Clinical comparison of inhaled budesonide delivered either via pressurized metered dose inhaler or Turbuhaler®

Engel, Tal; Heinig, J. H.; Malling, H.V.; Scharling, B.; Nikander, Kurt; Madsen, Flemming

doi:10.1111/j.1398-9995.1989.tb02266.x

Cited by 106 publications

(56 citation statements)

References 7 publications

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“…Earlier we performed two other pharmacokinetic studies with budesonide given via Nebuhaler to children [11,12] [14][15][16][17]. On the other hand Turbuhaler would also be expected to have a higher systemic activity than Nebuhaler.…”

Section: Discussionmentioning

confidence: 99%

The influence of orally deposited budesonide on the systemic availability of budesonide after inhalation from a Turbuhaler.

Pedersen

Steffensen

Ohlsson

1993

Brit J Clinical Pharma

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1 The aim of this pharmacokinetic study was to evaluate to what extent oropharyngeal deposition of drug contributes to the systemic availability of budesonide inhaled from a dry powder inhaler (Turbuhaler®). 2 The design was a randomized cross-over study in eight children aged 7-13 years. The plasma concentrations of the two epimers of budesonide (22R and 22S) after inhalation of 1 mg budesonide from a Turbuhaler were compared with the plasma concentrations obtained when the absorption of the drug deposited in the oropharynx was blocked by drinking and rinsing the mouth with charcoal before and after the inhalation. 3 The plasma concentrations of budesonide were significantly reduced by the charcoal treatment (P < 0.01) and the area under the time vs plasma concentration curve 0-4 h was significantly reduced from 9.5 to 8.0 mmol 1-1 h for 22S (P < 0.01) and from 7.6 to 5.7 mmol 1-1 h for 22R (P < 0.01). 4 The plasma concentrations and the AUCs after both Turbuhaler administrations were markedly higher than those obtained in earlier studies using other inhalers suggesting a higher intrapulmonary deposition of drug after Turbuhaler treatment. 5 It is concluded that oropharyngeal deposition of drug accounts for about 20% of the total systemic availability of budesonide inhaled from Turbuhaler. Thus, the main contribution to the system comes from budesonide absorbed in the airways.

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Section: Discussionmentioning

confidence: 99%

The influence of orally deposited budesonide on the systemic availability of budesonide after inhalation from a Turbuhaler.

Pedersen

Steffensen

Ohlsson

1993

Brit J Clinical Pharma

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“…No corresponding reduction could be obtained in patients continuing on BDP via pMDI, again suggesting greater clinical efficacy of the TH device [13]. ENGEL et al [17] described a significant increase in morning peak flow in patients with chronic stable asthma treated with budesonide via TH, compared to pMDI, although there was no difference in FEV1.…”

Section: Discussionmentioning

confidence: 98%

Comparative efficacy and potency of ipratropium via Turbuhaler and pressurized metered-dose inhaler in reversible airflow obstruction

Böllert

Matusiewicz²,

Dewar³

et al. 1997

Eur Respir J

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Ipratropium bromide (IB), typically delivered by pressurized metered dose inhaler (pMDI), is used to treat patients with reversible airways obstruction. Use of the pMDI, unlike the Turbuhaler® (TH), demands co-ordination of actuation with inspiration for efficient use. Two studies were carried out to compare the relative efficacy and potency of IB delivered by TH or pMDI.Both studies were of a randomized, double-blind and cross-over design. For the efficacy study, 15 patients received a cumulative dose of 160 µg IB via TH or pMDI as doses of 20, 20, 40 and 80 µg at 45 min intervals on two days. Forced expiratory volume in one second (FEV1) was measured prior to and 40 min after dosing. For the potency study, 33 patients received 10, 20 or 40 µg of IB via TH, 20 µg IB via pMDI, or placebo, on five days. FEV1 was recorded prior to and 15-360 min after dosing.For the efficacy study, there was no difference in FEV1 response to a cumulative dose of IB via pMDI and TH. More than 80% of the maximum effect was seen at the lowest dose (20 µg of IB). Regarding the potency study, the FEV1 response to 20 µg IB administered via pMDI was similar to that of 10 µg via TH; 20 µg via TH was significantly more effective than 20 µg via pMDI (p<0.05).In conclusion, the efficacy study showed that maximum FEV1 occurred at low doses of IB, negating any opportunity to identify differences between devices. The potency study indicated that the 10 µg dose via TH was of similar efficacy to the 20 µg dose via pMDI, confirming an efficacy ratio of 1.5-2.0:1 for the TH device. Eur Respir J 1997; 10: 1824-1828 The controversy surrounding β 2 -agonist bronchodilators has led to a renewed interest in the anticholinergic bronchodilator ipratropium bromide (IB) which has been available for about 20 yrs and has a good safety profile. IB is used to treat patients with reversible airways obstruction, e.g. patients with chronic obstructive pulmonary disease (COPD) [1], elderly patients with asthma [2], and patients still symptomatic despite treatment with β 2 -agonists [3]. Typically, delivery is by pressurized metered-dose inhaler (pMDI); however, use of the pMDI, unlike the Turbuhaler® (TH) (Astra Draco AB, Lund, Sweden), demands co-ordination of actuation with inspiration for efficient use [4]. Chlorofluorocarbons (CFCs), which act as the propellant gas in most pMDIs, deplete the ozone layer and their use will have ceased by the end of the century. As an alternative, inspiratory flow-driven dry powder devices have been developed. Their advantages include ease of use as well as lack of local irritation and paradoxical bronchoconstriction secondary to the propellants/surfactants [5,6]. TH, a multidose dry powder inhaler, contains pure drug (budesonide or terbutaline) or IB and lactose as diluent; an inspiratory flow of as low as 30 L·min -1 is sufficient for efficacy from the device [7]. Previous studies with other drugs have shown the TH to be of greater efficacy than the pMDI at the same nominal dose [8][9][10][11][12][13].Two studies were...

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“…This means that paradoxical bronchoconstriction to β 2 -agonists is not inevitably a classeffect, but can be related to exposure to a specific β 2 -agonist and not to others [9]. In a detailed appraisal of the problem, ENGEL et al [10] concluded that a rapid cooling of the upper airways produced with CFCs, plus the irritant effect of the nondrug components, were producing the paradoxical constrictor response. Although the mean maximum fall in sGaw was similar following inhalation of terbutaline and placebo via p-MDI after placebo, the effect lasted longer and was not followed by bronchodilation.…”

Section: Discussionmentioning

confidence: 99%

Terbutaline via pressurised metered dose inhaled (P-MDI) and Turbuhaler in highly reactive asthmatic patients

Jackson

Ståhl²,

Holgate³

1994

Eur Respir J

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There is some concern over the environmental consequences of chlorofluorocarbons (CFCs) used in pressurized metered-dose inhalers (p-MDIs). Turbuhaler® was designed to deliver a drug as a dry powder without administering additives directly to the airways. The aim of this study was to evaluate the comparative irritant and bronchodilating effects of the same dose of terbutaline delivered by a p-MDI and via Turbuhaler®.Ten symptomatic, asthmatic patients, with highly reactive airways (provocative concentration of methacholine producing a 20% fall in forced expiratory volume in one second (PC 20 ) <0.2 mg·ml -1 ), inhaled, on separate days, 0.25 mg terbutaline via p-MDI or Turbuhaler®. Changes in airway calibre were followed as specific airways conductance (sGaw). On a third day, patients inhaled from a placebo p-MDI containing all constituents except terbutaline. The study was conducted in a single-blind fashion and in random order. There were no significant differences in baseline sGaw on any of the study days.Inhalation of terbutaline from the p-MDI produced a transient percentage fall in sGaw at 1 min, reaching a mean maximum ± SD of 17±8% at 10 s and then returning to baseline value after 20 s, followed by a progressive increase in sGaw to a maximum of 39±45% above baseline at 45 min. In contrast, inhalation of terbutaline via Turbuhaler® caused no significant bronchoconstriction (fall in sGaw, 3± 16%) at 10 s and achieved a greater increase in sGaw, reaching 63±51% at 45 min, although just failing to reach statistical significance compared to terbutaline p-MDI inhalation. The placebo p-MDI caused a 16±15% fall in sGaw at 10 s, with values not returning to baseline until after one minuteThe present study showed that in highly reactive patients, inhalation of terbutaline via Turbuhaler® is an alternative to p-MDI, to avoid paradoxical bronchoconstriction.

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Clinical comparison of inhaled budesonide delivered either via pressurized metered dose inhaler or Turbuhaler®

Cited by 106 publications

References 7 publications

The influence of orally deposited budesonide on the systemic availability of budesonide after inhalation from a Turbuhaler.

The influence of orally deposited budesonide on the systemic availability of budesonide after inhalation from a Turbuhaler.

Comparative efficacy and potency of ipratropium via Turbuhaler and pressurized metered-dose inhaler in reversible airflow obstruction

Terbutaline via pressurised metered dose inhaled (P-MDI) and Turbuhaler in highly reactive asthmatic patients

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