| CTRI Number |
CTRI/2026/01/102452 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Intermittent Budesonide-Formoterol versus Daily Budesonide for Mild Asthma in Children aged 6 to 11 years |
|
Scientific Title of Study
|
Intermittent Budesonide-Formoterol versus Daily Budesonide for Mild Asthma in Children aged 6 to 11 years- A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kkomal C Suvarna |
| Designation |
Academic Senior Resident (DM Pediatric Pulmonology) |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
Department of Pediatrics, 2nd floor, College building, AIIMS Jodhpur
Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9828990018 |
| Fax |
|
| Email |
kkcvsuvarna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kkomal C Suvarna |
| Designation |
Academic Senior Resident (DM Pediatric Pulmonology) |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
Department of Pediatrics, 2nd floor, College building, AIIMS Jodhpur
Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9828990018 |
| Fax |
|
| Email |
kkcvsuvarna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kkomal C Suvarna |
| Designation |
Academic Senior Resident (DM Pediatric Pulmonology) |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
Department of Pediatrics, 2nd floor, College building, AIIMS Jodhpur
Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9828990018 |
| Fax |
|
| Email |
kkcvsuvarna@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lupin Limited Pharmaceutical company |
| Address |
Mumbai, Maharashtra |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kkomal C Suvarna |
Pediatric OPD, AIIMS Jodhpur |
Room 220/221, OPD Block 2B, 2nd floor, AIIMS Jodhpur hospital, AIIMS Jodhpur, Basni
Jodhpur
RAJASTHAN |
9828990018
kkcvsuvarna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (CLINICAL TRIALS), AIIMS JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J453||Mild persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Budesonide and Salbutamol |
Inhaled Budesonide (100 microgram) 1 puff twice daily plus as needed Inhaled Salbutamol (100 microgram) 2 puffs as needed (max 8 puffs) for 3 months |
| Intervention |
Placebo and Budesonide-Formoterol |
Inhaled Placebo 1 puff twice daily plus as needed inhaled Budesonide/formoterol (100/6 microgram) 2 puffs as needed (max 8 puffs) for 3 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6 years to 11 years with new diagnosis of Asthma, who stratify in step 1 or 2 (symptoms up to 5 days/week, no night-time awakening), according to GINA 2025
Newly diagnosed asthma in children aged 6-11 years as per GINA 2025 guidelines(1) who stratify in step 1 or 2 -
• Symptoms up to 5 days/week
• No night-time awakening
|
|
| ExclusionCriteria |
| Details |
-Child already on asthma medications
-Children with other chronic lung diseases
– Bronchopulmonary dysplasia, congenital thoracic malformations, airway malacia, mucociliary clearance defects, Tuberculosis, Allergic bronchopulmonary aspergillosis
• Children with frequent or recent exacerbations of asthma in the past 4 weeks
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare asthma control at 3 months between two groups using ACQ score |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the number of asthma exacerbations requiring steroids/hospital admissions between two groups |
3 months |
| 2. To compare time to first exacerbation between two groups |
3 months |
| 3. To compare cumulative dosage of ICS used between two groups |
3 months |
| 4. To compare the cost efficacy between two groups |
3 months |
| 5. To compare Quality of life between two groups |
3 months |
| 6. To compare frequency of adverse events between two groups |
3 months |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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
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