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PubMed1984

Fenoterol plus ipratropium ('Duovent') aerosol therapy delivered by a tube spacer.

A randomized crossover study was carried out in 12 patients with reversible airflow obstruction to investigate the bronchodilator effects of a single metered dose of fenoterol hydrobromide (200 micrograms) plus ipratropium bromide (80 micrograms) delivered by the standard aerosol inhaler or by the inhaler with an extension tube spacer. The results of lung function tests showed that there were significant increases from baseline values in FEV1, FVC and PEFR by 15 minutes using both drug delivery methods, and the improvement in PEFR was maintained for at least 8 hours in 11 of the 12 patients. Although no significant differences in the results was demonstrated between the two methods, which were used correctly by all the participants, it is suggested that the spacer device method would be particularly useful for patients who have difficulty in co-ordinating drug delivery with inhalation.

Adolescent↗
PubMed2003

Pharmacokinetics and systemic effects of inhaled fluticasone propionate in chronic obstructive pulmonary disease.

AIMS: We have previously shown that the systemic exposure to inhaled fluticasone propionate (FP) is reduced in asthmatics compared with healthy subjects. We have now compared its pharmacokinetics in patients suffering from chronic obstructive pulmonary disease (COPD, n = 10) and matched healthy subjects (n = 13). METHODS: A double-blind, randomized, cross-over study design was used. Plasma FP and serum cortisol were measured for 12 h after subjects received hydrofluoroalkane FP 1000 microg day-1 inhaled (via an MDI and spacer) for 7 days and following a single 1000- microg intravenous dose. RESULTS: The pharmacokinetics differed in the two groups. After inhalation, geometric least square means were significantly lower in the COPD group for the plasma AUC (1961 vs 2996 pg ml-1 h-1 for COPD and controls, respectively; P = 0.03) and the Cmax (235 vs 421 pg ml-1 for COPD and controls, respectively; P = 0.03). Suppression of serum cortisol concentration over 12 h was greater in healthy controls. Weighted mean serum cortisol concentration (nmol l-1) in healthy subjects and COPD was 93 and 170, respectively (P = 0.03). The intravenous pharmacokinetic parameters for FP were comparable in the two groups, resulting in similar suppression of serum cortisol. CONCLUSIONS: We conclude that the altered pharmacokinetics of inhaled fluticasone propionate in COPD caused less hypothalamic-pituitary-adrenal suppression than in healthy controls. This is further evidence that the systemic effects of inhaled corticosteroids should be assessed in patients and not healthy subjects.

Administration, Inhalation↗
PubMed1981

An objective assessment of the tube spacer in patients unable to use a conventional pressurized aerosol efficiently.

The tube spacer, a device designed to simplify the inhalation of terbutaline from a pressurized aerosol, was objectively assessed in a group of patients with reversible airways obstruction who were found to have some difficulty in using conventional inhalers. Terbutaline was administered to 22 patients in a dose of 250 micrograms via the conventional pressurized aerosol and the tube spacer. In 16 the improvements in FEV1 were greater after the tube spacer, in four they were greater after the conventional inhaler and in two patients there was no difference. Using an open sequential plan for evaluation of paired preferences it was concluded that the tube spacer was better than the conventional inhaler in these patients.

Adult↗
PubMed1996

Effect of electrostatic charge, flow, delay and multiple actuations on the in vitro delivery of salbutamol from different small volume spacers for infants.

BACKGROUND: A study was undertaken to determine the influences of electrostatic charge, flow, delay, and multiple actuations on the in vitro delivery of salbutamol generated by a pressurised metered dose inhaler (pMDI) from small volume spacers used in infants. METHODS: Ten actuations from a salbutamol pMDI were drawn at different flow rates after either single or multiple actuations, with or without delay, through either static or reduced static spacers. An ionic detergent was used to reduce the charge of plastic spacers (Babyhaler, Babyspacer, Aerochamber, Nebuhaler). Electrostatic charge was measured using an electrometer. A multistage liquid impinger was used to determine the particle size distribution of the output of the pMDI through the spacers. RESULTS: Electrostatic charge on the surface of plastic spacers had the greatest influence on delivery, causing a decrease in drug delivery. Reducing charge by coating the surface with ionic detergent resulted in an increase of 46.5-71.1% (p < 0.001) in small (< 6.8 microns) particle delivery from small volume plastic spacers. Lower flow, delay, and multiple actuations resulted in decreased delivery from static spacers. Lower flow resulted in a decrease of 15% in small (< 9.6 microns) particle delivery. Delay and multiple actuations resulted in a decrease of 40.7% and 76.0%, respectively, in small (< 6.8 microns) particle delivery. The influences of lower flow, delay, and multiple actuations were greatly reduced or even eliminated by reducing charge. However, multiple actuations still resulted in a significant decreased delivery (p < 0.05). The reduced static Nebuhaler had a higher delivery than all small volume spacers. CONCLUSIONS: Electrostatic charge has a major influence on the delivery of salbutamol from small volume spacers. Using a metal spacer or ionic detergent coating of plastic spacers resulted in no or reduced charge and hence in improved delivery. Lower flow, delay, and multiple actuations played a major part only in static spacers.

Albuterol↗
PubMed1994

The evolution of inhaler technology.

Historically, the evolution of inhalation therapy can be traced to India 4000 years ago. The antecedents of contemporary inhalation therapy, however, began in the nineteenth-century industrial age with the invention of the glass bulb nebulizer. From there, inhaler technology evolved along two pathways characterized by refinements in existent nebulizer technology and the invention of a portable inhalation device, the metered-dose inhaler (MDI). More recently, growing recognition of problems associated with MDI use (chiefly, its reliance on coordinated patient inhalation and actuation technique) led to modifications in the MDI itself with auxiliary devices (spacers) and the development of new inhaler systems--dry powdered inhalers (DPIs) and the breath-actuated metered-dose inhaler (BAI-MDI).

Asthma↗
PubMed1990

Aerosol delivery in lung disease.

Metered-dose inhalers are the preferred method of aerosol delivery under normal circumstances because of their convenient size, ease of use and better patient compliance. Where poor coordination exists a spacer device, breath-activated inhaler or powder inhalation should be used and if muscular weakness presents a problem a Haleraid should be tried. A clinical air pump with jet nebuliser is appropriate if these methods prove unsatisfactory; where wet aerosol has been shown to result in clearly superior effects; for very small children; and for the "brittle" asthmatic prone to sudden life-threatening attacks, especially patients living in isolated conditions. Regular checks on aerosol techniques and efficacy of therapy are important aspects of follow up and education of all patients with airflow obstruction.

Adult↗
PubMed1990

Complications of topical steroid therapy for asthma.

The oropharyngeal complications of IS therapy are seldom a serious problem. They may be avoided or ameliorated by inhaling the drug via a spacer and/or reducing the dosing frequency. Severe esophageal candidiasis or atrophic glossitis are rare and generally require discontinuation of IS therapy. Reflex cough or bronchospasm triggered by the inhaled drug occur fairly commonly, but are easily corrected by appropriate treatment. The systemic complications of IS therapy are inconsequential in most patients treated with conventional low doses. Higher doses are more effective but also more active systemically. Despite this, the ratio of systemic-to-antiasthmatic activities may be more favorable with high dose IS than with oral prednisone when the two treatments are compared at equivalent levels of asthma response. The potential risk of adverse systemic effects accruing from the long-term use of intermediate or high doses of IS needs to be rigorously studied.

Administration, Inhalation↗
PubMed1993

How to achieve better outcome in treatment of asthma in general practice.

The symptoms of many asthmatic patients are poorly controlled, and there are several reasons why this may be so. Doctors fail to find out about symptoms that asthmatic patients are experiencing. Doctors wrongly assume that regular use of bronchodilators in small doses is satisfactory treatment for asthma and that taking high doses of bronchodilator in an asthma attack may be dangerous. Doctors think that inhaled steroids may be dangerous and are reluctant to use them in effective doses. Doctors do not check that patients can use their inhalers properly and do not make enough use of large volume spacers, the best available method for giving inhaled asthma treatment. Doctors undermine patients' confidence in advice on treatment by failing to ensure that consistent advice is given and often make the management of asthma more troublesome for the patient than the symptoms of asthma.

Administration, Inhalation↗
PubMed1987

Terbutaline pressurised aerosol inhaled via a Nebuhaler--an effective alternative to subcutaneous adrenaline for treatment of acute severe asthma.

The study was designed to compare terbutaline inhaled via a 750 ml spacer (Nebuhaler) with subcutaneous adrenaline injection as a first-line treatment for acute severe asthma. Patients were randomly allocated to two treatment groups, receiving either 2 X 4 mg of inhaled terbutaline followed by 2 X 0.5 mg subcutaneous adrenaline (22 patients) or the same drugs in reverse order (24 patients). All patients received a further 2 mg inhaled terbutaline to assess remaining bronchodilator reversibility. Initial treatment with terbutaline produced near maximal bronchodilation (FEV1, FVC), whilst initial treatment with adrenaline did not. Terbutaline also reduced symptoms of dyspnoea and wheeze to a greater extent than adrenaline, and was better tolerated with respect to heart rate and side-effects such as tremor. In conclusion, terbutaline inhaled via Nebuhaler was at least as effective as subcutaneous adrenaline, produced fewer side-effects, and hence can be recommended for initial treatment of acute severe asthma.

Acute Disease↗
PubMed2001

In vitro and in vivo techniques used in drug development for evaluation of dose delivery of inhaled corticosteroids.

Oral inhaled corticosteroids are important in the treatment of asthma since their delivery is targeted directly to the lung, which is the site of action. Triamcinolone acetonide (TAA) is an effective and safe corticosteroid that is marketed as a metered-dose inhaler (MDI) with an integrated spacer (Azmacort) for the treatment of asthma. Due to the phasing out of chlorofluorocarbon (CFC) propellants, Azmacort has been reformulated with a non-CFC propellant. Due to the complexities of oral inhaled formulations and the topical nature of drug delivery to the lung for efficacy, the reformulation of oral inhaled MDIs requires careful consideration and support throughout their development, using a combination of in vitro and in vivo studies to ensure clinical comparability for both efficacy and safety. This paper describes a chronological series of studies designed to support the reformulation of Azmacort. These included in vitro studies to estimate respirable fraction, in vivo pulmonary deposition studies, in vivo pharmacokinetic-pharmacodynamic studies to estimate the systemic effects of each formulation, and final clinical studies in adult and pediatric patients to confirm the clinical comparability of the new formulation of Azmacort. The results of these studies, performed at various stages during the development of new formulations, were critical in guiding the reformulation efforts for Azmacort.

Absorption↗
PubMed2002

Effect of plastic spacer handling on salbutamol lung deposition in asthmatic children.

AIMS: To study the effects of electrostatics in a plastic spacer on the lung deposition of salbutamol in asthmatic children. METHODS: Twenty-five children (5-12 years) with mild asthma were given salbutamol hydrofluoroalkane pressurized metered dose inhaler 400 micro g via a 750 ml plastic spacer on separate days. Blood samples were taken for plasma salbutamol at 5, 10, 15 and 20 min after inhalation to measure lung bioavailability as a surrogate for relative lung dose. With immediate inhalation following actuation, a new rinsed spacer (NewRinsed ) was compared with a used spacer after repeated daily use (Used ), a spacer rinsed after repeated use (UsedRinsed ) and a spacer primed with benzalkonium chloride to avoid electrostatics (Primed1). In addition, spacers were evaluated using a 15 s inhalation delay following actuation with primed (PrimedDelay) and rinsed (RinsedDelay) spacers. Data were log transformed and expressed as geometric mean fold difference for the average plasma salbutamol concentration (Cav) over 20 min. RESULTS: There were significant differences (P < 0.05) in Cav (as geometric mean fold difference and 95% CI) between Primed1 vs NewRinsed 1.92 fold (95% CI 1.15, 3.20) and between Used vs NewRinsed 1.75 fold (1.11, 2.76). There were no significant differences comparing Primed1, Used or UsedRinsed. There were also significant differences (P < 0.05) between Primed1 vs PrimedDelay 2.34 fold (1.31, 4.19), or vs RinsedDelay 3.59 fold (2.15, 5.99); and for Used vs PrimedDelay 2.14 fold (1.24, 3.69), or vs RinsedDelay 3.28 fold (2.13, 5.04). CONCLUSIONS: The relative lung dose of salbutamol from a plastic spacer may differ considerably depending on spacer handling suggesting that nonelectrostatic spacers may be the best way forward.

Administration, Inhalation↗
PubMed1992

Evaluation of techniques for delivery of steroids to lungs of neonates using a rabbit model.

Little is known about delivery of aerosolised steroids to neonatal patients undergoing assisted positive pressure ventilation and after extubation. A rabbit model has been established to investigate factors influencing drug delivery. Beclomethasone dipropionate, in a metered dose inhaler, was radiolabelled with technetium 99m. The mass median aerodynamic diameter of the aerosol was 3.3 (2.0) microns and the impactor measurements confirmed that the technetium distribution corresponded with that of the drug particles. The metered dose inhaler was actuated into a collapsible spacer that was used to ventilate and deliver aerosol to anaesthetised rabbits by a tracheostomy. From each actuation of the drug 2.9 (0.4)% of the aerosol deposited in the trachea and main bronchi and 1.2 (0.4)% in the lung. When the drug was delivered by a spacer device, with face-mask attachment, to rabbits breathing freely through a tracheostomy, aerosol deposition increased to 4.4 (2.1)% in the trachea and main bronchi and 1.9 (0.9)% in the lung lobes. The maximum change in systolic blood pressure after administration of aerosol by the collapsible spacer was a decrease of 13%. The methods described may prove useful for the delivery of inhaled steroids to neonatal patients likely to develop bronchopulmonary dysplasia.

Administration, Inhalation↗
PubMed1999

Fluticasone propionate and bronchial hyperresponsiveness in childhood asthma.

Bronchial asthma is now agreed as being a chronic inflammatory disease of the airways. Inhaled steroids are widely accepted as a preventive medication in asthmatic patients of all ages and severity. However, the optimal use of inhaled steroids and the important issue of safety and efficacy still remain of concern, particularly in children. Recently, fluticasone propionate (FP) has been developed for use as an inhaled preparation for the treatment of asthma. Because of its high topical potency and increased lipophilicity, it is claimed that FP has an improved risk/benefit compared with other inhaled steroids. In order to evaluate the use of FP in children, we have studied the efficacy of high dose FP (500 microg/day) in asthmatic children. Thirteen children (9 boys and 4 girls), aged 7-17 years (10.8 +/- 2.6), were instructed to use a pressurized metered-dose inhaler connected to a Volumetric spacer. The standard methacholine bronchial challenge test was used as a principal outcome parameter. The PD20, a cumulative dose of methacholine inducing a 20% decrease in FEV1, was measured pre- and post-treatment with inhaled FP. After 4 weeks of FP, PD20 significantly increased from 21.6 +/- 14.3 inhalation unit to 106.6 +/- 78.5 inhalation unit (4.9 fold, p = 0.004) reflecting the improvement of airway reactivity. All subjects improved clinically. These results demonstrate that the anti-inflammatory action of FP 500 microg a day for four weeks can markedly reduce bronchial hyperresponsiveness, the basic physiologic abnormality in bronchial asthma.

Administration, Inhalation↗
PubMed2001

[Method for using inhalation chambers with facial masks in asthma. Evaluation in 60 children below four years of age].

UNLABELLED: Spacers with face masks are widely used for the treatment of asthma in young children. A poor inhalation technique may compromise the treatments efficiency. METHODS: The inhalation technique of spacers with face masks was evaluated in a prospective study of 60 children below four years of age. A checklist of 12 items was used, each one being coded by zero or one, and a total score < or = 12 points was calculated. RESULTS: Mean total score was 8.93 +/- 1.84 (extremes: 6-12). The canister was shaken before use in 48.3% of cases, one puff delivered when the child was breathing in 71.7% and the valve's mobility checked in 85%. The canister was shaken before the second puff in 13.3% of cases and two consecutive puffs individualized in 28%. DISCUSSION: The usual mistakes are lacking to shake the canister and consecutive puffs' individualization. Medical partners and families education should be reinforced.

Administration, Inhalation↗
PubMed2004

[Inhaled treatment for asthma in practice].

The modalities of an inhaled treatment depends on the characteristics of the aerosol, on the age of the child, and mainly on the inhalatory system. Before the age of 8 years, the pressurised metered dose inhaler must be used together with a spacer device. Above this age, the use of a breath-actuated inhaler or of a dry powder inhaler can be proposed. Demonstration and educational instructions will increase the probability of compliance and efficiency of the treatment.

Administration, Inhalation↗
PubMed1998

Pharmacological treatment in acute exacerbations of chronic obstructive pulmonary disease.

Exacerbations of chronic obstructive pulmonary disease (COPD) are usually treated with bronchodilator therapy, glucocorticoids and antibiotics. However, there are few experimental data on the effects of these agents in patients with acute COPD. A beta(2)-adrenoceptor agonist is usually given first because it can be expected to produce a rapid response. An anticholinergic agent should also be given when the patient is severely ill or responds inadequately to the beta(2) agonist. These agents can be administered via a nebuliser or using a metered-dose inhaler in conjunction with a spacer device. Glucocorticoids can accelerate recovery if the standard empirical regimens for acute exacerbations of asthma are used, although a longer treatment duration appears to be required. Theophylline provides little additional benefit in patients who receive frequent doses of inhaled bronchodilators and an adequate dosage of a glucocorticoid. Although the role of bacterial infections is not completely understood, the use of antibiotics is justified in patients with severe airflow limitation who have febrile tracheobronchitis.

Acetylcysteine↗
PubMed2002

Inhaled beclomethasone versus budesonide for chronic asthma.

BACKGROUND: Beclomethasone dipropionate (BDP) and budesonide (BUD) are used widely in the treatment of chronic asthma. The two drugs have different in vitro pharmacokinetic characteristics. It is unclear whether this translates into clinically significant differences in efficacy or safety when treating children and adults with chronic asthma. OBJECTIVES: To assess clinical outcomes in studies which have compared inhaled BDP and BUD in the treatment of chronic asthma. SEARCH STRATEGY: We searched the Cochrane Airways Group Trial Register (1999) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997-1999). SELECTION CRITERIA: Prospective, randomised trials comparing BDP to BUD in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality. DATA COLLECTION AND ANALYSIS: One reviewer extracted data; authors were contacted to clarify missing information. Quantitative analyses where undertaken using Review Manager 4.0.3 with Metaview 3.1. MAIN RESULTS: 24 studies met the criteria for inclusion (1174 subjects). Methodological quality was variable. A meta-analysis of crossover studies did not demonstrate a significant difference between BDP and BUD for FEV1, morning PEF, evening PEF, asthma symptoms or rescue beta2 agonist use, over a dose range of 400 to 1000 mcg/d. The majority of crossover trials had significant design flaws related to a lack of washout and/or failure to exclude carryover effects so the results must be viewed with caution. A single crossover study with adequate washout showed that BUD 400 mcg/d delivered via Turbohaler dry powder inhaler (DPI) may be more effective than BDP 400 mcg/d delivered via Rotahaler DPI in reducing histamine bronchial hyper-responsiveness: Weighted Mean Difference (WMD) 0.43 log10 PC20 FEV1 (95% Confidence Intervals (CI) 0.05, 0.81 log10 PC20 FEV1). A meta-analysis of two parallel group, dose down-titration studies (231 patients) showed that less BUD delivered via a Turbohaler DPI was required to maintain control in adults asthmatics compared to BDP delivered via metered dose inhaler with or without a spacer: WMD 444 mcg/d (95% CI 332, 556 mcg/d). REVIEWER'S CONCLUSIONS: There is limited high quality randomised controlled trial data comparing the relative efficacy of BDP and BUD. Current guidelines (BTS 1997, GINA 1995, NHLBI 1997) assume BDP and BUD to have equal efficacy, such that for each defined level of asthma severity, the recommended doses BDP and BUD are the same. Although there is some data to suggest that BUD via Turbohaler is more effective than BDP via either Rotahaler or MDI (with and without spacer), these comparisons are confounded by use of different delivery devices, and are not sufficient to warrant a change in guideline recommendations.

Administration, Inhalation↗
PubMed1994

Bronchodilating effect of terbutaline powder in acute severe bronchial obstruction.

The bronchodilating effect of terbutaline dry powder inhaled via Turbuhaler was compared with terbutaline inhaled via a conventional, chlorofluorocarbon (CFC) inhaler and Nebuhaler (750 ml spacer) in 68 consecutive patients attending the emergency department with acute severe bronchial obstruction. The study was of an open, randomized, parallel group design with one study day. Patients were treated with 2.5 mg of terbutaline 15 min apart, either as dry powder via Turbuhaler or with a CFC inhaler in conjunction with Nebuhaler. Data from 62 patients were analyzed. The mean baseline FEV1 values were 0.81 L (SD, 0.64; range, 0.14 to 2.74 L) in the Turbuhaler group (n = 33), and 0.90 L (SD, 0.90; range, 0.27 to 2.60 L) in the Nebuhaler group (n = 29). The mean increases in FEV1 from baseline were 0.40 L (SD, 0.40; range, 0.06 to 2.36 L) and 0.21 L (SD, 0.25; range, -0.05 to 0.95 L) 10 min after the last inhalation via Turbuhaler and Nebuhaler, respectively. The difference between mean values of the increase in FEV1 after terbutaline treatment with Turbuhaler and the CFC inhaler and Nebuhaler was statistically significant (p = 0.0004, ANOVA). This study showed that inhalation of terbutaline via Turbuhaler produced a significantly greater increase in FEV1 compared with the same dose of terbutaline administered via the CFC inhaler and Nebuhaler in patients attending the emergency department with acute severe bronchial obstruction.

Acute Disease↗