Chronic Obstructive Pulmonary Disease Clinical Trial
— AEFLUCOfficial title:
Acute Effects of a Flutter Device on Airways Resistance in Chronic Obstructive Pulmonary Disease (COPD)
NCT number | NCT01832961 |
Other study ID # | 13/C0346 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2013 |
Est. completion date | December 2013 |
Verified date | February 2020 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Asthma Lab, Royal Brompton Hospital, National Heart and Lung Institute, Imperial College London | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
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). — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Airways Resistance (IOS) | Airways resistance were measured by impulse oscillometry (IOS) method. | Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest | |
Primary | Airways Resistance (IOS) - Reactance Area (Ax) | Airways resistance were measured by impulse oscillometry (IOS) method. | Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest | |
Primary | Airways Resistance (IOS) - Resonant Frequency (Fres) | Airways resistance were measured by impulse oscillometry (IOS) method. | Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest | |
Secondary | Exhaled Nitric Oxide (FeNO) | Exhaled nitric oxide will be measured by chemiluminescence method. | Baseline and immediately after intervention | |
Secondary | 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) | Baseline and immediately after intervention | |
Secondary | Cough | Number of spontaneously reported cough episodes during each visit were collected. | During each session | |
Secondary | Secretion - Volume | Expectorated secretion volume during each visit were collected, weighted and classified with a purulence score. | During each session | |
Secondary | 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. |
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