Comparison of inhalation techniques in children with asthma using metered dose inhaler and spacer

Completed

• Conditions: Bronchial asthma

• Registration Number: CTRI/2013/04/003559
• Lead Sponsor: Divya Anna Stephen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-16
• Last Update Posted: 2013-03-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak expiratory flow rate	O1-Immediately prior to intervention. | O2-Half an after intervention.

Secondary Outcome Measures

Name	Time	Method
Breath hold time duration in single maximal inhalation with a breath hold group	Not applicable

Trial Locations

Locations (1)

AIIMS; 🇮🇳 Delhi, DELHI, India

AIIMS

🇮🇳Delhi, DELHI, India

Divya Anna Stephen

Principal investigator

08826052084

divstephen@gmail.com