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Clinical Investigations: ASTHMA |

Comparative In Vivo Lung Delivery of Hydrofluoroalkane-Salbutamol Formulation Via Metered-Dose Inhaler Alone, With Plastic Spacer, or With Cardboard Tube*

Stephen J. Fowler, MB, ChB; Andrew M. Wilson, MB ChB; Ewen A. Griffiths, BSc; Brian J. Lipworth, MD
Author and Funding Information

*From the Asthma and Allergy Research Group, Department of Clinical Pharmacology and Therapeutics, Ninewells Hospital and Medical School, University of Dundee, Dundee, Scotland, UK.

Correspondence to: Brian J. Lipworth, MD, Asthma and Allergy Research Group, Department of Clinical Pharmacology and Therapeutics, Ninewells Hospital and Medical School, University of Dundee, Dundee, DD1 9SY Scotland, UK; e-mail: b.j.lipworth@dundee.ac.uk



Chest. 2001;119(4):1018-1020. doi:10.1378/chest.119.4.1018
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Study objective: To compare the lung delivery of chlorofluorocarbon-free salbutamol via a pressurized metered-dose inhaler (pMDI) alone, a pMDI with a small-volume plastic spacer, and a pMDI with a cardboard tube.

Design: A randomized, single (investigator)-blind, three-way, crossover study.

Setting: The Asthma and Allergy Research Group, Ninewells Hospital, University of Dundee, Dundee, Scotland, UK.

Participants: Twelve healthy volunteers aged 16 to 65 years.

Interventions: The subjects were administered 400 μg of salbutamol via a pMDI alone, via a pMDI plus a small-volume plastic spacer, or via a pMDI plus a cardboard tube.

Measurements and results: Blood samples for plasma salbutamol concentrations were taken at 5 min, 10 min, and 20 min after inhalation, to measure lung bioavailability as a surrogate for relative lung dose. The addition of the plastic spacer resulted in a significantly higher maximal plasma salbutamol concentration (Cmax) and average plasma salbutamol concentration (Cav) than the pMDI used alone. This amounted to a 1.48-fold (32%) difference (95% confidence interval [CI], 1.03 to 2.13) for Cmax and a 1.42-fold (30%) difference (95% CI, 1.01 to 2.00) for Cav. There was no significant difference in the Cmax or Cav comparing the addition of the cardboard tube with the plastic spacer or the pMDI alone.

Conclusions: Using a chlorofluorocarbon-free pMDI with a plastic spacer produced statistically, but not biologically, significant greater lung delivery of salbutamol. If a spacer is required for reasons other than increasing delivered drug dose, then the addition of a readily available cardboard tube will fulfill many of the required functions with no expense to the patient.

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