Dose‐response Protective Effect of Salbutamol on Methacholine Airway Responsiveness using Pressurized Metered Dose Inhalers and Turbuhalers

Wong, A G; O’Byrne, Paul M.; Lindbladh, Christer; Inman, Mark D.; Ståhl, Elisabeth; Hargreave, Frederick E.

doi:10.1155/1998/865042

Cited by 14 publications

(7 citation statements)

References 8 publications

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“…Also, in the study by LoÈ fdahl (6), the observed dierences in FEV 1 between the lowest and highest dose of salbutamol was quite small, amounting to a mean of 0Á15 l suggesting a quite shallow dose±response curve in the studied patients. In a more recent study, we have been unable to detect any numeric dierences in the improvement in FEV 1 between salbutamol given by the Turbuhaler and pMDI (7), which others also have been unable to detect when evaluating eects of salbutamol on methacholine responsiveness (9).…”

Section: Discussionmentioning

confidence: 58%

Equivalent therapeutic ratio of salbutamol given by Turbuhaler®and Diskus™

Arvidsson

Mellén

Palmqvist

et al. 2000

Respiratory Medicine

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Some inhalers have been claimed to give better deposition, resulting in higher efficacy. In a previous study we did not find any evidence of different potency of salbutamol given either via pMDI or Turbuhaler. The aim of the present study was to compare the efficacy and safety of salbutamol given via Diskus or Turbuhaler. Twenty-five asthmatics with step-wise reversible airflow obstruction (total reversibility of at least 15%) were included in a randomized, double-dummy, placebo-controlled cross-over study. On each study day, the patients were given placebo repeatedly, or cumulative doses of 200, 400, 800, 1600 and 3200 microg salbutamol given via either device (double-blind, placebo-controlled). Salbutamol caused a dose-related increase in FEV1 when given by Diskus or Turbuhaler. The improvement in FEV1 was similar regardless of whether salbutamol was given via Diskus or Turbuhaler, at equivalent microgram doses. After a total cumulative dose of 3200 microg, mean FEV1 for Diskus was 2.46 l (change from baseline of 20.5%), for Turbuhaler 2.50 l (change from baseline 24.6%) and for placebo 2.11 l (3% change from baseline). After correcting for different baseline differences, the percentage difference between Diskus and Turbuhaler was -1.8% (P = 0.2). Systemic effects (potassium and heart rate) did not differ between Diskus or Turbuhaler. We conclude that the efficacy of salbutamol given at equivalent microgram doses, as well as side-effects, are comparable when the drug is given via Diskus or Turbuhaler. The present data shows that salbutamol given by these devices have similar therapeutic ratios.

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Section: Discussionmentioning

confidence: 58%

Equivalent therapeutic ratio of salbutamol given by Turbuhaler®and Diskus™

Arvidsson

Mellén

Palmqvist

et al. 2000

Respiratory Medicine

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“…In a similar study, in which 23 asthmatic patients were submitted to methacholineinduced bronchoconstriction, Wong et al (15) reported that the protective effect of salbutamol against bronchoconstriction was more pronounced when the drug was delivered via Turbuhaler than when delivered via MDI. In a study carried out by Mellén et al (16) , 20 asthmatic patients with airway obstruction received salbutamol via MDI or via Turbuhaler.…”

Section: Discussionmentioning

confidence: 98%

Efeito do salbutamol liberado através de inalador de pó seco sobre o broncoespasmo induzido por metacolina

Rubin¹,

Pelegrin²,

Perin³

et al. 2004

J. bras. pneumol.

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INTRODUÇÃO: Os beta2-agonistas de curta duração sob a forma de nebulímetro pressurizado são os fármacos utilizados rotineiramente na reversão do broncoespasmo induzido pela metacolina. A administração desses fármacos na forma de pó seco, liberados por inaladores de pó seco pode ser uma alternativa eficaz. OBJETIVO: Avaliar a efetividade e rapidez de ação do salbutamol liberado através de inalador de pó seco pulvinal (Butovent®) na reversão do broncoespasmo induzido por metacolina, comparando-o com o salbutamol liberado por nebulímetro pressurizado. MÉTODO: Foram avaliados prospectivamente 60 pacientes sucessivos com broncoespasmo induzido por metacolina, cuja queda do volume expiratório forçado no primeiro segundo (VEF1) foi de, no mínimo, 20%. Foram randomizados 30 pacientes para receber 200 mcg de salbutamol liberado por nebulímetro pressurizado e 30 pacientes para receber 200 mcg de salbutamol através de inalador de pó seco (pulvinal), na etapa final do teste de broncoprovocação, com o objetivo de reverter o broncoespasmo induzido pela metacolina. Foram avaliados os VEF1 obtidos 1 minuto e 5 minutos após a administração do broncodilatador. RESULTADOS: Os grupos foram pareados por sexo, idade, peso, altura, dose provocativa causadora de queda de 20% no VEF1 (primeiro grupo: 1,3 mg ; segundo grupo: 1,19 mg; p = 0,79) e VEF1 pós-metacolina (primeiro grupo: 2,03 l; segundo grupo: 1,99 l; p = 0,87), sem diferença significativa entre eles. O incremento médio do VEF1 foi de 16,2% (1 minuto) e 22,2% (5 minutos) no primeiro grupo e de 17% (1 minuto) e 23,6% (5 minutos) no segundo grupo, não havendo diferença estatística entre eles (p = 0,8). CONCLUSÕES: Os beta2-agonistas administrados através de inalador de pó seco (pulvinal) apresentam a mesma eficácia broncodilatadora e rapidez de ação que no tradicional método por nebulímetro pressurizado.

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“…Challenge methods are increasingly used to help achieve these conditions. For example, crossover studies of salbutamol Turbuhaler1 and pMDI required 23 patients to assess bronchoprotective effects against methacholine [24], whereas direct assessment of bronchodilation required o40 evaluable patients [7]. Methacholine-induced bronchoconstriction is now widely accepted as a method of increasing the sensitivity of the efficacy end-point in assessing inhaled b 2 -agonists, and was recently validated in a bioequivalence study of HFA and CFC pMDIs [25].…”

Section: Discussionmentioning

confidence: 99%

Protection against methacholine-induced bronchospasm: salbutamol pMDIversusClickhaler® DPI

Newhouse¹,

Patel²,

Parry-Billings³

2003

Eur Respir J

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Protection against methacholine-induced bronchospasm: salbutamol pMDI versus Clickhaler1 DPI. M.T. Newhouse, P. Patel, M. Parry-Billings. #ERS Journals Ltd 2003. ABSTRACT: Passive dry-powder inhalers (DPIs) have been developed as an alternative to pressurised metered-dose inhalers (pMDIs) to improve aerosol delivery on inhalation and eliminate the need for propellants. However, new DPI formulations of generic drugs must be rigorously compared with conventional pMDI therapy.This randomised, double-blind, double-dummy, placebo-controlled, seven-way crossover study evaluated bronchoprotection from methacholine challenge in order to compare a novel salbutamol DPI (Clickhaler1) with a reference salbutamol pMDI (Ventolin1). Adult asthma patients with airway hyperresponsiveness to methacholine (provocative concentration of methacholine causing a 20% fall in the forced expiratory volume in one second (PC20) v4 mg?mL -1 ) were treated on separate days with 0, 100, 200 or 400 mg of salbutamol via the DPI or pMDI. Methacholine challenge was performed before and after salbutamol treatment and the PC20 ratios analysed by Finney9s bioassay to test for therapeutic equivalence of the inhalers.Eighteen patients completed the study and showed significant dose-related responses to salbutamol. The relative potency of DPI:pMDI was 1.29 (90% confidence interval 1.04-1.63). There were no treatment differences in safety (cardiac frequency, blood pressure, adverse events).Methacholine-challenge methodology provides a sensitive bioassay and has demonstrated therapeutic equivalence of the salbutamol Clickhaler1 dry-powder inhaler with the conventional salbutamol pressurised metered-dose inhaler. Salbutamol, the b 2 -agonist bronchodilator most commonly used in the treatment of asthma, has been administered using pressurised metered-dose inhalers (pMDIs) and pressurised chlorofluorocarbon (CFC) propellants for the past 30 yrs. Substituting "ozone-friendly" alternatives puts the onus on the pharmaceutical industry to produce cost-effective replacement inhalers and establish that the switch-over from CFC pMDIs does not compromise patient care [1]. Each new device/formulation is a unique combination that must satisfy strict regulatory requirements [2].Pharmaceutical research and development has followed two major pathways: upgrading pMDIs with hydrofluoroalkanes (HFAs) as chlorine-free propellants, and innovative design of efficient dry-powder inhalers (DPIs) [3,4]. The activity of inhaled medications in the lung is determined by the amount of drug entering the lower respiratory tract [5], which is dependent on the mass of particles of y1-5 mm diameter and inspiratory flow velocity through the device [6]. Changes of formulation, humidity, device or handling may alter drug mass or deposition, with implications for both safety and efficacy [7][8][9]. Rapid systemic absorption of inhaled salbutamol occurs mainly at the vascular lung surface and the risk:benefit ratio can change with improved deposition [10]. In-vitro data therefore need the supp...

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Dose‐response Protective Effect of Salbutamol on Methacholine Airway Responsiveness using Pressurized Metered Dose Inhalers and Turbuhalers

Cited by 14 publications

References 8 publications

Equivalent therapeutic ratio of salbutamol given by Turbuhaler®and Diskus™

Equivalent therapeutic ratio of salbutamol given by Turbuhaler®and Diskus™

Efeito do salbutamol liberado através de inalador de pó seco sobre o broncoespasmo induzido por metacolina

Protection against methacholine-induced bronchospasm: salbutamol pMDIversusClickhaler® DPI

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