Salbutamol dry powder inhaler: efficacy, tolerability, and acceptability study

Area of Science:

• Pediatric Pulmonology
• Respiratory Medicine
• Pharmacology

Background:

• Dry powder inhalers (DPIs) are preferred for children over 5 to bypass coordination issues with pressurized metered dose inhalers (pMDIs).
• Assessing alternative inhaler devices is crucial for optimizing asthma management in pediatric populations.

Purpose of the Study:

• To compare the bronchodilator efficacy, tolerability, and acceptability of salbutamol delivered via a Clickhaler DPI versus a pMDI with a valved holding chamber (VHC).
• To evaluate salbutamol Clickhaler as a viable alternative for pediatric asthma patients.

Main Methods:

• A two-phase study involving 61 children (aged 6-17) with mild to moderate asthma.
• Primary endpoint: comparison of forced expiratory volume in 1 second (FEV1) changes after a single dose of salbutamol (100 microg) from Clickhaler and pMDI/VHC.
• Secondary assessments included patient-reported ease of use and device preference.

Main Results:

• No statistically significant difference in bronchodilator efficacy (FEV1 change) between Clickhaler and pMDI/VHC.
• Maximum post-treatment FEV1 change was 12.4% (SD 10.0) for Clickhaler and 14.15% (SD 9.3) for pMDI/VHC.
• High patient acceptability for Clickhaler: 97% found it easy to use, 84% liked the device.

Conclusions:

• Salbutamol delivered via Clickhaler is an effective bronchodilator in children with mild to moderate asthma.
• The Clickhaler is a well-tolerated and highly acceptable alternative to pMDI/VHC for pediatric asthma patients over 6 years old.
• DPIs like Clickhaler offer a practical solution for pediatric inhaler therapy.