| CTRI Number |
CTRI/2026/01/100519 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
MART versus ICS/LABA plus as-needed salbutamol in children 6-11 years with step 3 asthma |
|
Scientific Title of Study
|
Budesonide/formoterol Maintenance and Reliever Therapy (MART) versus budesonide/formoterol plus as-needed salbutamol in children 6-11 years with asthma: A Randomized Control 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 |
Sathya Srivatsav |
| Designation |
DM Senior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Pediatrics, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
08122989564 |
| Fax |
|
| Email |
sathya.srivatsav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagdish Goyal |
| Designation |
Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Pediatrics, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8475000270 |
| Fax |
|
| Email |
goyal.drjagdish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sathya Srivatsav |
| Designation |
DM Senior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Pediatrics, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
08122989564 |
| Fax |
|
| Email |
sathya.srivatsav@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Basni Industrial estate Phase-II, Jodhpur, Rajasthan. 600045 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
All India Institute of Medical Sciences, Basni Industrial estate Phase-II, Jodhpur, Rajasthan, 600045 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sathya Srivatsav |
AIIMS Jodhpur |
Department of Pediatrics, AIIMS Jodhpur
Jodhpur
RAJASTHAN |
08122989564
sathya.srivatsav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethical Committee |
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 |
Fixed low dose ICS+Laba + as needed SABA |
100mcg Budesonide + Formoterol twice daily dose + as needed Salbutamol; total duration 3 months |
| Intervention |
Very low dose MART |
100mcg Budesonide + formoterol Once daily + as needed Budesonide + formoterol (total maximum 8 puffs/day); total duration 3 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
GINA step 3 asthma |
|
| ExclusionCriteria |
| Details |
Chronic lung disease ~ BPD
Congenital thoracic malformations
Airway malacia
Mucociliary dysfunction- Cystic fibrosis, primary ciliary dyskinesia
History of recent exacerbation requiring oral/IM/IV corticosteroid in last 4 weeks
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Asthma Control Questionnaire (ACQ) score in children on Budesonide/formoterol MART in comparison to fixed-dose Budesonide/formoterol plus as-needed salbutamol.
|
0, 1, 2 & 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of exacerbations
Time to first exacerbation.
Quality of life
Improvement in lung function
Cumulative dosage
Adverse events
|
0, 1, 2, 3 months |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2026 |
| 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="0"
Months="9"
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
|
Asthma is the most common chronic respiratory condition of childhood worldwide. Current treatment recommended by guidelines in persistent asthma is fixed-dose inhaled corticosteroids (ICS) or ICS/LABA (long acting beta agonist) combination with as needed short acting beta-agonist (SABA). A novel approach is budesonide/formoterol Maintenance and Reliever Therapy (MART) using single inhaler, without requirement of SABA. Studies have shown MART is more effective at reducing exacerbations and improving daily asthma control than the same maintenance dose of budesonide/formoterol plus as needed SABA. Lacunae in existing literature- Paucity in existing literature comparing Budesonide/formoterol as MART versus Budesonide/formoterol plus as needed salbutamol as controller options in children 6-11 years with asthma.
|