| CTRI Number |
CTRI/2013/04/003559 [Registered on: 15/04/2013] Trial Registered Retrospectively |
| Last Modified On: |
25/03/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of inhalation techniques in children with asthma using metered dose inhaler and spacer |
|
Scientific Title of Study
|
A randomised controlled trial to compare the effectiveness of single maximal inhalation with breath holding versus five tidal breaths for inhalation of salbutamol delivered by metered dose inhaler and spacer in children with asthma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Anna Stephen |
| Designation |
MSc. Nursing student |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
MSc. Nursing(Pediatrics),College of nursing,AIIMS
New Delhi
DELHI
110029
India |
| Phone |
8826052084 |
| Fax |
|
| Email |
divstephen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Vatsa |
| Designation |
Principal |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
college of nursing,All India Institute Of medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
01126594457 |
| Fax |
911126588663 |
| Email |
mvatsa2001@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S K Kabra |
| Designation |
Professor, Department of pediatrics |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Professor, Department of pediatrics, All India Institute Of Medical Sciences.
New Delhi
DELHI
110029
India |
| Phone |
919868397540 |
| Fax |
|
| Email |
skkabra@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Divya Anna Stephen |
| Address |
MSc. Nursing(pediatrics), College of Nursing, AIIMS |
| Type of Sponsor |
Other [Investigator] |
|
|
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 |
| Divya Anna Stephen |
AIIMS |
College of nursing,old OT block, All India Institute Of medical Sciences
New Delhi
DELHI |
08826052084
divstephen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS ethics comitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Bronchial asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MDI 2puffs (100mcg, in each puff) |
MDI two puff either by five tidal breathing method or single maximal inhalation with a breath hold method ( for each puff) |
| Comparator Agent |
Single maximal inhalation with a breath hold,five tidal breaths |
MDI two puff either by five tidal breathing method or single maximal inhalation with a breath hold method ( for each puff) |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with asthma
a) Using metered dose inhaler.
b) Who are of age 5-15 yrs.
c) Whose parent’s give consent to participate in the study.
2. Children who are able to perform the manoeuvre for measuring PEFR.
3. Children who are able to perform breath holding.
|
|
| ExclusionCriteria |
| Details |
1. Children with
a) Acute exacerbations of asthma.
b) Chest malformation, congenital abnormalities of the chest.
c) Any other cardiovascular or neuromuscular disease.
d) Anthropometric parameters less than 3rd percentile.
2. Children receiving regular long acting beta-2 agonist (salmetrol, formetrol).
3. Children who have received beta2 agonist, 6 hrs prior to the observation (salbutamol).
4. Children who have received methylxanthines and anti cholinergic drugs prior to observation (Ipratropium bromide,Theophylline).
5. Children who are already performing single maximal inhalation with a breath hold
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peak expiratory flow rate |
O1-Immediately prior to intervention.
O2-Half an after intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Breath hold time duration in single maximal inhalation with a breath hold group |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/07/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a randomised control trial comparing the effectiveness of single maximal inhalation versus five tidal breaths for inhalation of salbutamol delivered by metered dose inhaler and spacer in children with asthma. The trial will be conducted at a single site in India. The primary outcome of the study is peak expiratory flow rate prior to administration of salbutamol with metered dose inhaler and half an hour after administration of salbutamol with metered dose inhaler either by five tidal breathing method or single maximal inhalation with a breath hold method.
|