Chronic Obstructive Pulmonary DiseaseAEFLUCNCT01832961
Acute Effects of a Flutter Device in COPD
A study testing Flutter valve exercises and Flutter and bronchodilator exercises in people with Chronic Obstructive Pulmonary Disease, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is not fully reversible, and is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases, most commonly cigarette smoking. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Flutter valve exercises and Flutter and bronchodilator exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with COPD meeting the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, with forced expiratory volume in the first second of expiration (FEV1) <80% predicted, FEV1/FVC ratio <70% predicted (FVC= forced vital capacity), and total lung capacity (TLC) >80% predicted), with or without sputum, will be included.
- The severity of COPD will be classified according to GOLD criteria:
- Stage I: mild FEV1/FVC<0.70 and FEV1>80% predicted; Stage II: moderate FEV1/FVC<0.70 and 50<FEV1<80% predicted; Stage III: severe FEV1/FVC<0.70 and 30<FEV1<50% predicted; Stage IV: very severe FEV1/FVC<0.70 and FEV1<30% or FEV1<50% predicted plus chronic respiratory failure,
Who cannot join
- Patients with:
- Upper respiratory tract infection within the previous 28 days
- Treatment with antibiotics within 4 weeks prior the study
- Acute dyspnoea or hemoptysis
- Chest pain or recent history of rib fracture or pneumothorax
- Acute cardiovascular events in the previous 3 months
Show all 13Show fewer
- Any history or evidence of renal, gastrointestinal or hepatic disease
- Any history and evidence of neuropsychiatric disease
- Alcohol, drug abuse or any other condition associated with poor compliance
- Breast feeding
- Pregnancy
- Other complications that hinder the completion of the tests
- Unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Asthma Lab, Royal Brompton Hospital, National Heart and Lung Institute, Imperial College London
London, SW3 6LY
About this study
Official title: Acute Effects of a Flutter Device on Airways Resistance in Chronic Obstructive Pulmonary Disease (COPD)
Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is not fully reversible, and is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases, most commonly cigarette smoking. The disease affects not only the large central airways but also the small, more peripheral airways deeper into the lung, defined as less than 2 mm in diameter.
Besides medical treatment, physiotherapy plays a major role in treatment and various methods have been suggested to remove airway of secretions. The flutter is a simple and small device shaped like a pipe that creates a positive expiratory pressure (PEP) and high frequency oscillation when the expired air passes through it. These vibrations are thought to mobilise airway secretions facilitating their clearance and improving breathing.
Read more
Standard blowing tests, like spirometry, where patients blow forcedly into a machine, have previously been used to investigate the efficacy of flutter devices. However, spirometry assesses the damage of larger airways but not small airways, also known as the "silent zone" which, crucially, are specifically damaged in COPD.
In this study the investigators hypothesise that because the flutter helps clear the airways from the excessive thick mucus produced by COPD patients, these patients may find it easier to breathe and have lower resistance to moving air in and out of their lungs.
The main objective of this study is to compare the effect of a flutter or a sham device on small airways damage using impulse oscillometry (IOS), a non-invasive method that, contrary to other common blowing tests, measures small airway resistance during normal breathing.
In addition, because COPD is characterised by inflammation, the investigators would also like to measure a gas the patients blow out, nitric oxide (NO) the levels of which reflect airway inflammation. This will give to investigators an insight into the relationship between airway inflammation and small airway function.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is not fully reversible. This limitation is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases.
Patients suffering from COPD may show pathologic changes not only in the large but also in the small airways, which are defined as less than 2mm in diameter. Airway inflammation may cause increased thick mucus secretions which can narrow the airways increasing the resistance to the airflow.
Physiotherapy to remove secretions is indicated for patients with COPD who have regular sputum or those with thick secretions and various techniques and physiotherapy devices can be applied for the removal of secretions. The flutter is a simple and small device shaped like a pipe that creates a positive expiratory pressure (PEP) and high frequency oscillation as expired air passes through it. These vibrations and PEP are thought to mobilise airway secretions facilitating their clearance and improving airflow.
The effects of the flutter device have been studied in different patient groups, but especially in lung diseases characterised by mucus hypersecretion such as COPD, cystic fibrosis and bronchiectasis. In COPD, even though the flutter device increases the volume of expectorated secretions, its beneficial effects on pulmonary function as assessed by spirometry and plethysmography are inconclusive. However, these standard lung function tests (such as spirometry) asses the large airways, but do not provide an accurate estimate of the small airways which have been described by some authors as "the silent zone".
The investigators hypothesise that the use of impulse oscillometry (IOS), a non-invasive technique that provides information on small airway resistance during normal breathing, may reveal the effect of the flutter device which may have not been accurately measured by spirometry in previous studies.
In addition, the investigators would like to measure exhaled nitric oxide (NO) levels which reflect airway inflammation and may therefore be useful to determine the association between small airway disease and inflammation.
In summary, the symptoms of patients with COPD improve following breathing exercises with a flutter device, however, the effect of this device on lung function is unclear. The investigators hypothesise that the combined use IOS and NO, would help understand and quantify the effects of the flutter device on the small airways disease in COPD.
The main objective of this study is to measure the effect of a 30 minutes breathing exercise with a flutter device on airway resistance as assessed by impulse oscillometry in patients with COPD.
The secondary objective is to investigate the association between inflammation, airway resistance and volume of secretions in COPD patients.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Flutter valve exercises, Flutter Sham exercises, Flutter and bronchodilator exercises
- Keywords
- COPD, physiotherapy care, lung function testing, inflammation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flutter valve exercisesDevice
Also called Breathing exercises with flutter device, Airway clearance technique
30 minutes of flutter exercises
Flutter Sham exercisesDevice
Also called Breathing exercises with flutter-sham device, Airway clearance technique
30 minutes of flutter-sham exercises
Flutter and bronchodilator exercisesDevice
Flutter + bronchodilator exercises with an interval of 3 to 5 days
| Study group | Role | What they receive |
|---|---|---|
| flutter valve exercises | Experimental | 30 minutes of breathing exercises with flutter device Receives: Device: Flutter valve exercises; Device: Flutter and bronchodilator exercises |
| flutter-sham exercises | Sham comparator | 30 minutes of breathing exercise with flutter-sham device Receives: Device: Flutter Sham exercises; Device: Flutter and bronchodilator exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airways Resistance (IOS)
Airways resistance were measured by impulse oscillometry (IOS) method.
Measured: Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest
Airways Resistance (IOS) - Reactance Area (Ax)
Airways resistance were measured by impulse oscillometry (IOS) method.
Measured: Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest
Airways Resistance (IOS) - Resonant Frequency (Fres)
Airways resistance were measured by impulse oscillometry (IOS) method.
Measured: Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest
Secondary outcomes (5)
Exhaled Nitric Oxide (FeNO)
Exhaled nitric oxide will be measured by chemiluminescence method.
Measured: Baseline and immediately after intervention
Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)
Forced expiratory volume in 1s (FEV1) and forced vital capacity (FVC) were measured using a dry wedge spirometer (Jaeger Co, Wurzburg, Germany)
Measured: Baseline and immediately after intervention
Cough
Number of spontaneously reported cough episodes during each visit were collected.
Measured: During each session
Secretion - Volume
Expectorated secretion volume during each visit were collected, weighted and classified with a purulence score.
Measured: During each session
Secretion - Purulence Score
The expectorated secretion was collected, weighted and classified with a purulence score based on a previously described numerical visual scale, which ranges from 1 (mucoid) to 5 (yellow/green).
Referee of the Purulence score: Barnes PJ, Dweik RA, Gelb AF, et al. Exhaled nitric oxide in pulmonary diseases: a comprehensive review. Chest. 2010;138:682-692.
Measured: In each session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omar Usmani, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832961
- Sponsor's protocol ID
- 13/C0346
- Acronym
- AEFLUC
- Status last verified
- Feb 2020
- First submitted
- 25 Mar 2013
- Last updated
- 27 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gastaldi AC, Paredi P, Talwar A, Meah S, Barnes PJ, Usmani OS. Oscillating Positive Expiratory Pressure on Respiratory Resistance in Chronic Obstructive Pulmonary Disease With a Small Amount of Secretion: A Randomized Clinical Trial. Medicine (Baltimore). 2015 Oct;94(42):e1845. doi: 10.1097/MD.0000000000001845.
PubMed 26496331
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of a Flutter Device on Airways Resistance in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01832961
- Acronym / sponsor ID
- AEFLUC / 13/C0346
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, physiotherapy care, lung function testing, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Posted 27 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is not fully reversible, and is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases, most commonly cigarette smoking. The disease affects not only the large central airways but also the small, more peripheral airways deeper into the lung, defined as less than 2 mm in diameter.
Besides medical treatment, physiotherapy plays a major role in treatment and various methods have been suggested to remove airway of secretions. The flutter is a simple and small device shaped like a pipe that creates a positive expiratory pressure (PEP) and high frequency oscillation when the expired air passes through it. These vibrations are thought to mobilise airway secretions facilitating their clearance and improving breathing.
Standard blowing tests, like spirometry, where patients blow forcedly into a machine, have previously been used to investigate the efficacy of flutter devices. However, spirometry assesses the damage of larger airways but not small airways, also known as the "silent zone" which, crucially, are specifically damaged in COPD.
In this study the investigators hypothesise that because the flutter helps clear the airways from the excessive thick mucus produced by COPD patients, these patients may find it easier to breathe and have lower resistance to moving air in and out of their lungs.
The main objective of this study is to compare the effect of a flutter or a sham device on small airways damage using impulse oscillometry (IOS), a non-invasive method that, contrary to other common blowing tests, measures small airway resistance during normal breathing.
In addition, because COPD is characterised by inflammation, the investigators would also like to measure a gas the patients blow out, nitric oxide (NO) the levels of which reflect airway inflammation. This will give to investigators an insight into the relationship between airway inflammation and small airway function.
Detailed description
Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is not fully reversible. This limitation is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases.
Patients suffering from COPD may show pathologic changes not only in the large but also in the small airways, which are defined as less than 2mm in diameter. Airway inflammation may cause increased thick mucus secretions which can narrow the airways increasing the resistance to the airflow.
Physiotherapy to remove secretions is indicated for patients with COPD who have regular sputum or those with thick secretions and various techniques and physiotherapy devices can be applied for the removal of secretions. The flutter is a simple and small device shaped like a pipe that creates a positive expiratory pressure (PEP) and high frequency oscillation as expired air passes through it. These vibrations and PEP are thought to mobilise airway secretions facilitating their clearance and improving airflow.
The effects of the flutter device have been studied in different patient groups, but especially in lung diseases characterised by mucus hypersecretion such as COPD, cystic fibrosis and bronchiectasis. In COPD, even though the flutter device increases the volume of expectorated secretions, its beneficial effects on pulmonary function as assessed by spirometry and plethysmography are inconclusive. However, these standard lung function tests (such as spirometry) asses the large airways, but do not provide an accurate estimate of the small airways which have been described by some authors as "the silent zone".
The investigators hypothesise that the use of impulse oscillometry (IOS), a non-invasive technique that provides information on small airway resistance during normal breathing, may reveal the effect of the flutter device which may have not been accurately measured by spirometry in previous studies.
In addition, the investigators would like to measure exhaled nitric oxide (NO) levels which reflect airway inflammation and may therefore be useful to determine the association between small airway disease and inflammation.
In summary, the symptoms of patients with COPD improve following breathing exercises with a flutter device, however, the effect of this device on lung function is unclear. The investigators hypothesise that the combined use IOS and NO, would help understand and quantify the effects of the flutter device on the small airways disease in COPD.
The main objective of this study is to measure the effect of a 30 minutes breathing exercise with a flutter device on airway resistance as assessed by impulse oscillometry in patients with COPD.
The secondary objective is to investigate the association between inflammation, airway resistance and volume of secretions in COPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flutter valve exercises | Experimental | Device: Flutter valve exercises, Device: Flutter and bronchodilator exercises30 minutes of breathing exercises with flutter device |
| flutter-sham exercises | Sham comparator | Device: Flutter Sham exercises, Device: Flutter and bronchodilator exercises30 minutes of breathing exercise with flutter-sham device |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with COPD meeting the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, with forced expiratory volume in the first second of expiration (FEV1) <80% predicted, FEV1/FVC ratio <70% predicted (FVC= forced vital capacity), and total lung capacity (TLC) >80% predicted), with or without sputum, will be included.
- Stage I: mild FEV1/FVC<0.70 and FEV1>80% predicted; Stage II: moderate FEV1/FVC<0.70 and 50<FEV1<80% predicted; Stage III: severe FEV1/FVC<0.70 and 30<FEV1<50% predicted; Stage IV: very severe FEV1/FVC<0.70 and FEV1<30% or FEV1<50% predicted plus chronic respiratory failure,
Key exclusion criteria (13 listed)
- Upper respiratory tract infection within the previous 28 days
- Treatment with antibiotics within 4 weeks prior the study
- Acute dyspnoea or hemoptysis
- Chest pain or recent history of rib fracture or pneumothorax
- Acute cardiovascular events in the previous 3 months
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 |
|---|---|---|
| Flutter valve exercisesAlso: Breathing exercises with flutter device, Airway clearance technique30 minutes of flutter exercises | Device | flutter valve exercises |
| Flutter Sham exercisesAlso: Breathing exercises with flutter-sham device, Airway clearance technique30 minutes of flutter-sham exercises | Device | flutter-sham exercises |
| Flutter and bronchodilator exercisesFlutter + bronchodilator exercises with an interval of 3 to 5 days | Device | flutter valve exercises, flutter-sham exercises |
Primary outcome
Airways Resistance (IOS)
Time frame: Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest
Airways resistance were measured by impulse oscillometry (IOS) method.
Airways Resistance (IOS) - Reactance Area (Ax)
Time frame: Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest
Airways resistance were measured by impulse oscillometry (IOS) method.
Airways Resistance (IOS) - Resonant Frequency (Fres)
Time frame: Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest
Airways resistance were measured by impulse oscillometry (IOS) method.
5 secondary outcomes
Exhaled Nitric Oxide (FeNO)
Time frame: Baseline and immediately after intervention
Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)
Time frame: Baseline and immediately after intervention
Cough
Time frame: During each session
Secretion - Volume
Time frame: During each session
Secretion - Purulence Score
Time frame: In each session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26496331Gastaldi AC, Paredi P, Talwar A, Meah S, Barnes PJ, Usmani OS. Oscillating Positive Expiratory Pressure on Respiratory Resistance in Chronic Obstructive Pulmonary Disease With a Small Amount of Secretion: A Randomized Clinical Trial. Medicine (Baltimore). 2015 Oct;94(42):e1845. doi: 10.1097/MD.0000000000001845.
- Gastaldi AC, et al. Oscillating Positive Expiratory Pressure on Respiratory Resistance in Chronic Obstructive Pulmonary Disease With a Small Amount of Secretion: A Randomized Clinical Trial. Medicine (Baltimore) 2015; 94(42): 1-8.Link provided by the sponsor.
- 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.
Omar Usmani, MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flutter valve exercises and Flutter and bronchodilator exercises in people with Chronic Obstructive Pulmonary Disease, run by Imperial College London at 1 site in United Kingdom.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Airways Resistance (IOS) (time frame: Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01832961, which also lists 1 linked publication.
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 27 Feb 2020.