NCT01480882

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

6 months

First QC Date

November 20, 2011

Last Update Submit

December 4, 2012

Conditions

Chronic BronchiectasisChronic Obstructive Pulmonary Disease (COPD)

Keywords

Manual percussionMechanical percussionChronic bronchiectasisChronic Obstructive Pulmonary DiseaseWet sputum weightDry sputum weight

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change in FEV1 and FVC before and after the two methods of therapy

    15 minutes after completion of the procedure compared to baseline

  • Changes in pulse, blood pressure and respiratory rate

    15 minutes after completion of treatment compared to baseline

  • Patient preference

    After completing 6 days of participation in the study

Study Arms (2)

Conventional Chest PhysioTherapy

ACTIVE COMPARATOR

Conventional Chest Physiotherapy (CCPT) is delivered by professional physiotherapist for 15 minutes.

Procedure: Conventional Chest Physiotherapy (CCPT)

Mechanical percussion

EXPERIMENTAL

Mechanical percussion will be delivered by a device called "LEGA" for 15 minutes

Device: Mechanical percussion (LEGA)

Interventions

Conventional Chest Physiotherapy (CCPT)PROCEDURE

Conventional chest percussion will be applied for a duration of 15 minutes.

Also known as: Manual percussion
Conventional Chest PhysioTherapy
Mechanical percussion (LEGA)DEVICE

Mechanical chest percussion will be delivered by a device for 15 minutes.

Also known as: LEGA
Mechanical percussion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penang hospital

George Town, Pulau Pinang, 10990, Malaysia

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ong L Meng, MBBS, FRCP

    Penang Hospital, Malaysia

    STUDY CHAIR

  • Mohd I Izmi, MBBS, MD

    Penang Hospital, Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Clinical Research Centre

Study Record Dates

First Submitted

November 20, 2011

First Posted

November 29, 2011

Study Start

December 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

MY(1)