Chronic Obstructive Pulmonary Disease Clinical Trial
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.
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.
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.
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