AEFLUC: Acute Effects of a Flutter Device in COPD

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT01832961
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 8
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Device: Flutter valve exercises; Device: Flutter Sham exercises; Device: Flutter and bronchodilator exercises	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Acute Effects of a Flutter Device on Airways Resistance in Chronic Obstructive Pulmonary Disease (COPD)
• Actual Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 ; Device: Flutter and bronchodilator exercises; Flutter + bronchodilator exercises with an interval of 3 to 5 days
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 ; Device: Flutter and bronchodilator exercises; Flutter + bronchodilator exercises with an interval of 3 to 5 days

Outcome Measures

Primary Outcome Measures

1. Airways Resistance (IOS) [Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest]

   Airways resistance were measured by impulse oscillometry (IOS) method.

2. Airways Resistance (IOS) - Reactance Area (Ax) [Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest]

   Airways resistance were measured by impulse oscillometry (IOS) method.

3. Airways Resistance (IOS) - Resonant Frequency (Fres) [Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest]

   Airways resistance were measured by impulse oscillometry (IOS) method.

Secondary Outcome Measures

1. Exhaled Nitric Oxide (FeNO) [Baseline and immediately after intervention]

   Exhaled nitric oxide will be measured by chemiluminescence method.

2. Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) [Baseline and immediately after intervention]

   Forced expiratory volume in 1s (FEV1) and forced vital capacity (FVC) were measured using a dry wedge spirometer (Jaeger Co, Wurzburg, Germany)

3. Cough [During each session]

   Number of spontaneously reported cough episodes during each visit were collected.

4. Secretion - Volume [During each session]

   Expectorated secretion volume during each visit were collected, weighted and classified with a purulence score.

5. Secretion - Purulence Score [In each session]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Asthma Lab, Royal Brompton Hospital, National Heart and Lung Institute, Imperial College London	London		United Kingdom	SW3 6LY

Sponsors and Collaborators

• Imperial College London

Investigators

• Principal Investigator: Omar Usmani, MD, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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.

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT01832961
• Other Study ID Numbers: 13/C0346
• First Posted: Apr 16, 2013
• Last Update Posted: Feb 27, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• 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; Bronchodilator Agents

Study Results

Participant Flow

Arm/Group Title	Flutter Valve, Then Flutter Sham and Flutter+Bronchodilator	Flutter Sham, Then Flutter Valve and Flutter+Bronchodilator
Arm/Group Description	Visit 1: medical history, physical examination and written informed consent Visit 2: FeNO, IOS and spirometry + 30 minutes of breathing exercises with flutter device Visit 3: FeNO, IOS and spirometry + 30 minutes of flutter-sham exercises Visit 4: FeNO, IOS and spirometry + bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device	Visit 1: medical history, physical examination and written informed consent Visit 2: FeNO, IOS and spirometry + 30 minutes of flutter-sham exercises Visit 3: FeNO, IOS and spirometry + 30 minutes of breathing exercises with flutter device Visit 4: FeNO, IOS and spirometry + bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
Period Title: First Intervention
STARTED	8	7
COMPLETED	8	7
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	8	7
COMPLETED	8	7
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	8	7
COMPLETED	8	7
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	8	7
COMPLETED	8	7
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Patient
Arm/Group Description	All volunteers had a following treatments as crossover design Visit 1: medical history, physical examination and written informed consent Visit 2: FeNO, IOS and spirometry + 30 minutes of breathing exercises with flutter device Visit 3: FeNO, IOS and spirometry + 30 minutes of flutter-sham exercises Visit 4: FeNO, IOS and spirometry + bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
Overall Participants	15
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.3 (9.1)
Sex: Female, Male (Count of Participants)
Female	10 66.7%
Male	5 33.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United Kingdom	15 100%

Outcome Measures

1. Primary Outcome

Title	Airways Resistance (IOS)
Description	Airways resistance were measured by impulse oscillometry (IOS) method.
Time Frame	Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest

Outcome Measure Data

Analysis Population Description

Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis, and no recent history of rib fractures or pneumothorax. In the Flutter-sham Control group after 20 minutes of rest - no data was collected.

Arm/Group Title	Flutter Exercises Session	Flutter+Bronchodilator Session	Flutter-sham - Control Group
Arm/Group Description	30 minutes of breathing exercises with flutter device	Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device	30 minutes of exercise with flutter-sham device
Measure Participants	15	15	15
R5 (kPa/L/s) Baseline	0.63 (0.16)	0.61 (0.28)	0.58 (0.15)
R5 (kPa/L/s) Immediately after	0.68 (0.21)	0.63 (0.26)	0.60 (0.22)
R5 (kPa/L/s) After 20 minutes of rest	0.61 (0.18)	0.56 (0.24)	NA (NA)
R20 (kPa/L/s) Baseline	0.42 (0.12)	0.41 (0.15)	0.40 (0.15)
R20 (kPa/L/s) Immediately after	0.43 (0.14)	0.42 (0.16)	0.41 (0.13)
R20 (kPa/L/s) After 20 minutes of rest	0.41 (0.15)	0.39 (0.14)	NA (NA)
R5-R20 (kPa/L/s) Baseline	0.21 (0.08)	0.20 (0.15)	0.19 (0.10)
R5-R20 (kPa/L/s) Immediately after	0.25 (0.10)	0.21 (0.12)	0.19 (0.11)
R5-R20 (kPa/L/s) After 20 minutes of rest	0.20 (0.06)	0.18 (0.25)	NA (NA)
X5 (kPa/L/s) Baseline	-0.27 (0.10)	-0.27 (0.15)	-0.23 (0.08)
X5 (kPa/L/s) Immediately after	-0.28 (0.11)	-0.25 (0.11)	-0.24 (0.09)
X5 (kPa/L/s) After 20 minutes of rest	-0.26 (0.10)	-0.25 (0.12)	NA (NA)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Flutter Exercises Session, Flutter+Bronchodilator Session, Flutter-sham - Control Group
	Comments	The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Friedman's Test
	Comments	Friedman's test followed by Dunn's multiple comparison
Other Statistical Analysis		The effect of size used to calculate responsiveness and classified as small (0.2), moderate (0.5) and large (0.8).

2. Primary Outcome

Title	Airways Resistance (IOS) - Reactance Area (Ax)
Description	Airways resistance were measured by impulse oscillometry (IOS) method.
Time Frame	Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest

Outcome Measure Data

Analysis Population Description

No data was collected from the Flutter-sham Control group after 20 minutes of rest.

Arm/Group Title	Flutter Exercises Session	Flutter+Bronchodilator Session	Flutter-sham - Control Group
Arm/Group Description	30 minutes of breathing exercises with flutter device	Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device	30 minutes of breathing exercises with flutter-sham device
Measure Participants	15	15	15
Ax (kPa/L) Baseline	-0.13 (0.17)	-0.19 (0.30)	1.89 (1.18)
Ax (kPa/L) Immediately after	-0.06 (0.20)	-0.20 (0.26)	2.22 (1.62)
Ax (kPa/L) After 20 minutes of rest	-0.10 (0.16)	-0.18 (0.26)	NA (NA)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Flutter Exercises Session, Flutter+Bronchodilator Session, Flutter-sham - Control Group
	Comments	The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Friedman's Test
	Comments
Other Statistical Analysis		The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)

3. Primary Outcome

Title	Airways Resistance (IOS) - Resonant Frequency (Fres)
Description	Airways resistance were measured by impulse oscillometry (IOS) method.
Time Frame	Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest

Outcome Measure Data

Analysis Population Description

No data was collected from the Flutter-sham Control group after 20 minutes of rest.

Arm/Group Title	Flutter Exercises Session	Flutter+Bronchodilator Session	Flutter-sham - Control Group
Arm/Group Description	30 minutes of breathing exercises with flutter device	Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device	30 minutes of breathing exercise with flutter-sham device
Measure Participants	15	15	15
Fres (Hz) Baseline	24.95 (4.03)	22.54 (7.70)	22.13 (5.71)
Fres (Hz) Immediately after	26.15 (4.78)	23.49 (6.14)	22.41 (8.24)
Fres (Hz) After 20 minutes of rest	24.24 (4.29)	21.85 (7.01)	NA (NA)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Flutter Exercises Session, Flutter+Bronchodilator Session, Flutter-sham - Control Group
	Comments	The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Friedman's Test
	Comments
Other Statistical Analysis		The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)

4. Secondary Outcome

Title	Exhaled Nitric Oxide (FeNO)
Description	Exhaled nitric oxide will be measured by chemiluminescence method.
Time Frame	Baseline and immediately after intervention

Outcome Measure Data

Analysis Population Description

Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.

Arm/Group Title	Flutter Exercises	Flutter-sham	Flutter+Bronchodilator
Arm/Group Description	Flutter exercises: 30 minutes of breathing exercises with flutter device	Flutter-sham: 30 minutes of flutter-sham exercises	Flutter+bronchodilator: Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
Measure Participants	15	15	15
Baseline	40.5 (29.9)	44.4 (33.7)	32.3 (29.4)
After intervention	39.3 (33.7)	43.6 (33.2)	31.7 (32.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Flutter Exercises Session, Flutter+Bronchodilator Session, Flutter-sham - Control Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	T-test
	Comments	T-test was used to comparisons before and after FeNO results

5. Secondary Outcome

Title	Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)
Description	Forced expiratory volume in 1s (FEV1) and forced vital capacity (FVC) were measured using a dry wedge spirometer (Jaeger Co, Wurzburg, Germany)
Time Frame	Baseline and immediately after intervention

Outcome Measure Data

Analysis Population Description

Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.

Arm/Group Title	Flutter Exercises	Flutter-sham	Flutter+Bronchodilator
Arm/Group Description	Flutter exercises: 30 minutes of breathing exercises with flutter device	Flutter-sham: 30 minutes of flutter-sham exercises	Flutter+bronchodilator: Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
Measure Participants	15	15	15
Baseline FVC (%)	109.4 (18.4)	109.8 (19.6)	105.8 (16.2)
After intervention FVC (%)	107.3 (18.1)	109.0 (17.5)	102.1 (18.0)
Baseline FEV1 (%)	67.6 (17.7)	67.0 (17.3)	62.1 (16.7)
After intervention FEV1 (%)	66.0 (15.5)	65.3 (14.6)	60.3 (17.1)
Baseline FEV1/FVC (%)	51.0 (13.0)	50.3 (12.0)	48.5 (12.8)
After intervention FEV1/FVC (%)	51.0 (12.5)	49.7 (10.8)	48.9 (12.8)
Baseline MEF 25-75 (%)	18.93 (8.0)	17.8 (6.8)	15.7 (6.4)
After intervention MEF 25-75 (%)	18.0 (7.1)	17.6 (6.9)	15.1 (7.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Flutter Exercises Session, Flutter+Bronchodilator Session, Flutter-sham - Control Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	T-test
	Comments

6. Secondary Outcome

Title	Cough
Description	Number of spontaneously reported cough episodes during each visit were collected.
Time Frame	During each session

Outcome Measure Data

Analysis Population Description

Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.

Arm/Group Title	Flutter Exercises Session	Flutter-sham Exercises Session	Flutter+Bronchodilator Session
Arm/Group Description	30 minutes of breathing exercises with flutter device	30 minutes of breathing exercises with a flutter-sham device	Pretreatment with a short-acting bronchodilator and 01 hour later they performed flutter exercises during 30 minutes
Measure Participants	15	15	15
Mean (Standard Deviation) [Coughs]	3.95 (2.41)	1.69 (1.49)	3.63 (3.07)

7. Secondary Outcome

Title	Secretion - Volume
Description	Expectorated secretion volume during each visit were collected, weighted and classified with a purulence score.
Time Frame	During each session

Outcome Measure Data

Analysis Population Description

COPD patients without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of a rib fracture or pneumothorax The volume fo secretion was obtained only for two groups: Flutter exercises and flutter-sham exercises.

Arm/Group Title	Flutter Exercises Session	Flutter-sham Exercises Session
Arm/Group Description	30 minutes of breathing exercises with flutter device	30 minutes of breathing exercises with a flutter-sham device
Measure Participants	15	15
Mean (Standard Deviation) [grams]	2.54 (1.39)	1.5 (1.33)

8. Secondary Outcome

Title	Secretion - Purulence Score
Description	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.
Time Frame	In each session

Outcome Measure Data

Analysis Population Description

COPD patients without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of a rib fracture or pneumothorax.

Arm/Group Title	Flutter Exercises Session	Flutter-sham Exercises Session	Flutter+Bronchodilator Session
Arm/Group Description	30 minutes of breathing exercises with flutter device	30 minutes of breathing exercises with a flutter-sham device	Pretreatment with a short-acting bronchodilator and 01 hour later they performed flutter exercises during 30 minutes
Measure Participants	15	15	15
Mean (Standard Deviation) [score on a scale]	2.30 (0.82)	2.57 (0.79)	2.60 (1.34)

Adverse Events

Time Frame	9 months
Arm/Group Title	Flutter Exercises		Flutter-sham		Flutter+Bronchodilator
Arm/Group Description	Flutter exercises: 30 minutes of breathing exercises with flutter device		Flutter-sham: 30 minutes of flutter-sham exercises		Flutter+bronchodilator: Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
All Cause Mortality
	Flutter Exercises		Flutter-sham		Flutter+Bronchodilator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Flutter Exercises		Flutter-sham		Flutter+Bronchodilator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Flutter Exercises		Flutter-sham		Flutter+Bronchodilator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		0/15 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.