NCT06201156Completed
Comparison of Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze
Comparison of Pulmonary Index Score After Treatment With Salbutamol Through Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze
Source: ClinicalTrials.gov · Last updated 11 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 15 Dec 2023
- Start date
- 10 Dec 2023
- Primary completion date
- 20 Feb 2024
- Lead sponsor
- Khyber Teaching Hospital
- Diseases
- Asthma
- NCT number
- NCT06201156
What you commit to
- Study type: Interventional
- Participants enrolled: 160
- From 10 Dec 2023 to the primary completion date, 20 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with history of chronic lung condition (including congenital anomalies, cystic fibrosis, and bronchopulmonary dysplasia).
- Patients with history of congenital heart disease.
- Patients with history of intubation for longer than 1 week during the neonatal period.
- Patients with signs of impending respiratory failure i.e Pulmonary index score of 12.
Other
- Patients having symptoms consistent with croup.
Who the study is looking for
- Patients aged 6 to 24 months
- Patients of both gender
- Patients presenting to emergency department with bilateral wheeze
Age in the registry: 6 months to 24 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Khyber Teaching Hospital Coordinator of this site? Confirm its status | Peshawar | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.