NCT03013452

Brief Summary

In this study, investigating two modes of chest physiotherapy on lung clearance index (LCI), 50 patients with bronchiectasis will be randomized to either oPEP or autogenic drainage.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 9, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 26, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

January 1, 2017

Last Update Submit

July 25, 2019

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

  • Change in LCI

    LCI will be determined before intervention and after 1 month and change will be recorded.

    1 month

Secondary Outcomes (4)

  • Total score on QOL- B questionnaire

    1 month

  • Score on respiratory domain of QOL-B questionnaire

    1 month

  • FEV1 (% predicted)- difference from baseline

    1 month

  • Forced Expiratory Volume (FVC) (% predicted)- difference from baseline

    1 month

Study Arms (2)

Autogenic drainage

ACTIVE COMPARATOR

Chest physiotherapy by autogenic drainage daily for 15 minutes each day, for 1 month. Instruction by a physiotherapist as to proper technique will be given at the beginning of the study.

Behavioral: Autogenic drainage

oPEP

ACTIVE COMPARATOR

Chest physiotherapy with an Aerobika oPEP device daily for 15 minutes each day for 1 month. Instruction by a physiotherapist as to proper technique will be given at the beginning of the study.

Device: oPEP

Interventions

oPEPDEVICE

Daily chest clearance (chest physiotherapy) using an oPEP (Aerobika) device.

Also known as: Aerobika device
oPEP
Autogenic drainageBEHAVIORAL

Daily chest clearance (chest physiotherapy) by Autogenic Drainage method.

Autogenic drainage

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High Resolution chest computerized tomography (HRCT) during stable disease imaging bronchiectasis in at least 2 lung lobes
  • Sputum production during most days of the year
  • Stable chronic therapy during last 4 weeks
  • FEV1 = 70% predicted or higher on spirometry
  • Able to give informed consent or assent
  • Age: 18- 80 years

You may not qualify if:

  • An exacerbation during last 4 weeks before randomization
  • Any change in respiratory medications during the past 4 weeks before randomization
  • A diagnosis of cystic fibrosis
  • A diagnosis of primary ciliary dyskinesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Carmel Medical Center

Haifa, 3436209, Israel

RECRUITING

Pulmonology Institute, Carmel Medical Center

Haifa, 34362, Israel

RECRUITING

Related Publications (4)

  • Flude LJ, Agent P, Bilton D. Chest physiotherapy techniques in bronchiectasis. Clin Chest Med. 2012 Jun;33(2):351-61. doi: 10.1016/j.ccm.2012.02.009. Epub 2012 Apr 4.

    PMID: 22640850BACKGROUND

  • Robinson PD, Latzin P, Verbanck S, Hall GL, Horsley A, Gappa M, Thamrin C, Arets HG, Aurora P, Fuchs SI, King GG, Lum S, Macleod K, Paiva M, Pillow JJ, Ranganathan S, Ratjen F, Singer F, Sonnappa S, Stocks J, Subbarao P, Thompson BR, Gustafsson PM. Consensus statement for inert gas washout measurement using multiple- and single- breath tests. Eur Respir J. 2013 Mar;41(3):507-22. doi: 10.1183/09031936.00069712. Epub 2013 Feb 8.

    PMID: 23397305BACKGROUND

  • Gonem S, Scadding A, Soares M, Singapuri A, Gustafsson P, Ohri C, Range S, Brightling CE, Pavord I, Horsley A, Siddiqui S. Lung clearance index in adults with non-cystic fibrosis bronchiectasis. Respir Res. 2014 May 18;15(1):59. doi: 10.1186/1465-9921-15-59.

    PMID: 24884343RESULT

  • Rowan SA, Bradley JM, Bradbury I, Lawson J, Lynch T, Gustafsson P, Horsley A, O'Neill K, Ennis M, Elborn JS. Lung clearance index is a repeatable and sensitive indicator of radiological changes in bronchiectasis. Am J Respir Crit Care Med. 2014 Mar 1;189(5):586-92. doi: 10.1164/rccm.201310-1747OC.

    PMID: 24428575RESULT

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 modes of physiotherapy: 1- autogenic drainage; 2- oscillating positive expiratory pressure device
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2017

First Posted

January 6, 2017

Study Start

March 9, 2017

Primary Completion

December 30, 2019

Study Completion

June 30, 2020

Last Updated

July 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)