N/A
N=15
Acute Effects of a Flutter Device in COPD
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT01832961 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Airways Resistance (IOS) — 0.63; 0.61; 0.58; 0.68 kPa/L/s — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Flutter valve exercises (Device); Flutter Sham exercises (Device); Flutter and bronchodilator exercises (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Airways Resistance (IOS) |
0.63; 0.61; 0.58; 0.68; 0.63; 0.60 | <0.05 sig |
| PRIMARY Airways Resistance (IOS) - Reactance Area (Ax) |
-0.13; -0.19; 1.89; -0.06; -0.20; 2.22 | <0.05 sig |
| PRIMARY Airways Resistance (IOS) - Resonant Frequency (Fres) |
24.95; 22.54; 22.13; 26.15; 23.49; 22.41 | <0.05 sig |
| SECONDARY Exhaled Nitric Oxide (FeNO) |
40.5; 44.4; 32.3; 39.3; 43.6; 31.7 | <0.05 sig |
| SECONDARY Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) |
109.4; 109.8; 105.8; 107.3; 109.0; 102.1 | <0.05 sig |
| SECONDARY Cough |
3.95; 1.69; 3.63 | — |
| SECONDARY Secretion - Volume |
2.54; 1.5 | — |
| SECONDARY Secretion - Purulence Score |
2.30; 2.57; 2.60 | — |
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.
Eligibility 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), with or without sputum, will be included.
The severity of COPD will be classified according to GOLD criteria:
Stage I: mild FEV1/FVC 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
Data sourced from ClinicalTrials.gov (NCT01832961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.