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PubMed1996

Inhalers and nebulizers: which to choose and why.

It is obvious that many factors should be considered when an inhaler is prescribed. Based upon the information discussed above, a rational inhaler strategy could be as follows: (1) Children < or = 5 years and elderly patients are prescribed a spacer with a valve system (and a face mask for the children) for the delivery of all drugs. When they are severely obstructed, some may need a nebulizer. If the patient cannot be taught the correct use of a spacer, a nebulizer should be prescribed. (2) Children > or = 5 years and adults are prescribed a spacer or a Turbuhaler for the administration of inhaled corticosteroids and a dry powder inhaler (preferably multiple dose) or a breath-actuated MDI for other drugs. If these alternatives are not available or the patient prefers, a conventional MDI can be used (preferably not for other corticosteroids than fluticasone propionate) provided that careful tuition is given. Fluticasone dipropionate may be given by DPI, Spacer or MDI. (3) Nebulizers are mainly reserved for severe acute attacks of bronchoconstriction. With this approach, most patients can be taught effective inhaler use with a minimum of instructional time. Finally, it must always be remembered to consider the patient's wish, since prescription of an inhaler which the physician likes but the patient does not is likely to reduce compliance.

Administration, Inhalation↗

PubMedDate not supplied

[The best way to apply aerosol therapy. I--Methods].

The dimension of the particles delivered by a compressor-nebulizer system and therefore the ability to penetrate in the distal lung, varies according to different nebulizers. Moreover the aerosol is better in quality higher the flow furnished by the compressors is. The quantity of drug inhaled is greater as lower the residual amount of liquid left in the nebulizer is: the latter is less in glass nebulizers than in plastic nebulizers. The ultrasonic inhaler does not present any qualitative or quantitative advantages respect to the pneumatic inhaler. A very important point in the execution of an aerosol is oral respiration. The administration of the drug through a mouthpiece does not present substantial differences respect to the use of a face mask kept in a vertical position and adherent to the face. Metered-dose inhalers shorten the time of performance, but an active cooperation is needed; moreover the quantity of drug that resides in the oropharynx increases and consequently adverse effects, too. These two obstacles are overcome by the use of spacers which are chosen on the basis of the child's age. Aerosolic treatment has been simplified by the use of powders for inhalation, but we do not always obtain correct inhaling flows in children, especially when they are bronchoobstructed. Therefore compressor or ultrasonic aerosol is more useful in bronchoobstruction, while metered-dose inhalers with spacers are more useful in long-term treatment. Powder is usually used in children over 6-7 years of age and excludes the use of important drugs, such as cortisone, which may present relevant adverse effects.

Administration, Inhalation↗

PubMed2004

Simultaneous treatment of asthma and allergic rhinitis.

Asthma and allergic rhinitis (AR) form a well-recognized comorbidity. This study aims at assessing the efficacy of nasally inhaled beclomethasone dipropionate (BDP) in their simultaneous treatment. A randomized controlled trial was conducted with 78 allergic rhinitis and asthma patients aged 5-17 years. Seventy-five individuals completed the study. During 8 weeks, 38 subjects received BDP-CFC aerosol (>or= 500 mcg/day) exclusively via nasal inhalation through a facemask attached to a plastic valved spacer. The control group (37 patients) received 200 mcg/day of aqueous intranasal beclomethasone plus oral inhalation of BDP-CFC (>or= 500 mcg/day) through a mouthpiece connected to the same spacer. Primary outcomes analyzed in order to assess the response to treatment were clinical scoring for allergic rhinitis and measurements of nasal inspiratory peak flow (NIPF). AR clinical scoring and NIPF did not differ in the two groups at admission or at nearly all follow-up visits. Nasal inhalation of beclomethasone dipropionate provides AR symptom relief while maintaining control of asthma by delivering it to the lungs. Therefore, this therapeutic strategy might be considered for patients suffering from this comorbidity, especially in low-resource countries, since it is less expensive than the conventional treatment.

Anti-Asthmatic Agents↗

PubMed1995

Drug delivery in asthma: a comparison of spacers with a jet nebuliser.

BACKGROUND: Although spacer devices are frequently used for aerosol therapy in asthma, the commonly used spacers have undergone little controlled evaluation, and their relation to nebuliser therapy is unclear. AIMS: The aims of this study were to compare three delivery methods (Breath-A-Tech spacer, Volumatic spacer and jet nebuliser) for the administration of salbutamol to reverse acute histamine induced airway narrowing in asthma (Study 1); and to assess asthma control during two weeks use of inhaled therapy via Volumatic or Breath-A-Tech spacer (Study 2). METHODS: A randomised double-blind cross-over comparison was conducted. In Study 1, 27 adults with stable asthma who were currently using pressurised metered dose inhaler therapy attended for three study days. On each study day subjects inhaled doubling doses of histamine and were randomised to receive: (a) salbutamol 200 micrograms via Breath-A-Tech spacer and placebo 200 micrograms via Volumatic spacer; (b) placebo two puffs via Breath-A-Tech spacer and salbutamol 200 micrograms via Volumatic spacer; or (c) salbutamol 1 mg in 2 mL saline via jet nebuliser. FEV1 and FEF 25-75% were measured at two minute intervals for 20 minutes. In Study 2, subjects were randomised to use regular asthma medication by Volumatic or Breath-A-Tech spacers and recorded symptoms and peak expiratory flow (PEF) in a daily diary. RESULTS: Lung function improved from a baseline FEV1 of 51% predicted to 72% after salbutamol inhalation from each of the delivery systems. The spacers and nebulisers produced the same maximum improvement in FEV1, however, lung function improved more rapidly when salbutamol was delivered by spacer. There was no difference in asthma control comparing inhaler use via Breath-A-Tech with Volumatic spacer over two weeks use. Subject preference favoured the Breath-A-Tech spacer (72% vs 4%). CONCLUSIONS: The Volumatic and Breath-A-Tech spacer devices are effective delivery systems in asthma and may offer a more rapid response than jet nebulisation at a lower cost.

Adult↗

PubMed1994

Pharmacokinetic optimisation of asthma treatment.

Asthma is generally managed with bronchodilator therapy and/or anti-inflammatory drugs. Guidelines now advocate selection of drugs and pharmaceutical formulations (long-acting vs short-acting, inhaled vs systemic) on the basis of disease severity. Theophylline has a narrow therapeutic margin. Clearance is highly variable and plasma concentrations should be monitored to avoid the occurrence of plasma concentration-related adverse effects. The rate of absorption of theophylline differs depending on the sustained release formulation administered. Some products do not provide sufficient plasma drug concentrations for therapeutic efficacy over a 12-hour period, particularly in patients with high clearance rates (e.g. children and patients who smoke). Administration of drugs via inhalation offers several advantages over systemic routes of administration (e.g. adverse effects are decreased). Inhalation is now advocated as first-line therapy. Aerosol medications available for the treatment of asthma are beta 2-agonist (including the newer long-acting agents such as salmeterol), corticosteroids, anticholinergic drugs, sodium cromoglycate (cromolyn sodium) and nedocromil. To reach the airways, aerosolised particles should be 1 to 5 microns in diameter. Particles of this size can be produced by nebuliser for continuous administration or by metered-dose inhaler and drug powder inhaler for unit dose medication. For efficient use of the metered-dose inhaler, slow inhalation and actuation must be coordinated. However, efficacy and convenience can be improved when spacer devices are used. Furthermore, spacer devices lessen the oropharyngeal adverse effects of inhaled corticosteroids. Dry powder inhalers are more easily used by children and elderly patients than metered-dose inhalers. Regardless of the device used, a maximum of 10% of the inhaled dose reaches the airways. The rest of the dose is swallowed and absorbed through the gastrointestinal tract. Most inhaled drugs have low oral bioavailability, either because of a high first-pass metabolism (beta 2-agonists and glucocorticoids) or because of lack of absorption (sodium cromoglycate). Sulphation of beta 2-agonists occurs in the wall of the gastrointestinal tract and extensive metabolism of inhaled corticosteroids occurs in the liver. Low bioavailability of the swallowed fraction contributes to reduced adverse effects. The pharmacokinetic properties of an inhaled drug are of interest. The fraction of the dose absorbed through the lung has the same disposition characteristics as an intravenous dose, and the swallowed fraction has the same disposition as an orally administered dose. However, for many drugs, pharmacokinetic data after inhalation are limited and cannot be used as a criteria for selection of therapy.(ABSTRACT TRUNCATED AT 400 WORDS)

Administration, Inhalation↗

PubMed1991

Dry powder inhalers: advantages and limitations.

New inhalers have been developed because of difficulty of using the conventional metered dose inhaler (MDI) and because of the impending ban on CFC's. Dry powder inhalers (DPI's) in general are easier to use than the MDI and cause fewer irritant effects. Unlike the MDI few patients develop a poor inhalation technique with continued use of DPI's. Comparisons of multidose DPI's have shown that they achieve a similar degree of bronchodilatation to the MDI. Comparisons of the Diskhaler and Turbuhaler have shown little difference in therapeutic efficacy, but most indicate patient preference for the Turbuhaler. The inspiratory flow necessary to achieve a therapeutic effect is critical with DPI's. The majority of patients with severe acute asthma can achieve a peak inspiratory flow sufficient to inhale a bronchodilator from a Turbuhaler. DPI's cannot be used with spacers; this may be a disadvantage in patients who inhale large doses of steroids.

Administration, Inhalation↗

PubMed1996

Pilot study to assess the effect of inhaled corticosteroids on lung function in patients with cystic fibrosis.

OBJECTIVE: To determine the effect of inhaled corticosteroids on lung function in patients with cystic fibrosis. STUDY DESIGN: We report a pilot study of 49 patients with cystic fibrosis and moderate to severe bronchial obstruction (forced expiratory volume in 1 second < or = 55% of the predicted value); 25 patients were given inhaled corticosteroids for 30 days (1500 micrograms of beclomethasone via spacer), and 24 patients had the same standard treatment but no inhaled corticosteroids. RESULTS: Forced vital capacity, forced expiratory volume in 1 second, and airway resistance showed significant improvement in both study groups, but thoracic gas volume and the diffusion capacity of the lung for carbon monoxide improved significantly only in the group given inhaled corticosteroids. When concomitant medications were taken into account, analysis of variance confirmed a significant effect of inhaled corticosteroids on the improvement of thoracic gas volume. CONCLUSION: Inhaled corticosteroids in combination with standard treatment can contribute to the improvement of lung function in patients with cystic fibrosis and moderate to severe bronchial obstruction. Our preliminary data seem encouraging enough to warrant a multicenter, long-term, blind control study.

Administration, Inhalation↗

PubMed1983

Bronchodilation of terbutaline in small doses from a 750 ml spacer. A cumulative dose-response study.

The influence on lung function of small cumulative doses (31 + 31 + 63 + 125 + 250 micrograms) of terbutaline inhalations from a pressurized aerosol with a 750 ml spacer was evaluated in 12 stable asthmatics. The trial was double-blind and cross-over, using the double-dummy method. Lung functions was recorded 5, 30, and 60 min after each inhalation. No significant differences in FEV1, FVC and FMF25-75% were found between the two devices. A very marked response, which was not a placebo effect, was noted after the subjects had inhaled the first 31 micrograms dose. The results suggest that the number of inhalations is more important for the response in lung function than the dose administered. The addition of a 750 ml spacer to the pressurized aerosol is not likely to be beneficial for adults who are able to handle an ordinary aerosol properly.

Adult↗

PubMed1990

Particle size of beclomethasone dipropionate produced by two nebulisers and two spacing devices.

An impactor method was used to assess the amount of beclomethasone dipropionate in particles less than 5 microns produced by two nebulisers (Pari Inhalierboy, Medix Traveller compressor with cirrhus nebuliser chamber) and two spacer devices (Volumatic and Nebuhaler). After nebulisation of 3 ml (150 micrograms) beclomethasone dipropionate the amount of drug in particles less than 5 microns was 16 micrograms (GSD 1.1) with the Pari Inhalierboy, and 27 micrograms (1.4) with the Medix Traveller with cirrhus nebuliser. This was less than the amount in particles less than 5 microns after three metered dose inhaler actuations (150 micrograms) from the Nebuhaler (58.2 (1) micrograms) or the Volumatic spacer (46.5 (1) micrograms). The greater amount of beclomethasone dipropionate in small particles with administration from a metered dose inhaler with a spacer device means that considerably more drug is likely to reach the airways than when the same dose is given by the two nebulisers studied.

Beclomethasone↗

PubMed1999

The effect of inhaled fluticasone propionate in the treatment of young asthmatic children: a dose comparison study.

The response in asthmatic young children to inhaled steroids within the usual pediatric dose range is unknown. We therefore evaluated the dose-related response in young children with moderate asthma to inhaled fluticasone propionate (FP) (delivered via the Babyhaler spacer device) within the pediatric dose range. A total of 237 children (mean age 28 mo, range 12 to 47) with moderate asthmatic symptoms were studied in this multicenter, randomized, double-blind, parallel group, placebo-controlled study of 12 wk treatment following a 4-wk run-in period. The median use of rescue medication was 1 dose in 2 d during the run-in period. FP 50 micrograms twice daily (FP100) and 100 micrograms twice daily (FP200) was compared with placebo inhaled from a pressurized metered-dose inhaler (pMDI) and the Babyhaler spacer device. With FP200 there was a statistically significant improvement from baseline, as compared with the placebo group, in 8 of 10 diary card parameters, including the three symptom domains of wheeze, cough, and breathlessness, and use of rescue medication. FP100 produced a significant reduction in 5 of these 10 parameters, whereas no significant differences were found between the FP200 and FP100. The numbers of patients with at least one exacerbation during treatment with placebo, FP100, and FP200 were 37%, 26%, and 20%, respectively. This difference between placebo and FP200, as well as the dose-related order was significant (p < 0.05). Both FP doses were as well tolerated as placebo over the 12 wk treatment with a similar incidence of adverse effects. Asthmatic symptoms in 1- to 3-yr-old children responded in a significant and dose-related manner to treatment with FP within a pediatric dose range.

Administration, Inhalation↗

PubMed2006

Comparative efficacy of once-daily ciclesonide and budesonide in the treatment of persistent asthma.

BACKGROUND: The aim of this study was to compare the efficacy and safety of once-daily ciclesonide, a new-generation, on-site-activated, inhaled corticosteroid, with once-daily budesonide in persistent asthma. METHODS: Eligible patients requiring budesonide or equivalent 320-640 microg (ex-mouthpiece, equivalent to 400-800 microg; Turbohalertrade mark) daily entered a 2-week baseline, and then a 2- to 4-week pretreatment period (budesonide 1280 microg/day; ex-mouthpiece, equivalent to 1600 microg/day). Patients with an increase in forced expiratory volume in 1s (FEV1) of 7% or 0.15 L were randomised to ciclesonide 320 microg (ex-actuator, equivalent to 400 microg ex-valve) via a hydrofluoroalkane-metered dose inhaler (HFA-MDI) without a spacer or budesonide 320 microg once daily in the morning for 12 weeks. Change in FEV1 was the primary endpoint. RESULTS: In all, 359 patients were randomised. The FEV1 and forced vital capacity (FVC) decreased by 0.18 and 0.12L, respectively, in the ciclesonide group, and by 0.23 and 0.21L in the budesonide group. For FEV1, ciclesonide was noninferior and numerically superior to budesonide. For FVC, ciclesonide was statistically superior to budesonide (P=0.010). Asthma symptom scores were comparable; the median percentage of symptom-free days was significantly higher for ciclesonide (43.6%) versus budesonide (25.8%) (P=0.017). Rescue medication use decreased significantly only for ciclesonide patients (P=0.009). Frequency of adverse events was low in both groups. CONCLUSION: Ciclesonide 320 microg once daily by HFA-MDI without a spacer was at least as effective as budesonide 320 microg once daily in persistent asthma.

Administration, Inhalation↗

PubMed1995

Compliance with inhaled asthma medication in preschool children.

BACKGROUND: Previous studies have shown poor compliance with regular drug therapy in children and adults with asthma. In preschool children the parents supervise and are responsible for drug administration, but little is known of compliance in this group. In addition, there are few data on the patterns of drug use of inhaled prophylactic asthma therapy or of the relation between compliance and symptom control. A study was undertaken to address these issues with the hypothesis that parental supervision would result in good compliance. METHODS: The subjects were 29 asthmatic children aged 15 months to five years already established on inhaled prophylactic medication delivered through a large volume spacer. The prescribed drug regimens varied between subjects. This was an observational study using an electronic inhaler timer device to record the date and time of each actuation of the aerosol canister. Diary cards were used for parallel recording of symptoms and parentally reported compliance with a drug regimen. RESULTS: Variable and generally poor compliance was demonstrated with a median of 50% of study days with full compliance (subject range 0-94%) and an overall median of 77% of prescribed doses of therapy taken during the study period. No relation was found between frequency of prescribed regimen and good compliance. Day care was associated with poorer compliance. No relation between good compliance and low symptom scores was found. CONCLUSION: Compliance with inhaled prophylactic therapy is poor in preschool children with asthma whose medication is administered under parental supervision.

Administration, Inhalation↗

PubMed1998

A new beclomethasone dipropionate multidose powder inhaler in the treatment of bronchial asthma.

The clinical efficacy, tolerability and acceptability of a new multidose powder inhaler (MDPI) containing beclomethasone dipropionate (BDP) were compared with those of a BDP aerosol administered with a large volume spacer (MDI-spacer) among adult asthmatics currently receiving from 500 to 1,000 microgram/day of an inhaled corticosteroid. During the study, the dosage of BDP from both devices was 400 microgram twice daily. Ninety-one patients were randomized to the MDPI group and 42 to the MDI-spacer group. The trial was performed as an open, randomized, parallel group multicenter study. The duration of the treatment period was 12 weeks, and the study was preceded by a 2-week run-in period. During the run-in period, the mean morning peak expiratory flow (PEF) was 487 and 466 1/min in the MDPI and MDI-spacer groups, respectively. After the 12-week treatment, the morning PEF was 491 1/min in the MDPI group and 463 1/min in the MDI-spacer group. The evening values were 500 and 479 1/min during the run-in period and 496 and 476 1/min after the 12-week treatment, respectively. Asthma symptom scores and the use of rescue medication were low in both groups, indicating good efficacy of the preparations tested. The median dose of histamine required to decrease forced expiratory volume in 1 s by 15% increased during the study from 800 to 1,098 microgram in the MDPI group and from 795 to 960 microgram in the MDI-spacer group. The most frequent adverse events in both groups were hoarseness and sore throat. There were no statistically significant differences between the treatment groups in serum cortisol values or in the number of patients with thrush. Seventy-two percent of the patients regarded the MDPI easier to use while 95% considered it more portable. Over 80% of the patients felt that the MDPI was also easier to clean and as easy or easier to learn to use than the MDI-spacer. To conclude, the novel powder inhaler is well tolerated and at least equally effective as the conventional MDI-spacer combination in the treatment of asthma with BDP. However, in everyday use, patients clearly favored the powder inhaler.

Administration, Inhalation↗

PubMed2005

Development and performance of a new hydrofluoroalkane (HFA 134a)-based metered dose inhaler (MDI) of salmeterol.

In response to the Montreal Protocol, a salmeterol (Serevent) metered dose inhaler (MDI) has been developed containing the non-chlorofluorocarbon propellant, hydrofluoroalkane 134a (HFA), to replace the marketed Serevent chlorofluorocarbon (CFC) propellant MDI. This paper details the pharmaceutical assessment of salmeterol HFA MDI and confirms that this product meets the current Committee for Proprietary Medicinal Products regulatory requirements, and is comparable to the CFC MDI in product performance. Criteria investigated included fine particle mass (FPM), dose delivery and uniformity, priming requirements and simulated-use-testing. Dose delivery was unaffected by changing product orientation during storage. The mean dose delivered per actuation ranged from 21.3 to 22.4 microg, and all individual doses were within the +/-25% defined limits of the target ex-actuator dose of 21 microg. The FPM results, defined as the mass of particles between 1.1 and 4.7 microm in diameter (the sum of the mass deposited on stages 3-5 of the Andersen Cascade Impactor), were similar for the HFA and CFC products. The mean FPM values of the two HFA clinical batches were 8.7 and 10.1 microg, covering the values obtained during the development, and the one of the CFC clinical batch was 10.0 microg. Comparability in aerosol characteristics was also demonstrated when the salmeterol HFA inhaler was tested using a large volume spacer (Volumatic).

Administration, Inhalation↗

PubMed1986

Comparison of two chamber devices in patients using a metered-dose inhaler with satisfactory technique.

A randomized clinical crossover trial was carried out to compare the use in the home, during 1-week periods, of two commercially available chamber devices (the Aerochamber and the Spacer) and a standard metered-dose inhaler (MDI) in 24 patients with reversible bronchospasm and satisfactory inhaler technique. Measurements of peak flow, forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), ratio of FEV1 to FVC and forced midexpiratory flow rate were made immediately before and 15 minutes after inhalation of terbutaline sulfate. No difference was noted in results of spirometry, peak flow readings or side effects between the devices. The results of spirometry were better during the trial than immediately before it (p less than 0.01). The mean score for inhaler technique was significantly lower at follow-up than during the trial (p less than 0.001). The results suggest that in this population there is no advantage to using either a chamber device rather than an MDI or one chamber device rather than the other.

Asthma↗

PubMed2002

Single-dose study to compare the pharmacokinetics of HFA flunisolide and CFC flunisolide.

The hydrofluoroalkane (HFA) formulation of the inhaled corticosteroid flunisolide is a modification of the original chlorofluorocarbon (CFC) formulation. HFA flunisolide replaces CFC with an HFA propellant and uses a built-in spacer in its pressurized metered-dose inhaler. The average HFA flunisolide particle size is 1.2 microm compared with 3.8 microm for the CFC formulation. The smaller particle size improves lung targeting, allowing a reduction in the HFA flunisolide dose relative to CFC flunisolide while maintaining comparable efficacy. In a study of 12 healthy men, pharmacokinetic parameters were determined after single doses of 1000 microg CFC flunisolide delivered without a spacer, 340 microg HFA flunisolide delivered through a spacer, and 516 microg HFA flunisolide delivered without a spacer. A standard noncompartmental analysis of the concentration data was performed and mean (+/- S.D.) pharmacokinetic values were reported. Peak plasma concentrations (observed C(max)) were similar for the three treatments. Area under the curve up to the time corresponding to the last measurable concentration (AUC(0)(-)(tlast)) was similar for the CFC and HFA flunisolide, plus spacer groups (4.4 +/- 1.6 ng x h/mL and 5.0+/- 4.2 ng x h/mL, respectively); however, AUC(0)(-)(tlast) for the HFA flunisolide without spacer group was comparatively lower than for the CFC group (3.5 +/- 1.6 ng x h/mL). Observed C(max) and AUC(0)(-)(tlast) for 6 beta-OH flunisolide, the first-pass metabolite of flunisolide and an indicator of oropharyngeal deposition, were significantly higher in the CFC flunisolide group than in either HFA flunisolide group.

Adolescent↗

PubMed2003

Efficacy response of inhaled HFA-albuterol delivered via the breath-actuated Autohaler inhalation device is comparable to dose in patients with asthma.

Handling difficulties, such as poor coordination of actuation and inhalation, are common in patients using press and breathe (P&Bs) metered-dose inhalers to administer asthma medication. Although spacers can help overcome some difficulties, the cumbersome nature of these devices often detracts from their use for the administration of rescue medications, where portability is important. This randomized, placebo-controlled, multicenter, crossover study investigated the efficacy, dose-response and safety of HFA-albuterol delivered via a breath-actuated Autohaler inhalation device in comparison with the same medication delivered using a conventional P&B device. In total, 39 patients received six study treatments in a random sequence at clinic visits separated by 2-7 days: 2 puffs from a HFA-placebo Autohaler; 1, 2, or 4 puffs from a HFA-albuterol Autohaler; I or 2 puffs from a HFA-albuterol P&B. Both active inhalers delivered 90 microg albuterol base equivalent/actuation from the actuator. The change from baseline in forced expiratory volume in 1 s (FEV1) and the area under the FEV1 curve (FEV1 AUC) were significantly greater than placebo for all active treatment groups (p < or = 0.01) and were suggestive of a dose response for each inhaler. Examination of the pooled slope of the dose responses for the Autohaler and P&B using Finney's Parallel Line Bioassay Methodology found a highly statistically significant relationship indicating the equivalence of the two inhalers on both parameters (p < or = 0.002). The relative potency of the two inhalers was 0.8 (95% CI: 0.47, 1.46) for the mean change from baseline in FEV1 and 0.9 (95% CI, 0.56, 1.48) for the change from baseline in FEV1 AUC. There was also a trend toward an increase in the mean percentage change from baseline in FEV1 as the number of puffs increased for both inhalers. Furthermore, there were no significant differences between the treatment groups with regard to time to onset of bronchodilator effect and the duration of effect was significantly greater than placebo (p < or = 0.01) in each of the active groups. Adverse events were generally mild to moderate in nature and were of similar incidence (< or = 18% of patients) in each group. This study demonstrates a dose-response for HFA-albuterol on bronchodilation using both the Autohaler and P&B devices and illustrates that, in patients with good coordination of inhalation with actuation, the efficacy and safety of the two inhalers is similar at equivalent doses.

Administration, Inhalation↗

PubMed2004

Decreased cortisol response to insulin induced hypoglycaemia in asthmatics treated with inhaled fluticasone propionate.

AIMS: To assess adrenal function in asthmatic children treated with inhaled fluticasone propionate for up to 16 weeks. METHODS: Children with asthma and bronchial hyperresponsiveness to inhaled methacholine were treated with inhaled fluticasone 250-750 microg/day via Volumatic spacer. The insulin tolerance test (ITT) was performed to assess adrenal function. RESULTS: Eighteen asthmatic patients (10 boys, 8 girls), aged 7-17 years received inhaled fluticasone therapy at a median dose of 477 microg/m2 per day for 5-16 weeks. Adrenal suppression, defined as 60 minute serum cortisol less than 500 nmol/l, was found in 9 of 18 children. Following the ITT, the median basal and 60 minute serum cortisol concentrations of the suppressed group were 135.0 and 350.0 nmol/l, respectively; the corresponding values for the unsuppressed group were 242.2 and 564.7 nmol/l. Repeat ITT in the suppressed group 2-3 months after discontinuation of fluticasone revealed that all patients had a 60 minute serum cortisol greater than 500 nmol/l. CONCLUSION: After therapy for asthma with inhaled fluticasone at approximately 500 microg daily for up to 16 weeks, half the children had evidence of adrenal suppression.

Administration, Inhalation↗