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Acute Effects of a Flutter Device in COPD (AEFLUC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01832961
Recruitment Status : Completed
First Posted : April 16, 2013
Results First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Device: Flutter valve exercises
Device: Flutter Sham exercises
Device: Flutter and bronchodilator exercises
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Flutter Valve, Then Flutter Sham and Flutter+Bronchodilator Flutter Sham, Then Flutter Valve and Flutter+Bronchodilator
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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: Washout
Started 8 7
Completed 8 7
Not Completed 0 0
Period Title: Second Intervention
Started 8 7
Completed 8 7
Not Completed 0 0
Period Title: Third Intervention
Started 8 7
Completed 8 7
Not Completed 0 0
Arm/Group Title All Patient
Hide 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 Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
67.3  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
10
  66.7%
Male
5
  33.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 15 participants
15
1.Primary Outcome
Title Airways Resistance (IOS)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: kPa/L/s
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 [1]   (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 [1]   (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 [1]   (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 [1]   (NA)
[1]
No data was collected from this group after 20 minuted of rest.
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: kPa/L
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 [1]   (NA)
[1]
No data was collected from this group after 20 minutes of rest.
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman's Test
Comments [Not Specified]
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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: Hz
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 [1]   (NA)
[1]
No data was collect from this group after 20 minutes of rest.
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman's Test
Comments [Not Specified]
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)
Hide Description Exhaled nitric oxide will be measured by chemiluminescence method.
Time Frame Baseline and immediately after intervention
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: parts per billion
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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flutter Exercises, Flutter-sham, Flutter+Bronchodilator
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: percent predicted spirometry assessment
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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flutter Exercises, Flutter-sham, Flutter+Bronchodilator
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method T-test
Comments [Not Specified]
6.Secondary Outcome
Title Cough
Hide Description Number of spontaneously reported cough episodes during each visit were collected.
Time Frame During each session
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: Coughs
3.95  (2.41) 1.69  (1.49) 3.63  (3.07)
7.Secondary Outcome
Title Secretion - Volume
Hide Description Expectorated secretion volume during each visit were collected, weighted and classified with a purulence score.
Time Frame During each session
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
30 minutes of breathing exercises with flutter device
30 minutes of breathing exercises with a flutter-sham device
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: grams
2.54  (1.39) 1.5  (1.33)
8.Secondary Outcome
Title Secretion - Purulence Score
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.30  (0.82) 2.57  (0.79) 2.60  (1.34)
Time Frame 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flutter Exercises Flutter-sham Flutter+Bronchodilator
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Hide Serious Adverse Events
Flutter Exercises Flutter-sham Flutter+Bronchodilator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Flutter Exercises Flutter-sham Flutter+Bronchodilator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Absence of some objective measurement of dyspnea, well being or satisfaction scales.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ada Clarice Gastaldi
Organization: Imperial College
Phone: 55 020 7351 8051
EMail: ada@fmrp.usp.br
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01832961    
Other Study ID Numbers: 13/C0346
First Submitted: March 25, 2013
First Posted: April 16, 2013
Results First Submitted: August 14, 2019
Results First Posted: February 27, 2020
Last Update Posted: February 27, 2020