Acute Effects of a Flutter Device in COPD

NCT01832961 | Completed Results

• 1 other identifier: 13/C0346
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; physiotherapy care; lung function testing; inflammation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Exhaled Nitric Oxide (FeNO)

  Baseline and immediately after intervention

• Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)

  Baseline and immediately after intervention

• Cough

  During each session

• Secretion - Volume

  During each session

• Secretion - Purulence Score

  In each session

Study Arms (2)

flutter valve exercises

EXPERIMENTAL

30 minutes of breathing exercises with flutter device

Device: Flutter valve exercises; Device: Flutter and bronchodilator exercises

flutter-sham exercises

SHAM COMPARATOR

30 minutes of breathing exercise with flutter-sham device

Device: Flutter Sham exercises; Device: Flutter and bronchodilator exercises

Interventions

Flutter valve exercises DEVICE

30 minutes of flutter exercises

Also known as: Breathing exercises with flutter device, Airway clearance technique

flutter valve exercises

Flutter Sham exercises DEVICE

30 minutes of flutter-sham exercises

Also known as: Breathing exercises with flutter-sham device, Airway clearance technique

flutter-sham exercises

Flutter and bronchodilator exercises DEVICE

Flutter + bronchodilator exercises with an interval of 3 to 5 days

flutter valve exercises; flutter-sham exercises

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Asthma Lab, Royal Brompton Hospital, National Heart and Lung Institute, Imperial College London

London, SW3 6LY, United Kingdom

Location

Related Publications (1)

• 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). 2015 Oct;94(42):e1845. doi: 10.1097/MD.0000000000001845.

  PMID: 26496331 RESULT

Related Links

• Gastaldi AC, et al. Oscillating Positive Expiratory Pressure on Respiratory Resistance in Chronic Obstructive Pulmonary Disease With a Small Amount of Secretion: A Randomized Clinical Trial. Medicine (Baltimore) 2015; 94(42): 1-8.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Inflammation

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Limitations and Caveats

Absence of some objective measurement of dyspnea, well being or satisfaction scales.

Results Point of Contact

• Title: Ada Clarice Gastaldi
• Organization: Imperial College

ada@fmrp.usp.br

55 020 7351 8051

Study Officials

• Omar Usmani, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 16, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 27, 2020
• Results First Posted: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)