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Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage (LEGA)

Primary Purpose

Chronic Bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 2

Locations

Malaysia

Study Type

Interventional

Intervention

Conventional Chest Physiotherapy (CCPT)

Mechanical percussion (LEGA)

About this trial

This is an interventional treatment trial for Chronic Bronchiectasis focused on measuring Manual percussion, Mechanical percussion, Chronic bronchiectasis, Chronic Obstructive Pulmonary Disease, Wet sputum weight, Dry sputum weight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patients > 18 years of age
Chronic sputum expectoration-(producing >30ml/day of sputum at baseline)
Clinical diagnosis of bronchiectasis or COPD
Not carrying out regular chest physiotherapy (for the purposes of this study this will be defined as less than two occasions per week)
Clinically stable disease (defined as no requirement for antibiotics in the 4 weeks preceding study entry).
FEV1 of > 35% of the predicted value in COPD patients

Exclusion Criteria:

Primary diagnosis of asthma;
Active sarcoidosis
Active Pulmonary tuberculosis.
History of brittle bones,
History of broken ribs in the past one year.
History of severe osteoporosis
Bleeding from the lungs or haemoptysis
Experiencing intense pain in the thoracic region
Clinical suspicion of increased intracranial pressure.
Have head or neck injuries
Have collapsed lungs or a damaged chest wall;
Recent myocardial infarction, unstable angina and stroke (Within 6 months prior to enrollment)
Have a pulmonary embolism or lung abscess;
Have an active hemorrhage
Have injuries to the spine
Have open wounds or burns in the thoracic region
Have had recent surgery (Within six months prior to enrollment.)
Any systemic steroids within 4/52 prior to enrollment
Any antibiotics within 4/52 prior to enrollment

Sites / Locations

Penang hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Chest PhysioTherapy

Mechanical percussion

Arm Description

Conventional Chest Physiotherapy (CCPT) is delivered by professional physiotherapist for 15 minutes.

Mechanical percussion will be delivered by a device called "LEGA" for 15 minutes

Outcomes

Primary Outcome Measures

Comparing the 'wet weight' and 'dry weight' of the sputum expectorated during 20 minutes of the two procedures.

The patients will be instructed to cough out the sputum into a preweighed container during the 15 minutes of the procedure(Manual or mechanical percussion)and 5 minutes after the procedure.Container will be weighed to get the wet weight of the sputum then will be dried in a laboratory oven at 60degree c for 48 hours and weighed again to get the dry weight of the sputum

Secondary Outcome Measures

Change in FEV1 and FVC before and after the two methods of therapy

Any changes in the lung function will be measured as - FEV1 (%predicted) and FVC (%predicted)

Changes in pulse, blood pressure and respiratory rate

Monitoring of Pulse, blood pressure, respiratory rate, skin colour and patients reaction to treatment.

Patient preference

Patients will be participating in the study for 6 days. On the 6th day after completion of treatment they will be required to answer a simple questionnaire to find out if they prefer one procedure over the other and why.

Full Information

NCT ID

NCT01480882

First Posted

November 20, 2011

Last Updated

December 4, 2012

Sponsor

Penang Hospital, Malaysia

1. Study Identification

Unique Protocol Identification Number

NCT01480882

Brief Title

Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage

Acronym

LEGA

Official Title

"A Prospective, Cross-over Randomized Trial to Assess the Efficacy and Safety of Mechanical Percussor "LEGA" Compared With Conventional Chest Physiotherapy in Adults With Chronic Bronchiectasis or Chronic Obstructive Pulmonary Disease (COPD

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Penang Hospital, Malaysia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A Malaysian company by name Formedic Technologies SDN BHD has devised a hand held machine which is supposed to mimic the chest percussion performed by professional physiotherapist to mobilize sputum through the respiratory passage. The aim of this study is to compare the effectiveness and safety of this mechanical percussion device in the treatment of airway clearance with conventional chest physiotherapy carried out by qualified physiotherapists in patients suffering from bronchiectasis or Chronic obstructive Pulmonary disease (COPD).

Detailed Description

This study will compare the amount of sputum expectorated during the two procedures and not intended to look at the clinical improvement of the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Manual percussion, Mechanical percussion, Chronic bronchiectasis, Chronic Obstructive Pulmonary Disease, Wet sputum weight, Dry sputum weight

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional Chest PhysioTherapy

Arm Type

Active Comparator

Arm Description

Conventional Chest Physiotherapy (CCPT) is delivered by professional physiotherapist for 15 minutes.

Arm Title

Mechanical percussion

Arm Type

Experimental

Arm Description

Mechanical percussion will be delivered by a device called "LEGA" for 15 minutes

Intervention Type

Procedure

Intervention Name(s)

Conventional Chest Physiotherapy (CCPT)

Other Intervention Name(s)

Manual percussion

Intervention Description

Conventional chest percussion will be applied for a duration of 15 minutes.

Intervention Type

Device

Intervention Name(s)

Mechanical percussion (LEGA)

Other Intervention Name(s)

LEGA

Intervention Description

Mechanical chest percussion will be delivered by a device for 15 minutes.

Primary Outcome Measure Information:

Title

Comparing the 'wet weight' and 'dry weight' of the sputum expectorated during 20 minutes of the two procedures.

Description

Time Frame

6 days

Secondary Outcome Measure Information:

Title

Change in FEV1 and FVC before and after the two methods of therapy

Description

Any changes in the lung function will be measured as - FEV1 (%predicted) and FVC (%predicted)

Time Frame

15 minutes after completion of the procedure compared to baseline

Title

Changes in pulse, blood pressure and respiratory rate

Description

Monitoring of Pulse, blood pressure, respiratory rate, skin colour and patients reaction to treatment.

Time Frame

15 minutes after completion of treatment compared to baseline

Title

Patient preference

Description

Time Frame

After completing 6 days of participation in the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients > 18 years of age Chronic sputum expectoration-(producing >30ml/day of sputum at baseline) Clinical diagnosis of bronchiectasis or COPD Not carrying out regular chest physiotherapy (for the purposes of this study this will be defined as less than two occasions per week) Clinically stable disease (defined as no requirement for antibiotics in the 4 weeks preceding study entry). FEV1 of > 35% of the predicted value in COPD patients Exclusion Criteria: Primary diagnosis of asthma; Active sarcoidosis Active Pulmonary tuberculosis. History of brittle bones, History of broken ribs in the past one year. History of severe osteoporosis Bleeding from the lungs or haemoptysis Experiencing intense pain in the thoracic region Clinical suspicion of increased intracranial pressure. Have head or neck injuries Have collapsed lungs or a damaged chest wall; Recent myocardial infarction, unstable angina and stroke (Within 6 months prior to enrollment) Have a pulmonary embolism or lung abscess; Have an active hemorrhage Have injuries to the spine Have open wounds or burns in the thoracic region Have had recent surgery (Within six months prior to enrollment.) Any systemic steroids within 4/52 prior to enrollment Any antibiotics within 4/52 prior to enrollment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ong L Meng, MBBS, FRCP

Organizational Affiliation

Penang Hospital, Malaysia

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mohd I Izmi, MBBS, MD

Organizational Affiliation

Penang Hospital, Malaysia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penang hospital

City

George Town

State/Province

Penang

ZIP/Postal Code

10990

Country

Malaysia

12. IPD Sharing Statement

Links:

URL

http://www.nmrr.gov.my

Description

Click here for more information about this study- NMRR-11-661-10072

Learn more about this trial

Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage

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