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Federica Di Berardino, MD; Stella Forti, BMath; Gioia Piatti, MD, PhD; Valter Fasano, MD, PhD
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From the Audiology Unit (Dr Berardino and Ms Forti), Department of Specialistic Surgical Sciences, and Department of Thoracic and Cardiovascular (Drs Piatti and Fasano), IRCCS Policlinico, Mangiagalli e Regina Elena, University of Milan.

Correspondence to: Federica Di Berardino, MD, Department of Specialistic Surgical Science, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, University of Milan, Via Festa del loss 7 - 20122 Milano, Italy; e-mail: federica.diberardino@unimi.it


Financial/nonfinancial disclosures: The authors have reported to CHEST that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


© 2010 American College of Chest Physicians


Chest. 2010;138(3):759-760. doi:10.1378/chest.10-0932
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To the Editor:

In reply to the response by García-Arietato regarding our previous correspondence,1 we are pleased to see that we have attained our initial objective of drawing attention to and provoking discussion on the unacceptable situation concerning drug delivery through pressurized metered-dose inhalers (pMDI) and spacers. The main problem is that summaries of product characteristics of drugs in pMDIs currently available on the market often do not contemplate the use of valved holding chambers (VHCs), even if evidence suggests that they should not be used without them in order to avoid oropharyngeal deposition, and do not report instructions for use or therapeutic dose when administered with specific VHCs. Moreover, it has even been suggested that plastic or glass bottles can be used instead of VHCs. On the basis of this evidence, many patients probably do not use drugs properly delivered by pMDIs and do not receive the optimal therapeutic dose.

We agree that if a pMDI has been designed for use with a specific spacer it should always be used with this named spacing device.2 In this case, however, both should be present in the same package to avoid misuse and must be reported in the product warnings, for example, “These instructions are not necessarily valid when this pMDI is used with other spacers.”

Aerosol therapy is a complex process that depends on nebulizer performance and patient features. In order to avoid errors, these variables should be studied separately. The amount of drug within the respirable range is an objective parameter to quantify the amount of drug available at the end of the spacer system and potentially capable of reaching the lower airways. This simple method has been suggested to standardize first-step aerosol therapy delivery3 and is currently the only way of assessing the effective amount of drug administered. Moreover, if comparative in vitro determination does not show equivalence, it is highly likely that either will clinical comparison. If pMDI drugs are to be used with different spacers, instructions must be given about how to make the same effective amount of drug to be administered available at the end of each spacer. Our results were supported by statistical analysis, particularly a general linear model for repeated measures using type of treatment and sex as factors and age as covariate. FEV1 (F = 28.733; P < .001) and peak expiratory flow (F = 25.879; P < .001) were shown to increase significantly after both treatments.

Di Berardino F, Forti S, Piatti G, Fasano V. A comparative study of two different metered-dose inhaler-valved holding chambers in the administration of salbutamol. Chest. 2010;1372:502-503. [CrossRef] [PubMed]
 
European Medicines Agency; Committee for Medicinal Products for Human UseEuropean Medicines Agency; Committee for Medicinal Products for Human Use Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP) Including the Requirements for Demonstration of Therapeutic Equivalence Between Two Inhaled Products for Use in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) in Adults and for Use in the Treatment of Asthma in Children and Adolescents. 2009; London, England European Medicines Agency
 
Di Berardino L, Varricchio A, Teti L. Two basic parameters to standardize the delivery of aerosolized drugs. Respir Drug Deliv. 20049;:545-548
 

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References

Di Berardino F, Forti S, Piatti G, Fasano V. A comparative study of two different metered-dose inhaler-valved holding chambers in the administration of salbutamol. Chest. 2010;1372:502-503. [CrossRef] [PubMed]
 
European Medicines Agency; Committee for Medicinal Products for Human UseEuropean Medicines Agency; Committee for Medicinal Products for Human Use Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP) Including the Requirements for Demonstration of Therapeutic Equivalence Between Two Inhaled Products for Use in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) in Adults and for Use in the Treatment of Asthma in Children and Adolescents. 2009; London, England European Medicines Agency
 
Di Berardino L, Varricchio A, Teti L. Two basic parameters to standardize the delivery of aerosolized drugs. Respir Drug Deliv. 20049;:545-548
 
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