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

NCT03910985 | Unknown Phase 4

• 1 other identifier: B039201938727
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Acute inspiratory capacity increase

  30 minutes

Interventions

Duovent HFA DRUG

bronchodilation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to comply with bronchodilator weaning time :
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire UCLouvain Namur: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator Eric MARCHAND

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 10, 2019
• Study Start: April 23, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share