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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480882
• Other study ID #: CT-11-HPP-001
• Secondary ID: NMRR-11-661-1007
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 20, 2011
• Last updated: December 4, 2012
• Start date: December 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2012
• Source: Penang Hospital, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis
• Chronic Bronchiectasis
• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Conventional Chest Physiotherapy (CCPT)
Conventional chest percussion will be applied for a duration of 15 minutes.

Device:
• Mechanical percussion (LEGA)
Mechanical chest percussion will be delivered by a device for 15 minutes.

Locations

Country	Name	City	State
Malaysia	Penang hospital	George Town	Penang

Sponsors (1)

Lead Sponsor	Collaborator
Penang Hospital, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No

External Links

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