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CTRI Number  CTRI/2024/07/070571 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 12/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effect of addition of Budesonide nebulisation to standard first line therapy in management of acute asthma exacerbations. 
Scientific Title of Study   Nebulised Budesonide as an adjunct to standard first line therapy for emergency management of moderate to severe acute asthma exacerbations in children aged 2 to 18 years age. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jigyasa Goswami 
Designation  M.D student 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Paediatrics, 4th floor, D Block, Government Medical College and Hospital, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9819387546  
Fax    
Email  jigyasa.jessy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pankaj Kumar 
Designation  Associate Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Paediatrics, 4th floor, D Block, Government Medical College and Hospital, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  8894286467  
Fax    
Email  drpankaj.kr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jigyasa Goswami 
Designation  M.D student 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Paediatrics, 4th floor, D Block, Government Medical College and Hospital, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9819387546  
Fax    
Email  jigyasa.jessy@gmail.com  
 
Source of Monetary or Material Support  
Department of Paediatrics, Government Medical College and Hospital, Chandigarh 
 
Primary Sponsor  
Name  Government Medical College and Hospital Chandigarh 
Address  Department of Paediatrics,4th floor, D Block, Government Medical College and Hospital, Sector 32 B, Chandigarh, India Pincode- 160030 
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 Jigyasa Goswami  Government Medical College and Hospital, Chandigarh  Department of Paediatrics, A Block, Level 2, Area 22, Paediatric Emergency ward
Chandigarh
CHANDIGARH 		 9819387546

jigyasa.jessy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (GMCH,Chandigarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J459||Other and unspecified asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Budesonide  Patients will receive oxygen driven (6L/min) nebulisation via face mask containing Budesonide 0.5 mg (2 ml) plus Salbutamol 2.5 mg (0.5ml) plus Normal saline 1ml (as diluent) for 3 doses 20 mins apart over 1 hour. 
Comparator Agent  Placebo  Patients will receive oxygen driven (6l/min) nebulisation via face mask containing Salbutamol 2.5 mg(0.5 ml) plus 3ml Normal saline (as diluent) for 3 doses 20 mins apart over 1 hour. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children 2 to 18 years of age diagnosed to have an acute exacerbation of asthma. The diagnosis will be based on the following criteria:
1.Children aged 2 to 18 years of age presenting to paediatric emergency with acute exacerbation of asthma having Paediatric asthma severity score of 8 to 15
And
2. Is a known case of childhood asthma or past history of at least two similar episodes in last 12 months relieved with bronchodilator therapy or already on controller therapy or with family history of asthma ,atopy ,nebulisations or personal history of atopic dermatitis, food allergy or allergic rhinitis. 
 
ExclusionCriteria 
Details  1. Presence of signs or symptoms suggestive of pneumonia, tuberculosis, heart disease croup, pertussis, measles, foreign body aspiration.
2.Documented fever >38 degrees Celsius
3.Life threatening exacerbation attack necessitating PICU admission and/or intubation owing to respiratory failure or depressed consciousness (GCS<8), and/or inotropes
4.Children enrolled in any other trial.
5.Children previously enrolled in this trial within last one month
6.Children who have received systemic corticosteroids for any indication within the previous 4weeks
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Difference in proportion of patients who needed systemic corticosteroid at one hour of presentation in each group
 		 One hour of presentation 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in mean reduction in Pediatric asthma severity score indicating clinical improvement at one hour of presentation
 		 One hour of presentation 
Difference in mean duration of hospital stay in each group
 		 At discharge 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   23/07/2024 
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="2"
Months="0"
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   This study is a randomized, double blind, parallel group trial comparing the efficacy of addition of budesonide to nebulized salbutamol against standard therapy of only nebulized salbutamol for management of moderate to severe acute asthma exacerbations in children aged 2 to 18 years presenting to the Paediatric emergency department. The primary outcome will be to measure the requirement for systemic corticosteroids at hour of admission .The secondary outcome will be to compare the effect of the intervention on improvement in Paediatric asthma severity score and duration of hospital stay. 
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