Home » Trials » SLCTR/2018/010


Comparison of the effectiveness of hypertonic saline nebulization prior to chest physiotherapy over conventional physiotherapy in children with non cystic fibrosis bronchiectasis -Randomized Control Trial

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SLCTR Registration Number

SLCTR/2018/010


Date of Registration

20 Mar 2018

The date of last modification

Jan 28, 2019



Application Summary


Scientific Title of Trial

Comparison of the effectiveness of hypertonic saline nebulization prior to chest physiotherapy over conventional physiotherapy in children with non cystic fibrosis bronchiectasis -Randomized Control Trial


Public Title of Trial

Comparison of the effectiveness of 3% saline nebulization prior to chest physiotherapy over conventional physiotherapy in children with non cystic fibrosis bronchiectasis


Disease or Health Condition(s) Studied

Non Cystic Fibrosis Bronchiectasis


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

EC-17-151 (ERC: Faculty of Medicine, University of Colombo)


Trial Details


What is the research question being addressed?

Is nebulization with hypertonic saline prior to chest physiotherapy more effective in improving lung functions than conventional physiotherapy in children with non cystic fibrosis bronchiectasis?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Crossover


Purpose

Treatment


Study Phase

Phase 4


Intervention(s) planned

Study setting: Lady Ridgeway Hospital Colombo

Method of randomization: Block randomization

Intervention arm: Nebulized 3% sodium chloride 3 ml before physiotherapy for a period of 2 months

Control arm: Standard therapy which is salbutamol metered dose inhaler 200 micrograms prior to physiotherapy

Binding: There will be no blinding of any group


Inclusion criteria

  1. Children aged 5-15 years with the clinical and radiological diagnosis of Bronchiectasis.
  2. Negative sweat test

Exclusion criteria

  1. Inability to comply with regular follow up
  2. On regular hypertonic saline nebulization for one year.
  3. Diagnosed with chronic colonization of Pseudomonas (2 or more sputum cultures positive)
  4. Subjected to a change in antibiotic regimen within 4 weeks prior to enrollment
  5. Any suspicion of hypersensitivity for any of the medications used (salbutamol, hypertonic saline)
  6. Presence of typical extra pulmonary features of cystic fibrosis
  7. Unable to perform spirometry test due to poor effort
  8. Children who showed FEV1 <60% of expected at baseline spirometry even after a bronchodilator therapy


Primary outcome(s)

  1. Directly measured FEV1 (Forced expiratory volume in one second) values using a spirometer will be compared pre and post treatment and a 10% improvement will be considered a significant change.

    [

    Day 0, day 28, day 56, day 84, day 112, and day 140 from commencement of treatment

    ]

Secondary outcome(s)

  1. Directly measured FEV1 and FVC (forced vital capacity) values using spirometry

    [

    Day 0, day 28, day 56, day 84, day 112, and day 140 from commencement of treatment

    ]
  2. Six min walk test

    [

    Day 0, day 28, day 56, day 84, day 112, and day 140 from commencement of treatment

    ]
  3. Documented number of asthma exacerbations

    [

    Day 0, day 84 for 1st allocated intervention arm, day 84, day 168 for the 2nd allocated intervention arm (Day 168 = 4 weeks after the completion of the study)

    ]

Target number/sample size

63 (32 and 31 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2018-03-20


Anticipated end date

2020-03-05


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None (investigator funded)


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2018-02-15


Approval number

EC-17-151


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo
Institutional Address: No. 25, Kynsey Road, Colombo 00800 Sri Lanka
Telephone: +94-11-2695300 (Extension: 240)
Email: ethicscommitteemfc@gmail.com


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr.K.W.D.A Anuradha
Senior Registrar in Paediatric Respiratory Medicine
Ward 1 Lady Ridgeway Hospital for Children Colombo
0112 693711 ext 201
+94714450378

anujaya2008@gmail.com

Contact Person for Public Queries

Prof Pujitha Wickramasinghe
Consultant Paediatrician
Department of Paediatrics Faculty of Medicine University of Colombo
011 2691425


pujithaw@yahoo.com


Primary study sponsor/organization

Lady Ridgeway Hospital for Children

Dr. Denister De Silva Mawatha, Colombo 08, Sri Lanka
011 2693711, 011 2693712
011 2686859

dir@lrh-hospital.health.gov.lk http://www.lrh.health.gov.lk/

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not Available


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results