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Updated: Aug 1, 2026
08:05
Murine Model of Allergen Induced Asthma
Published on: May 14, 2012
Protection against methacholine-induced bronchospasm: salbutamol pMDI versus Clickhaler DPI
M T Newhouse1, P Patel, M Parry-Billings
1St Josephs Hospital, Hamilton, Ontario, Canada.
The European Respiratory Journal
|May 27, 2003
Summary
A new salbutamol dry-powder inhaler (DPI) demonstrated therapeutic equivalence to the traditional metered-dose inhaler (pMDI) in asthma patients. This study confirms the salbutamol Clickhaler is a viable alternative for managing airway hyperresponsiveness.
Area of Science:
- Respiratory Medicine
- Pharmacology
- Clinical Trials
Background:
- Pressurised metered-dose inhalers (pMDIs) are standard for asthma treatment.
- Passive dry-powder inhalers (DPIs) offer an alternative, eliminating propellants and potentially improving aerosol delivery.
- New generic DPI formulations require rigorous comparison with established pMDI therapies.
Purpose of the Study:
- To compare the bronchoprotective effects of a novel salbutamol DPI (Clickhaler) against a reference salbutamol pMDI (Ventolin).
- To evaluate the therapeutic equivalence of the two inhaler devices using methacholine challenge.
Main Methods:
- Randomised, double-blind, double-dummy, placebo-controlled, seven-way crossover study.
- Adult asthma patients with methacholine hyperresponsiveness received escalating doses of salbutamol via DPI or pMDI.
- Methacholine challenge assessed before and after treatment; PC20 ratios analyzed using Finney's bioassay.
Main Results:
- Eighteen patients completed the study, showing dose-related responses to salbutamol.
- The relative potency of DPI to pMDI was 1.29 (90% CI 1.04-1.63), indicating therapeutic equivalence.
- No significant differences in safety parameters (heart rate, blood pressure, adverse events) were observed between devices.
Conclusions:
- Methacholine challenge serves as a sensitive bioassay for comparing inhaled therapies.
- The salbutamol Clickhaler dry-powder inhaler is therapeutically equivalent to the conventional salbutamol pressurised metered-dose inhaler.
- The Clickhaler represents a comparable alternative for delivering salbutamol in asthma management.
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