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

"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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Chronic Bronchiectasis
• Intervention / Treatment: Procedure: Conventional Chest Physiotherapy (CCPT); Device: Mechanical percussion (LEGA)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Malaysia
  • Penang
    • George Town, Penang, Malaysia, 10990
      • Penang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Chest PhysioTherapy; Conventional Chest Physiotherapy (CCPT) is delivered by professional physiotherapist for 15 minutes.	Procedure: Conventional Chest Physiotherapy (CCPT); Conventional chest percussion will be applied for a duration of 15 minutes.; Other Names: Manual percussion
Experimental: Mechanical percussion; Mechanical percussion will be delivered by a device called "LEGA" for 15 minutes	Device: Mechanical percussion (LEGA); Mechanical chest percussion will be delivered by a device for 15 minutes.; Other Names: LEGA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	15 minutes after completion of the procedure compared to baseline
Changes in pulse, blood pressure and respiratory rate	Monitoring of Pulse, blood pressure, respiratory rate, skin colour and patients reaction to treatment.	15 minutes after completion of treatment compared to baseline
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.	After completing 6 days of participation in the study

Collaborators and Investigators

• Sponsor: Penang Hospital, Malaysia
• Investigators: Study Chair: Ong L Meng, MBBS, FRCP, Penang Hospital, Malaysia; Principal Investigator: Mohd I Izmi, MBBS, MD, Penang Hospital, Malaysia

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 20, 2011
• First Submitted That Met QC Criteria: November 24, 2011
• First Posted (Estimate): November 29, 2011

Study Record Updates

• Last Update Posted (Estimate): December 6, 2012
• Last Update Submitted That Met QC Criteria: December 4, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Manual percussion; Mechanical percussion; Chronic bronchiectasis; Wet sputum weight; Dry sputum weight
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CT-11-HPP-001; NMRR-11-661-10072 (Registry Identifier: National Medical Reseach Register (NMRR))