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Acute Effects of a Flutter Device in COPD

Acute Effects of a Flutter Device on Airways Resistance in Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01832961
Acronym
AEFLUC
Enrollment
15
Registered
2013-04-16
Start date
2013-04-30
Completion date
2013-12-31
Last updated
2020-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, physiotherapy care, lung function testing, inflammation

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.

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.

Interventions

DEVICEFlutter valve exercises

30 minutes of flutter exercises

DEVICEFlutter Sham exercises

30 minutes of flutter-sham exercises

DEVICEFlutter and bronchodilator exercises

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

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Airways Resistance (IOS)Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of restAirways resistance were measured by impulse oscillometry (IOS) method.
Airways Resistance (IOS) - Reactance Area (Ax)Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of restAirways resistance were measured by impulse oscillometry (IOS) method.
Airways Resistance (IOS) - Resonant Frequency (Fres)Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of restAirways resistance were measured by impulse oscillometry (IOS) method.

Secondary

MeasureTime frameDescription
Exhaled Nitric Oxide (FeNO)Baseline and immediately after interventionExhaled nitric oxide will be measured by chemiluminescence method.
Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)Baseline and immediately after interventionForced expiratory volume in 1s (FEV1) and forced vital capacity (FVC) were measured using a dry wedge spirometer (Jaeger Co, Wurzburg, Germany)
CoughDuring each sessionNumber of spontaneously reported cough episodes during each visit were collected.
Secretion - VolumeDuring each sessionExpectorated secretion volume during each visit were collected, weighted and classified with a purulence score.
Secretion - Purulence ScoreIn each sessionThe 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.

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
All Patient
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
15
Total15

Baseline characteristics

CharacteristicAll Patient
Age, Continuous67.3 years
STANDARD_DEVIATION 9.1
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United Kingdom
15 participants
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 150 / 15
other
Total, other adverse events
0 / 150 / 150 / 15
serious
Total, serious adverse events
0 / 150 / 150 / 15

Outcome results

Primary

Airways Resistance (IOS)

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Flutter Exercises SessionAirways Resistance (IOS)R5 (kPa/L/s) Baseline0.63 kPa/L/sStandard Deviation 0.16
Flutter Exercises SessionAirways Resistance (IOS)R5 (kPa/L/s) Immediately after0.68 kPa/L/sStandard Deviation 0.21
Flutter Exercises SessionAirways Resistance (IOS)R5 (kPa/L/s) After 20 minutes of rest0.61 kPa/L/sStandard Deviation 0.18
Flutter Exercises SessionAirways Resistance (IOS)R20 (kPa/L/s) Baseline0.42 kPa/L/sStandard Deviation 0.12
Flutter Exercises SessionAirways Resistance (IOS)R20 (kPa/L/s) Immediately after0.43 kPa/L/sStandard Deviation 0.14
Flutter Exercises SessionAirways Resistance (IOS)R20 (kPa/L/s) After 20 minutes of rest0.41 kPa/L/sStandard Deviation 0.15
Flutter Exercises SessionAirways Resistance (IOS)R5-R20 (kPa/L/s) Baseline0.21 kPa/L/sStandard Deviation 0.08
Flutter Exercises SessionAirways Resistance (IOS)R5-R20 (kPa/L/s) Immediately after0.25 kPa/L/sStandard Deviation 0.1
Flutter Exercises SessionAirways Resistance (IOS)R5-R20 (kPa/L/s) After 20 minutes of rest0.20 kPa/L/sStandard Deviation 0.06
Flutter Exercises SessionAirways Resistance (IOS)X5 (kPa/L/s) Baseline-0.27 kPa/L/sStandard Deviation 0.1
Flutter Exercises SessionAirways Resistance (IOS)X5 (kPa/L/s) Immediately after-0.28 kPa/L/sStandard Deviation 0.11
Flutter Exercises SessionAirways Resistance (IOS)X5 (kPa/L/s) After 20 minutes of rest-0.26 kPa/L/sStandard Deviation 0.1
Flutter+Bronchodilator SessionAirways Resistance (IOS)X5 (kPa/L/s) After 20 minutes of rest-0.25 kPa/L/sStandard Deviation 0.12
Flutter+Bronchodilator SessionAirways Resistance (IOS)R5 (kPa/L/s) Baseline0.61 kPa/L/sStandard Deviation 0.28
Flutter+Bronchodilator SessionAirways Resistance (IOS)R5-R20 (kPa/L/s) Baseline0.20 kPa/L/sStandard Deviation 0.15
Flutter+Bronchodilator SessionAirways Resistance (IOS)R5-R20 (kPa/L/s) After 20 minutes of rest0.18 kPa/L/sStandard Deviation 0.25
Flutter+Bronchodilator SessionAirways Resistance (IOS)R5 (kPa/L/s) Immediately after0.63 kPa/L/sStandard Deviation 0.26
Flutter+Bronchodilator SessionAirways Resistance (IOS)R20 (kPa/L/s) After 20 minutes of rest0.39 kPa/L/sStandard Deviation 0.14
Flutter+Bronchodilator SessionAirways Resistance (IOS)X5 (kPa/L/s) Immediately after-0.25 kPa/L/sStandard Deviation 0.11
Flutter+Bronchodilator SessionAirways Resistance (IOS)R5 (kPa/L/s) After 20 minutes of rest0.56 kPa/L/sStandard Deviation 0.24
Flutter+Bronchodilator SessionAirways Resistance (IOS)R5-R20 (kPa/L/s) Immediately after0.21 kPa/L/sStandard Deviation 0.12
Flutter+Bronchodilator SessionAirways Resistance (IOS)R20 (kPa/L/s) Immediately after0.42 kPa/L/sStandard Deviation 0.16
Flutter+Bronchodilator SessionAirways Resistance (IOS)R20 (kPa/L/s) Baseline0.41 kPa/L/sStandard Deviation 0.15
Flutter+Bronchodilator SessionAirways Resistance (IOS)X5 (kPa/L/s) Baseline-0.27 kPa/L/sStandard Deviation 0.15
Flutter-sham - Control GroupAirways Resistance (IOS)R20 (kPa/L/s) Baseline0.40 kPa/L/sStandard Deviation 0.15
Flutter-sham - Control GroupAirways Resistance (IOS)R20 (kPa/L/s) Immediately after0.41 kPa/L/sStandard Deviation 0.13
Flutter-sham - Control GroupAirways Resistance (IOS)X5 (kPa/L/s) Baseline-0.23 kPa/L/sStandard Deviation 0.08
Flutter-sham - Control GroupAirways Resistance (IOS)R20 (kPa/L/s) After 20 minutes of restNA kPa/L/s
Flutter-sham - Control GroupAirways Resistance (IOS)R5-R20 (kPa/L/s) Baseline0.19 kPa/L/sStandard Deviation 0.1
Flutter-sham - Control GroupAirways Resistance (IOS)R5-R20 (kPa/L/s) Immediately after0.19 kPa/L/sStandard Deviation 0.11
Flutter-sham - Control GroupAirways Resistance (IOS)X5 (kPa/L/s) Immediately after-0.24 kPa/L/sStandard Deviation 0.09
Flutter-sham - Control GroupAirways Resistance (IOS)R5 (kPa/L/s) Baseline0.58 kPa/L/sStandard Deviation 0.15
Flutter-sham - Control GroupAirways Resistance (IOS)R5 (kPa/L/s) Immediately after0.60 kPa/L/sStandard Deviation 0.22
Flutter-sham - Control GroupAirways Resistance (IOS)R5-R20 (kPa/L/s) After 20 minutes of restNA kPa/L/s
Flutter-sham - Control GroupAirways Resistance (IOS)R5 (kPa/L/s) After 20 minutes of restNA kPa/L/s
Flutter-sham - Control GroupAirways Resistance (IOS)X5 (kPa/L/s) After 20 minutes of restNA kPa/L/s
Comparison: 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 testp-value: <0.05Friedman's Test
Primary

Airways Resistance (IOS) - Reactance Area (Ax)

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Flutter Exercises SessionAirways Resistance (IOS) - Reactance Area (Ax)Ax (kPa/L) Immediately after-0.06 kPa/LStandard Deviation 0.2
Flutter Exercises SessionAirways Resistance (IOS) - Reactance Area (Ax)Ax (kPa/L) Baseline-0.13 kPa/LStandard Deviation 0.17
Flutter Exercises SessionAirways Resistance (IOS) - Reactance Area (Ax)Ax (kPa/L) After 20 minutes of rest-0.10 kPa/LStandard Deviation 0.16
Flutter+Bronchodilator SessionAirways Resistance (IOS) - Reactance Area (Ax)Ax (kPa/L) Immediately after-0.20 kPa/LStandard Deviation 0.26
Flutter+Bronchodilator SessionAirways Resistance (IOS) - Reactance Area (Ax)Ax (kPa/L) Baseline-0.19 kPa/LStandard Deviation 0.3
Flutter+Bronchodilator SessionAirways Resistance (IOS) - Reactance Area (Ax)Ax (kPa/L) After 20 minutes of rest-0.18 kPa/LStandard Deviation 0.26
Flutter-sham - Control GroupAirways Resistance (IOS) - Reactance Area (Ax)Ax (kPa/L) Baseline1.89 kPa/LStandard Deviation 1.18
Flutter-sham - Control GroupAirways Resistance (IOS) - Reactance Area (Ax)Ax (kPa/L) After 20 minutes of restNA kPa/L
Flutter-sham - Control GroupAirways Resistance (IOS) - Reactance Area (Ax)Ax (kPa/L) Immediately after2.22 kPa/LStandard Deviation 1.62
Comparison: 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 testp-value: <0.05Friedman's Test
Primary

Airways Resistance (IOS) - Resonant Frequency (Fres)

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Flutter Exercises SessionAirways Resistance (IOS) - Resonant Frequency (Fres)Fres (Hz) Immediately after26.15 HzStandard Deviation 4.78
Flutter Exercises SessionAirways Resistance (IOS) - Resonant Frequency (Fres)Fres (Hz) Baseline24.95 HzStandard Deviation 4.03
Flutter Exercises SessionAirways Resistance (IOS) - Resonant Frequency (Fres)Fres (Hz) After 20 minutes of rest24.24 HzStandard Deviation 4.29
Flutter+Bronchodilator SessionAirways Resistance (IOS) - Resonant Frequency (Fres)Fres (Hz) Immediately after23.49 HzStandard Deviation 6.14
Flutter+Bronchodilator SessionAirways Resistance (IOS) - Resonant Frequency (Fres)Fres (Hz) Baseline22.54 HzStandard Deviation 7.7
Flutter+Bronchodilator SessionAirways Resistance (IOS) - Resonant Frequency (Fres)Fres (Hz) After 20 minutes of rest21.85 HzStandard Deviation 7.01
Flutter-sham - Control GroupAirways Resistance (IOS) - Resonant Frequency (Fres)Fres (Hz) Baseline22.13 HzStandard Deviation 5.71
Flutter-sham - Control GroupAirways Resistance (IOS) - Resonant Frequency (Fres)Fres (Hz) After 20 minutes of restNA Hz
Flutter-sham - Control GroupAirways Resistance (IOS) - Resonant Frequency (Fres)Fres (Hz) Immediately after22.41 HzStandard Deviation 8.24
Comparison: 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 testp-value: <0.05Friedman's Test
Secondary

Cough

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

Time frame: During each session

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Flutter Exercises SessionCough3.95 CoughsStandard Deviation 2.41
Flutter+Bronchodilator SessionCough1.69 CoughsStandard Deviation 1.49
Flutter-sham - Control GroupCough3.63 CoughsStandard Deviation 3.07
Secondary

Exhaled Nitric Oxide (FeNO)

Exhaled nitric oxide will be measured by chemiluminescence method.

Time frame: Baseline and immediately after intervention

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Flutter Exercises SessionExhaled Nitric Oxide (FeNO)Baseline40.5 parts per billionStandard Deviation 29.9
Flutter Exercises SessionExhaled Nitric Oxide (FeNO)After intervention39.3 parts per billionStandard Deviation 33.7
Flutter+Bronchodilator SessionExhaled Nitric Oxide (FeNO)Baseline44.4 parts per billionStandard Deviation 33.7
Flutter+Bronchodilator SessionExhaled Nitric Oxide (FeNO)After intervention43.6 parts per billionStandard Deviation 33.2
Flutter-sham - Control GroupExhaled Nitric Oxide (FeNO)Baseline32.3 parts per billionStandard Deviation 29.4
Flutter-sham - Control GroupExhaled Nitric Oxide (FeNO)After intervention31.7 parts per billionStandard Deviation 32
p-value: <0.05T-test
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.

Time frame: In each session

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Flutter Exercises SessionSecretion - Purulence Score2.30 score on a scaleStandard Deviation 0.82
Flutter+Bronchodilator SessionSecretion - Purulence Score2.57 score on a scaleStandard Deviation 0.79
Flutter-sham - Control GroupSecretion - Purulence Score2.60 score on a scaleStandard Deviation 1.34
Secondary

Secretion - Volume

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

Time frame: During each session

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Flutter Exercises SessionSecretion - Volume2.54 gramsStandard Deviation 1.39
Flutter+Bronchodilator SessionSecretion - Volume1.5 gramsStandard Deviation 1.33
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)

Time frame: Baseline and immediately after intervention

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Flutter Exercises SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)Baseline FVC (%)109.4 percent predicted spirometry assessmentStandard Deviation 18.4
Flutter Exercises SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)After intervention FVC (%)107.3 percent predicted spirometry assessmentStandard Deviation 18.1
Flutter Exercises SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)Baseline FEV1 (%)67.6 percent predicted spirometry assessmentStandard Deviation 17.7
Flutter Exercises SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)After intervention FEV1 (%)66.0 percent predicted spirometry assessmentStandard Deviation 15.5
Flutter Exercises SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)Baseline FEV1/FVC (%)51.0 percent predicted spirometry assessmentStandard Deviation 13
Flutter Exercises SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)After intervention FEV1/FVC (%)51.0 percent predicted spirometry assessmentStandard Deviation 12.5
Flutter Exercises SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)Baseline MEF 25-75 (%)18.93 percent predicted spirometry assessmentStandard Deviation 8
Flutter Exercises SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)After intervention MEF 25-75 (%)18.0 percent predicted spirometry assessmentStandard Deviation 7.1
Flutter+Bronchodilator SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)Baseline FEV1 (%)67.0 percent predicted spirometry assessmentStandard Deviation 17.3
Flutter+Bronchodilator SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)Baseline MEF 25-75 (%)17.8 percent predicted spirometry assessmentStandard Deviation 6.8
Flutter+Bronchodilator SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)After intervention FEV1 (%)65.3 percent predicted spirometry assessmentStandard Deviation 14.6
Flutter+Bronchodilator SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)Baseline FEV1/FVC (%)50.3 percent predicted spirometry assessmentStandard Deviation 12
Flutter+Bronchodilator SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)After intervention FEV1/FVC (%)49.7 percent predicted spirometry assessmentStandard Deviation 10.8
Flutter+Bronchodilator SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)Baseline FVC (%)109.8 percent predicted spirometry assessmentStandard Deviation 19.6
Flutter+Bronchodilator SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)After intervention FVC (%)109.0 percent predicted spirometry assessmentStandard Deviation 17.5
Flutter+Bronchodilator SessionSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)After intervention MEF 25-75 (%)17.6 percent predicted spirometry assessmentStandard Deviation 6.9
Flutter-sham - Control GroupSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)Baseline FEV1 (%)62.1 percent predicted spirometry assessmentStandard Deviation 16.7
Flutter-sham - Control GroupSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)After intervention FVC (%)102.1 percent predicted spirometry assessmentStandard Deviation 18
Flutter-sham - Control GroupSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)Baseline FVC (%)105.8 percent predicted spirometry assessmentStandard Deviation 16.2
Flutter-sham - Control GroupSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)After intervention FEV1 (%)60.3 percent predicted spirometry assessmentStandard Deviation 17.1
Flutter-sham - Control GroupSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)Baseline MEF 25-75 (%)15.7 percent predicted spirometry assessmentStandard Deviation 6.4
Flutter-sham - Control GroupSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)After intervention FEV1/FVC (%)48.9 percent predicted spirometry assessmentStandard Deviation 12.8
Flutter-sham - Control GroupSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)Baseline FEV1/FVC (%)48.5 percent predicted spirometry assessmentStandard Deviation 12.8
Flutter-sham - Control GroupSpirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)After intervention MEF 25-75 (%)15.1 percent predicted spirometry assessmentStandard Deviation 7
p-value: <0.05T-test

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026