Proventil HFA Provides Bronchodilation Comparable to Ventolin Over 12 Weeks of Regular Use in Asthmatics

Bleecker, Eugene R.; Tinkelman, David G.; Ramsdell, Joe; Ekholm, Bruce P.; Klinger, Nancy M.; Colice, Gene; Slade, Herbert B.

doi:10.1378/chest.113.2.283

Cited by 36 publications

(9 citation statements)

References 15 publications

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“…Compared with CFC salbutamol, the HFA pMDI spray looks different mainly because of the reduced jetting velocity, sounds different for the same reason, and tastes different, largely due to the ethanol, which has recently been reported to cause a transient increase in breath alcohol levels (7). Clinically, the effects and incidence of side effects are similar as has been demonstrated in a number of clinical trials (8)(9)(10)(11).…”

Section: Figure 1) Packaging Of Inhalant Therapies In Canada For the supporting

confidence: 68%

New Delivery Systems and Propellants

Dolovich

1999

Canadian Respiratory Journal

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The removal of chlorofluorocarbon (CFC) propellants from industrial and household products has been agreed to by over 165 countires of which more than 135 are developing countries. The timetable for this process is outlined in the Montreal Protocol on Substances that Deplete the Ozone Layer document and in several subsequent amendments. Pressured metered dose inhalers (pMDIs) for medical use have been granted temporary exemptions until replacement formulations, providing the same medication via the same route, and with the same efficacy and safety profiles, are approved for human use. Hydrofluoroalkanes (HFAs) are the alternative propellants for CFCs-12 and -114. Their potential for damage to the ozone layer is nonexistent, and while they are greenhouse gases, their global warming potential is a fraction (one-tenth) of that of CFCs. Replacement formulations for almost all inhalant respiratory medications have been or are being produced and tested; in Canada, it is anticipated that the transition to these HFA or CFC-free pMDIs will be complete by the year 2005. Initially, an HFA pMDI was to be equivalent to the CFC pMDI being replaced, in terms of aerosol properties and effective clinical dose. However, this will not necessarily be the situation, particularly for some corticosteroid products. Currently, only one CFC-free formulation is available in Canada -Airomir, a HFA salbutamol pMDI. This paper discusses the in vitro aerosol characteristics, in vivo deposition and clinical data for several HFA pMDIs for which there are data available in the literature. Alternative delivery systems to the pMDI, namely, dry powder inhalers and nebulizers, are briefly reviewed. sont des gaz à effet de serre, leur potentiel global de réchauffement repré-sente une fraction (un dixième) de celui des CFC. Des formules de substitution pour presque tous les médicaments respiratoires administrés par inhalation ont été et sont testées. Au Canada, on espère que la transition vers ces aérosols-doseurs générés aux HFA ou ne contenant pas de CFC sera terminée vers 2005. Initialement, un aérosol-doseur généré par HFA devait être équivalent à l'aéro-sol-doseur généré par CFC que l'on remplaçait, relativement aux propriétés de l'aérosol et à la dose clinique efficace. Cependant, ce ne sera pas nécessairement le cas, en particulier pour certains produits contenant des corticostéroïdes. Actuellement, une seule formulation sans CFC est disponible au Canada -Airomir, un aérosol-doseur contenant du salbutamol et généré par HFA. Le présent article discute des caractéristiques de l'aérosol in vitro et du dépôt in vivo, et des données cliniques obtenues sur plusieurs aérosols-doseurs générés par HFA et sur lesquels des données sont disponibles dans la littérature. L'alternative aux aérosols-doseurs, à savoir, les inhalateurs à poudre sèche et les nébuliseurs, sont brièvement passés en revue.

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Section: Figure 1) Packaging Of Inhalant Therapies In Canada For the supporting

confidence: 68%

New Delivery Systems and Propellants

Dolovich

1999

Canadian Respiratory Journal

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“…The events most often considered by general practitioners to be related to the hydrofluoroalkane salbutamol formulation were those commonly associated with salbutamol treatment—headache, nausea, and tremor. This is unlikely to be the result of an increased availability of salbutamol since clinical studies have shown that the adverse event profiles of hydrofluoroalkane inhaler and chlorofluorocarbon salbutamol are the same 5 – 8…”

Section: Discussionmentioning

confidence: 99%

“…The study complied with the safety assessment of marketed medicines guidelines 1. Controlled trials had shown that metered dose salbutamol inhalers using hydrofluoroalkane as the propellant were comparable in terms of efficacy and safety to existing salbutamol inhalers using chlorofluorocarbon as the propellant 5 – 8…”

Section: Introductionmentioning

confidence: 99%

Postmarketing surveillance study of a non-chlorofluorocarbon inhaler according to the safety assessment of marketed medicines guidelines

Ayres

Frost

Holmes³

et al. 1998

BMJ

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The hydrofluoroalkane inhaler was as safe as the chlorofluorocarbon inhaler when judged by hospital admissions and adverse affects. The study design successfully fulfilled the recommendations of the guidelines. Differences between postmarketing surveillance studies and randomised clinical trials in assessing safety were identified. These may lead to difficulties in the design of postmarketing surveillance studies.

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“…Chlorofluorocarbons (CFC) were commonly used as propellants in these devices but have been associated with depletion of the protective ozone layer above the earth, leading to increased exposure to UV radiation. The use of CFC in MDI was phased out by 2005, by international agreement, and CFC have been replaced with hydrofluoroalkanes (HFA) as propellants in MDI 1,2 …”

Section: Introductionmentioning

confidence: 99%

“…The use of CFC in MDI was phased out by 2005, by international agreement, and CFC have been replaced with hydrofluoroalkanes (HFA) as propellants in MDI. 1,2 The CFC-free MDI, which contain HFA as propellants, have different characteristics to the previous MDI. Some of these new MDI also contain ethanol.…”

Section: Introductionmentioning

confidence: 99%