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PubMed1997

Randomised placebo-controlled trial of inhaled sodium cromoglycate in 1-4-year-old children with moderate asthma.

BACKGROUND: Inhalation therapy with sodium cromoglycate is recommended as the first-line prophylactic treatment for moderate asthma in children. The availability of spacer devices with face-masks has extended the applicability of metered-dose inhalers to younger children. We studied the feasibility and effects of this therapy compared with placebo in children aged 1-4 years. METHODS: 218 children aged 1-4 years with moderate asthma were recruited through 151 general practitioners between March, 1995, and March, 1996. They were randomly assigned sodium cromoglycate (10 mg three times daily) or placebo, given by inhaler with spacer device and face-mask for 5 months. Rescue medication (ipratropium plus fenoterol aerosol) was available during the baseline period of 1 month and the intervention period. Parents completed a daily symptom-score list. The primary outcome measure was the proportion of symptom-free days in months 2 to 5. Analysis was by both intention to treat and on treatment. FINDINGS: 167 (77%) children completed the trial. 131 (78%) of these children used at least 80% of the recommended dose. Of the 51 children who stopped prematurely, 23 had difficulties with inhaled treatment. The mean proportion of symptom-free days for both groups was greater for the treatment period than for the baseline period (95% CI for mean difference 5.1 to 17.5 cromoglycate, 11.9 to 23.3 placebo). However there were no differences between the sodium cromoglycate and placebo groups in the proportion of symptom-free days (mean 65.7 [SD 25.3] vs 64.3 [24.5]%; 95% CI for difference -8.46 to 5.70) or in any other outcome measure. INTERPRETATION: Our study in a general practice setting shows that inhalation therapy with a spacer device and face-mask is feasible in a majority of children below the age of 4 years. However, long-term prophylactic therapy with inhaled sodium cromoglycate is not more effective than placebo in this age-group.

Administration, Inhalation↗
PubMed1999

Reducing adverse effects of inhaled fenoterol through optimization of the aerosol formulation.

We compared the adverse effects of 160 micrograms of fenoterol in the form of a 2.8-micron monodisperse aerosol with those of 800 micrograms of fenoterol as a conventional metered dose inhaler (MDI) aerosol plus spacer. Previously, a monodisperse aerosol was shown to elicit equivalent degrees of bronchodilation at an 80% lower dose using a standard MDI. A total of 12 healthy volunteers (8 women and 4 men) participated in this study and inhaled in random order a placebo, the monodisperse aerosol, and the MDI aerosol. Changes in serum potassium level, finger tremor, blood pressure, heart rate, and specific airway conductance were measured before and 15 minutes after administration. Compared with placebo, the active aerosols elicited a significant improvement in airway conductance and adverse effects. Serum potassium level decreased by 0.27 mmol/L after the monodisperse aerosol, and the MDI lowered it by 0.67 mmol/L (P = 0.001). Finger tremor also increased less: 0.07 versus 0.29 V (P = 0.029). Changes in cardiovascular parameters were not significantly different from those elicited by the placebo. There were no significant specific airway conductance differences between the two active aerosols. By changing the formulation of MDI aerosols, the occurrence of adverse effects can be reduced.

Absorption↗
PubMed1989

[Effectiveness of various inhalation aids in children with bronchial asthma].

The effect on lung function of two puffs of a mixture of 1 mg disodium cromoglycate (DNCG) and 0.5 mg of reproterol hydrochloride (Aarane) administered by metered dose inhaler through 4 different spacer devices (Volumatic, Nebuhaler, InspirEase and Synchron-Aerosol) was tested in 18 asthmatic patients (age 8-15 years). There was no loss or gain in the effectiveness of treatment from the tested aerosol according to the type of inhalation device used.

Adolescent↗
PubMed2005

[Acute asthma attacks in childhood].

The diagnosis of an acute asthmatic attack in a child is made on a clinical basis. The severity of the exacerbation can be assessed by physical examination and measurement of the transcutaneous oxygenation saturation. A blood gas analysis can be helpful in this assessment. A child with a severe asthma exacerbation should be promptly referred to an emergency department of a hospital. Oxygen should be given to keep the oxygen saturation above 92% and short-acting, selective beta-2 agonists should be administered. Beta-2 agonists can be delivered by intermittent nebulization, continuous nebulization or by metered dose inhaler (MDI) with a spacer They can also be given intravenously in patients who are unresponsive to escalating therapy. The early administration of systemic corticosteroids is essential for the management of acute asthma in children. When tolerated, systemic corticoseroids can be given orally but inhaled corticosteroids are not recommended. Oxygen delivery, beta-2 agonists and steroid therapy are the mainstay of emergency treatment. Hypovolemia should be corrected either intravenously or orally. Administration of multiple doses of ipratropium bromide has been shown to decrease the hospitalization rate in children and adolescents with severe asthma. Clinical response to initial treatment is the main criterion for hospital admission. Patients with failure to respond to treatment should be transferred to an intensive care unit. A critical aspect of management of the acute asthma attack in a child is the prevention of similar attacks in the future.

Acute Disease↗
PubMed2004

A new asthma spacer device to improve compliance in children: a pilot study.

OBJECTIVE: This pilot study was designed to compare the acceptance, ease of use, and effects on compliance between currently used spacer devices and the Funhaler--a new small volume spacer device designed to improve adherence to asthma medication in children. METHODOLOGY: A matched questionnaire-based survey was conducted by two interviews of each caregiver by the same person. A total of 32 children were randomly recruited from seven clinics spanning widely differing socioeconomic and geographical areas of Perth, Western Australia. Preschool children taking regular inhaled asthma medication using an existing low volume spacer device and aged between 1.5 and 6 years, took part in the pilot study. Parents completed two matched questionnaires. The first questionnaire was completed at the beginning of the study and the second after 2 weeks' use of the Funhaler spacer. Data collected related primarily to ease of use of the devices, child and parental compliance, and treatment attitudes. During the study, parents were also called at random on one occasion to ascertain whether they had attempted to medicate their child the previous day. RESULTS: Using the Funhaler incentive spacer device, parents reported significantly more success at medicating their children (22/30 always successful) in comparison to using their existing spacer device (3/30). Parental adherence to prescribed frequency and the delivery technique of children were also improved. The children also showed improved satisfaction and willingness to use the device and parents' attitude towards medicating their children was improved with the Funhaler spacer device. CONCLUSIONS: Use of a novel, incentive spacer device (Funhaler) appeared to be associated with increased success and fewer problems in medicating children, improved child and parental adherence, and a more positive attitude towards treatment, suggesting that more extensive long-term efficacy trials with the device are warranted.

Anti-Asthmatic Agents↗
PubMed1994

Cushing's syndrome from an inhaled glucocorticoid.

OBJECTIVE: To report a case of significant systemic side effects from an inhaled glucocorticoid at a reported dose in the upper recommended therapeutic range. CLINICAL FEATURES: A 25-year-old white man with asthma treated with inhaled glucocorticoid (beclomethasone 1500 micrograms daily), and primary testicular failure with inadequate androgen replacement, was referred with back pain. He was found to have osteoporosis, clinical features of Cushing's syndrome and complete suppression of endogenous adrenocorticotrophic hormone adrenal function. INTERVENTION AND OUTCOME: He was recommended to receive adequate androgen replacement and to use a spacer device with the inhaled beclomethasone, or to change to budesonide via a Turbuhaler (AB Astra, Sweden). CONCLUSIONS: Inhaled glucocorticoids should not be regarded as entirely safe, as serious systemic side effects may occur at doses at the upper level of the recommended therapeutic range.

Administration, Intranasal↗
PubMed2001

Duration of salbutamol-induced bronchodilation delivered by metered-dose inhaler in mechanically ventilated COPD patients.

The delivery of bronchodilators with metered-dose inhaler (MDI) and a spacer in mechanically ventilated patients has become a widespread practice. However, the duration of action of bronchodilators delivered with this technique is not well established. The purpose of the study was to examine the duration of bronchodilation induced by short-term beta 2-agonists administered with an MDI and a spacer in a group of mechanically ventilated patients with exacerbation of chronic obstructive pulmonary disease (COPD). Ten patients with COPD, mechanically ventilated on volume-controlled mode, received 6 puffs of salbutamol (S, 100 micrograms/puff). S was administered with an MDI adapted to the inspiratory limb of the ventilator circuit using an aerosol cloud enhance spacer. Static and dynamic airway pressures, minimum (Rint) and maximum (Rrs) inspiratory resistance, the difference between Rrs and Rint (delta R), static end-inspiratory system compliance (Cst, rs), intrinsic positive end-expiratory pressure (PEEPi) and heart rate (HR) were measured before and at 15, 30, 60, 120, 180, 240, 300, 360 min after S. S caused a significant decrease in dynamic and static airway pressures, PEEPi, Rint and Rrs. These changes were evident at 15 minutes and remained significant for 2 hours after S. The duration of bronchodilation was highly variable and unpredictable among patients, lasting in some patients more than 4 hours while in others wearing off in less than 2 hours. We conclude that 6 puffs of S delivered with an MDI and a spacer device induces significant bronchodilation in mechanically ventilated patients with COPD, the duration of which is highly variable precluding guidelines regarding the time scheduled for dosing.

Administration, Inhalation↗
PubMed1992

Clinical evaluation of the "Siriraj Spacer" in asthmatic Thai children.

We designed a new, washable, and collapsible bag spacer (the Siriraj Spacer) for use with metered-dose inhalers (MDI) by Thai asthmatic patients. The Siriraj Spacer consists of a mouthpiece, a front panel to which any type of MDI could be attached and a collapsible 800 mL ringed-plastic bag. Fifteen asthmatic children (6-13 years of age) were enrolled into a randomized, double-blind, triple crossover study (spanning a period of three days) to compare the clinical effectiveness of the Siriraj Spacer with that of the Volumatic Spacer (Glaxo, Inc., Research Triangle Park, NC, U.S.A.) and with the use of MDI alone. Medication used with the active method of administration was 2 puffs of albuterol (100 micrograms/puff) while 2 puffs from placebo MDI were used with the other two methods in succession. All children were stable asthmatic patients, and had been instructed how to use MDI properly by an open mouth technique just before the initiation of the study. Spirometry (FEV1, FVC, PEFR, and FEF25-75%) was followed for six hours after the administration of albuterol. The baseline FEV1s of the three study days were within 50% to 70% of the predicted values (with baseline variability of less than 20%). Data were expressed as percentage of improvement from baseline. By an analysis of variance with repeated measures, no significant differences were observed between pulmonary function data obtained with any of the three methods of bronchodilator administration (P > .05) at any time point throughout the 6-hour period.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed2000

The protective effect of salbutamol inhaled using different devices on methacholine bronchoconstriction.

STUDY OBJECTIVE: To determine the protective effect of salbutamol, 100 microg, inhaled by different devices (pressurized metered-dose inhaler [pMDI; Ventolin; GlaxoWellcome; Greenford, UK], pMDI + spacer [Volumatic; GlaxoWellcome], or breath-activated pMDI [Autohaler; 3M Pharmaceuticals; St. Paul, MN]) on bronchoconstriction induced by methacholine. DESIGN: Randomized, double-blind, cross-over, placebo-controlled study. PATIENTS: Eighteen subjects with stable, moderate asthma, asymptomatic, receiving regular treatment with salmeterol, 50 microg bid, and inhaled beclomethasone dipropionate, 250 microg bid, in the last 6 months, with high hyperreactivity to methacholine (baseline provocative dose of methacholine causing a 20% fall in FEV(1) [PD(20)] geometric mean [GM], 0.071 mg). Subjects were classified into two groups: subjects with incorrect (n = 5) pMDI inhalation technique, and subjects with correct (n = 13) inhalation technique. METHODS AND MEASUREMENTS: After cessation of therapy for 3 days, all subjects underwent four methacholine challenge tests, each test 1 week apart, each time 15 min after inhalation of salbutamol, 100 microg (via pMDI, pMDI + spacer, or Autohaler), or placebo. The protective effect on methacholine challenge test was evaluated as the change in the PD(20), and expressed in terms of doubling doses of methacholine in comparison with placebo treatment. RESULTS: The PD(20) was significantly higher after salbutamol inhalation than after placebo inhalation, but no significant difference was observed among the three different inhalation techniques. Only when salbutamol was inhaled via pMDI + spacer, PD(20) was slightly but not significantly higher (pMDI GM, 0.454 mg; pMDI + spacer GM, 0.559 mg; and Autohaler GM, 0.372 mg; not significant [NS]) than other inhalation techniques. Similar results (mean +/-SEM) were obtained with doubling doses of methacholine (pMDI, 2 +/- 0.47; pMDI + spacer, 3 +/- 0.35; and Autohaler, 2.4 +/- 0.40; NS). No significant difference was found among techniques when subjects with correct or incorrect inhalation technique were separately considered. CONCLUSIONS: Our data show that the protective effect of salbutamol, 100 microg, on methacholine-induced bronchoconstriction is not affected by the different inhalation techniques, although inhalation via pMDI + spacer tends to improve the bronchoprotective ability of salbutamol. These data confirm the clinical efficacy of salbutamol, whatever the device, and the patient's inhalation technique.

Adolescent↗
PubMed1992

New method of evaluating patient preference for different inhalation delivery systems.

In order to assess patients' preferences for different inhalation devices a questionnaire has been developed. The questionnaire consisted of items covering various aspects considered important for patients who regularly use inhalation devices. The questions were designed to be of a general character so any inhalation device could be evaluated. We evaluated the questionnaire in a multicenter, open crossover study comparing patients' opinions of MDI with and without spacer and of a dry powder inhaler, Turbuhaler. One hundred twenty-three patients with stable asthma confirmed by daily peak expiratory flow rate (PEF) measurements used for 2 weeks MDI only and MDI with spacer and for 2 weeks Turbuhaler. The order was randomized. The drugs were terbutaline inhaled via MDI and Turbuhaler and budesonide inhaled via MDI with spacer and turbuhaler. At the end of each evaluation period the patients answered a number of questions about their opinion by marking on a visual analogue scale. A factor analysis revealed that the different questions represent a few common factors important for evaluating opinion about inhalation devices. These factors are handling of the device, use, time to learn how to use the device properly, how confident the patients feel about the use of it, and taste/irritation. A standardized questionnaire of reduced size seems to be a suitable method for evaluating patient preference for different inhalation devices.

Administration, Inhalation↗
PubMed1994

[Glucocorticosteroid therapy in bronchial asthma].

Corticosteroid inhibits airway inflammation associated with eosinophils and lymphocytes in bronchial asthma. Asthma severity is classified according to symptoms, airflow obstruction (PEF) and treatment requirement. Step 1: A patient has mild asthma. Inhaled corticosteroid, beclomethasone dipropionate (BDP), is used not to exceed 200 micrograms a day. Step 2: A patient has moderate asthma. The primary therapy is 200-400 micrograms of BDP a day. Step 3: If the patient experiences exacerbations, 400 to 1000 micrograms of BDP a day are required. Step 4: A patient has severe asthma. Oral corticosteroid and/or 800-1600 micrograms of BDP are available. Intravenous corticosteroid therapy for acute exacerbation of asthma is applied for patients who have moderate or severe exacerbation. Corticosteroids are currently the most effective anti-inflammatory drugs for the treatment of asthma. Corticosteroids, however, have many sort of adverse effects. Adverse effects of inhaled corticosteroids are less than those of oral corticosteroid except for local effects. Use of spacer and gargle after the inhalation are recommended to reduce the local adverse effects.

Administration, Inhalation↗
PubMed1999

One year prospective open study of the effect of high dose inhaled steroids, fluticasone propionate, and budesonide on bone markers and bone mineral density.

BACKGROUND: Inhaled corticosteroids are recognised as the most effective agents in the treatment of asthma. However, concerns have been expressed about the effects of high doses of inhaled corticosteroids on safety in relation to bone resorption and formation. This study measures the effects of two inhaled corticosteroids on bone markers and bone mineral density (BMD) over one year. METHODS: A one year randomised, prospective, open parallel study comparing inhaled fluticasone propionate (FP), 500 micrograms twice daily in 30 patients, and budesonide (BUD), 800 micrograms twice daily in 29 patients, delivered by metered dose inhaler and large volume spacers was performed in adults with moderate to severe asthma. Biochemical markers of bone turnover (osteocalcin, procollagen type 1 C-terminal propeptide (PICP), immunoreactive free deoxypyridinoline (iFDpd), N-terminal crosslinked telopeptides of type I collagen (NTx)), BMD at the spine and femoral neck, and serum cortisol concentrations were measured at baseline and 12 months later. RESULTS: There were no significant differences between the inhaled steroids on bone markers of bone resorption and formation or bone mineral density. Bone mineral density of the spine increased slightly in both groups over the 12 month period. Serum osteocalcin levels increased from baseline in both treatment groups (FP 16.9%, p = 0.02; BUD 14.3%, p = 0.04). PICP did not differ significantly from baseline. Both markers of bone resorption (iFDpd, NTx) varied considerably with no significant changes after one year. There was a significant correlation in percentage change from baseline between BMD of the spine and osteocalcin at 12 months (r = 0.4, p = 0.017). Mean serum cortisol levels remained within the normal range in both groups following treatment. CONCLUSION: There was no evidence of a decrease in BMD during 12 months of treatment with high doses of either FP or BUD. The change in spine BMD correlated with the increase in osteocalcin. Studies extending over several years are needed to establish whether these findings persist.

Administration, Inhalation↗
PubMed2000

Asthma education in the Emergency Department. On behalf of the MARC Investigators.

STUDY OBJECTIVE: We surveyed emergency department-based asthma researchers to study the presence of formal asthma education programs (AEPs), and examined data from prospective cohort studies to compare sites with and without AEPs. METHODS: We contacted site investigators in the Multicenter Airway Research Collaboration (MARC) in July 1998 by mail, fax, or telephone. Main outcomes were the percentage of sites using AEPs and the percentage of AEPs using each of 7 "key" teaching items in national guidelines. MARC data provided site and patient characteristics. RESULTS: All 77 site investigators (100%) responded to the survey. Using a scale from 1 to 5 (mean+/-SD), respondents identified instruction in proper inhaler technique (4.8+/-0.5), "spacer" use (4.3+/-0.7), recognition of asthma triggers (4.3+/-0.8), and rationale for medications (4. 6+/-0.6) as priorities for teaching. Twelve sites (16%; 95% confidence interval [CI] 8% to 26%) had AEPs; most (8) were at pediatric sites. Patients presenting to sites with AEPs were younger (22+/-16 years versus 25+/-15 years, P <.001), more likely to be uninsured (26% versus 23%, P <.001), and less likely to be taking inhaled corticosteroids (30% versus 37%, P <.001). AEP sites uniformly stressed "key" items, except for "written action plan" (50% of sites) and "peak flow diary" (33% of sites). CONCLUSION: Although asthma researchers agree that patient education is very important, few EDs involved in asthma research use AEPs. Sites with AEPs appear to serve patients at higher risk of poor asthma outcomes. Further study is needed to address the effectiveness of AEPs in the ED.

Administration, Inhalation↗
PubMed1997

[Influence of the inhaler device on bronchodilatation in the asthmatic child].

The use of spacer devices is recommended in asthmatic children for inhaled therapeutics. Therefore, in vitro studies prove the dependent-device delivery of the drug. The aim of this study was to compare, in vivo, the effect of 200 micrograms of albuterol, delivered via one of the five spacer devices currently marketed in France (Aerochamber, Aeroscopic, Babyhaler with a face mask, Nebuhaler or Volumatic) and assessed by the induced peak expiratory flow (PEF) change. One hundred asthmatic children were recruited and randomized in 5 groups. The mean age was 8.9 +/- 3.3 years. Each group was comparable regardless of gender, height, weight, characteristics of asthma and baseline PEF. The maximal change in PEF was obtained with Babyhaler (14.9 +/- 12.8%; p = 0.009). The increase in PEF elicited with Aeroscopic was 9.7 +/- 10.2%. The others spacer devices did not offer a change greater than the variation of PEF in the studied population. Further studies, concerned with a measurement of drug deposition or with an assessment of its use in obstructive episodes of asthma, are required, but Babyhaler with a face mask, usually reserved to infants, deserves to be advised to older children for salbutamol intake.

Administration, Inhalation↗
PubMed2001

Comparison of the effectiveness of inhaler devices in asthma and chronic obstructive airways disease: a systematic review of the literature.

BACKGROUND: Asthma and chronic obstructive pulmonary disease (COPD) are common diseases of the airways and lungs that have a major impact on the health of the population. The mainstay of treatment is by inhalation of medication to the site of the disease process. This can be achieved by a number of different device types, which have wide variations in costs to the health service. A number of different inhalation devices are available. The pressurised metered-dose inhaler (pMDI) is the most commonly used and cheapest device, which may also be used in conjunction with a spacer device. Newer chlorofluorocarbons (CFC)-free inhaler devices using hydrofluoroalkanes (HFAs) have also been developed. The drug is dissolved or suspended in the propellant under pressure. When activated, a valve system releases a metered volume of drug and propellant. Other devices include breath-actuated pMDIs (BA-pMDI), such as Autohaler and Easi-Breathe. They incorporate a mechanism activated during inhalation that triggers the metered-dose inhaler. Dry powder inhalers (DPI), such as Turbohaler, Diskhaler, Accuhaler and Rotahaler, are activated by inspiration by the patient. The powdered drug is dispersed into particles by the inspiration. With nebulisers oxygen, compressed air, or ultrasonic power is used to break up solutions or suspensions of medication into droplets for inhalation. The aerosol is administered by mask or by a mouthpiece. There has been no previous systematic review of the evidence of clinical effectiveness and cost-effectiveness of these different inhaler devices. OBJECTIVES: To review systematically the clinical effectiveness and cost-effectiveness of inhaler devices in asthma and COPD. METHODS: The different aspects of inhaler devices were separated into the most clinically relevant comparisons. Methods involved systematic searching of electronic databases and bibliographies for randomised controlled trials (RCTs) and systematic reviews. Pharmaceutical companies and experts in the field were contacted for further information. Trials that met the inclusion criteria were appraised and data extraction was under-taken by one reviewer and checked by a second reviewer, with any discrepancies being resolved through agreement. RESULTS--IN VITRO CHARACTERISTICS VERSUS IN VIVO TESTING AND CLINICAL RESPONSE: There is evidence that when comparative testing is performed on inhaler devices using the same methods, there is some correlation between particle size measurements and clinical response. However, the measurements are dependent upon the methods used, and a single measure of a device in isolation is of limited value. Also, there is little data on comparing devices of different types. There is currently insufficient data to verify the ability of in vitro assessments to predict inhaler performance in vivo. RESULTS--EFFECTIVENESS OF METERED-DOSE INHALERS FOR THE DELIVERY OF CORTICOSTEROIDS IN ASTHMA: The review of three trials in children and 21 trials in adults demonstrated no evidence to suggest clinical benefits of any other inhaler device over a pMDI in corticosteroid delivery. RESULTS--EFFECTIVENESS OF METERED-DOSE INHALERS FOR THE DELIVERY OF BETA-AGONISTS IN STABLE ASTHMA: In children, 11 studies were reviewed, of which seven compared the Turbohaler with the pMDI. One study found a significant treatment difference in peak expiratory flow rate, although there were differences in the patients' baseline characteristics. In adults, a review of 70 studies found no demonstrable difference in the clinical bronchodilator effect of short-acting b2-agonists delivered by the standard pMDI compared with that produced by any other DPI, HFA-pMDI or the Autohaler device. The finding that HFA-pMDIs may reduce treatment failure and oral steroid requirement in beta-agonist delivery needs further confirmatory research in adequately randomised clinical trials. RESULTS--EFFECTIVENESS OF NEBULISERS VERSUS METERED-DOSE INHALERS FOR THE DELIVERY OF BRONCHODILATORS IN STABLE ASTHMA: In children, three included trials compared different devices with a nebuliser and demonstrated no evidence of clinical superiority of nebulisers over inhaler devices in bronchodilator delivery. A total of 23 studies in adults found no equivalence for the main pulmonary outcomes and no evidence of difference in other outcomes. RESULTS--EFFECTIVENESS OF METERED-DOSE INHALERS FOR THE DELIVERY OF BETA-AGONISTS IN COPD: Only two studies were included in this review. No evidence of clinical difference was found in beta-agonist delivery. RESULTS--EFFECTIVENESS OF NEBULISERS VERSUS METERED-DOSE INHALERS FOR THE DELIVERY OF BRONCHODILATORS IN COPD: Evidence from 14 trials demonstrated equivalence for the main outcomes of pulmonary function. For other outcomes there was no evidence of treatment difference in bronchodilator delivery. RESULTS--PATIENTS' ABILITY TO USE METERED-DOSE INHALERS: Differences among studies and the heterogeneity of the results make it difficult to draw conclusions about inhaler technique differences between device types. The review of technique after teaching the correct technique suggests that there is no difference in patients' ability to use DPI or pMDIs. RESULTS--ECONOMIC ANALYSIS: The total number of NHS prescriptions for inhaler therapy for asthma in 1998 was over 31 million, with a net ingredient cost in excess of 392 million GB pounds. This economic assessment uses decision analysis to estimate the relative cost-effectiveness of inhaler devices for the delivery of bronchodilator and corticosteroid inhaled therapy. Overall, there were no differences in patient outcomes among the devices. On the assumption that the devices were clinically equivalent, pMDIs were the most cost-effective devices for asthma treatment. CONCLUSIONS: This systematic review examined the evidence from clinical trials evaluating the clinical effectiveness of different inhaler devices in the delivery of inhaled corticosteroids and beta2-bronchodilators for patients with asthma and COPD. The evidence from the published clinical literature demonstrates no difference in clinical effectiveness between nebulisers and alternative inhaler devices compared to standard pMDI with or without a spacer device. The cost-effectiveness evidence therefore favours pMDIs (or the cheapest inhaler device) as first-line treatment in all patients with stable asthma unless other specific reasons are identified. Patients can use pMDIs as effectively as other inhaler devices as long as the correct inhalation technique is taught. CONCLUSIONS--RECOMMENDATIONS FOR RESEARCH: Further clinical trials are required to demonstrate any differences in the clinical effectiveness and cost-effectiveness of inhaler devices and nebulisers compared with pMDIs. These should be of sufficient statistical power and methodological rigour to demonstrate any clinical benefit. Trials should be undertaken in community settings to ensure the generalisability of results. Outcome measures should be more patient-centred and report adverse effects more completely. Reporting of data from trials should be improved.

Adolescent↗
PubMed2006

Practical problems with aerosol therapy in COPD.

Inhaled aerosol drugs commonly used by patients with chronic obstructive pulmonary disease include short-acting and long-acting bronchodilators, as well as corticosteroids. These agents are available in a variety of inhaler devices, which include metered-dose inhalers (MDI), breath-actuated MDIs, nebulizers, and, currently, 5 different models of dry powder inhaler (DPI). There is evidence to suggest that multiple inhaler types cause confusion among patients and increase errors in patient use. Problems with MDIs include failure to coordinate inhalation with actuation of the MDI, inadequate breath-hold, and inappropriately fast inspiratory flow. Lack of a dose counter makes determining the number of remaining doses in an MDI problematic. Patient misuse of MDIs is compounded by lack of knowledge of correct use among health-care professionals. Several factors often seen with elderly patients have been identified as predictive of incorrect use of MDIs. These include mental-state scores, hand strength, and ideomotor dyspraxia. Holding chambers and spacers are partially intended to reduce the need for inhalation-actuation coordination with MDI use. However, such add-on devices can be subject to incorrect assembly. Possible delays between MDI actuation and inhalation, rapid inspiration, chamber electrostatic charge, and firing multiple puffs into the chamber can all reduce the availability of inhaled drug. Because they are breath-actuated, DPIs remove the need for inhalation-actuation synchrony, but there is evidence that patient errors in use of DPIs may be similar to those with MDIs. One of the biggest problems is loading and priming the DPI for use, and this may be due to the fact that every DPI model in current use is different. Medical personnel's knowledge of correct DPI use has also been shown to be lacking. The optimum inhalation profiles are different for the various DPIs, but, generally, chronic obstructive pulmonary disease patients have been shown to achieve a minimum therapeutic dose, although the inhaled amount may be suboptimal. A limitation of DPIs that have multidose powder reservoirs (eg, the Turbuhaler) is ambient humidity, which can reduce the released dose. Small-volume nebulizers are limited by bulk, treatment time, and variable performance, but are easy for patients to use. Important features identified by patients for an ideal inhaler are ease of use during an attack, dose counter, and general ease of use and learning. A breath-actuated-pMDI, such as the Autohaler, ranked at the top of inhaler preference in a study of 100 patients with airflow obstruction, compared to DPIs and MDIs. Short of a universal simple inhaler, patient and caregiver education remains the best solution to correct patient errors in use.

Administration, Inhalation↗
PubMed2001

Relative lung delivery of fluticasone propionate via large volume spacer or nebuliser in healthy volunteers.

OBJECTIVES: High-dose nebulised fluticasone propionate (FP) has been advocated for use in patients with severe persistent asthma. As there is complete first-pass inactivation of FP for the swallowed fraction, systemic absorption is due solely to its lung bioavailability. We wished to compare the relative lung delivery of FP, using adrenal suppression as a surrogate for the respirable dose, when administered via large volume spacer (FP-spacer) or nebuliser (FP-neb) in healthy adults. METHODS: Fourteen healthy subjects, mean (SEM) age 29.4 +/- 2.6 years, were studied in a placebo-controlled, randomised study with three-way crossover design. Single nominal 2-mg doses of the following were given at 1700 hours in randomised sequence: a. FP-spacer: fluticasone pressurised metered dose inhaler (as Flixotide 250 microg ex-valve per actuation), eight puffs via a primed Volumatic 750-ml spacer. b. FP-neb: (as Flixotide Nebule 2 mg/2 ml) via Pari LC Plus nebuliser. c. Placebo nebuliser. Following each dose, measurements were made of corrected 0800-hours urinary cortisol/creatinine ratio (the primary outcome variable) and 0800-hours plasma cortisol. RESULTS: Significant (P<0.05) suppression of both endpoints occurred only with FP-spacer, FP-neb being statistically no different from placebo. Geometric mean fold differences between FP-spacer and placebo were 9.8-fold [95% confidence interval (CI) 3.4, 28.8] for urinary cortisol/creatinine and 4.1-fold (95% CI 2.2, 7.5) for plasma cortisol. Comparing FP-spacer with FP-neb, these differences were 6.8-fold (95% CI 2.3, 20.0) for urinary cortisol/creatinine and 3.3-fold (95% CI 1.8, 6.0) for plasma cortisol. CONCLUSION: For a 2-mg labelled nominal dose of fluticasone, the spacer produced about a sevenfold higher relative lung dose than the nebuliser. This suggests that a very little of the labelled nebulised dose is respirable. Other factors such as patient preference, cost and compliance will determine the inhaler device that is chosen.

Administration, Inhalation↗
PubMed2006

Influence of respiratory efforts on b2-agonist induced bronchodilation in mechanically ventilated COPD patients: a prospective clinical study.

BACKGROUND: Several in vitro studies have shown that at similar tidal volume (VT), bronchodilator delivery to target sites is significantly lower during controlled mechanical ventilation (CMV) than that during simulated spontaneous breathing. However, the influence of active respiratory efforts on the magnitude of b2-agonist induced bronchodilation in mechanically ventilated patients has not been examined. OBJECTIVE: To examine the influence of controlled and assisted modes of ventilatory support on the bronchodilative effect induced by b2-agonists administered with a metered dose inhaler (MDI) and a spacer device in a homogeneous group of mechanically ventilated patients with acute exacerbation of chronic obstructive pulmonary disease (COPD). METHODS: Prospective clinical study. Ten mechanically ventilated patients with acute exacerbation of COPD were prospectively randomized to receive 4 puffs of salbutamol (S, 100 micro g/puff) either with volume-controlled (VC) or pressure-support (PS) ventilation. On PS the pressure level was such that VT was comparable between ventilatory modes. After a 6-h washout period, patients were crossed-over to receive the drug by the alternative mode of ventilation. Static and dynamic airway pressures, minimum (R(int)) and maximum (R(rs)) inspiratory resistance, the difference between R(rs) and R(int) (DeltaR), end-inspiratory static compliance of the respiratory system (C(rs)), intrinsic positive end-expiratory pressure (PEEP(i)) and heart rate (HR) were measured before and at 15, 30, 60, 120, 180 and 240 min after S administration. RESULTS: S caused a significant decrease in dynamic and static airway pressures, PEEP(i), R(int) and R(rs). These changes were not influenced by the ventilatory mode and were evident at 15, 30, 60 and 120 min after S. HR, C(rs) and DeltaR did not change after S administration. CONCLUSIONS: Considering the use of propofol with its presumed bronchodilative properties as a shortcoming of our study, it is concluded that the magnitude of bronchodilation induced by salbutamol delivered by an MDI and a spacer device in mechanically ventilated COPD patients is not affected by the presence or absence of active respiratory efforts.

Adrenergic beta-Agonists↗