Comparison of Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze

NCT06201156 | Completed

• 1 other identifier: 847/DME/KMC
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Asthma With Acute Exacerbation

Outcome Measures

Primary Outcomes (1)

• compare mean pulmonary index score after treatment with salbutamol through nebulizers vs metered dose inhalers

  primary outcome is defined as Comparison of mean pulmonary index score after treatment with salbutamol through nebulizers vs metered dose inhalers with spacers for treatment of wheezing in children aged 6 to 24 months in a pediatric emergency department

  1 hour

Study Arms (2)

Group A / Nebulizer Group

ACTIVE COMPARATOR

Group A/ Nebulizer group will receive 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.

Device: Metered Dose Inhaler With Spacer Device

Group B / MDI with Spacer Device Group

EXPERIMENTAL

Group B/ MDI with Spacer Group will receive 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.

Device: Metered Dose Inhaler With Spacer Device

Interventions

Metered Dose Inhaler With Spacer Device DEVICE

Bronchodilator Therapy

Group A / Nebulizer Group; Group B / MDI with Spacer Device Group

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 6 to 24 months
• Patients of both gender
• Patients presenting to emergency department with bilateral wheeze

You may not qualify if:

• 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 having symptoms consistent with croup.
• Patients with signs of impending respiratory failure i.e Pulmonary index score of 12.

Sponsors & Collaborators

• Khyber Teaching Hospital: lead

Study Sites (1)

Khyber Teaching Hospital

Peshawar, 25000, Pakistan

Location

Related Publications (7)

• Csonka P, Tapiainen T, Makela MJ, Lehtimaki L. Optimal administration of bronchodilators with valved holding chambers in preschool children: a review of literature. Eur J Pediatr. 2021 Oct;180(10):3101-3109. doi: 10.1007/s00431-021-04074-3. Epub 2021 Apr 20.

  PMID: 33877400 BACKGROUND

• Nurmagambetov T, Kuwahara R, Garbe P. The Economic Burden of Asthma in the United States, 2008-2013. Ann Am Thorac Soc. 2018 Mar;15(3):348-356. doi: 10.1513/AnnalsATS.201703-259OC.

  PMID: 29323930 BACKGROUND

• Roncada C, Andrade J, Bischoff LC, Pitrez PM. COMPARISON OF TWO INHALATIONAL TECHNIQUES FOR BRONCHODILATOR ADMINISTRATION IN CHILDREN AND ADOLESCENTS WITH ACUTE ASTHMA CRISIS: A META-ANALYSIS. Rev Paul Pediatr. 2018 Jul-Sep;36(3):364-371. doi: 10.1590/1984-0462/;2018;36;3;00002. Epub 2018 Jul 10.

  PMID: 29995144 BACKGROUND

• Alharbi AS, Yousef AA, Alharbi SA, Al-Shamrani A, Alqwaiee MM, Almeziny M, Said YS, Alshehri SA, Alotaibi FN, Mosalli R, Alawam KA, Alsaadi MM. Application of aerosol therapy in respiratory diseases in children: A Saudi expert consensus. Ann Thorac Med. 2021 Apr-Jun;16(2):188-218. doi: 10.4103/atm.atm_74_21. Epub 2021 Apr 17.

  PMID: 34012486 BACKGROUND

• Payares-Salamanca L, Contreras-Arrieta S, Florez-Garcia V, Barrios-Sanjuanelo A, Stand-Nino I, Rodriguez-Martinez CE. Metered-dose inhalers versus nebulization for the delivery of albuterol for acute exacerbations of wheezing or asthma in children: A systematic review with meta-analysis. Pediatr Pulmonol. 2020 Dec;55(12):3268-3278. doi: 10.1002/ppul.25077. Epub 2020 Sep 25.

  PMID: 32940961 BACKGROUND

• Schell DN, Durham D, Murphree SS, Muntz KH, Shaul PW. Ontogeny of beta-adrenergic receptors in pulmonary arterial smooth muscle, bronchial smooth muscle, and alveolar lining cells in the rat. Am J Respir Cell Mol Biol. 1992 Sep;7(3):317-24. doi: 10.1165/ajrcmb/7.3.317.

  PMID: 1325812 BACKGROUND

• Dimino, K. Using A Metered Dose Inhaler (Mdi) With Spacer or Nebulizer for Managing Children Under 5 Years of Age with Exacerbation of Wheezing or Asthma. 2019; 11(2): 555815.10.19080/JOJNHC.2019.11.555815

  BACKGROUND

MeSH Terms

Interventions

Metered Dose Inhalers

Intervention Hierarchy (Ancestors)

Nebulizers and Vaporizers; Equipment and Supplies

Study Officials

• Arooj Khan, MBBS

  Khyber Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 11, 2024
• Study Start: December 10, 2023
• Primary Completion: February 20, 2024
• Study Completion: March 30, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 months

Locations

PA (1)