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

Penang Hospital, Malaysia

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Bronchiectasis; Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Procedure: Conventional Chest Physiotherapy (CCPT); Device: Mechanical percussion (LEGA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01480882

NMRR-11-661-10072 (Registry Identifier)

CT-11-HPP-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Conventional Chest PhysioTherapy

Active Comparator group

Description:

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

Treatment:

Procedure: Conventional Chest Physiotherapy (CCPT)

Mechanical percussion

Experimental group

Description:

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

Treatment:

Device: Mechanical percussion (LEGA)