Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage
NCT ID: NCT01480882
Last Updated: 2012-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
20 participants
INTERVENTIONAL
2011-12-31
2012-06-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Conventional Chest PhysioTherapy
Conventional Chest Physiotherapy (CCPT) is delivered by professional physiotherapist for 15 minutes.
Conventional Chest Physiotherapy (CCPT)
Conventional chest percussion will be applied for a duration of 15 minutes.
Mechanical percussion
Mechanical percussion will be delivered by a device called "LEGA" for 15 minutes
Mechanical percussion (LEGA)
Mechanical chest percussion will be delivered by a device for 15 minutes.
Interventions
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Conventional Chest Physiotherapy (CCPT)
Conventional chest percussion will be applied for a duration of 15 minutes.
Mechanical percussion (LEGA)
Mechanical chest percussion will be delivered by a device for 15 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Penang Hospital, Malaysia
OTHER_GOV
Responsible Party
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Dr.Ong Loke Meng
Head, Clinical Research Centre
Principal Investigators
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Ong L Meng, MBBS, FRCP
Role: STUDY_CHAIR
Penang Hospital, Malaysia
Mohd I Izmi, MBBS, MD
Role: PRINCIPAL_INVESTIGATOR
Penang Hospital, Malaysia
Locations
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Penang hospital
George Town, Pulau Pinang, Malaysia
Countries
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Related Links
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Click here for more information about this study- NMRR-11-661-10072
Other Identifiers
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NMRR-11-661-10072
Identifier Type: REGISTRY
Identifier Source: secondary_id
CT-11-HPP-001
Identifier Type: -
Identifier Source: org_study_id