CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
Metered Dose Inhaler With Spacer Devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06201156
NCT06201156N/ACompleted

Comparison of Pulmonary Index Score After Treatment With Salbutamol Through Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze

Khyber Teaching Hospital·interventional·Posted Jan 11, 2024·Updated Mar 11, 2025

In Brief

A clinical study evaluating Metered Dose Inhaler With Spacer Device for Childhood Asthma With Acute Exacerbation. Completed, enrolled 160 participants across 1 site.

Detailed Summary

The goal of this randomized controlled trial is to compare two different devices for the administration of the standard protocol drug. The main question it aims to answer is are metered dose inhalers with spacer device as effective as nebulization with salbutamol in treatment of childhood wheeze Children will be divided in two groups using block randomization method. Children in group A will be nebulizer group, treatment will consist of 3 puffs of a placebo MDI with a spacer, followed immediately by a standard dose of 0.15 mg/kg of salbutamol in 3 mL of isotonic sodium chloride solution delivered by an oxygen-driven nebulizer at a flow rate of 6 L/min. For patients in group B spacer group, treatment consisted of 3 puffs (90 pg per puff) of salbutamol MDI with a spacer, followed by 3 mL of nebulized isotonic sodium chloride solution. All treatments will be given at 20-minute intervals. For administration of the MDI, the investigator will dispense I puff of salbutamol or placebo into the spacer and held the mask on the child's face while the child breathed 5 to 6 times through the mask. This process will b-e repeated for a total of 3 puffs per treatment. All patients will be treated by the principal investigator, at end of treatment need for admission and pulmonary index will be noted.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPakistan
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJan 11, 2024
Enrollment StartDec 10, 2023
Primary CompletionFeb 20, 2024
Study CompletionMar 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 2.5 years ago

Interventions

Metered Dose Inhaler With Spacer Devicedevice

Bronchodilator Therapy