NCT00522314

Brief Summary

This clinical trial is investigating the efficacy of Non Invasive Ventilation (NIV) as a method of airway clearance in patients with an acute exacerbation and moderate to severe bronchiectasis disease. Current treatment focuses on the use of Active Cycle of Breathing Techniques (ACBT) but this modality alone may not be sufficient when patients have more severe disease and an acute infection. The use of NIV may result in better patient care and more appropriate physiotherapy treatment in the more unwell population.The aim of this study is to compare the efficacy of two physiotherapy airways clearance interventions in bronchiectasis.

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 not_applicable

Timeline
Completed

Started Oct 2003

Typical duration for not_applicable

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

Study Start

First participant enrolled

October 1, 2003

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2007

Completed
Last Updated

August 29, 2007

Status Verified

August 1, 2007

First QC Date

August 28, 2007

Last Update Submit

August 28, 2007

Conditions

Bronchiectasis

Keywords

Non-invasive ventilationAirway clearanceBronchiectasis

Outcome Measures

Primary Outcomes (1)

  • Respiratory muscle strength

    Before; mid-way; on completion of intravenous antibiotics

Secondary Outcomes (3)

  • Sputum weight

    During airway clearance; half hour after airway clearance; 24 hour sputum clearance

  • Breathlessness

    Before and after each airway clearance session

  • respiratory mechanics (Vivometrics Lifeshirt)

    On first and last airway clearance session

Study Arms (2)

1

ACTIVE COMPARATOR

NIV \& ACBT

Device: NIV and ACBT

2

PLACEBO COMPARATOR

Active cycle of breathing techniques

Other: Active Cycle of Breathing Techniques

Interventions

NIV and ACBTDEVICE
1
Active Cycle of Breathing TechniquesOTHER
2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe bronchiectasis (FEV1 \< 60%),
  • Indicators of difficulty expectorating sputum, and
  • An acute exacerbation requiring intravenous antibiotics (IVAB)

You may not qualify if:

  • Unable to tolerate positive pressure
  • Presence of pneumothorax

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Belfast City Hospital

Belfast, Northern Ireland, BT 9 7AB, United Kingdom

Location

MeSH Terms

Conditions

Bronchiectasis

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Prof Elborn, MD

    Belfast City Hospital and Queens University Belfast

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 29, 2007

Study Start

October 1, 2003

Study Completion

April 1, 2006

Last Updated

August 29, 2007

Record last verified: 2007-08

Locations

GB(1)