Oral montelukast versus inhaled steroids for mild persistent asthma among 1 to 5 year old children

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2011/006
• Date of registration: 20/05/2011
• Primary sponsor: Getz Pharma (Pvt) Limited
• Public title: Oral montelukast versus inhaled steroids for mild persistent asthma among 1 to 5 year old children
• Scientific title: Oral montelukast versus inhaled steroids for mild persistent asthma among 1 to 5 year old children
• Date of first enrolment: 1/6/2011
• Target sample size: 50 per each
• Recruitment status: Pending
• URL: http://www.slctr.lk/trial_details.asp?reg_id={FB46400A-2781-4A5E-BD31-F788FF247CE0}
• Study type: Interventional
• Study design: Randomized controlled trial

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr. (Mrs.) P. P. Jayawardena
• Affiliation: Consultant Paediatrician, Senior lecturer, Faculty of Medicine , University of Ruhuna

• Name: Dr. (Mrs.) P. P. Jayawardena
• Affiliation: Consultant Paediatrician , Senior Lecturer, Faculty of Medicine , University of Ruhuna

Key inclusion & exclusion criteria

Inclusion criteria: Children between 1-5 yrs of age
Symptoms of cough variant asthma persisting for more than 2 months

Exclusion criteria: Premature birth (less than37/52)
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


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Bronchial Asthma

Intervention(s)

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 100and#956;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.

Primary Outcome(s)

Improvement of asthma symptoms detected by reduction of Asthma score

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 ID(s)

Getz and Cipla pharmaceutical Companies

Source(s) of Monetary Support

Getz Pharma and Cipla Pharmaceutical Companies

Secondary Sponsor(s)

Citi Health Import Pvt ltd