Clinical trial NCT01480882: Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage
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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Bronchiectasis
Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Manual percussion
Mechanical percussion
Chronic bronchiectasis
Chronic Obstructive Pulmonary Disease
Wet sputum weight
Dry sputum weight
Lead sponsor: Penang Hospital, Malaysia
Sponsor class: OTHER_GOV
First posted: 2011-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparing the 'wet weight' and 'dry weight' of the sputum expectorated during 20 minutes of the two procedures.
timeFrame: 6 days
Secondary outcomes:
measure: Change in FEV1 and FVC before and after the two methods of therapy
timeFrame: 15 minutes after completion of the procedure compared to baseline
measure: Changes in pulse, blood pressure and respiratory rate
timeFrame: 15 minutes after completion of treatment compared to baseline
measure: Patient preference
timeFrame: After completing 6 days of participation in the study
Other outcomes:
Locations:
city: George Town
country: Malaysia
facility: Penang hospital
state: Penang
Study officials:
affiliation: Penang Hospital, Malaysia
name: Ong L Meng, MBBS, FRCP
role: STUDY_CHAIR
affiliation: Penang Hospital, Malaysia
name: Mohd I Izmi, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: