Chronic Obstructive Pulmonary DiseasePhase 4NCT03910985
Assessment of Reactance Parameters Measured by the Forced Oscillation Technique for the Bronchodilator Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing Duovent HFA in people with Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Universitaire UCLouvain Namur.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Duovent HFA
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2019to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- History of urinary retention (only for patients not usually treated with anticholinergic bronchodilators)
- Pregnancy
- Acute illness contraindicating the performance of respiratory tests
About this study
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
Read the 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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Duovent HFA
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duovent HFADrug
bronchodilation
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute inspiratory capacity increase
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start23 Apr 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire UCLouvain Namur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marchand Eric, Centre Hospitalier Universitaire UCLouvain Namur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910985
- Sponsor's protocol ID
- B039201938727
- Status last verified
- Apr 2019
- First submitted
- 9 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Reactance Parameters Measured by the Forced Oscillation Technique for the Bronchodilator Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03910985
- Acronym / sponsor ID
- B039201938727
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire UCLouvain NamurUniversity, hospital or other
- Study start
- 23 Apr 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duovent HFAbronchodilation | Drug | – |
Primary outcome
Acute inspiratory capacity increase
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duovent HFA in people with Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Universitaire UCLouvain Namur.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute inspiratory capacity increase (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.