FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062290 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 25/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Formoterol and Budesonide inhaler in childhood asthma 
Scientific Title of Study   Comparison of Efficacy of Inhaled Formoterol and Budesonide Combination versus Budesonide Monotherapy in Children Aged 6 to 18 years with Bronchial Asthma in Improving Disease Control and Quality of Life: A Randomized Controlled Trial 
Trial Acronym  FORM-BUD  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khushboo Kamal Taneja 
Designation  Senior Resident (Academic) 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Division of Pediatric Pulmonology and Critical Care Department of Pediatrics Level 6,Medical College Block A All Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9599717001  
Fax    
Email  khushbooktaneja@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Meenu Singh 
Designation  Professor of Pediatric Pulmonology and Executive Director, AIIMS Rishikesh 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Director Office All India Institute of Medical Sciences, Rishikesh Level 1, Block A Medical College, Veerbhadra Road, Shivaji Nagar Rishikesh, Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9814117152  
Fax    
Email  meenusingh4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Meenu Singh 
Designation  Professor of Pediatric Pulmonology and Executive Director, AIIMS Rishikesh 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Director Office All India Institute of Medical Sciences, Rishikesh Level 1, Block A Medical College, Veerbhadra Road, Shivaji Nagar Rishikesh, Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9814117152  
Fax    
Email  meenusingh4@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Rishikesh 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Rishikesh 
Address  Shivaji Nagar, Veerbhadra Road Rishikesh, Uttarakhand-249203 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Khushboo Kamal Taneja  All India Institute of Medical Sciences, Rishikesh  Pediatric OPD, 2nd floor, Block C1 All India Institute of Medical Sciences, Rishikesh Shivaji Nagar, Veerbhadra Road Rishikesh, Uttarakhand India, PIN code- 249203
Dehradun
UTTARANCHAL 		 9599717001

khushbooktaneja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences, Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J452||Mild intermittent asthma, (2) ICD-10 Condition: J453||Mild persistent asthma, (3) ICD-10 Condition: J454||Moderate persistent asthma, (4) ICD-10 Condition: J455||Severe persistent asthma, (5) ICD-10 Condition: J459||Other and unspecified asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inhaled Budesonide with as needed Inhaled Salbutamol  Inhaled Budesonide(100 or 200 micrograms per puff of Metered Dose Inhaler)- to be given via inhalational route. Dosing as per age and symptoms in accordance with GINA guidelines 2023 for maintenance dosing- 1. 6 to 11 yrs- a) Step 1-100 mcg- one or two puffs SOS with as needed SABA (Inhaled Salbutamol 100 mcg) b) Step 2- 100 mcg one puff once daily c) Step 3- 100 mcg- one puff twice daily d) Step 4 and 5- 100 mcg- two puffs twice daily 2. 12 years and above- a) Step 1 and 2 - 200mcg one or two puffs SOS b) Step 3- 200mcg- one puff twice daily c) Step 4 and 5- 200mcg- two puffs twice daily Inhaled Salbutamol (100 mcgs per puff of Metered Dose Inhaler) will be used as needed as a reliever- 100mcg- two puffs every 20 mins upto 4 puffs  
Intervention  Inhaled Formoterol and Budesonide combination  One puff of Metered Dose Inhaler containing 100 or 200 micrograms of Budesonide and 6 micrograms of Formoterol to be given via inhalational route using Metered Dose inhaler with spacer. Dose as per symptom severity and age according to GINA guidelines 2023 for maintenance dosing as follows- 1. 6- 11 yrs- a)Step 1 -100/6 mcg- one puff SOS b)Step 2- 100/6 mcg- one puff once daily or SOS c) Step 3- 100/6 mcg-one puff once or twice daily d) Step 4 to 5-100/6- one puff twice daily or 200/6 one puff twice daily 2. 12 yrs and above- a)Step 1 and 2- 200/6 mcg one puff sos b) Step 3- 200/6 mcg one or two puffs once daily c) Step 4- 200/6 mcg two puffs twice daily d) Step 5-200/6 two puffs twice daily Same inhaler combination to be used as a reliever as required- 1. 6 to 11 yrs-100/6 mcg-maximum 8 puffs in 24 hrs as rescue therapy 2. 12 yrs and above- 200/6 mcg- maximum 12 puffs in 24 hrs as rescue therapy  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1.Children aged 6-18 years
2. Bronchial asthma requiring treatment as per GINA guidelines step 1 to 4
3. Ability to perform spirometry in accordance with the standards of the American
Thoracic Society 
 
ExclusionCriteria 
Details  1. Co-existent other chronic pulmonary diseases
2. Chronic renal, gastrointestinal diseases, hepatic or cardiac diseases
3. History of active smoking
4. Patient who took a systemic corticosteroid within the previous 4 weeks
5. Prior PICU admission for asthma 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the proportion of children with asthma showing improved asthma control questionnaire(ACQ) score between the two groups  12 weeks and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the proportion of children showing improved Pediatric Asthma Quality of life score(PAQLQ) between the two groups  24 weeks 
To compare the proportion of children with improved spirometric parameters between the two groups  24 weeks 
To compare the improvement in level of control of asthma, number and severity of exacerbations and
time to first exacerbation on treatment in both groups 		 24 weeks 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   08/02/2024 
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  

Background: Asthma is a common illness in children, requiring multiple inhalers and frequent hospital visits, especially in younger children. Many studies in the West have shown the benefits of a single inhaler as controller and reliever in moderate asthma, with no added side effects. There is also a recent interest in using a single inhaler in mild asthma, which is being studied by a multi-centric trial. This study will be a step forward for improving evidence in favour of a single inhaler as rescue and reliever medicine in children with asthma, thereby helping in improving compliance, quality of life and decreasing disease severity.

Aim: To compare the efficacy of inhaled Formoterol/ Budesonide combination (controller + reliever) vs budesonide controller with salbutamol reliever in children (6 to 18 years) with bronchial asthma.

Primary Objective: To compare the proportion of children with asthma showing improved Asthma Control  Questionnaire score (ACQ) after 12 weeks and 24 weeks of inhaled formoterol/ budesonide combination (controller + reliever) vs budesonide controller with salbutamol reliever.

Secondary Objectives: To compare in both arms- 

1. The proportion of children showing improved Pediatric Asthma Quality of Life score (PAQLQ)

2. The proportion of children with improved spirometric parameters

3. The improvement in level of control of asthma, number and severity of exacerbations, and time to first exacerbation on treatment

Methodology:  This study would be single blinded, parallel design, active controlled, two armed randomized control trial to be carried out over 24 weeks. Computer generated random numbers would help the randomization, to be implemented by Sequentially Numbered Opaque Sealed Envelopes. One arm would receive inhaled Formoterol and Budesonide combination as controller in doses appropriate for age and symptom severity as per GINA guidelines. The other arm would receive inhaled Budesonide as controller, and inhaled Salbutamol as reliever, in age and symptom appropriate doses as per GINA guidelines. Spirometry would be done at 0, 12 and 24 weeks. ACQ scoring and PAQLQ scoring would be done at 0 and 24 weeks.

 
Close