RESUMEN
In 9 study centers, 419 patients with asthma or COPD were randomized to receive two forms of salbutamol metered-dose-inhalers (MDIs), i.e. CFC-driven MDI, non-CFC (HFA) MDI and one salbutamol dry powder inhaler (DPI), in a multi-center, comparative, cross-over and randomized study, performed to facilitate the formulation of a strategic plan to phase out CFC MDIs. After having received all three forms of test products, the patients completed an evaluation questionnaire indicating their preferences, likelihood of treatment compliance on each product and the easiest one to use. Statistical analysis showed that the CFC MDI was significantly less irritating (p < 0.014) but lower in its overall appeal (p < 0.0001). The "most preferred form to be prescribed" was DPI at 47.5% followed by non-CFC at 32.5% and CFC MDI at 20.1%. Concerning the ease of use among the three forms of test products, 59.9% of the patients indicated "no difference". Adverse events were mild and occurred in only 8.2%. In conclusion, patients' preference and sensory perception among the three forms of inhalers were comparable except that the CFC MDI was significantly less irritating but lower in its overall appeal. DPI was the most preferred and easiest form to use but also the most expensive. Taking public health into consideration, a non-CFC MDI with a similar market price to the CFC MDI would be the obvious choice in a strategic plan to phase out CFC MDIs with the least difficulty to the consumers.
Asunto(s)
Albuterol/administración & dosificación , Asma/tratamiento farmacológico , Clorofluorocarburos de Metano , Inhaladores de Dosis Medida , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Administración por Inhalación , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Albuterol/uso terapéutico , Clorofluorocarburos de Metano/efectos adversos , Estudios Cruzados , Método Doble Ciego , Femenino , Humanos , Masculino , Inhaladores de Dosis Medida/efectos adversos , Persona de Mediana Edad , Encuestas y CuestionariosRESUMEN
In response to the Montreal Protocol and the calls for global early-bird CFC phase-out before 2010, the demand and supply status of both CFC and non-CFC inhalers for prevention and treatment of asthma and COPD in Thailand were evaluated to determine how soon the country would be able to discontinue CFC MDIs with least impacts to both consumers and importers. Availability and supply of the inhalers were collected from registration and importation database of the Thai FDA. Demand and product cost were obtained from the local importers and from IMS, Thailand. Available inhaled products comprise of 39% CFC MDIs, 28% DPIs, 20% solutions for nebulizers and 13% HFA MDls, respectively. All 31 brands of portable hand-held inhalers, comprising 16 CFC MDIs, 6 HFA MDIs and 9 DPIs, are imported, only solutions for nebulization are locally manufactured. Salbutamol is mostly prescribed MDI, its consumption is over 50% of all. The transition to non-CFC alternatives (HFA MDIs and DPIs) has become evidence since 2000. After being informed about the demand and supply of the inhalers, in 2005, Thai FDA has announced its CFC phase-out policy and encouraged importation of HFA alternatives by facilitating the registration and approval process. When the most prescribing CFC MDls, salbutamol, is completely replaced with non-CFC form in 2006, Thailand would be able to reduce considerable amount of CFCs into our atmosphere.