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Acute Effects of a Flutter Device in COPD (AEFLUC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01832961
First received: March 25, 2013
Last updated: July 12, 2013
Last verified: April 2013
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
Device: flutter valve exercises
Device: flutter-sham exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Effects of a Flutter Device on Airways Resistance in Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Airways resistance [ Time Frame: change from baseline and after one session (30 minutes) ] [ Designated as safety issue: Yes ]
    Airways resistance will be measured by impulse oscillometry (IOS) method.


Secondary Outcome Measures:
  • Exhaled nitric oxide [ Time Frame: change from baseline and after one session (30 minutes) ] [ Designated as safety issue: Yes ]
    Exhaled nitric oxide will be measured by chemiluminescence method.


Estimated Enrollment: 15
Study Start Date: April 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: flutter valve exercises
30 minutes of breathing exercises with flutter device
Device: flutter valve exercises
30 minutes of flutter exercises
Other Names:
  • Breathing exercises with flutter device
  • Airway clearance technique
Sham Comparator: flutter-sham exercises
30 minutes of breathing exercise with flutter-sham device
Device: flutter-sham exercises
30 minutes of flutter-sham exercises
Other Names:
  • Breathing exercises with flutter-sham device
  • Airway clearance technique

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.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- 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,

Exclusion Criteria:

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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832961

Contacts
Contact: Ada Gastaldi, PhD 020 7351 8053 ext 8053 a.gastaldi@imperial.ac.uk
Contact: Paolo Paredi, MD 020 7351 8051 ext 8051 p.paredi@imperial.ac.uk

Locations
United Kingdom
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    a.gastaldi@imperial.ac.uk   
Contact: Paolo Paredi, MD    020 7351 8051 ext 8051    p.paredi@imperial.ac.uk   
Sub-Investigator: Ada Gastaldi, PhD         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Omar Usmani, MD Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01832961     History of Changes
Other Study ID Numbers: 13/C0346
Study First Received: March 25, 2013
Last Updated: July 12, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
COPD
physiotherapy care
lung function testing
inflammation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014