Evaluation of a Breath Operated Powder Inhaler

Pover, G.; Langdon, C.G.; Jones, Spencer; Fidler, Carrie

doi:10.1177/030006058801600306

Cited by 33 publications

(10 citation statements)

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“…Inspiratory flow-driven dry powder inhalers (DPI) have been shown to be safe and effective means of drug delivery in the inhalation therapy [3, 4]. Easyhaler (EH) is a novel multidose DPI for the treatment of obstructive lung diseases such as asthma.…”

Section: Introductionmentioning

confidence: 99%

Therapeutic Equivalence and Acceptability of Two Multidose Powder Inhalers in the Treatment of Asthma

Wettengel¹,

Laurikainen²,

Silvasti³

et al. 2000

Respiration

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Background: Problems in using conventional inhalation aerosols, in addition to environmental reasons, have driven development of the dry powder inhalers. Objective: To compare therapeutic equivalence and acceptability of two dry powder inhalers, Easyhaler (EH) and Diskhaler (DH), in the delivery of beclomethasone dipropionate (BDP) in the treatment of asthma. Methods: Adult asthmatics (n = 185), previously treated with inhaled steroids, were recruited in this open parallel-group study. After a run-in period of 2 weeks during which the patients inhaled 800 μg/day of BDP via DH, the patients were randomly allocated into three groups: EH 200 group (62 patients) using EH 200 μg/dose inhaler (1 inhalation q.i.d.), EH 400 group (62 patients) using EH 400 μg/dose inhaler (1 inhalation b.i.d.), and DH group (61 patients) using DH 200 μg/dose inhaler (1 inhalation q.i.d.) for 12 weeks. The primary outcome variables were PEF and FEV₁. Results: The 95% CI for treatment difference in morning PEF between the EH 200 and DH groups was –16 to 23 litres/min and between the EH 400 and DH groups –18 to 21 litres/min. There was an increase in the morning PEF of 13 litres/min (p < 0.05) in the EH 200 group, and 9 and 11 litres/min in the DH and EH 400 groups. No differences between the groups were seen in the lung function parameters, in the symptom scores, in the use of rescue medication or in the incidence of adverse events. The treatments had no effects on morning cortisol levels. The patients in the EH groups compared the inhalers by using an 11-item questionnaire. In 8 questions the majority of the patients rated EH superior to DH. Conclusion: The tested inhalers were therapeutically equal. However, based on the acceptability data, the EH was better accepted by the patients than DH.

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Section: Introductionmentioning

confidence: 99%

Therapeutic Equivalence and Acceptability of Two Multidose Powder Inhalers in the Treatment of Asthma

Wettengel¹,

Laurikainen²,

Silvasti³

et al. 2000

Respiration

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“…Investigators have demonstrated pharmacodynamic similarity between inhaled products using FEV I (Pover et al 1988;Ruffin et al 1989), PEFR (Hartley et al 1977;Tukiainen & Terho 1985;Zainudin et al 1990) and a combination of FEV I and MEFR (Zanen et al 1992). The last-named study highlights the need for guidelines because although FEV 1 values were similar after inhalation of different products, there was a significant difference between MEFR values recorded 60 minutes after each dose.…”

Section: Pharmacodynamic Methodsmentioning

confidence: 96%

Standards for Bioequivalence of Inhaled Products

Chrystyn

1994

Clinical Pharmacokinetics

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“…If a study is performed at only one dose level for each of the devices, it is not possible to verify that the response is on the slope of the dose-response curve if no difference between the two ways of administering the drug is observed. Unfortunately, many of the studies presented in the literature [8,[72][73][74][75][76][77][78] have an inadequate design and are, thus, inconclusive. A well-designed comparative study should include at least two dose levels, for at least one of the devices, and it is necessary to show a difference in the response between the two dose levels to draw conclusions.…”

Section: Airway Effectsmentioning

confidence: 99%

“…In spite of an inconclusive design, the effect of 200 µg salbutamol delivered via a pMDI was claimed to be equivalent to 400 µg delivered via Diskhaler® when using a single-dose design [8]. Autohaler® has been compared to an ordinary pMDI in a single-dose study [75].…”

Section: Salbutamolmentioning

confidence: 99%

“…A number of dry powder inhalers (DPIs), using different dosing principles, have appeared on the market: e.g. Spinhaler® (Fisons, UK) [6] and Rotahaler® (Glaxo, UK) [7], which use single prefilled capsules; Diskhaler® (Glaxo, UK) [8], which is a multidose system using disks with 4 or 8 doses; Turbuhaler® (Astra, Sweden), which is a multidose inhaler that can dispense and deliver up to 200 metereddoses of dry powder [9]; and Diskus®/Accuhaler® (Glaxo, UK), which is based on a continuous strip of prefilled blisters [10].…”

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confidence: 99%

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