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

Childhood Asthma With Acute Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201156
• Other study ID #: 847/DME/KMC
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: December 2023
• Source: Khyber Teaching Hospital
• Contact: Arooj Khan, MBBS
• Phone: +923129190773
• Email: aroojkhan1011[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 30, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

Inclusion Criteria:

Patients aged 6 to 24 months

• Patients of both gender

• Patients presenting to emergency department with bilateral wheeze

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Childhood Asthma With Acute Exacerbation

Intervention

Device:
• Metered Dose Inhaler With Spacer Device
Bronchodilator Therapy

Locations

Country	Name	City	State
Pakistan	Khyber Teaching Hospital	Peshawar

Sponsors (1)

Lead Sponsor	Collaborator
Khyber Teaching Hospital

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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