Status:
COMPLETED
Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage
Lead Sponsor:
Penang Hospital, Malaysia
Conditions:
Chronic Bronchiectasis
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 t...
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
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01480882
Start Date
December 1 2011
End Date
June 1 2012
Last Update
December 6 2012
Active Locations (1)
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1
Penang hospital
George Town, Pulau Pinang, Malaysia, 10990