Intermittent Budesonide-Formoterol versus Daily Budesonide for Mild Asthma in Children aged 6 to 11 years- A Randomized Controlled Trial

Rationale of the study supported by cited literature:

GINA 2025 recommends the use of low-dose ICS taken whenever SABA is taken for step 1, and daily low-dose ICS for step 2 asthma in children aged 6-11 years. However, this requires the use of different inhalers involved for controller and reliever therapy, leading to a higher chance of parental confusion. This often leads to poor compliance, infrequent use of controller therapy, and, in turn, frequent exacerbations. Hence, Intermittent Budesonide-Formoterol might be beneficial because there is a single inhaler both for maintenance and relief of symptoms, and it has been proven to have reduced exacerbations in the adolescent age group.

Hypothesis:

Intermittent Budesonide-Formoterol is not inferior to Daily Budesonide for control of mild asthma in children aged 6 to 11 years.

Research questions: Is Intermittent Budesonide-Formoterol non-inferior to Daily Budesonide for control of mild asthma in children aged 6 to 11 years?

Detailed methodology:

All children aged 6-11 years with asthma presenting to the paediatric chest clinic will be screened for enrolment according to the inclusion criteria. An information sheet will be provided to the parents (in both Hindi and English languages) explaining the details of the study, and they will be invited to participate in the study. A written informed consent will be taken from the parents/guardians. Enrolment of participants will be done after approval by the Institute Ethics Committee. The study will be registered under the Clinical Trials Registry India (CTRI). Once enrolled, the patient details, demographic data, anthropometry values, and basic demographic data will be recorded in pre-designed proformas. After assessing exclusion criteria, the participant will be randomised into either of the two groups, and intervention will be given for a total of 3 months in both groups (as per the CONSORT flow chart). ACQ-5 scoring will be done at baseline, end of first month, end of second month, and end of third month. At every visit, the technique of using MDI will be assessed. Compliance will be assessed based on patient history, diary maintenance, and the number of puffs used in the cannister.

All other parameters of the primary and secondary outcomes will be recorded in the proforma. Except drug trial, the rest of the management will be done as per the treating team’s discretion.

Data analysis plan:

• Statistical analyses will be performed by SPSS 21

• P value of less than 0.05 will be considered as significant.

• Categorical and continuous values will be expressed as frequency (percentage) and mean ± SD or median and interquartile range (IQR) as appropriate depending on Normality.

• Descriptive statistics will be used to summarise demographic and clinical characteristics of the patients

• Associations between two or more qualitative variables will be assessed using chi-square test and Fisher Exact test as appropriate

• Quantitative data between the two independent groups will be analysed using unpaired ‘t’ and Mann Whitney U tests as appropriate