| Scientific Title of Trial | Oral montelukast versus inhaled steroids for mild persistent asthma among 1 to 5 year old children | |
| Public Title of Trial (in lay language) | Oral montelukast versus inhaled steroids for mild persistent asthma among 1 to 5 year old children | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
Getz and Cipla pharmaceutical Companies | |
| Disease or Health Condition(s) studied | Bronchial Asthma | |
| 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. ? | |
| Study design | Randomized controlled trial | |
| 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 100μg 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 | |
| Target number / sample size | 50 per each | |
| Primary outcome(s) | Improvement of asthma symptoms detected by reduction of Asthma score | |
| Primary outcome(s) - time of assessment(s) | 4 months after the study (at the end of the study) | |
| Secondary outcome(s) | Reduction of frequency of using beta agonists, Reduction of number of hospital admissions, Reduction of number of school absenteeism, Improvement of allergic rhinitis | |
| Secondary outcome(s) - time of assessment(s) | 4 months after the study (at the end of the study) | |
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 01/06/2011 | |
| Anticipated end date | 01/10/2011 | |
| Recruitment status | Not Started | |
| State of ethics review approval | Granted ethical clearance by the ethics committee, Faculty of Medicine, Karapitiya | |
| Funding source(s) | Getz Pharma and Cipla Pharmaceutical Companies | |
| Applicant's Email | pushpikaja@yahoo.com.au | |
| Approval Status | Approved | |
| 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 |
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| Primary Study Sponsor/ Organization | Getz Pharma (Pvt) Limited
No. 439, Galle Road, Colombo 3, Sri Lanka 0114766666 0112255743 URL: www.getzpharma.com |
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| 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 0914924263 pushpikaja@yahoo.com.au |
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| Secondary Study Sponsor(s), (if any) | Citi Health Import Pvt ltd 29/3, Kirimandala Mawatha, Nawala, Rajagiriya 0112861800, 0114405864 0114412055 www.cipladoc.com |
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