Home » Trials » SLCTR/2011/006
Oral montelukast versus inhaled steroids for mild persistent asthma among 1 to 5 year old children
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SLCTR Registration Number
SLCTR/2011/006
Date of Registration
The date of last modification
Sep 08, 2020
Trial Status
Scientific Title of Trial
Oral montelukast versus inhaled steroids for mild persistent asthma among 1 to 5 year old children
Public Title of Trial
Oral montelukast versus inhaled steroids for mild persistent asthma among 1 to 5 year old children
Disease or Health Condition(s) Studied
Bronchial Asthma
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
To compare the efficacy of oral Montelukast verses inhaled steroids for mild persistent bronchial asthma in children among 1 to 5 years.
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Children who fulfill the criteria will be selected after a preliminary inquiry by a trained interviewers and they will be enlisted for the study. Every parent will be educated by a trained medical person and the informed written consent will be obtained. The study group will be divided into 2 groups according to a random number table. One group will be treated with Montelukast 4mg nocte (standard dose for the age group) and the other group will be treated with Beclamethsone dipropionate 100?g 1 puff twice daily .Parents will be educated to maintain a diary for asthma symptoms. All patients will be monitored in the clinic fortnightly for the improvement of symptoms and the compliance.
Inclusion criteria
Children between 1-5 yrs of age Symptoms of cough variant asthma persisting for more than 2 months
Exclusion criteria
Premature birth (<37/52) Past history of Respiratory distress syndrome Past history of Pneumonia Chronic lung disease Past history of ETU/ITU admissions Previous nebulization (>3 in the past) Previous use of any preventers
Primary outcome(s)
|
1.
Improvement of asthma symptoms detected by reduction of Asthma score |
[ 4 months after the study (at the end of the study) ] |
Secondary outcome(s)
|
1.
Reduction of frequency of using beta agonists, Reduction of number of hospital admissions, Reduction of number of school absenteeism, Improvement of allergic rhinitis |
[ 4 months after the study (at the end of the study) ] |
Target number/sample size
50 per each
Countries of recruitment
Sri Lanka
Anticipated start date
2011-06-01
Anticipated end date
2012-10-10
Date of first enrollment
2011-12-09
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Getz Pharma and Cipla Pharmaceutical Companies
Regulatory approvals
Status
Approved
Date of Approval
2011-01-25
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr. (Mrs.) P. P. Jayawardena
Consultant Paediatrician , Senior Lecturer
Faculty of Medicine , University of Ruhuna
24/5, Maitipe Lane 1, Karapitiya, Galle, Sri Lanka
0914924263
pushpikaja@yahoo.com.au
Contact Person for Public Queries
Dr. (Mrs.) P. P. Jayawardena
Consultant Paediatrician , Senior Lecturer
Faculty of Medicine , University of Ruhuna
24/5, Maitipe Lane 1, Karapitiya, Galle, Sri Lanka
0914924263
pushpikaja@yahoo.com.au
Primary study sponsor/organization
Getz Pharma (Pvt) Limited
No. 439, Galle Road, Colombo 3, Sri Lanka
0114766666 0112255743
www.getzpharma.com
Secondary study sponsor (If any)
Citi Health Import Pvt ltd
29/3, Kirimandala Mawatha, Nawala, Rajagiriya
0112861800, 0114405864 0114412055
www.cipladoc.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
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
