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PubMedDate not supplied

A new spacer device for administration of inhaled salbutamol: use in elderly asthmatics.

This randomized, parallel-group study compared the use of a metered-dose inhaler (MDI) equipped with a new spacer device (Jet spacer) with that of a standard actuator in the administration of salbutamol (two puffs, 100 micrograms four times daily) to 36 elderly patients with moderate asthma and poor inhalation technique. After a 1-week run-in period, patients entered the 1-week study. Forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR) were measured at screening (both groups using the standard actuator) before and 30, 60, 120, and 240 minutes after administration; these measurements were repeated at the start and end of treatment (patients using the spacer or standard actuator). Ratings of efficacy and tolerability by investigators and of acceptability by patients were recorded at the end of treatment. Increases from baseline (from 0 to 240 minutes) in FEV1 and PEFR were comparable in the two groups at screening visit but proved higher (significantly for FEV1: P < .01) in the Jet group than in the standard-actuator group after both the first and last doses of the 7-day treatment period. the Jet group reported greater acceptability than the standard-actuator group. One patient in each group had tremors. The new spacer device is thus a valid alternative to the conventional actuator in patients with definitely or potentially poor hand-mouth coordination.

Aged↗
PubMedDate not supplied

Assessment of inhalation technique in primary care asthmatic patients using metered-dose inhalers with or without a spacer.

BACKGROUND: Asthma is a chronic disease with increasing morbidity and mortality. Although the development of metered-dose inhalers (MDIs) was a landmark in asthma management, their use is burdened by inappropriate training. Inadequate inhalation technique is reported in 24% to 89% of patients. We assessed how a sample of adult asthmatic patients seen in primary healthcare clinics (PHCs) in Riyadh used their metered-dose inhalers (MDI). PATIENTS AND METHODS: We conducted a cross-sectional survey of asthmatic adults â yen 18 years of age who attended PHCs and used an MDI with or without a spacer device. Patient inhalation technique was observed independently by the primary researcher and a respiratory therapist using a checklist based on US (National Heart, Lung and Blood Institute) asthma management guidelines. RESULTS: The mean age of the 191 patients in the survey was 40.64 years (range, 18 to 80 years). Fifty-nine percent were females and 41% were males. Most (77%) were illiterate and most (86%) had received previous education on MDI inhalation technique. Ninety-three percent were using an MDI without a spacer, but none could use their MDI without committing at least one error in both groups. In patients using an MDI without a spacer, the most common error was not tilting the head backward slightly and breathing out to residual volume (85%), followed by not breathing in slowly (84%). In patients using an MDI with a spacer, the most common errors were not tilting the head back slightly and breathing out slowly to residual volume (77%), and not holding the breath for 10 seconds (77%). CONCLUSION: Despite that MDIs are a mainstay in the management of our asthmatic patients, inhalation technique is very poor among our patients.

Journal Article↗
PubMed1998

Albuterol delivered by metered-dose inhaler (MDI), MDI with spacer, and Rotahaler device--a comparison of efficacy and safety.

A randomized double-blind, triple crossover study was conducted on 20 asthmatic patients (7 males and 13 females; age 40.9 +/- 14.2 Caucasians, 11 blacks, and 1 oriental. Criteria for admission included FEV1 < or = 80% of predicted when inhaled beta-agonists were witheld for at least 6 hrs and oral beta-agonists for 12 hr, in addition to at least 15% increase in FEV1, 15 min after treatment with albuterol with spacer delivery. Each of the study patients were tested on each of 3 separate days (within the same week) at baseline, 15, 30, 60, 120, 180, 240, 300, and 360 min post treatment. On each day albuterol was delivered by one of the 3 delivery devices and the other two methods delivered placebo. Albuterol was administered at the maximum recommended dosages of two puffs for MDI. Two puffs for MDI with spacer, and two capsules for Rotahaler. Spirometry, blood pressure and heart rate were measured at each testing interval. The mean percentage in FEV1 was higher in Rotahaler group compared to MDI with spacer (p < 0.001) and no significant difference in FEV1 was found between Rotahaler and MDI alone (p = 0.31). No significant changes in heart rate or blood pressure were associated with albuterol delivery by any of the three methods. Albuterol inhaled as a microfine powder was more effective than the same drug delivered as an aerosol by either MDI or MDI with spacer.

Adult↗
PubMed2005

Device selection and outcomes of aerosol therapy: Evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology.

BACKGROUND: The proliferation of inhaler devices has resulted in a confusing number of choices for clinicians who are selecting a delivery device for aerosol therapy. There are advantages and disadvantages associated with each device category. Evidence-based guidelines for the selection of the appropriate aerosol delivery device in specific clinical settings are needed. AIM: (1) To compare the efficacy and adverse effects of treatment using nebulizers vs pressurized metered-dose inhalers (MDIs) with or without a spacer/holding chamber vs dry powder inhalers (DPIs) as delivery systems for beta-agonists, anticholinergic agents, and corticosteroids for several commonly encountered clinical settings and patient populations, and (2) to provide recommendations to clinicians to aid them in selecting a particular aerosol delivery device for their patients. METHODS: A systematic review of pertinent randomized, controlled clinical trials (RCTs) was undertaken using MEDLINE, EmBase, and the Cochrane Library databases. A broad search strategy was chosen, combining terms related to aerosol devices or drugs with the diseases of interest in various patient groups and clinical settings. Only RCTs in which the same drug was administered with different devices were included. RCTs (394 trials) assessing inhaled corticosteroid, beta2-agonist, and anticholinergic agents delivered by an MDI, an MDI with a spacer/holding chamber, a nebulizer, or a DPI were identified for the years 1982 to 2001. A total of 254 outcomes were tabulated. Of the 131 studies that met the eligibility criteria, only 59 (primarily those that tested beta2-agonists) proved to have useable data. RESULTS: None of the pooled metaanalyses showed a significant difference between devices in any efficacy outcome in any patient group for each of the clinical settings that was investigated. The adverse effects that were reported were minimal and were related to the increased drug dose that was delivered. Each of the delivery devices provided similar outcomes in patients using the correct technique for inhalation. CONCLUSIONS: Devices used for the delivery of bronchodilators and steroids can be equally efficacious. When selecting an aerosol delivery device for patients with asthma and COPD, the following should be considered: device/drug availability; clinical setting; patient age and the ability to use the selected device correctly; device use with multiple medications; cost and reimbursement; drug administration time; convenience in both outpatient and inpatient settings; and physician and patient preference.

Adrenergic beta-Agonists↗
PubMed2007

Effective inhaled drug administration to mechanically ventilated patients.

Inhaled therapy is commonly employed in mechanically ventilated patients with chronic obstructive pulmonary disease or asthma. The efficacy of inhaled drugs is comparable to that achieved with systemic routes of administration, but the dose of drug required to achieve a therapeutic effect is generally much smaller. Moreover, limited systemic absorption of inhaled drugs minimises systemic side effects. Aerosol administration to ventilated patients differs from that in ambulatory patients in several respects. Optimal techniques for using pressurised metered-dose inhalers and nebulisers in ventilator circuits have been developed. With these techniques, the efficiency of inhaled drug delivery in mechanically ventilated patients is now comparable to that in ambulatory patients. Pressurised metered-dose inhalers are chiefly used to deliver bronchodilator and corticosteroid aerosols, and are more efficient and convenient to use than nebulisers for routine therapy in ventilated patients. However, nebulisers are more versatile and are employed to generate aerosols of bronchodilators, corticosteroids, antibiotics, prostaglandins, surfactant and mucolytic agents. Improvements in drug formulations and the design and efficiency of aerosol generating devices have led to increasing application of inhaled therapies in mechanically ventilated patients.

Administration, Inhalation↗
PubMed1995

[Influence of beclomethasone dipropionate inhalation therapy with a large spacer on emergency room visits by patients with bronchial asthma].

From April 1992 we introduced beclomethasone dipropionate (BDP) inhalation therapy with a large spacer for patients with bronchial asthma who were admitted to the internal medicine department of our hospital because of an exacerbation of asthma. To investigate the influence of this BDP inhalation therapy on emergency room visits by patients with bronchial asthma, we studied the patients who were admitted to the emergency room at our hospital with asthmatic attacks from April 1991 to March 1994. A significant (p < 0.05) reduction in the number of patients who visited our emergency room with asthmatic attacks was found over the 3 years: from April 1991 to March 1992 (before the introduction of BDP inhalation therapy), 575 patients (47.9 +/- 7.5 patients/month) were admitted with asthmatic attacks; from April 1992 to March 1993, 341 patients (28.4 +/- 13.0 patients/month) were admitted, and from April 1993 to March 1994, 285 patients (25.1 +/- 9.2 patients/month). Among the patients who were admitted to our emergency room, the proportion of first-visit patient tended to increase. We studied 27 emergency-room-visit patients who attended our hospital regularly from one year before to one year after the introduction of BDP therapy. The therapy failed to control asthmatic symptoms in 12 patients on long courses of oral corticosteroids, on the other hand control of 15 patients without oral steroid was favorable. These results suggests that BDP inhalation therapy with a large spacer decreases the number of emergency room visits by patients with bronchial asthma.

Administration, Inhalation↗
PubMed2001

Plastic bottles as spacers for a pressurized metered-dose inhaler: in vitro characteristics.

Homemade spacer devices are commonly used by children with asthma to improve aerosol deposition from pressurized metered dose inhalers (pMDI); however, the efficacy and efficiency of these devices are not fully characterized. We determined the quality of fine particle fraction (< 4.7 microns) and ultrafine particle fraction (< 3.3 microns) of three bottles (from 280 ml to 500 ml) commonly used as spacers in Trinidad and Tobago and compared their performance to the commercially available valved holding chamber (OpT) and pMDI. These data were obtained in vitro using a cascade impactor. All 3 bottles and the OpT were similar (p > 0.05) in reducing the amount of albuterol emitted as large particles (> 4.7 microns) to less than 10 micrograms. The different sized bottles (from 280 ml to 500 ml) produced identical quantities of albuterol in the fine particle and ultrafine particle ranges (p > 0.05). All of the sample bottle spacers emitted a higher amount (p < 0.002) of fine and ultrafine particles than the OpT and pMDI alone. The OpT resulted in a significantly higher fraction of fine particles (p < 0.05) and a greater quantity of drug (p < 0.05) in the ultrafine range as compared to the MDI only. The sizes of particles obtained from the bottle spacers are those that have a high probability of reaching the lower airway; however, the clinical relevance of these findings remains to be determined.

Asthma↗
PubMedDate not supplied

[Metered-dose inhalers with home-made spacers versus nebulizers to treat moderate wheezing attacks in children].

OBJECTIVE: To compare the effectiveness of salbutamol administration by metered-dose inhaler with a home-made spacer versus jet nebulizer in children with moderate wheezing attacks. MATERIAL AND METHODS: A randomized, single-blinded trial was performed with a convenience sample of children presenting wheezing. The children were enrolled in an emergency room and randomly assigned to one of two treatment groups: home-made spacer group or nebulizer group. Clinical scores and oxygen saturation were recorded at baseline and 15 minutes after salbutamol administration. Treatment with salbutamol (100 microg/3 kg in the spacer group, and 250 microg/3 kg in the nebulizer group) was repeated at 20-minute intervals, until the child was considered to have improved significantly, with no need of any further dose, or until three doses were delivered. Treatment cost, time spent to prepare and deliver the drug, and level of parental satisfaction with the treatment were recorded. RESULTS: Fifty-four children with age between 22 days and 11.7 years were enrolled--27 in each group. Baseline and demographic characteristics were similar for both groups. The spacer was as effective as the nebulizer in terms of clinical score and oxygen saturation. The different doses (100 microg/3 kg with the spacer, and 250 microg/3 kg with the nebulizer) were shown to be clinically equivalent. Treatment cost was significantly lower in the spacer group, as was the time to prepare and deliver the drug. Parental satisfaction was similar for both inhaler devices. CONCLUSION: The home-made spacer with a metered-dose inhaler is a cost-effective alternative to a jet nebulizer in the delivery of salbutamol to children with moderate wheezing attacks.

Albuterol↗
PubMed2006

Randomized controlled trial of ipratropium bromide and salbutamol versus salbutamol alone in children with acute exacerbation of asthma.

OBJECTIVE: To evaluate effect of addition of ipratropium to salbutamol delivered by metered dose inhaler and spacer in the beginning of treatment of mild to moderate exacerbation of asthma. METHODS: Children between 5 to 15 years of age with mild to moderate exacerbation of asthma were randomized to receive either a combination of ipratropium bromide and salbutamol or salbutamol alone administered by metered dose inhaler and spacer. The effects on clinical asthma score and spirometric parameters were compared. RESULTS: A total of 60 children were randomized in the study. The baseline characteristics of two groups were comparable. Children getting combination of salbutamol and ipratropium showed significantly greater improvement in percent-predicted PEFR and FEF25-75% than children receiving salbutamol alone. CONCLUSION: There was beneficial effect of addition of ipratropium to salbutamol administered by MDI with spacer at the beginning of therapy for mild to moderate acute exacerbation of asthma in children.

Adolescent↗
PubMed2000

Cost comparison of bronchodilator delivery methods in Emergency Department treatment of asthma.

Various methods of bronchodilator delivery are used in the Emergency Department, with similar efficacy. Our goal was to compare the costs of intermittent updraft nebulization, continuous nebulization, and metered-dose inhaler with spacer. Comparison was made for an average 1-h treatment. Material costs to the hospital were ascertained, and labor costs were estimated from salary and time studies in our urban community hospital. In this setting, the total cost for intermittent updraft nebulization was $11.66 for 1 h (three treatments). Cost for continuous nebulization was $9.66. Metered-dose inhaler with spacer had a cost of $15.45 for 1 h (three treatments). For the Emergency Department treatment of asthma, continuous nebulization may be a less costly method of bronchodilator delivery.

Administration, Inhalation↗
PubMed1992

Clinical comparison of Gentle-Haler Actuator and Aerochamber Spacer for Metered Dose Inhaler (MDI) use by asthmatics.

UNLABELLED: Spacing devices such as the Aerochamber have been shown to improve delivery of medication from MDIs in patients who could not use proper technique with an MDI alone, but the Aerochamber may be inconvenient to carry & use because of its bulkiness. We therefore compared clinical responses of asthmatics using a new, smaller MDI actuator (Gentle-Haler) with no spacer to their responses using a standard MDI actuator & spacer (Aerochamber). METHODS: We treated 30 asthmatic patients in 2 sessions with the beta-agonist albuterol using the above-mentioned devices. Both devices were utilized in each treatment session, with one delivering albuterol & the other generating a placebo. During the second session on a different day, the albuterol & placebo were reversed with respect to the two devices. On each study day, physiologic measurements of FEV1, FVC, FEF25-75, blood pressure, & pulse were obtained at pretreatment (baseline) & after treatment at 15 & 30 minutes & 1, 2, 3, 4, 5 & 6 hours. Analysis of variance & Student's t test were used to compare the ratio of physiologic responses to albuterol delivered with the two devices. RESULTS: Both devices were equally effective in eliciting desirable increases in FEV1, FEF25-75, & FVC. No statistically significant differences (5% significance level) in effectiveness of the albuterol were associated with the use of either device. A very small (< 7%) but statistically significant reduction in diastolic blood pressure (3 of 8 time points) & systolic pressure (1 of 8 time points) was associated with the use of the Gentle-Haler.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1999

Once-daily inhaled corticosteroids in children with asthma: nebulisation.

Current guidelines on the management of childhood asthma have emphasised the important preventive role of inhaled corticosteroids, which should be used at the lowest possible doses that are compatible with good disease control. However, some children do not respond to inhaled corticosteroids, the most common reasons for which are inability to use conventional hand-held inhalers (plus spacers and face masks) effectively or lack of cooperation with them, particularly among infants and young children. In these patients, nebulisers have proved effective in administering corticosteroids, and this form of delivery is often preferred by both the children and their parents, despite their longer administration times (commonly around 10 minutes). Compliance with these devices may therefore be better than with a conventional pressurised metered-dose inhaler plus spacer and face mask. Recent studies with nebulised budesonide have demonstrated that once-daily administration is as effective in maintaining control of asthma symptoms in children as the usual twice-daily administration. In children with moderately severe persistent asthma, the improvement provided by once-daily nebulised doses of 1.0 mg budesonide has been found to be equivalent to that with twice-daily doses of 0.25 or 0.5 mg, indicating that once-daily therapy is an effective option that can be considered in many patients. In view of the time-consuming nature of nebuliser administration, reduction of the frequency of corticosteroid administration from twice to once daily may be useful in simplifying the treatment programme and improving compliance with it. This may be beneficial in reducing under-utilisation of inhaled corticosteroids in children with asthma and improving long term control of the disease.

Administration, Inhalation↗
PubMed2002

Estimation of the dose of fluticasone propionate inhaled by infants after bronchiolitis: Effect on urinary cortisol excretion.

BACKGROUND: Information on the dose of steroid infants inhale from spacer devices and its potential effect on adrenal suppression is limited. OBJECTIVE: We sought to determine the total dose of fluticasone propionate (FP) inhaled from a spacer device (Babyhaler) with face mask attachment by infants recovering from acute bronchiolitis and the effect of inhaled FP on the infants' overnight urinary cortisol/creatinine ratios (UCCRs). METHODS: Infants studied were recovering from acute bronchiolitis. In study 1, 22 infants inhaled 150 microg of FP through the Babyhaler. The likely inhaled dose was estimated by trapping it on a filter held within the face mask. In study 2, 40 infants had UCCRs measured before and during 3 months of treatment with either FP (150 microg twice daily, n = 20) or placebo (n = 20). RESULTS: In study 1 the mean +/- SD dose of captured FP was 12.8 +/- 6.9 microg (ie, 2.1 +/- 1.2 microg/kg). In study 2 the pretreatment UCCR medians (interquartile ranges) were as follows: FP, 22.8 (23.0) nmol/mmol; placebo, 24.0 (28.3) nmol/mmol. Within-group UCCR changes (median and interquartile range DeltaUCCR) were significantly different in the FP group (-8.9 and -20.6 nmol/mmol at 6 weeks and -12.6 and -25.9 nmol/mmol at 12 weeks, respectively; P =.0008) but not in the placebo group ( -5.8 and -10.7 nmol/mmol at 6 weeks and +0.3 and -17.9 nmol/mmol at 12 weeks, respectively; P =.45). Intergroup changes were insignificant in the follow-up period (6 weeks, P =.52; 12 weeks, P =.19). CONCLUSION: After bronchiolitis, infants are likely to inhale approximately 8 % of the nominal steroid dose from the Babyhaler. UCCRs can be used to monitor the bioavailability of inhaled steroids in young infants.

Acute Disease↗
PubMed1998

Inhaled flunisolide for acute severe asthma.

This randomized, double-blind trial was designed to determine the benefit of high and cumulative doses of flunisolide added to salbutamol in patients with acute asthma in the emergency room (ER). Ninety-four patients who presented to an ER for treatment of an acute exacerbation of asthma were assigned in a randomized, double-blind fashion to receive salbutamol and placebo (n = 47) or salbutamol combined with flunisolide (n = 47). Both drugs were administered successively through a metered-dose inhaler and spacer at 10-min intervals for 3 h (400 microg of salbutamol and 1 mg of flunisolide every 10 min). In both groups, FEV1 and peak expiratory flow rate (PEFR) improved significantly over baseline values (p < 0.01). Results in the flunisolide group were significantly different from those in the placebo group at 90, 120, 150, and 180 min. Data analyzed separately in accord with the duration of the attack before presenting at the ER (< 24 or > or = 24 h) showed that the placebo > or = 24 h group produced a significantly lower FEV1 at 120, 150, and 180 min (p = 0.041) than did the remaining groups. Our data support the theory that high and cumulative doses of inhaled flunisolide administered by metered-dose inhaler with spacer and added to salbutamol are an effective therapy for patients with acute asthma and a prolonged duration of symptoms before ER presentation.

Acute Disease↗
PubMed1993

[High dose steroid inhalation therapy using a large spacer: laboratory and clinical study on usefulness of the 4-puffs/inhalation method].

We investigated whether or not the inhalation method of beclomethasone dipropionate (BDP) influences patient compliance and the clinical effects of therapy in chronic bronchial asthma, together with a basic study on the lung deposition of BDP using a twin Impinger when various numbers of puffs were discharged into three different spacers (Volumatic, InspirEase, Aerochamber). It was clearly shown that only the spacer, Volumatic maintained a high deposition rate of BDP in the lung model with a dose of 4-puffs/inhalation. Eighteen chronic asthmatic patients were studied. The patients inhaled BDP (800-1600 micrograms/day) by 1-puff/inhalation using a large spacer, Volumatic, for 12 weeks, and they then inhaled the same dose of BDP as given in the previous period by 4-puffs/inhalation using the spacer for 16 weeks. We compared the compliance of BDP, attack score, %PEFR and frequency of beta-agonist inhalation between these two periods. The compliance of BDP was markedly improved after changing from 1-puff/inhalation (92.8%) to 4-puffs/inhalation (99.8%). In the 4-puffs/inhalation period, attack score and %PEFR were significantly improved as compared to the 1-puff/inhalation period. The frequency of beta-agonist inhalation use in the 4-puffs/inhalation period was significantly lower than that in the 1-puff/inhalation period. These results indicate that when high dose steroid inhalation is given with a large spacer in chronic asthmatic patients, we should advice them of the appropriate inhalation method in order to obtain good compliance and clinical effects.

Adult↗
PubMed2006

Formoterol Turbuhaler as reliever medication in patients with acute asthma.

The aim of this study was to compare the efficacy and safety of formoterol versus salbutamol as reliever medication in patients presenting at an emergency dept with acute asthma. A randomised, double-blind, double-dummy, parallel group study was performed in four Australian emergency treatment centres. The study included a total of 78 adult patients (mean baseline forced expiratory volume in one second (FEV1) 1.83 L; 59% predicted) with acute asthma. Based on the expected dose equivalence of formoterol Turbuhaler 4.5 microg (delivered dose) and salbutamol pressurised metered-dose inhaler 200 microg (metered dose), patients received a total of formoterol Turbuhaler 36 microg (delivered) or salbutamol pressurised metered-dose inhaler with spacer 1,600 microg (metered), divided into two equal doses at 0 and 30 min. FEV1, peak expiratory flow and systemic beta2-agonist effects were monitored for 4 h. The primary variable was FEV1% pred at 45 min. At 45 min, mean increases in FEV1 expressed in % pred were 6.6% and 9.3%, respectively, with a small adjusted mean difference in favour of salbutamol (3.0%, 95% confidence interval -2.0-8.0). Transient increases in systemic beta2-agonist effects occurred predominantly with salbutamol, although no significant treatment differences were observed. Eight patients discontinued due to adverse events. In this study of patients presenting at emergency depts with acute asthma, formoterol Turbuhaler 36 microg was well tolerated and, as rescue therapy, had an efficacy that was not different from that of salbutamol pressurised metered-dose inhaler with spacer 1,600 microg in the number of patients studied.

Acute Disease↗