatator short action(share) (ß 2 agonist or ipratropium) within 6 hours before the respiratory evaluation and the test of reversibility.
- Patient under current treatment (ß2 long-acting agonist (LABA) or anticholinergic long-acting (LLAMA(LAMA)) or LABA-corticoid association inhaled (CSI), or triples LABA-CSI-LAMA association) stable for at least 4 weeks, and taken for at least the 1 hour the day of the visit
- Having given a written consent
Exclusion Criteria:
- Patient Under 18
- Other respiratory illness
- Clinically significant left cardiac failure
- Obesity with BMI > 35 kg / m2)
- Unable to perform respiratory evaluations
- Contraindication to the salbutamol or to the ipratropium bromide or to one of its components
- Pregnant or breast-feeding woman
- Unable to agree
- No social security scheme
Sites / Locations
- CHRU
- Hôpital Foch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COPD
Arm Description
Outcomes
Primary Outcome Measures
Percentage of obstruction reversibility
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02928744
Brief Title
Evaluation of the Reversibility of the Bronchial Obstruction by Impulse Oscillometry Technique in Chronic Obstructive Pulmonary Disease (COPD): Correlation With Functional Features Measured by Plethysmography and Dyspnoea
Acronym
OSCILLOREVERS
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Limitation of expiratory flows is considered as the main determiner of dynamic distension and dyspnoea in chronic obstructive pulmonary disease (COPD). The analysis of proximal and distal resistances should allow to better appreciate the functional impact.
This study should also allow to specify the best parameters in respiratory functional explorations useful for the follow-up in COPD and to specify the relevance of functional indications other than the forced expiration volume at 1 second (FEV1) or the functional residual capacity (FRC) to estimate in a more relevant way the clinical improve with the increase of the therapeutic load (increase of posology, association of two bronchodilatators, addition of an anti-inflammatory drug, thus etc…) at already handled patients suffering from a persistent dyspnoea insufficiently relieved.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Resistance, Forced oscillations, Dyspnea
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPD
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
COPD
Intervention Description
Plethysmography
Intervention Type
Other
Intervention Name(s)
COPD
Intervention Description
Forced oscillations
Primary Outcome Measure Information:
Title
Percentage of obstruction reversibility
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD with dyspnoea with Medical Research Council scale (MRC) >1,
No exacerbation for 6 weeks
No bronchodilatator short action(share) (ß 2 agonist or ipratropium) within 6 hours before the respiratory evaluation and the test of reversibility.
Patient under current treatment (ß2 long-acting agonist (LABA) or anticholinergic long-acting (LLAMA(LAMA)) or LABA-corticoid association inhaled (CSI), or triples LABA-CSI-LAMA association) stable for at least 4 weeks, and taken for at least the 1 hour the day of the visit
Having given a written consent
Exclusion Criteria:
Patient Under 18
Other respiratory illness
Clinically significant left cardiac failure
Obesity with BMI > 35 kg / m2)
Unable to perform respiratory evaluations
Contraindication to the salbutamol or to the ipratropium bromide or to one of its components
Pregnant or breast-feeding woman
Unable to agree
No social security scheme
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène Neveu
Organizational Affiliation
Hôpital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Reversibility of the Bronchial Obstruction by Impulse Oscillometry Technique in Chronic Obstructive Pulmonary Disease (COPD): Correlation With Functional Features Measured by Plethysmography and Dyspnoea
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