| CTRI Number |
CTRI/2020/03/024170 [Registered on: 23/03/2020] Trial Registered Prospectively |
| Last Modified On: |
20/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Of Efficacy Of Levosalbutamol Given By Nebuliser VS Metered Dose Inhaler-Spacer In Children With Wheezing |
|
Scientific Title of Study
|
Comparison Of Efficacy Of Nebulised Levosalbutamol Vs Levosalbutamol Metered Dose Inhaler-Spacer: A Single Centre Open Label Randomized Controlled Trial In Hospitalized Children With Wheezing |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chauhan Ankit Jaisinh |
| Designation |
DNB Resident(paediatics) |
| Affiliation |
Jaipur Golden Hospital |
| Address |
Department of paediatics,room no 145, 1st floor,
Jaipur golden hospital, sector 3,rohini.
North West
DELHI
110085
India |
| Phone |
9643900490 |
| Fax |
|
| Email |
ajchauhan34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Gupta |
| Designation |
Consultant |
| Affiliation |
Jaipur Golden Hospital |
| Address |
Department of paediatics,room no 145, 1st floor,
Jaipur golden hospital, sector 3,rohini.
North West
DELHI
110085
India |
| Phone |
9319732500 |
| Fax |
|
| Email |
yamaha_2390@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chauhan Ankit Jaisinh |
| Designation |
DNB Resident(paediatics) |
| Affiliation |
Jaipur Golden Hospital |
| Address |
Department of paediatics,room no 145, 1st floor,
Jaipur golden hospital, sector 3,rohini.
North West
DELHI
110085
India |
| Phone |
9643900490 |
| Fax |
|
| Email |
ajchauhan34@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jaipur Golden Hospital,Sector 3, Rohini, New Delhi, 110085 |
|
|
Primary Sponsor
|
| Name |
Jaipur Golden Hospital |
| Address |
Jaipur golden hospital, sector 3,rohini- 110085. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 ankit chauhan |
Jaipur Golden Hospital |
Department of paediatics,room no 145, 1st floor,
Jaipur golden hospital, sector 3,rohini.
North West
DELHI |
9643900490
ajchauhan34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levosalbutamol by Metered dose inhaler-spacer. |
MDI-SPACER (GROUP A): Levosalbutamol MDI (50 micrograms/puff) 4-8 puffs(4 puffs for 5-10kg, 6 puffs for 10-20kg, 8 puffs more than 20kg) at a time 20 minutes interval for 3 doses will be given with the help of MDI-spacer with valve. |
| Comparator Agent |
Nebulised levosalbutamol |
nebulised levosalbutamol will be given in the dose of 75 mcg/kg at a time 20 mins interval for 3 doses |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 1-12 year with acute wheezing and who will be admitted to Department of Pediatrics, Jaipur Golden Hospital.
2.Pulmonary score : 4-9( MODERATE TO SEVERE)
|
|
| ExclusionCriteria |
| Details |
-Chronic lung disease
-Cyanotic congenital heart disease
-Suspected foreign body aspiration
-Life threatening signs (altered sensorium, bradycardia, poor pulse volume, cyanosis, silent chest)
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement in the pulmonary score.
|
Improvement in the pulmonary score at 0 minute, 30 minute, 60 minute, 3 hour, 6 hour, 12 hour, 24hour.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of hospital stay. |
Example. 24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
23/03/2020 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In
hospital, nebuliser and MDI-spacer are
two mainstay aerosol drug delivery method for β 2 agonists administration, but due to the lack of awareness
and lack of understanding of the inhalational technique MDI –spacer is not
commonly employed in the acute management. However,
in clinical routine and under the supervision of trained proÂfessionals, the
MDI-spacer technique may be just as effecÂtive as nebulisation. Although the efficacy of nebulization is broadly acknowledged, the method has
several disadvanÂtages. Studies show that nebulization may be ineffective in
delivering aerosolized medicine compared to the combinaÂtion MDI-spacer.In
case of acute wheezing current guidelines recommend the use of short-acting
bronchodilators (β 2 agonists) inhalation to reverse airflow obstruction and
treat patients. That
being said, the purpose of this study is to compare
the efficacy of levosalbutamol aerosol therapy given via MDI-spacer to that given
via nebulizer in hospitalised children with wheezing by using pulmonary score. |