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Completed

NCT Number: NCT01480882

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Penang hospital

George Town, Pulau Pinang, 10990, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Conventional Chest Physiotherapy (CCPT)

Procedure

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

Other names: Manual percussion

Mechanical percussion (LEGA)

Device

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

Other names: LEGA

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Any changes in the lung function will be measured as - FEV1 (%predicted) and FVC (%predicted)

  2. Changes in pulse, blood pressure and respiratory rate

    Time frame: 15 minutes after completion of treatment compared to baseline

    Monitoring of Pulse, blood pressure, respiratory rate, skin colour and patients reaction to treatment.

  3. Patient preference

    Time frame: After completing 6 days of participation in the study

    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.

Sponsors and collaborators

Lead sponsor

Penang Hospital, Malaysia

Other Gov

Registry information

Official study 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

Acronym: LEGA

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 29, 2011
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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