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CTRI Number  CTRI/2017/06/008730 [Registered on: 01/06/2017] Trial Registered Retrospectively
Last Modified On: 29/03/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study between two techniques to improve airway clearance in patients with Chronic Obstructive Pulmonary Disease 
Scientific Title of Study   Comparison of Lung flute and Threshold PEP for airway clearance in Chronic Obstructive Pulmonary Disease patients: A Randomized Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Fernandes Orein Lawrence 
Designation  Post Graduate Student (MPT) 
Affiliation  Father Muller Medical College 
Address  Department of Physiotherapy, Father Muller Medical College, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  8861495310  
Fax    
Email  oreinfernandes@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Cherishma DSilva 
Designation  Assistant Professor 
Affiliation  Father Muller Medical College 
Address  Department of Physiotherapy, Father Muller Medical College, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  08242238290  
Fax    
Email  cheri8585@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ms Fernandes Orein Lawrence 
Designation  Post Graduate Student (MPT) 
Affiliation  Father Muller Medical College 
Address  Department of Physiotherapy, Father Muller Medical College, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  8861495310  
Fax    
Email  oreinfernandes@yahoo.com  
 
Source of Monetary or Material Support  
Ms Fernandes Orein Lawrence, Department of Physiotherapy, Father Muller Medical College, Kankanady, Mangalore  
 
Primary Sponsor  
Name  Ms Fernandes Orein Lawrence 
Address  Department of Physiotherapy, Father Muller Medical College, Mangalore-575002 
Type of Sponsor  Other [[Self Sponsered]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ms Fernandes Orein Lawrence  Father Muller Medical College Hospital  Department of Physiotherapy, R Ward, 3rd Floor, Father Muller Medical College, Mangalore-575002
Dakshina Kannada
KARNATAKA 
8861495310

oreinfernandes@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Obstructive Pulmonary Disease (COPD),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lung Flute  Subjects will be instructed to blow twice in to the device vigorously enough to make the reed oscillate, followed by 5 normal breaths. 10 repetitions per set, followed by 3 huff coughs, 2 sets per session, 1 session per day, 30 minutes, for 6 days. Treatment will be stopped at the end of a 6 day session 
Comparator Agent  Threshold PEP  Subjects will be instructed to slowly inspire to vital capacity and then hold their breath for about 3 seconds. Then slowly exhale through the mouth piece with the fixed orifice resistor set to create expiratory pressure resistance between10-20 cm H20. 20 repetitions per set, followed by huff or forced exhalation, periods of relaxation and breathing control (2 minutes), 2 sets per session,1 session per day, 30 minutes, for 6 days. Treatment will be stopped at the end of a 6 day session 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  95.00 Year(s)
Gender  Female 
Details  Presence of airflow obstruction by spirometry (GOLD stage 2-4) 
 
ExclusionCriteria 
Details  Active tuberculosis patients;
Patients with emphysematous bullae;
History of cough syncope;
Patients undergone abdominal, thoracic or cardiac surgeries in the last 6 months;
Pregnant women;
Un-cooperative patients 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quantity of sputum  Total quantity of sputum in 6 days 
 
Secondary Outcome  
Outcome  TimePoints 
Pulmonary Functions- Parameters (FVC, FEV1, FEV1/FVC ratio, PEFR)  Difference in Pulmonary Functions after 6 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2016 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Chronic Obstructive Pulmonary Disease (COPD) is characterized by mucus hypersecretion and impaired mucociliary clearance, and significantly contributes to the morbidity and mortality of this disease. According to World Health Organization, 5% of all deaths globally occurred due to COPD in 2005 and it is estimated to be the third leading cause of death by 2030. In this condition, patients complain of chronic symptoms of cough, sputum production, shortness of breath, and/or wheezing.

             Currently available mucolytics and expectorants are not proven to be effective in COPD. The available evidence indicates that Active Breathing Techniques such as Active Cycle of Breathing Techniques (ACBT), Autogenic Drainage and Forced Expiration, can be effective in treatment of COPD. The Passive Techniques such as Postural Drainage, Percussion as well as Supporting Techniques such as Intrapulmonary Percussive Ventilation, PEP and Non-Invasive Ventilation have little evidence due to the small number of studies.

             The Lung Flute is a new, Food and Drug Administration (FDA) approved Oscillatory Positive Expiratory Pressure (OPEP) device which has been shown to be effective in inducing sputum when used once. It produces a low frequency acoustic wave with an exhalation vigorous enough to make the reed oscillate thereby increasing mucociliary clearance. Threshold PEP has a flow independent one way valve, ensuring consistent resistance through adjustable specific pressure settings (in cm H2O) set by healthcare professionals. When patients exhale through it, the resistive load creates positive pressure that helps open the airways and allows mucus to be expelled during “huff” coughing (Forced Expiratory Technique) thus helping in airway clearance, bronchial hygiene and can be used as an alternate to Chest Physical Therapy.

             Current choices for treatment of mucus hypersecretion are few with limited data to support their effectiveness in COPD. Although Lung Flute and Threshold PEP have found to be effective in airway clearance in COPD patients, no previous studies have been done comparing the two devices to know which is more effective for airway clearance in this disease. Hence there is a need of this study to compare the two devices. 
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