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PubMed2004

Twelve-month safety and efficacy of inhaled fluticasone propionate in children aged 1 to 3 years with recurrent wheezing.

OBJECTIVE: Our aim was to compare the 12-month safety and efficacy of fluticasone propionate (FP) and sodium cromoglycate (SCG) in children aged 1 to 3 years with mild to moderate recurrent wheeze. METHODS: The study was a randomized, parallel-group, open-label multicenter study of 625 children, aged 1 to 3 years, with recurrent wheeze randomized in a 3:1 ratio to treatment for 52 weeks with FP (100 microg twice daily) via metered-dose inhaler and Babyhaler spacer device or SCG (5 mg 4 times daily) via metered-dose inhaler and Nebuhaler spacer device, respectively. RESULTS: There was no significant difference in mean adjusted growth rates between the 2 groups: 84.0 mm/year in the FP group versus 86.4 mm/year in the SCG group (difference FP-SCG: -2.4 mm/year; 95% confidence interval: -6.6 to 1.8). Growth comparisons were independent of age, gender, previous use of steroid, or whether measured as length and/or height. Serum and urinary cortisol concentrations showed a statistically significant suppression of 10% and 14%, respectively, but the number of patients with serum cortisol levels below the lower normal limit was reduced during the trial. Both treatments were well tolerated. The most common drug-related adverse events were cough (2% FP vs 1% SCG) and hoarseness (1% FP vs 0% SCG). One incident of cataract was observed at baseline and 1 after FP treatment; the latter had resolved after 12 months. The efficacy of FP was superior to SCG with fewer cases of symptom worsening, exacerbations, and requirements for oral steroid treatment and more symptom-free days and days without use of rescue treatment. CONCLUSIONS: Twelve months of treatment with inhaled FP (100 microg twice daily) in preschool children aged 1 to 3 years with recurrent wheeze has no effect on growth and no other clinically important side effects but is more efficacious than SCG.

Administration, Inhalation↗
PubMed1994

Multiple actuations of salbutamol MDI into a spacer device reduce the amount of drug recovered in the respirable range.

We wanted to determine the amount of salbutamol available in respirable particles from the Volumatic spacer device after one, two or five actuations of a metered-dose inhaler into the spacer prior to analysis. A glass multistage liquid impinger was used to determine particle size. Aerosol was sampled after one, two or five actuations from a metered-dose inhaler into a Volumatic spacer. Each experiment was repeated four times. The amount of salbutamol recovered per actuation in particles less than 5 microns (mean and 95% confidence intervals) was: 54.3 micrograms (48.3-60.1) after one actuation; 42.4 micrograms (38.2-46.5) after two actuations, and 20.7 micrograms (17.5-23.9) after five actuations. We conclude that multiple actuations of salbutamol into the Volumatic spacer do not linearly increase the amount of drug available for inhalation. To maximize drug delivery, single actuations should be used prior to inhalation. In comparative studies of drugs and dosages, it must be remembered that the amount of drug delivered is not the same as that administered.

Administration, Inhalation↗
PubMed1987

[Bronchodilating effect of terbutaline inhaled with and without a tube spacer in asthmatic children].

Eighteen children aged 10.3 +/- 2.4 years who needed regular use of antiasthmatic drugs and showed after abandoning them with the appropriate intervals a FEV1 below 85% of their highest previous value, received in a randomized, double-blind crossover fashion two puffs of terbutaline 1 hour apart on two consecutive days. The drug was administered either with the conventional inhaler or a 10.3 X 2 cm. Forced spirometry, peak flow, flow-volume loops, and whole body plethysmography were performed basally, and 5, 15 and 45 minutes after each puff. The peak increase of the FEV1 was greater with the spacer (41.7% vs 30.4%, p less than 0.05). The increase of FEV1 was higher with the spacer at 5 minutes following the first puff and at 15 and 45 minutes after the second puff. No difference was observed in the other variables measured. Sixteen inhaled the drug "coordinatedly". The spacer offers some advantage in asthmatic children who inhale terbutaline mostly in a coordinated way.

Administration, Inhalation↗
PubMedDate not supplied

Inhaled beclomethasone dipropionate administered through a new spacer device: a controlled clinical study.

This 4-week, randomized, parallel-group study compared the efficacy and safety of a metered-dose inhaler equipped with a new spacer device (Jet spacer) with those of a standard actuator in the administration of inhaled beclomethasone dipropionate (0.5 mg twice daily) in 66 adults with chronic obstructive pulmonary disease (COPD) who were responsive to beta 2-agonists. Lung function values, symptom scores, and daily consumption of a beta 2-agonist determined efficacy. At baseline and after treatment, levels of morning serum and 24-hour urinary cortisol were measured in half of the patients (one center). Ease of use of the two devices was expressed by patients at the final visit. Lung function values and clinical symptoms improved in both groups (P < .01 at the final visit); the Jet group reported a better outcome (P < .05 between groups) than the standard-actuator group for predicted normal values of forced expiratory volume in 1 second, forced vital capacity, and bronchial noises. Salbutamol consumption decreased in both groups. One patient in the Jet group and 5 patients in the standard-actuator group reported adverse reactions. No significant between-group differences were found in plasma and urinary cortisol levels. The Jet device was judged easier to use (P < .05 between groups) than the standard actuator. In conclusion, the jet device was more effective than a standard actuator in reducing local adverse reactions to inhaled beclomethasone dipropionate in adults with COPD, with a better efficacy profile.

Adolescent↗
PubMed1993

[Efficacy and tolerance of terbutaline and budesonide administered via a pressurized aerosol inhaler or a Turbohaler in asthmatic patients].

35 asthmatic patients, aged from 23 to 73 years, participated in an open study aimed to compare the efficacy and tolerance of terbutaline and budesonide administered in similar amounts with a metered-dose inhaler fitted with a spacer (Nebuhaler) or by a powder inhaler (Turbuhaler). The patients used each device for seven weeks after a running-in phase of two weeks and gave at the end their preference for one or the other mode of administration. Among lung function values, the forced expiratory volume in the first second (FEV1) was significantly higher during the Turbuhaler period than during the period with metered-dose inhaler whereas the forced vital capacity, mid-expiratory flow rate and peak-flow morning and evening were not significantly different. The use of beta 2-bronchodilators and clinical scores were similar with a non-significant trend in favor of the Turbuhaler period. 25 patients on 35 expressed a preference for the Turbuhaler. The administration of terbutaline and budesonide by Turbuhaler is similarly or more efficient then the inhalation from a metered-dose inhaler with a Nebuhaler spacer and is preferred by a majority of patients.

Administration, Inhalation↗
PubMed1997

Lung delivery of salbutamol by dry powder inhaler (Turbuhaler) and small volume antistatic metal spacer (Airomir CFC-free MDI plus NebuChamber).

As a worldwide ban on the use of chlorofluorocarbons (CFCs) in inhaler devices approaches, considerable attention has been focused on the production of CFC-free delivery devices. The aim of our study was to compare the delivery of salbutamol by dry powder inhaler (DPI), Turbuhaler and a CFC-free metered-dose inhaler (MDI), Airomir, used with a novel small volume metal spacer (NebuChamber). Ten healthy volunteers, mean (SEM) age 21 (0.7) yrs were studied in a randomized, single (investigator)-blind cross-over design. Single doses of 1,200 microg salbutamol, from Turbuhaler DPI and Airomir CFC-free MDI via a NebuChamber, were given as 12 sequential 100 microg inhalations over 6 min. The lung delivery of salbutamol was assessed by measuring the plasma salbutamol profile over the first 20 min after inhalation. Plasma salbutamol concentration was expressed as maximal (Cmax) and average (Cav) value. Significant differences (p<0.001) were found between the NebuChamber (N) and the Turbuhaler (T) for salbutamol Cmax and Cav. This amounted to a 1.89 fold difference (95% CI 1.56-2.22) between these devices for Cmax, and a 1.78 fold difference (95% CI 1.42-2.15) for Cav. We have demonstrated that, in vivo, salbutamol from a chlorofluorocarbon-free metered-dose inhaler given via a small volume metal spacer (NebuChamber) produces significantly greater delivery than from an efficient dry powder inhaler (Turbuhaler).

Administration, Inhalation↗
PubMedDate not supplied

[Response to bronchodilator administered directly with spray or with spacer].

If we assume that the only function of a spacer is that to facilitate the esecution of a spray, its use is limited to small children who do not collaborate (below age 6-7 years). However, spacers seem to improve the effectiveness of drugs and reduce both directly and indirectly the side effects. The assess if these characteristics have a role in clinical practice, the response to 100 micrograms of salbutamol administered directly by Autohaler was compared to that obtained with the same dose administered with three different spacers, Aerochamber, Babyhaler, Volumatic. A series of 88 asthmatic subjects with a FEF 25-75 less than 70% of the predicted value was considered. Overall patients provided 118 responses to the bronchodilator: 17 using the Aerotec (Autohaler), 38 the Aerochamber, 33 the Babyhaler, 30 the Volumatic. The response was evaluated considering the parameters obtained by spirometry just before, 5 and 20 minutes after the inhalation of salbutamol. Heart rate was also measured at the same time points. Heart rate, but not spirometric parameter were increased by the use of the Autohaler, proving that the drug had been inhaled. All the spacers determined a significant increase in the parameters considered. No significant difference was detected among spacers, although the smallest (Aerochamber, Babyhaler) showed a trend to a better response, in particular before age 7 years. The complete ineffectiveness of direct inhalation and the excellent response to inhalation with spacers show the indispensability of the latter, independent of age. Although no substantial difference among spacers was detected, the trend to obtain a better response with smaller spacers inclines us to use them in particular between 4 and 7 years of age. The negative correlation between the increase in spirometric parameters and the age of the patient would allow to have doses aimed to age or to body weight.

Administration, Inhalation↗
PubMed1990

Nasal inhalation of the glucocorticoid budesonide from a spacer for the treatment of patients with pollen rhinitis and asthma.

Glucocorticoid sprays are increasingly used for the treatment of allergic rhinitis and asthma. This therapy is highly effective, and side effects are few and mild. It was the aim of the present study to evaluate a physiological nasal inhalation technique, which results in airway deposition of the steroid molecule similar to that of inhaled allergen particles. Thirty adults with grass pollen-induced rhinitis and asthma inhaled the steroid molecule budesonide through the nose from a pressurized aerosol attached to a spacer device. Compared with inhalation of placebo, the treatment resulted in a significant reduction of nasal symptoms (P = 0.005), of bronchial symptoms (P = 0.005), but not of eye symptoms. In addition, nasal peak inspiratory flow (P = 0.0003) and oral peak expiratory flow (P = 0.02) increased. There was no difference between budesonide and placebo with regard to local side effects, such as nose bleeding, hoarseness, and irritation in mouth and throat. It is concluded that nasal inhalation of a steroid from a spacer offers effective therapy of pollen rhinitis and asthma without significant local side effects. This therapeutic modality may have advantages over the ordinarily used nasal and bronchial spray treatment in patients with both rhinitis and asthma, especially when conventional spray therapy is associated with local side effects.

Administration, Topical↗
PubMed1995

Comparison of gamma scintigraphy and a pharmacokinetic technique for assessing pulmonary deposition of terbutaline sulphate delivered by pressurized metered dose inhaler.

A comparison has been made of pulmonary deposition of terbutaline sulphate from a pressurized metered dose inhaler (pMDI), measured in 8 healthy male subjects by gamma scintigraphy and by a pharmacokinetic (charcoal-block) method, involving drug recovery in urine. Measurements were carried out with a pMDI at slow (27 l/min) and fast (151 l/min) inhaled flows and with Nebuhaler large volume spacer device (average inhaled flow 17 l/min). Overall, the two methods did not differ significantly in their estimates of whole lung deposition, although values obtained by gamma scintigraphy exceeded those from the charcoal-block method for the pMDI with fast inhalation. The regional distribution of drug within the lungs and deposition in the oropharynx could be assessed by gamma scintigraphy, but not by the charcoal-block method. It is concluded that either method may be used to assess whole lung deposition of terbutaline sulphate from pMDIs, both with and without a spacer, although each method has its own inherent advantages and disadvantages.

Adult↗
PubMed2004

In vitro performance characteristics of valved holding chamber and spacer devices with a fluticasone metered-dose inhaler.

STUDY OBJECTIVE: To compare the in vitro aerosol deposition characteristics of several commercially available valved holding chamber (VHC) and spacer devices used with a fluticasone metered-dose inhaler (MDI). DESIGN: In vitro aerosol deposition study SETTING: University-affiliated research center. DEVICES: Seven VHC devices: BreatheRite, E-Z Spacer, EasiVent, AeroChamber, InspirEase, OptiChamber, and Space Chamber. Six spacer devices: OptiHaler, Aerosol Cloud Enhancer (ACE), Gentle-Haler, MediSpacer, Ellipse, and a 6-inch tube (1-inch inside diameter). INTERVENTION: The respirable dose (aerosol particles 1-5 microm) of fluticasone was determined by sampling 10 220-microg actuations from five runs with each spacer or VHC plus MDI combination, by using a well-established in vitro cascade impactor method. MEASUREMENTS AND MAIN RESULTS: Fluticasone aerosol was washed from the impactor with methanol and quantified by means of high-performance liquid chromatography. Differences among outcomes were determined with analysis-of-variance testing. Among spacers, Ellipse had the highest respirable dose (104 microg, p < 0.01). Respirable doses for the 6-inch tube (74.3 microg), Gentle-Haler (81.7 microg), and MediSpacer (82.6 microg) were no different from that of the MDI (p > 0.05), whereas respirable doses of OptiHaler (44.6 microg) and ACE (47.2 microg) were less than those of all other spacers (p < 0.001). Among VHC devices, respirable doses from EasiVent (35.6 microg), AeroChamber (47.0 microg), InspirEase (52.7 microg), OptiChamber (53.1 microg), and Space Chamber (58.3 microg) were not different (p > 0.05), whereas BreatheRite (13.1 microg) and E-Z Spacer (27.3 microg) respirable doses were less than those of the other VHC devices (p < 0.05). CONCLUSION: Spacers and VHC devices available in the United States do not demonstrate equivalent in vitro performance with the fluticasone MDI. The difference between highest and lowest respirable doses in each device category would likely lead to clinically relevant differences in the quantity of fluticasone delivered to a patient.

Aerosols↗
PubMed1999

A comparison of bronchodilator therapy delivered by nebulization and metered-dose inhaler in mechanically ventilated patients.

BACKGROUND: The optimal method of delivering bronchodilators in mechanically ventilated patients is unclear. The purpose of this study was to compare the pulmonary bioavailability of albuterol delivered by the nebulizer, the metered-dose inhaler (MDI) and spacer, and the right-angle MDI adaptor in ventilated patients using urinary analysis of drug levels. METHODS: Mechanically ventilated patients who had not received a bronchodilator in the previous 48 h and who had normal renal function were randomized to receive the following: (1) five puffs (450 microg) of albuterol delivered by the MDI with a small volume spacer; (2) five puffs of albuterol delivered by the MDI port on a right-angle adaptor; or (3) 2.5 mg albuterol delivered by a nebulizer. Urine was collected 6 h after the administration of the drug, and the amounts of albuterol and its sulfate conjugate were determined in the urine by a chromatographic assay. RESULTS: Thirty patients were studied, 10 in each group: their mean age and serum creatinine level were 62 years and 1.3 mg/dL, respectively. With the MDI and spacer, (mean +/- SD) 169+/-129 microg albuterol (38%) was recovered in the urine; with the nebulizer, 409+/-515 microg albuterol (16%) was recovered in the urine; and with the MDI port on the right-angle adaptor, 41+/-61 microg albuterol (9%) was recovered in the urine (p = 0.02 between groups). The level of albuterol in the urine was below the level of detection in four patients in whom the drug was delivered using the right-angle MDI adaptor. CONCLUSION: The three delivery systems varied markedly in their efficiency of drug delivery to the lung. As previous studies have confirmed, this study has demonstrated that using an MDI and spacer is an efficient method for delivering inhaled bronchodilators to the lung. The pulmonary bioavailability was poor with the right-angle MDI port. This port should not be used to deliver bronchodilators in mechanically ventilated patients.

Administration, Inhalation↗
PubMed1999

A comparative analysis of the particle size output of beclomethasone diproprionate, salmeterol xinafoate and fluticasone propionate metered dose inhalers used with the Babyhaler, Volumatic and Aerochamber spacer devices.

AIMS: To determine in vitro the effect of delay, inspiratory flow, and spacer washing on the drug output of metered dose inhalers (MDIs) used with different spacer devices. METHODS: The amount of drug in particles <5 microm diameter from MDI+spacer, sampling after a delay of up to 20 s, was measured using a Multistage Liquid Impinger. Drug output was also measured at different flow rates, and after washing the Babyhaler in household detergent. RESULTS: More fluticasone in small particles was recovered from the Babyhaler than the Volumatic or the Aerochamber spacers, and more beclomethasone and salmeterol was recovered from the Babyhaler and Volumatic spacers than from the Aerochamber. Washing the Babyhaler reduced the recovery of salmeterol, and did not alter the recovery of the other drugs tested. CONCLUSIONS: Spacer devices need to be fully evaluated for each drug prescribed for them.

Albuterol↗
PubMed2002

Drug delivery.

What we know: In preschool children, small-volume spacers perform better than large-volume spacers. Detergent is the best antistatic agent for spacers, increasing lung delivery two- to threefold, but it must not be rinsed off. A mouthpiece should be used in children aged 2-3 years or older, as lung delivery is two- to threefold higher for oral inhalation than nasal inhalation (ie, by mask). Inhaled drug doses do not generally need to be reduced in infants and young children owing to inefficiencies of delivery in younger patients. Nebulisers are "dinosaurs" and not needed for most children with asthma. What we need to know: What is the best inhalation technique for spacers? How long should children breathe, how many breaths should they take, and at what age should they breath-hold? How should children, parents and doctors be instructed to achieve optimal levels of electrostatic charge reduction for spacers? How much should inhaled steroid dose be reduced when a spacer is used optimally? What dosing instructions should be given for beta(2)-agonists delivered by spacer?

Administration, Inhalation↗
PubMed2001

Inhaled corticosteroids and growth.

Since inhaled corticosteroids may circulate systemically, a risk of growth suppression in asthmatic children treated with these drugs cannot be ruled out. When assessing the risk, specific drugs, delivery systems, doses, administration regimens, and compliance with treatment regimens must be considered. Although reassuring results have been reported, methodological flaws have meant that the published follow-up evaluations of final height may not be valid for the sound assessment of any growth effects of inhaled corticosteroids. Short-term studies suggest that twice-daily administration of budesonide 200-400 microg delivered from a metered-dose inhaler with a spacer, dry powder budesonide 200 microg, and fluticasone propionate 200 microg per day in children with mild asthma, are not associated with growth-rate effects. The risk may become significant with budesonide 800 microg administered via a metered-dose inhaler with a spacer, and with 400 microg from a dry powder inhaler. The risk of growth suppression can be reduced by dosing once daily in the morning. In children with severe asthma, high doses of inhaled corticosteroids may be potentially lifesaving and thus outweigh the potential risk of mild growth suppression.

Administration, Inhalation↗
PubMed1997

Ambulatory inhalation therapy in obstructive lung diseases.

The inhalation route is widely used for the treatment of obstructive lung diseases, because administered drugs have a high therapeutic index as they reach their target directly; this requires that they be of adequate size to penetrate the conducting airways, i.e. 2-5 microns. Pressurized inhalers were the first reliable metered-dose devices available, and are still the most frequently used. However, metered-dose inhaler (MDI) suspensions will have to be reformulated: they contain chlorofluorocarbons (CFCs), whose production has to be stopped within a few years, as they affect the stratosphere. Another limitation of MDI usage is paradoxical bronchospasm; this phenomenon, however, occurs in a low number of patients and is rarely clinically relevant. The main cause of concern with MDIs is their misuse by more than 50% of patients, which leads to a reduced lung deposition and clinical efficacy. Therefore, other inhalation devices have been developed: spacers, dry-powder inhalers (DPIs), and breath-actuated MDIs have been shown to increase lung deposition of drugs in poor coordinators. However, all have limitations which may have varying consequences on clinical efficacy: cumbersome dimensions of spacers, effect of inspiratory flow rate and humidity on lung deposition of dry powders, need for reformulation with CFC-free gases for breath-actuated pressurized inhalers. Reformulation of MDI aerosols is a complex procedure, which may not be feasible for all drugs. The new products need extensive toxicological and clinical testing, as some of their characteristics may differ from those of their predecessors.

Aerosols↗
PubMed2006

Speed of onset of bronchodilator response to salbutamol inhaled via different devices in asthmatics: a bioassay based on functional antagonism.

AIMS: To evaluate the speed of onset of bronchodilation following salbutamol administered via a metered-dose inhaler with a spacer (pMDI + Volumatic) and a dry-powder inhaler (Diskus), as well as the relative potencies of these devices in asthmatic patients with methacholine-induced bronchoconstriction. METHODS: Eighteen patients inhaled methacholine (MCh) until FEV(1) decreased by 35% of control. Following administration of placebo, 200 microg salbutamol or 400 microg salbutamol through the pMDI + Volumatic or the Diskus, we calculated the time elapsed from drug administration and the appearance of a 90% increase in post-MCh forced vital capacity (FVC), FEV(1) and volume-adjusted mid-expiratory flow (recovery times). The salbutamol doses to be delivered by the two inhalation devices to achieve similar recovery times and the relative potencies of the devices were calculated by using the 2-by-2 Finney parallel regression method. RESULTS: For all functional variables, recovery times were significantly (P < 0.01) shorter in pMDI + Volumatic than Diskus trials. The salbutamol doses to be delivered by the Diskus to achieve recovery times for FVC, FEV(1) and volume-adjusted mid-expiratory flow similar to those obtained with 200 microg salbutamol administered via the pMDI + Volumatic were 558 (95% CI 537, 579) microg, 395 (95% CI 388, 404) microg and 404 (95% CI 393, 415) microg, respectively, and corresponded to relative potencies of 2.79 (95% CI 2.68, 2.90), 1.98 (95% CI 1.94, 2.02), and 2.02 (95% CI 1.96, 2.07). CONCLUSIONS: Administration of salbutamol via the pMDI + Volumatic provides faster reversal of induced bronchoconstriction than via the Diskus. The salbutamol dose targeting the lungs with the pMDI + Volumatic is approximately twice that with the Diskus.

Administration, Inhalation↗
PubMed2006

Ability of preschool children to use dry powder inhalers as evaluated by In-Check Meter.

BACKGROUND: Although current guidelines recommend the pressurized metered-dose inhaler with a spacer for preschool children with asthma, dry powder inhalers (DPI) may be a valuable treatment alternative. METHODS: To evaluate the ability of preschool children to inhale through DPI, peak inspiratory flow rates (PIFR) of 57 healthy children aged 3-6 years were measured with In-Check Meter after practising with an instructor. Two different calibrated resistances were attached to the Meter to mimic the internal resistance of each inhaler; Diskus and Turbuhaler. RESULTS: The ability of children to generate adequate inspiratory flow increased with age. The percentages of the 3-, 4-, 5-, and 6-year-old children who were able to inhale reliably through the devices were 30% (3/10), 79.0% (15/19), 100% (16/16), and 100% (12/12), respectively. In these children, 100%, 93.3%, 100%, and 100% achieved an adequate PIFR for the Diskus (30 L/min). In contrast, 66.7%, 66.7%, 62.5%, and 91.7% generated an adequate PIFR for the Turbuhaler (60 L/min). CONCLUSIONS: The In-Check Meter is a useful device to assess the ability of preschool children to generate adequate PIFR for each inhaler. Most children aged > or =5 years could use DPI.

Age Factors↗