| CTRI Number |
CTRI/2020/06/026247 [Registered on: 30/06/2020] Trial Registered Prospectively |
| Last Modified On: |
24/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing drug combination (low-dose steroid/long acting B2 agonist) versus medium-dose steroid as an inhaled medication in children with asthma |
|
Scientific Title of Study
|
Randomised controlled trial comparing inhaled low-dose budesonide/formoterol combination versus conventional medium-dose budesonide in children with persistent bronchial asthma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Himasnhu Gupta |
| Designation |
Junior Resident (MD) Paediatrics |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room No 3419, level 3,block D, Advanced Pediatrics Centre, PGIMER, Chandigarh
Room No 253, N Block, New Doctors Hostel, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9799833433 |
| Fax |
|
| Email |
himanshu.gupta678@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joseph L Mathew |
| Designation |
Professor (Pediatric Pulmonology) |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room No 3118, level 3, block A , Advanced Pediatric Centre, PGIMER, Chandigarh
Advanced Paediatrics Centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008357 |
| Fax |
|
| Email |
dr.joseph.l.mathew@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Himasnhu Gupta |
| Designation |
Junior Resident (MD) Paediatrics |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room No 3419, level 3,block D, Advanced Pediatrics Centre, PGIMER, Chandigarh
Room no 253, N Block, New Doctors Hostel, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9799833433 |
| Fax |
|
| Email |
himanshu.gupta678@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Advanced Paediatrics Centre, PGIMER, Chandigarh |
| 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 |
| Himanshu Gupta |
Allergy and Asthma Clinic, Department of Paediatrics |
Advanced Paediatrics Centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
9799833433
himanshu.gupta678@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inhaled low-dose Budesonide/Formoterol combination |
1 puff of Budesonide (100 mcg) + Formoterol (6 mcg), twice daily, by metered dose inhaler through a spacer |
| Comparator Agent |
Medium-dose Budesonide |
2 puffs of Budesonide (100 mcg), twice daily, by metered dose inhaler through a spacer |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) Children 6 to 12 years of age
2) New physician diagnosed persistent asthma as per definition by GINA 2019 ( variable respiratory symptoms such as wheeze, shortness of breath, chest tightness, cough with daytime symptoms >2 times/week, nocturnal symptoms >3-4/month, use of SABA >2/week and documented variable expiratory airflow limitation with FEV1 <80% of predicted, FEV1/FVC ratio <80%, PEFR variability >20%
3) Children eligible for medium dose inhaled corticosteroid therapy based on disease severity |
|
| ExclusionCriteria |
| Details |
1) Previously diagnosed asthma already receiving inhaled corticosteroid in any form
2) Children having a disease ( other than asthma) that causes wheezing such as lower respiratory tract infections or inhaled foreign body
3) Children with known respiratory disease ( cystic fibrosis, primary ciliary dyskinesia)
4) Children with clinical features suggesting hepatic impairment
5) Children having known seizure disorder, Type-1 DM
6) children with known autoimmune and immunodeficiency disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in PEFR (%) 4 weeks after initiation of therapy (compared to baseline) |
Increase in PEFR (%) 4 weeks after initiation of therapy (compared to baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Increase in PEFR (%) 8 weeks after initiation of therapy
2) Increase in PEFR (%) 12 weeks after initiation of therapy
3) PEFR (%) at 4, 8 and 12 weeks of therapy
4) Asthma symptoms score at 4, 8 and 12 weeks of therapy
5) Solicited and unsolicited side effects at 4, 8 and 12 weeks of therapy
6) Exacerbations requiring home or hospital treatment at 4, 8 and 12 weeks of therapy
7) Total dosage of inhaled steroid plus oral steroid consumed at 4, 8 and 12 weeks of therapy
|
At 4, 8 and 12 weeks of therapy |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
15/07/2020 |
| 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="1"
Months="6"
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
|
Children aged 6-12 years presenting to the Department of Pediatrics (OPD or Allergy & Asthma Clinic) at PGIMER with symptoms of recurrent, episodic, reversible wheeze, and/or shortness of breath, and/or chest tightness and/or cough will be screened for eligibility criteria. Parents of those fulfilling the Inclusion and Exclusion criteria will be clearly explained about the purpose and nature of this study, associated benefits and risks, and management protocol. This will be done verbally as well as with a written Participant Information Sheet. Parents and children will be provided the opportunity to ask questions, which will be answered by the Investigator. They will then be invited to permit their child to participate in the study. Parents expressing willingness for their child to participate in the study will be offered an Informed Consent Form. Parents and children will be provided the opportunity to ask questions, which will be answered by the Investigator. Children will be enrolled only after obtaining written informed consent from parents. If neither parent is available, a Legally Acceptable Representative will be considered if he/she is also the primary caregiver for the child. In addition, children older than 8 years will be offered an Assent form, and enrolled in this age group will be only with written assent of the child.
|