Acute Effects of a Flutter Device in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

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. 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.
    

Intervention name(s): Flutter valve exercises; Flutter Sham exercises; Flutter and bronchodilator exercises
Intervention type(s): Device; Device; Device
Intervention description(s): 30 minutes of flutter exercises; 30 minutes of flutter-sham exercises; Flutter + bronchodilator exercises with an interval of 3 to 5 days
Other intervention name(s): Breathing exercises with flutter device; Airway clearance technique; Breathing exercises with flutter-sham device; Airway clearance technique
Intervention MeSH terms: Bronchodilator Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; physiotherapy care; lung function testing; inflammation