Acute Effects of a Flutter Device in COPD (AEFLUC)
|ClinicalTrials.gov Identifier: NCT01832961|
Recruitment Status : Unknown
Verified April 2013 by Imperial College London.
Recruitment status was: Recruiting
First Posted : April 16, 2013
Last Update Posted : July 15, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Device: flutter valve exercises Device: flutter-sham exercises||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acute Effects of a Flutter Device on Airways Resistance in Chronic Obstructive Pulmonary Disease (COPD)|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Experimental: flutter valve exercises
30 minutes of breathing exercises with flutter device
Device: flutter valve exercises
30 minutes of flutter exercises
Sham Comparator: flutter-sham exercises
30 minutes of breathing exercise with flutter-sham device
Device: flutter-sham exercises
30 minutes of flutter-sham exercises
- Airways resistance [ Time Frame: change from baseline and after one session (30 minutes) ]Airways resistance will be measured by impulse oscillometry (IOS) method.
- Exhaled nitric oxide [ Time Frame: change from baseline and after one session (30 minutes) ]Exhaled nitric oxide will be measured by chemiluminescence method.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832961
|Contact: Ada Gastaldi, PhD||020 7351 8053 ext email@example.com|
|Contact: Paolo Paredi, MD||020 7351 8051 ext firstname.lastname@example.org|
|Asthma Lab, Royal Brompton Hospital, National Heart and Lung Institute, Imperial College London||Recruiting|
|London, United Kingdom, SW3 6LY|
|Contact: Ada Gastaldi, PhD 020 7351 8053 ext 8053 email@example.com|
|Contact: Paolo Paredi, MD 020 7351 8051 ext 8051 firstname.lastname@example.org|
|Sub-Investigator: Ada Gastaldi, PhD|
|Principal Investigator:||Omar Usmani, MD||Imperial College London|