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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 -

SLCTR Registration Number

SLCTR/2018/010


Date of Registration

20 Mar 2018

The date of last modification

Mar 20, 2018



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 of Health Condition(s) Studied

Non Cystic Fibrosis Bronchiectasis


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail 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


Assignment

Crossover


Purpose

Treatment


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)

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.


Primary outcome(s) - Time of assessment(s)

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


Secondary outcome

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

  2. Six min walk test

  3. Documented number of asthma exacerbations


Secondary outcome(s) - Time of assessment(s)

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

  2. Six min walk test

  3. Documented number of asthma exacerbations



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


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee of the Faculty of Medicine, University of Colombo on 16.02.2018 (Ref. No. EC-17-151)


Funding source

None (investigator funded)



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