RESUMEN
Short-acting beta-agonist (SABA) over-use in asthma is harmful for patients and the environment. The Investment and Impact Fund (IIF) 2022/2023 financially rewarded English primary care networks that achieved specific targets, including reducing SABA over-use (RESP-02) and lowering the mean carbon footprint per salbutamol inhaler prescribed (ES-02). SENTINEL Plus is a co-designed quality improvement package that aims to improve asthma outcomes and reduce asthma's environmental impact by addressing SABA over-use. We investigated the impact of (i) the IIF incentives and (ii) SENTINEL Plus implementation on asthma prescribing. Using Openprescribing.net data, we demonstrate that IIF 2022-2023 had no significant impact on the total number of SABA prescribed in England (25,927,252 during 12-months pre- and 25,885,213 12-months post-IIF; 0.16% decrease; p=NS), but lower carbon footprint SABA inhaler use increased (Salamol™ prescribing increased from 5.1% to 19% of SABA prescriptions, p < 0.01). In contrast, SENTINEL Plus sites significantly reduced SABA prescribing post-implementation (5.43% decrease, p < 0.05).
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Asma , Pautas de la Práctica en Medicina , Humanos , Agonistas Adrenérgicos beta/uso terapéutico , Agonistas Adrenérgicos beta/administración & dosificación , Albuterol/uso terapéutico , Albuterol/administración & dosificación , Antiasmáticos/uso terapéutico , Antiasmáticos/administración & dosificación , Asma/tratamiento farmacológico , Inglaterra , Pautas de la Práctica en Medicina/estadística & datos numéricos , Atención Primaria de Salud/estadística & datos numéricos , Mejoramiento de la CalidadRESUMEN
Since the recognition of angiotensin-converting enzyme inhibitors (ACEIs)-induced cough, drug has been considered as a potential cause of chronic cough. This review presents recent knowledge on drug-induced coughs in patients with chronic cough. The focus is placed on ACEIs, for which there are a multitude of studies documenting their associations with cough. Additional drugs are discussed for which there are reports of cough as a side effect of treatment, and the potential mechanisms of these effects are discussed.
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Inhibidores de la Enzima Convertidora de Angiotensina/efectos adversos , Tos/inducido químicamente , Tos/fisiopatología , Analgésicos Opioides/efectos adversos , Animales , Bloqueadores de los Canales de Calcio/efectos adversos , Enfermedad Crónica , Tos/diagnóstico , Fentanilo/efectos adversos , Humanos , Reflejo/efectos de los fármacos , Reflejo/fisiologíaRESUMEN
INTRODUCTION: Citric acid has been used for over six decades to induce cough; however the mechanism of its pro-tussive effect is still not fully understood. We assessed the response to inhalation of citric acid at varying levels of acidity to determine if the pH of the solution plays a role in the induction of cough. Data was collected from both healthy volunteers and patients with chronic cough. METHODS: 20 chronic cough patients and 20 healthy volunteers were recruited and underwent three cough challenges on separate days. Each visit involved 5 repeated one second inhalations of 300â¯mM citric acid solution. The concentration of the citrate cation remained constant, but the pH of the solution altered by the addition of sodium bicarbonate to 3, 5 and 6, representing the pKa values of the individual acid moieties. The total number of coughs elicited was recorded for each inhalation. RESULTS: Two subjects withdrew and were not included in the analysis. Participants were gender matched, each group consisting of 12 females. 74% of chronic coughers coughed at pH 3 (mean coughs 16), 89% coughed at pH 5 (18) and 63% coughed at pH 6 (7). In healthy volunteers, 60% of subjects coughed at pH 3 (9), 30% of subjects coughed at pH 5 (3), and 10% of subjects coughed at pH 6 (0). Thus chronic cough patients coughed more than healthy volunteers and did not exhibit a clear pH concentration response. There was also a greater variability in their response to individual challenges.
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Ácido Cítrico/efectos adversos , Tos/fisiopatología , Adulto , Anciano , Anciano de 80 o más Años , Enfermedad Crónica , Ácido Cítrico/química , Método Doble Ciego , Femenino , Humanos , Concentración de Iones de Hidrógeno , Masculino , Persona de Mediana Edad , Bicarbonato de Sodio/química , Adulto JovenRESUMEN
OBJECTIVES: To investigate the efficacy and safety of CS1002, an over-the-counter cough treatment containing diphenhydramine, ammonium chloride and levomenthol in a cocoa-based demulcent. DESIGN: A multicentre, randomised, parallel group, controlled, single-blinded study in participants with acute upper respiratory tract infection-associated cough. SETTING: 4 general practitioner (GP) surgeries and 14 pharmacies in the UK. PARTICIPANTS: Participants aged ≥18â years who self-referred to a GP or pharmacist with acute cough of <7â days' duration. Participant inclusion criterion was cough severity ≥60â mm on a 0-100â mm visual analogue scale (VAS). Exclusion criteria included current smokers or history of smoking within the past 12â months (including e-cigarettes). 163 participants were randomised to the study (mean participant age 38â years, 57% females). INTERVENTIONS: Participants were randomised to CS1002 (Unicough) or simple linctus (SL), a widely used cough treatment, and treatment duration was 7â days or until resolution of cough. MAIN OUTCOME MEASURES: The primary analysis was intention-to-treat (157 participants) and comprised cough severity assessed using a VAS after 3â days' treatment (prespecified primary end point at day 4). Cough frequency, sleep disruption, health status (Leicester Cough Questionnaire (LCQ-acute)) and cough resolution were also assessed. RESULTS: At day 4 (primary end point), the adjusted mean difference (95% CI) in cough severity VAS between CS1002 and SL was -5.9â mm (-14.4 to 2.7), p=0.18. At the end of the study (day 7) the mean difference in cough severity VAS was -4.2â mm (-12.2 to 3.9), p=0.31. CS1002 was associated with a greater reduction in cough sleep disruption (mean difference -11.6â mm (-20.6 to 2.7), p=0.01) and cough frequency (mean difference -8.1â mm (-16.2 to 0.1), p=0.05) compared with SL. There was greater improvement in LCQ-acute quality of life scores with CS1002 compared with SL: mean difference (95% CI) 1.2 (0.05 to 2.36), p=0.04 after 5 days' treatment. More participants prematurely stopped treatment due to cough improvement in the CS1002 group (24.4%) compared with SL (10.7%; p=0.02). Adverse events (AEs) were comparable between CS1002 (20.5%) and SL (27.6%) and largely related to the study indication. 6 participants (7%) in the CS1002 group reduced the dose of medication due to drowsiness/tiredness, which subsequently resolved. These events were not reported by participants as AEs. CONCLUSIONS: Although the primary end point was not achieved, CS1002 was associated with greater reductions in cough frequency, sleep disruption and improved health status compared with SL. TRIAL REGISTRATION NUMBER: EudraCT number 2014-004255-31.
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Cloruro de Amonio/uso terapéutico , Tos/tratamiento farmacológico , Difenhidramina/uso terapéutico , Mentol/uso terapéutico , Medicamentos sin Prescripción/uso terapéutico , Enfermedad Aguda , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Antipruriginosos/uso terapéutico , Cacao , Demulcentes/uso terapéutico , Combinación de Medicamentos , Femenino , Antagonistas de los Receptores Histamínicos H1/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Método Simple Ciego , Resultado del Tratamiento , Reino Unido , Adulto JovenRESUMEN
Cough remains a serious unmet clinical problem, both as a symptom of a range of other conditions such as asthma, chronic obstructive pulmonary disease, gastroesophageal reflux, and as a problem in its own right in patients with chronic cough of unknown origin. This article reviews our current understanding of the pathogenesis of cough and the hypertussive state characterizing a number of diseases as well as reviewing the evidence for the different classes of antitussive drug currently in clinical use. For completeness, the review also discusses a number of major drug classes often clinically used to treat cough but that are not generally classified as antitussive drugs. We also reviewed a number of drug classes in various stages of development as antitussive drugs. Perhaps surprising for drugs used to treat such a common symptom, there is a paucity of well-controlled clinical studies documenting evidence for the use of many of the drug classes in use today, particularly those available over the counter. Nonetheless, there has been a considerable increase in our understanding of the cough reflex over the last decade that has led to a number of promising new targets for antitussive drugs being identified and thus giving some hope of new drugs being available in the not too distant future for the treatment of this often debilitating symptom.
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Antitusígenos , Tos/tratamiento farmacológico , Descubrimiento de Drogas , Terapia Molecular Dirigida , Animales , Antitusígenos/clasificación , Antitusígenos/farmacología , Antitusígenos/uso terapéutico , Ensayos Clínicos como Asunto , Tos/etiología , Tos/metabolismo , Descubrimiento de Drogas/métodos , Descubrimiento de Drogas/tendencias , Humanos , Estructura Molecular , Terapia Molecular Dirigida/métodos , Terapia Molecular Dirigida/tendenciasRESUMEN
AIM: We have explored the association of the upper airway symptoms related to cough with exacerbation frequency, sputum microbiology and inflammatory markers in patients with non cystic fibrosis bronchiectasis. METHODS: Patients with bronchiectasis completed the Hull Airway Reflux Questionnaire (HARQ). A score of >13 was taken to indicate the presence of reflux. Patients were followed-up with longitudinal spirometry, sputum culture and Leicester cough questionnaire (LCQ). Myeloperoxidase (MPO), free neutrophil elastase (NE) activity, Interleukin (IL)-8 and Tumour Necrosis Factor (TNF)-α was measured from spontaneous sputum samples. RESULTS: 163 completed the study. 59.5% were female. Mean age was 65.7 years. 73.6% reported airway reflux using HARQ. Patients with airway reflux had more severe cough symptoms as assessed by the LCQ [15.2 (3.5) vs. 19.4 (1.9)], p < 0.001. Sputum levels of MPO, NE, IL-8 and TNF-α were all significantly higher in the reflux positive group (p < 0.05 for all comparisons). In a multivariable logistic regression, airway reflux was independently associated with cough severity (-3.27, standard error 0.81, p = 0.0002). Airway reflux, age, FEV1 % predicted and colonization with Pseudomonas aeruginosa were independently associated with an increased risk of ≥3 bronchiectasis exacerbations in one year. CONCLUSION: The symptoms of airway reflux independently predict severity and exacerbation frequency in non cystic fibrosis bronchiectasis.
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Bronquiectasia/complicaciones , Reflujo Gastroesofágico/etiología , Calidad de Vida , Anciano , Antibacterianos/uso terapéutico , Bronquiectasia/tratamiento farmacológico , Bronquiectasia/microbiología , Bronquiectasia/fisiopatología , Tos/etiología , Femenino , Volumen Espiratorio Forzado/fisiología , Reflujo Gastroesofágico/microbiología , Humanos , Mediadores de Inflamación/metabolismo , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Prospectivos , Índice de Severidad de la Enfermedad , Esputo/química , Capacidad Vital/fisiologíaRESUMEN
BACKGROUND: Gastro-oesophageal reflux disease (GERD) is one of the commonest diseases of Western populations, affecting 20 to 30% of adults. GERD is multifaceted and the classical oesophageal symptoms such as heartburn and regurgitation often overlap with atypical symptoms that impact upon the respiratory system and airways. This is referred to as extra-oesophageal reflux disease (EERD), or laryngopharyngeal reflux (LPR), which manifests as chronic cough, laryngitis, hoarseness, voice disorders and asthma. AIM: The 'Reflux and its consequences' conference was held in Hull in 2010 and brought together a multidisciplinary group of experts all with a common interest in the many manifestations of reflux disease to present recent research and clinical progress in GERD and EERD. In particular new techniques for diagnosing reflux were showcased at the conference. METHODS: Both clinical and non-clinical key opinion leaders were invited to write a review on key areas presented at the `Reflux and its consequences' conference for inclusion in this supplement. RESULTS AND CONCLUSION: Eleven chapters contained in this supplement reflected the sessions of the conference and included discussion of the nature of the refluxate (acid, pepsin, bile acids and non-acid reflux); mechanisms of tissue damage and protection in the oesophagus, laryngopharynx and airways. Clinical conditions with a reflux aetiology including asthma, chronic cough, airway disease, LPR, and paediatric EERD were reviewed. In addition methods for diagnosis of reflux disease and treatment strategies, especially with reference to non-acid reflux, were considered.
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Reflujo Gastroesofágico/complicaciones , Fármacos Gastrointestinales/efectos adversos , Pepsina A/efectos adversos , Adulto , Asma/complicaciones , Niño , Tos/etiología , Reflujo Gastroesofágico/diagnóstico , Fármacos Gastrointestinales/uso terapéutico , Ronquera/etiología , Humanos , Enfermedades de la Laringe/etiología , Pepsina A/uso terapéuticoRESUMEN
We postulate that most patients with chronic cough have a single discrete clinical entity: cough hypersensitivity syndrome. We constructed a questionnaire that elicits the major components of the syndrome. Here we describe the validation of this questionnaire. Following iterative development, the Hull Airway Reflux Questionnaire (HARQ) was administered to patients and normal volunteers. It is self-administered and comprises 14 items with a maximum score of 70. Unselected patients were recruited sequentially from the Hull Cough Clinic. Preclinic questionnaires were compared with those obtained at the clinic. Responsiveness was assessed 2 months after the clinic visit. One hundred eighty-five patients and 70 normal volunteers were included in this study. There was a marked difference in HARQ scores between patients with chronic cough and normal volunteers. The sensitivity (94%) and specificity (95%) of the HARQ was high, with an area under the ROC curve of 0.99. All items of the scale significantly correlated positively with others in the scale and with the total score. On repeatability testing using Cohen's kappa with quadratic weights, significant agreement was noted for all items. Good correlation was observed between the total scores (r = 0.78). The questionnaire was also responsive to treatment; the minimum clinically significant change was estimated to be 16 points. We have demonstrated the HARQ to have good construct and criterion validity. It is both reproducible and responsive to change. It can be used as a diagnostic instrument and demonstrates that chronic cough represents a single coherent entity: cough hypersensitivity syndrome.
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Tos/clasificación , Hipersensibilidad Respiratoria/clasificación , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Casos y Controles , Niño , Enfermedad Crónica , Tos/diagnóstico , Tos/terapia , Inglaterra , Femenino , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Satisfacción del Paciente , Valor Predictivo de las Pruebas , Estudios Prospectivos , Psicometría , Curva ROC , Reproducibilidad de los Resultados , Hipersensibilidad Respiratoria/diagnóstico , Hipersensibilidad Respiratoria/terapia , Sensibilidad y Especificidad , Encuestas y Cuestionarios , Síndrome , Resultado del Tratamiento , Adulto JovenRESUMEN
The ability to control locomotion through the environment and to intercept, or avoid objects is fundamental to the survival of all locomotor species. The extent to which this control relies upon optic flow, visual direction cues or non-visual sensory inputs has long been debated. Here we look at the use of sensory information in young and middle-aged participants using a locomotor-driven interceptive task. Both groups of participants were asked to produce forward displacements in more or less impoverished environments by manipulating a joystick and to regulate, if necessary, their displacement velocity so as to intercept approaching targets. We show that the displacements produced by the middle-aged participants were more nonlinear in comparison with young participants. The errors in the middle-aged group can be accounted for by a constant bearing angle (CBA) model that incorporates a decrease in the sensitivity of sensory detection with advancing age. The implications of this study to a better understanding of the mechanisms underlying the detection of the rate of change in bearing angle are discussed.
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Envejecimiento/fisiología , Trastornos Neurológicos de la Marcha/patología , Trastornos del Movimiento/patología , Trastornos de la Percepción/patología , Células Receptoras Sensoriales/fisiología , Trastornos Somatosensoriales/patología , Adulto , Femenino , Trastornos Neurológicos de la Marcha/diagnóstico , Trastornos Neurológicos de la Marcha/etiología , Humanos , Persona de Mediana Edad , Trastornos del Movimiento/diagnóstico , Trastornos del Movimiento/etiología , Trastornos de la Percepción/diagnóstico , Trastornos de la Percepción/etiología , Células Receptoras Sensoriales/patología , Trastornos Somatosensoriales/diagnóstico , Trastornos Somatosensoriales/etiología , Adulto JovenRESUMEN
Whilst recent large-scale studies have provided much evidence on the natural history and therapeutic response in patients with chronic obstructive pulmonary disease (COPD), relatively little is known about the effect in younger patients. We report a pre-specified post-hoc analysis of 356 patients with COPD ≤ 50 years old from the four year randomised, double blind placebo controlled Understanding Potential Long Term Impact on Function with Tiotropium (UPLIFT) trial. Inclusion criteria included a post-bronchodilator forced expiratory volume in 1 s (FEV(1)) of ≤70%, FEV(1)/FVC < 0.70, age ≥40 years, and smoking history of ≥10 pack years. Younger patients had a mean FEV(1) of 1.24 L (39% predicted) and an impaired health-related quality of life (St. George's Respiratory Questionnaire (SGRQ)) compared to the entire UPLIFT population. There were 40.2% women and 51.1% current smokers in the younger age group. Tiotropium was associated with a sustained improvement in spirometry and SGRQ. Mean decline in post-bronchodilator FEV(1) was 58 ml/year (placebo) vs. 38 ml/year (tiotropium) (p = 0.01). Corresponding values for pre-bronchodilator FEV(1) were 41 ml/year (placebo) compared with 34 ml/year (tiotropium) (p = 0.34). The hazard ratio (95%CI) for an exacerbation in the younger age group was 0.87(0.68, 1.13)). The rate of exacerbations was reduced by tiotropium (rate ratio (95%CI) = 0.73(0.56, 0.95)). Tiotropium resulted in sustained bronchodilation, improved quality of life, and a decreased exacerbation rate in younger patients. Tiotropium also resulted in a significant reduction in the decline in post-bronchodilator FEV(1), suggesting possible disease modification by tiotropium in younger patients with COPD.
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Broncodilatadores/uso terapéutico , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Derivados de Escopolamina/uso terapéutico , Progresión de la Enfermedad , Método Doble Ciego , Femenino , Volumen Espiratorio Forzado/efectos de los fármacos , Volumen Espiratorio Forzado/fisiología , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Pulmonar Obstructiva Crónica/mortalidad , Enfermedad Pulmonar Obstructiva Crónica/fisiopatología , Calidad de Vida , Encuestas y Cuestionarios , Bromuro de Tiotropio , Resultado del TratamientoAsunto(s)
Tos/diagnóstico , Tumor Glómico/diagnóstico , Medios de Contraste/farmacología , Tos/patología , Diagnóstico Diferencial , Femenino , Tumor Glómico/patología , Humanos , Venas Yugulares/patología , Angiografía por Resonancia Magnética/métodos , Imagen por Resonancia Magnética/métodos , Persona de Mediana Edad , Pronóstico , Fumar , Tomografía Computarizada por Rayos X/métodosRESUMEN
Sitaxentan, a highly-selective endothelin receptor antagonist (ETRA) and bosentan a non-selective ETRA are both approved for the treatment of idiopathic pulmonary arterial hypertension (iPAH). Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor used in the treatment of iPAH. Tadalafil is a long acting PDE-5 inhibitor largely unexplored for the treatment of iPAH. Following failure of monotherapy combination therapy with an ETRA and a PDE-5 inhibitor is often used, a frequently used combination being bosentan with sildenafil. We report our clinical experience in three patients with iPAH treated with a combination of sitaxentan and tadalafil, who previously discontinued bosentan. There was sustained symptomatic and haemodynamic improvement in all three patients treated with the combination. No adverse effect related to the combination treatment was noted. Sitaxentan and tadalafil, both being once a day treatments, can also possibly increase compliance.
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Antihipertensivos/uso terapéutico , Carbolinas/uso terapéutico , Hipertensión Pulmonar/tratamiento farmacológico , Isoxazoles/uso terapéutico , Sulfonamidas/uso terapéutico , Tiofenos/uso terapéutico , Adulto , Bosentán , Quimioterapia Combinada , Antagonistas de los Receptores de Endotelina , Femenino , Humanos , Hipertensión Pulmonar/fisiopatología , Masculino , Persona de Mediana Edad , Tadalafilo , Resultado del Tratamiento , Vasodilatadores/uso terapéuticoRESUMEN
The aim of the present study was make chronic cough guidelines more practical and user friendly by developing an internet-based interactive diagnostic questionnaire for chronic cough. A prospective cohort study of chronic cough sufferers was conducted in the UK, following European Respiratory Society guidelines for the diagnosis and management of chronic cough. Depending on the response to 16 specific questions, the medical condition responsible for the patient's chronic cough was ascertained according to a predetermined diagnostic algorithm designed to differentiate the three common causes of chronic cough. Appropriate advice and treatment recommendations were then provided. 8,546 adults with chronic cough completed the Cough Clinic diagnostic questionnaire. 46.1% were suggested to have reflux, 38.7% asthma and 15.2% rhinitis. Participants found the website easy to use (94%), the advice helpful (73%) and that it helped them to communicate with their general practitioner better (60%), and 62% reported taking the recommended treatment. The Cough Clinic, an internet-based diagnostic site for chronic cough, had a large uptake by chronic cough sufferers in the UK. Almost half were diagnosed as having reflux as the probable cause of their chronic cough. Internet diagnosis by expert algorithm provides a novel mechanism for patients to access guideline-recommended therapies and enhances dialogue between patients and physicians.
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Tos/diagnóstico , Internet , Guías de Práctica Clínica como Asunto , Interfaz Usuario-Computador , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Algoritmos , Enfermedad Crónica , Tos/terapia , Medicina Basada en la Evidencia , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Proyectos Piloto , Evaluación de Programas y Proyectos de Salud , Reproducibilidad de los Resultados , Encuestas y Cuestionarios/normas , Reino Unido , Adulto JovenRESUMEN
Chronic cough is a common and frequently disruptive symptom which can be difficult to treat with currently available medicines. Asthma/eosinophilic airway disease and gastro-oesophageal reflux disease are most commonly associated with chronic cough but it may also trouble patients with chronic obstructive pulmonary disease, pulmonary fibrosis and lung cancer. Over the last three decades there have been a number of key advances in the clinical approach to cough and a number of international guidelines on the management of cough have been developed. Despite the undoubted benefit of such initiatives, more effective treatments for cough are urgently needed. The precise pathophysiological mechanisms of chronic cough are unknown but central to the process is sensitization (upregulation) of the cough reflex. One well-recognized clinical consequence of this hypersensitive state is bouts of coughing triggered by apparently trivial provocation such as scents and odours and changes in air temperature. The main objective of new treatments for cough would be to identify ways to downregulate this heightened cough reflex but yet preserve its crucial role in protecting the airway. The combined efforts of clinicians, scientists and the pharmaceutical industry offer most hope for such a treatment breakthrough. The aim of this chapter is to provide some rationale for the current treatment recommendations and to offer some reflections on the management of patients with chronic cough.
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Antitusígenos/uso terapéutico , Tos/tratamiento farmacológico , Animales , Asma/tratamiento farmacológico , Asma/fisiopatología , Enfermedad Crónica , Tos/fisiopatología , Tos/terapia , Humanos , Reflejo/efectos de los fármacos , Reflejo/fisiologíaAsunto(s)
Antibacterianos/uso terapéutico , Fibrosis Quística/complicaciones , Fosfomicina/uso terapéutico , Infecciones por Pseudomonas/tratamiento farmacológico , Infecciones por Pseudomonas/etiología , Adulto , Fibrosis Quística/fisiopatología , Femenino , Humanos , Masculino , Pruebas de Sensibilidad Microbiana , Persona de Mediana Edad , Infecciones por Pseudomonas/fisiopatología , Pseudomonas aeruginosa/efectos de los fármacos , Pruebas de Función Respiratoria , Resultado del Tratamiento , Adulto JovenRESUMEN
Chronic cough is perhaps the commonest symptom of medical importance with some 12% of the general population having the symptom on a daily or weekly basis. Chronic cough causes a large degree of morbidity, with both the physical e.g. incontinence, and the psychological e.g. social isolation, domains. The causes of chronic cough are numerous, but fall into two broad categories; that causing an asthma-like syndrome characterized by eosinophilic infiltration of the airways, and oesophageal disease, particularly weakly acid reflux. Failure to make, particularly this latter, diagnosis leads to enormous consequences in terms of loss of employment, healthcare utilisation and a psychosocial morbidity.
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Tos/epidemiología , Enfermedad Crónica , Costo de Enfermedad , Tos/diagnóstico , Tos/economía , Tos/etiología , Reflujo Gastroesofágico/complicaciones , Humanos , Atención Primaria de SaludRESUMEN
BACKGROUND: Budesonide/formoterol is an effective treatment for both asthma and chronic obstructive pulmonary disease. This study compared the efficacy and safety of a novel hydrofluoroalkane (HFA) pressurised metered-dose inhaler (pMDI) formulation of budesonide/formoterol with that of budesonide pMDI and budesonide/formoterol dry-powder inhaler (DPI; Turbuhaler). METHODS: This was a 12-week, multinational, randomised, double-blind, double-dummy study involving patients aged > or = 12 years with asthma. All patients had a forced expiratory volume in 1 s of 50-90% predicted normal and were inadequately controlled on inhaled corticosteroids (500-1600 microg/day) alone. Following a 2-week run-in, during which they received their usual medication, patients were randomised (two inhalations twice daily) to budesonide pMDI 200 microg, budesonide/formoterol DPI 160/4.5 microg or budesonide/formoterol pMDI 160/4.5 microg. The primary efficacy end-point was change from baseline in morning peak expiratory flow (PEF). RESULTS: In total, 680 patients were randomised, of whom 668 were included in the primary analysis. Therapeutically equivalent increases in morning PEF were observed with budesonide/formoterol pMDI (29.3 l/min) and budesonide/formoterol DPI (32.0 l/min) (95% confidence interval: -10.4 to 4.9; p = 0.48). The increase in morning PEF with budesonide/formoterol pMDI was significantly higher than with budesonide pMDI (+28.7 l/min; p < 0.001). Similar improvements with budesonide/formoterol pMDI vs. budesonide pMDI were seen for all secondary efficacy end-points. Both combination treatments were similarly well tolerated. CONCLUSIONS: Budesonide/formoterol, administered via the HFA pMDI or DPI, is an effective and well-tolerated treatment for adult and adolescent patients with asthma, with both devices being therapeutically equivalent.