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
The date of last modification
Aug 24, 2019
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)
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
Exclusion criteria
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
2019-03-22
Date of study completion
Recruitment status
Recruiting
Funding source
None (investigator funded)
Regulatory approvals
Not applicable
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 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/
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
