Chronic BronchiectasisPhase 2/3LEGANCT01480882
Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage
A Phase 2/3 study testing Conventional Chest Physiotherapy (CCPT) and Mechanical percussion (LEGA) in people with Chronic Bronchiectasis and Chronic Obstructive Pulmonary Disease (COPD), run by Penang Hospital, Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Conventional Chest Physiotherapy (CCPT) and Mechanical percussion (LEGA)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMalaysia
- Study dates
- Dec 2011to Jun 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Being tested
- Conventional Chest Physiotherapy (CCPT), Mechanical percussion (LEGA)
- Keywords
- Manual percussion, Mechanical percussion, Chronic bronchiectasis, Chronic Obstructive Pulmonary Disease, Wet sputum weight, Dry sputum weight
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Chest Physiotherapy (CCPT)Procedure or surgery
Also called Manual percussion
Conventional chest percussion will be applied for a duration of 15 minutes.
Mechanical percussion (LEGA)Device
Also called LEGA
Mechanical chest percussion will be delivered by a device for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Chest PhysioTherapy | Active comparator | Conventional Chest Physiotherapy (CCPT) is delivered by professional physiotherapist for 15 minutes. Receives: Procedure: Conventional Chest Physiotherapy (CCPT) |
| Mechanical percussion | Experimental | Mechanical percussion will be delivered by a device called "LEGA" for 15 minutes Receives: Device: Mechanical percussion (LEGA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 days
Secondary outcomes (3)
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)
Measured: 15 minutes after completion of the procedure compared to baseline
Changes in pulse, blood pressure and respiratory rate
Monitoring of Pulse, blood pressure, respiratory rate, skin colour and patients reaction to treatment.
Measured: 15 minutes after completion of treatment compared to baseline
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.
Measured: After completing 6 days of participation in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penang Hospital, Malaysia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr.Ong Loke Meng, Penang Hospital, Malaysia
- Investigators
- Ong L Meng, MBBS, FRCP, Study chair, Penang Hospital, MalaysiaMohd I Izmi, MBBS, MD, Principal investigator, Penang Hospital, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480882
- Sponsor's protocol ID
- CT-11-HPP-001
- Other IDs
- NMRR-11-661-10072
- Acronym
- LEGA
- Status last verified
- Dec 2012
- First submitted
- 20 Nov 2011
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01480882
- Acronym / sponsor ID
- LEGA / CT-11-HPP-001
- Keywords
- Manual percussion, Mechanical percussion, Chronic bronchiectasis, Chronic Obstructive Pulmonary Disease, Wet sputum weight, Dry sputum weight
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Penang Hospital, MalaysiaOther government
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Chest PhysioTherapy | Active comparator | Procedure: Conventional Chest Physiotherapy (CCPT)Conventional Chest Physiotherapy (CCPT) is delivered by professional physiotherapist for 15 minutes. |
| Mechanical percussion | Experimental | Device: Mechanical percussion (LEGA)Mechanical percussion will be delivered by a device called "LEGA" for 15 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (19 listed)
- Primary diagnosis of asthma;
- Active sarcoidosis
- Active Pulmonary tuberculosis.
- History of brittle bones,
- History of broken ribs in the past one year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Chest Physiotherapy (CCPT)Also: Manual percussionConventional chest percussion will be applied for a duration of 15 minutes. | Procedure or surgery | Conventional Chest PhysioTherapy |
| Mechanical percussion (LEGA)Also: LEGAMechanical chest percussion will be delivered by a device for 15 minutes. | Device | Mechanical percussion |
Primary outcome
Comparing the 'wet weight' and 'dry weight' of the sputum expectorated during 20 minutes of the two procedures.
Time frame: 6 days
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
3 secondary outcomes
Change in FEV1 and FVC before and after the two methods of therapy
Time frame: 15 minutes after completion of the procedure compared to baseline
Changes in pulse, blood pressure and respiratory rate
Time frame: 15 minutes after completion of treatment compared to baseline
Patient preference
Time frame: After completing 6 days of participation in the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
- Click here for more information about this study- NMRR-11-661-10072Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ong L Meng, MBBS, FRCP study chair
Penang Hospital, Malaysia
Mohd I Izmi, MBBS, MD principal investigator
Penang Hospital, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Conventional Chest Physiotherapy (CCPT) and Mechanical percussion (LEGA) in people with Chronic Bronchiectasis and Chronic Obstructive Pulmonary Disease (COPD), run by Penang Hospital, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the 'wet weight' and 'dry weight' of the sputum expectorated during 20 minutes of the two procedures. (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012.