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PubMed1999

The effect of high-dose inhaled beclomethasone dipropionate in patients with stable COPD.

BACKGROUND: The benefits of inhaled corticosteroids in the management of COPD are less apparent than they are in asthma therapy, and the potential for adverse systemic effects of high-dose inhaled corticosteroids has been recognized recently. It is therefore essential to know the maximal obtainable benefits in order to assess the risk/benefit ratio of this treatment. PURPOSE: The aim of this study was to investigate the maximal obtainable benefits of high-dose inhaled corticosteroids, 3 mg/d of beclomethasone dipropionate (BDP), when used in combination with adequate doses of regular bronchodilators in patients with stable COPD. STUDY DESIGN: Thirty patients with stable COPD completed a randomized, double-blind, placebo-controlled cross-over trial with either 3 mg/d of BDP or with a matching placebo using a metered-dose inhaler with a spacer device for 4 weeks during each treatment period. All of the patients continued to inhale both 400 microg of salbutamol qid and 80 microg of ipratropium bromide qid. RESULTS: The mean prebronchodilator FEV1 was 0.97+/-0.35 L during the placebo period and 1.08+/-0.38 L during the BDP period (p < 0.001). While on BDP, five patients demonstrated a response in their FEV1 of more than 8.5% of the predicted value, which was above the range that covered 95% of the distribution of the placebo response. The mean absolute improvement in the FEV1 in these 5 objective responders was 0.34+/-0.10 L, compared to 0.06+/-0.09 L in the 25 objective nonresponders. Symptom scores for wheezing and dyspnea were significantly better with BDP than with placebo. Hoarseness and sore throat were associated more with BDP treatment. CONCLUSION: Although a considerable minority of patients benefited substantially from this treatment, the overall outcome does not seem to justify the widespread use of this treatment in the light of increasing recognition of the potential adverse systemic effects of high-dose inhaled corticosteroids.

Administration, Inhalation↗
PubMed2004

Canadian Standards Association standard CAN/CSA/Z264.1-02:2002: a new voluntary standard for spacers and holding chambers used with pressurized metered-dose inhalers.

A new Canadian standard (CAN/CSA/Z264.1-02:2002) has been published with the purpose of helping to ensure the safety, efficacy and functionality of spacers and/or holding chambers. They are prescribed for use by spontaneously breathing patients for the treatment of various respiratory diseases where medication is delivered to the lungs using pressurized-metered dose inhalers. This consensus standard was developed with the support of pharmaceutical companies and manufacturers of spacers and holding chambers, and with the help of clinicians, retail pharmacists and representatives of patient advocate bodies associated with respiratory diseases and the dissemination of information related to the treatment and the delivery of inhaled medications. Advice was also sought from expert groups outside of Canada to ensure that the standard would be relevant internationally. Whereas monographs in the pharmaceutical compendia and guidance documents published by regulatory bodies provide information that is largely about the drug product and inhaler, this is the only standard whose focus is primarily on these add-on devices. The purpose of the present review is to highlight the main features of the standard for clinicians by describing its scope, the tests that are intended to assure the robustness of the construction of these devices, the type of testing that is specified to establish in vitro efficacy, and the recommendations for the marking and labelling of the device and its associated packaging. Manufacturers who test their products to this Canadian Standards Association standard will be able to provide performance information about add-on devices to the clinician, facilitating an informed decision when selecting devices for patients.

Adolescent↗
PubMed2001

Randomised controlled study of clinical efficacy of spacer therapy in asthma with regard to electrostatic charge.

BACKGROUND: Inhalation therapy using a pressured metered dose inhaler (pMDI) and a spacer is frequently used in the treatment of airway disease in children. Several laboratory studies found a clear negative influence of electrostatic charge (ESC) on plastic spacers on the delivery of aerosol. AIMS: To investigate whether ESC on plastic spacers could diminish bronchodilating responses to salbutamol. METHODS: Ninety asthmatic children (aged 4-8 years) were randomised into three groups: metal Nebuchamber, plastic Volumatic, and plastic Aerochamber. The bronchodilating response was measured by the change in peak expiratory flow rate (PEF) after 100 microgram and 400 microgram salbutamol. Within the Volumatic and Aerochamber groups, a crossover comparison was made between electrostatic and non-electrostatic spacers. RESULTS: We found no significant effect of ESC on the bronchodilating response to salbutamol with any of the doses in the Aerochamber and Volumatic groups. For the plastic spacers, the mean difference of the change in PEF after 100 microgram salbutamol between non-electrostatic and electrostatic spacers was only +1.7% (95% CI -1.3% to 4.7%). After 400 microgram salbutamol this was +1.9% (95% CI -1.4% to 5.1%). A comparable efficacy was found for the Nebuchamber, the Aerochamber, and Volumatic with respect to the change in PEF after 100 and 400 microgram salbutamol. CONCLUSION: This study showed no negative influence of ESC on plastic spacers with regard to clinical efficacy of a beta(2) agonist (salbutamol) in children with asthma. The metal Nebuchamber, plastic Aerochamber, and plastic Volumatic were equally effective.

Administration, Inhalation↗
PubMed2003

[Inhaled treatments delivery in children].

The most efficient method to deliver drugs to the lungs in children is the inhaled way. Its success depends on the characteristics of the aerosol, on those of the patient, and mainly on the inhalatory system. Before the age of 8 years, the most efficient system is the pressurised metered dose inhaler used together with a spacer device. Above this age, the use either of the pressurised metered dose inhaler, with a spacer device or a breath-actuated inhaler, or of a dry powder inhaler is discussed. Nebulisation is rarely indicated, except in cystic fibrosis. Demonstration with repeated medical instructions allows adequate inhalation technique. Inhaled treatments are efficient when used in diseases requiring this type of treatment, when several inhalers with different inhalatory techniques are not prescribed together, and when delivery is once or twice daily. At last, inhaled way is a new approach for different drugs with an extra-respiratory activity.

Administration, Inhalation↗
PubMed2005

Childhood asthma: treatment update.

The prevalence of childhood asthma has risen significantly over the past four decades. A family history of atopic disease is associated with an increased likelihood of developing asthma, and environmental triggers such as tobacco smoke significantly increase the severity of daily asthma symptoms and the frequency of acute exacerbations. The goal of asthma therapy is to control symptoms, optimize lung function, and minimize days lost from school. Acute care of an asthma exacerbation involves the use of inhaled beta2 agonists delivered by a metered-dose inhaler with a spacer, or a nebulizer, supplemented by anticholinergics in more severe exacerbations. The use of systemic and inhaled corticosteroids early in an asthma attack may decrease the rate of hospitalization. Chronic care focuses on controlling asthma by treating the underlying airway inflammation. Inhaled corticosteroids are the agent of choice in preventive care, but leukotriene inhibitors and nedocromil also can be used as prophylactic therapy. Long-acting beta2 agonists may be added to one of the anti-inflammatory medications to improve control of asthma symptoms. Education programs for caregivers and self-management training for children with asthma improve outcomes. Although the control of allergens has not been demonstrated to work as monotherapy, immunotherapy as an adjunct to standard medical therapy can improve asthma control. Sublingual immunotherapy is a newer, more convenient option than injectable immunotherapy, but it requires further study. Omalizumab, a newer medication for prevention and control of moderate to severe asthma, is an expensive option.

Administration, Inhalation↗
PubMed2003

Influence of particle size on lung deposition and pharmacokinetics of beclomethasone dipropionate in children.

We set out to evaluate lung deposition, systemic availability, and basic pharmacokinetic parameters of beclomethasone dipropionate (BDP) in children with chronic asthma. Plasma levels of BDP, 17 and 21 beclomethasone monopropionate (17-BMP and 21-BMP), and beclomethasone were measured after an intravenous infusion of 60 microg BDP and after inhalation of A) 100 microg HFA-BDP, B) 200 microg HFA-BDP, C) 200 microg HFA-BDP after ingestion of charcoal to block gastrointestinal (GI) absorption of drug, and D) 400 microg CFC-BDP. A breath-actuated pMDI (Autohaler) was used for HFA inhalations, and a pMDI with a large volume spacer (Volumatic) for CFC inhalations. Treatments A-D were given in a randomized, cross-over design. Fourteen patients aged 10-14 years completed all 5 study days. The mean systemic bioavailabilities in percent of dose leaving the canister valve (ex-valve) were 70% (100 HFA), 74% (200 HFA), 60% (200 HFA + charcoal), and 27% (400 microg CFC). After HFA treatment, 82% of the systemically available dose was absorbed through the lungs, and 18% from the gastrointestinal tract. The estimated bioavailability of BDP from the GI tract was 68%. BDP was metabolized to 17-BMP within minutes. Mean steady-state volume of distribution of 17-BMP was 84 L, and the mean terminal half-life (T((1/2))) after the four inhalations was 2.7 hr (range, 2.2-3.7 hr). Mean T((1/2)) and clearance after i.v. administration were 1.7 hr and 0.9 L/min, respectively. The HFA Autohaler delivers approximately three times as much BDP to the intrapulmonary airways as a CFC-pMDI with a large volume spacer.

Administration, Inhalation↗
PubMed1990

Inhaled budesonide for treatment of recurrent wheezing in early childhood.

77 children, aged 11 to 36 months (mean 24) with moderately severe recurrent wheezing, were treated with budesonide pressurised aerosol 400 micrograms twice daily or placebo for 12 weeks in a double-blind, parallel-group trial. Aerosols were inhaled from a spacer with a facemask. Budesonide significantly improved symptom scores of wheezing, sleep disturbance, and patient happiness. The frequency of severe exacerbations that required a course of oral prednisolone was also significantly reduced. The treatment effect appeared to be fully established after 6-8 weeks and no side-effects could be ascribed to the active treatment. The findings indicate that young children below 3 years of age can inhale a pressurised aerosol from a spacer with a facemask. Use of topically active glucocorticosteroids with this simple device may reduce symptoms and distress in young children with moderately severe recurrent wheeze and dyspnoea, and possibly reduce their requirement for oral steroids.

Administration, Inhalation↗
PubMed2000

Costs and effectiveness of spacer versus nebulizer in young children with moderate and severe acute asthma.

OBJECTIVE: To compare the costs and effectiveness of albuterol by metered dose inhaler (MDI) and spacer versus nebulizer in young children with moderate and severe acute asthma. DESIGN: Randomized, double-blind, placebo-controlled trial in an emergency department at a children's hospital. The participants were children 1 to 4 years of age with moderate to severe acute asthma. Patients assigned to the spacer group received albuterol (600 microg) by MDI by spacer (AeroChamber) followed by placebo by nebulizer (n = 30). The nebulizer group received placebo MDI by spacer followed by 2.5 mg albuterol by nebulizer (n = 30). Treatments were repeated at 20-minute intervals until the patient was judged to need no further doses of bronchodilator, or a total of 6 treatments. RESULTS: Clinical score, heart rate, respiratory rate, auscultatory findings, and oxygen saturation were recorded at baseline, after each treatment, and 60 minutes after the last treatment. Baseline characteristics and asthma severity were similar for the treatment groups. The spacer was as effective as the nebulizer for clinical score, respiratory rate, and oxygen saturation but produced a greater reduction in wheezing (P =.03). Heart rate increased to a greater degree in the nebulizer group (11.0/min vs 0.17/min for spacer, P <.01). Fewer children in the spacer group required admission (33% vs 60% in the nebulizer group, P =.04, adjusted for sex). No differences were seen in rates of tremor or hyperactivity. The mean cost of each emergency department presentation was NZ$825 for the spacer group and NZ$1282 for the nebulizer group (P =.03); 86% of children and 85% of parents preferred the spacer. CONCLUSION: The MDI and spacer combination was a cost-effective alternative to a nebulizer in the delivery of albuterol to young children with moderate and severe acute asthma.

Acute Disease↗
PubMed2002

[The beta-2-agonists in asthma in infants and young children].

beta 2-agonists, by inducing a fast and long relaxation of the bronchial smooth muscle, are considered as the more potent bronchodilators. beta 2-receptors are present from the 16th gestational week, explaining a possible bronchial response in the youngest children. beta 2-agonists do not induce any bronchodilator response in healthy children. Short-acting beta 2-agonists (salbutamol or albuterol, terbutaline) are indicated for asthma attacks, as needed in chronic asthma, and for prevention of symptoms during effort. They are safe and secure. The more efficient route of administration in preschool children is pressurized metered-dose inhaler used with a spacer device. Therefore, whatever the route of inhalation chosen (inhalation, injection, or continuous nebulization in acute asthma attack), more specified indications and doses are needed in young children. Long-acting beta 2-agonists (formoterol, salmeterol) are not authorized in France in children under 4 to 5 years of age depending on the drug used. Because of new oral formulations and recent considerations about their use in asthma attack, instead of short-acting beta 2-agonists, their indication in preschool asthmatic children might be reconsidered.

Administration, Oral↗
PubMed2000

Lung deposition of inhaled drugs increases with age.

Budesonide plasma concentrations after inhalation of a fixed dose of the drug from a pressurized metered dose inhaler (pMDI) with spacer (Nebuchamber) were compared in young children and adults: 26 patients with mild asthma comprising 8 children 2-3 yr, 8 children 4-6 yr, and 10 adults 20-41 yr. Budesonide 2 x 200 microg was given by pMDI via Nebuchamber with mouthpiece and noseclip. Children of 2-3 yr used a facemask. Plasma was collected regularly for 8 h after drug administration. Budesonide was measured by liquid chromatography plus tandem mass spectrometry. The dose to patient was estimated as the dose of budesonide delivered from the pMDI with adapter minus the amount of budesonide recovered from the spacer, facemask, or mouthpiece, mouth rinse, and facial skin. The systemic exposure was estimated from the plasma concentration and expressed as the area under the curve of plasma concentration versus time (AUC). Terminal half-life (T(1/2)) was evaluated. Dose to patient, AUC, and T(1/2) were similar in the three age groups (p > 0.35). Nebuchamber delivers the same dose of budesonide to young children and adults. Yet the plasma concentration of budesonide was similar in young children and adults. Therefore, lung dose is increased with age. This suggests that from a safety perspective, the prescribed dose of budesonide inhaled from a pMDI with Nebuchamber spacer need not be adjusted for age or use of facemask. Children and adults can use the same nominal dose of budesonide via Nebuchamber as adults without an increased risk of systemic exposure.

Administration, Inhalation↗
PubMedDate not supplied

[Effect on FEV1 induced by the administration of salbutamol with aerochamber and metered dose inhaler].

There are several devices known as spacers and aerochambers designed to help in the administration of drugs in spray into pulmonary airways in asthmatic patients. This study was done to determine the effect on FEV1 of salbutamol given through an aerochamber compared with metered dose inhaler and spacer. Thirteen asthmatic patients who met all selection criteria proposed, were included. Spirometry was operformed before and after salbutamol application by means of one of the aforementioned devices, assigned at random. The effect on FEV1 with metered dose inhaler was 22.76%, with spacer it was of 23.35% and with aerochamber it was of 23.94%. Statistical analysis did not show significant differences among groups. These data suggest that each of the three devices tested have the same effectiveness for administration of salbutamol in spray. This is, however, a preliminary study.

Adult↗
PubMed1995

Physician-targeted program on inhaled therapy for childhood asthma.

BACKGROUND: Inhaled medications are the mainstay of asthma therapy, but significant deficiencies exist in the knowledge and skills of physicians regarding use of metered-dose inhalers (MDI) and spacer devices. OBJECTIVE: We developed, implemented, and evaluated the effects of a physician-targeted educational program on inhaled therapy in a group of pediatric residents in our institution. METHODS: Patient-directed instruction sheets on aerosol therapy were developed on the basis of literature review and expert guidelines. These served to establish a consistent foundation for the educational curriculum. The program was delivered through one-on-two teaching sessions (45 minutes). Residents were provided with a summary of theoretical and practical information and with devices for practice (a placebo MDI, InspirEase and AeroChamber holding chambers, and the AeroChamber device with mask). Each session included review of an educational monograph, demonstration of proper technique, and practice with the different devices. The program was evaluated by a randomized-control design. Assessment of practical skills included number of correct steps for the use of MDI (maximum score, 7), InspirEase (maximum, 7) and AeroChamber (maximum, 6). Theoretical knowledge was assessed with 25 multiple-choice questions. RESULTS: Pretest scores in the experimental group (n = 24) were 3.7 of 7, 1.9 of 7, and 0.3 of 6 steps correct for MDI, InspirEase, and AeroChamber devices, respectively, and 13 of 25 for the theoretical knowledge assessment. The control group (n = 26) had similar pretest scores. After the program the experimental group significantly improved in all parameters: 6.3 of 7, 5.9 of 7, and 4.5 of 6 steps correct for MDI, InspirEase, and AeroChamber devices, respectively, and 18 of 25 questions correct (p < 0.01 for all parameters). CONCLUSIONS: Implementation of a simple educational program among pediatric residents can significantly increase their skills in the use of inhalational therapy.

Administration, Inhalation↗
PubMed1993

Allergist influence on asthma care.

In 1989, the hospitalization rate for asthma at our institution had increased 23%. To evaluate possible reasons for this we examined all new patients seen in our clinic between June, 1985 and June, 1986. A second assessment of the same patients between June, 1987 and June, 1988 was also performed. Two-hundred nine patients were seen for asthma in 1986. Analyzed by follow-up care provider, care by an allergist (CA), and nonallergist care (NAC), at baseline patients had similar hospitalization (CA = 37%, NAC = 40%) and emergency room (CA = 61%, NAC = 45%) visit rates. At follow-up (1988), there was a significantly higher hospitalization rate in the NAC group (35%) than in the CA group (13%). Emergency room visits during the previous year were also significantly greater in the NAC group (47%) compared with the CA group (18%). Major differences in drug therapy between 1986 and 1988 included a marked increase in the utilization of inhaled corticosteroids and sodium cromolyn in the maintenance therapy of patients followed by an allergist. The use of spacer devices for inhalers and home peak flow meters also increased significantly in the CA group. Oral corticosteroid use increased similarly in both groups. Although there is an overall increase in admissions for asthma at our institution in 1989, these data suggest that continued follow-up care by an allergist is associated with a decreased hospital admission and emergency room visit rates when compared with care given by a generalist.

Administration, Inhalation↗
PubMed2001

The efficacy of a new salbutamol metered-dose powder inhaler in comparison with two other inhaler devices.

An open cross-over and randomized study was carried out in order to compare the efficacy and safety of inhaled salbutamol delivered from a new 50 microg dose(-1) metered-dose dry powder inhaler Taifun, and a commercially available 50 microg dose(-1) dry powder inhaler Turbuhaler, and a conventional 100 microg dose(-1) pressurized metered-dose inhaler with a spacer (pMDI+S). Twenty-one patients, aged 21-70 years, with stable asthma and with demonstrated reversibility upon inhalation of salbutamol were included in the study. On three separate study days, the patients received a total dose of 400 microg of salbutamol from the dry powder inhalers and a dose of 800 microg from the pMDI+S in a cumulative fashion: 1,1, 2 and 4 doses at 30 min intervals. The percent change in forced expiratory volume in 1 sec (FEV1), was used as the primary efficacy variable. Salbutamol inhaled via the Taifun produced greater bronchodilation than the other devices. The difference in percent change in FEV1 between the Taifun and the other devices was statistically significant at the two first dose levels, but diminished towards the higher doses when the plateau of the dose-response curve was reached. The estimated relative dose potency of the Taifun was approximately 1.9- and 2.8-fold compared to the Turbuhaler and the pMDI+S, respectively. The Taifun caused a slight, but clinically insignificant, decrease in serum potassium concentration. There were no significant changes in the other safety parameters (blood pressure, heart rate and electrocardiogram recordings) with any of the used devices. In conclusion, this study indicates that salbutamol inhaled via the Taifun is more potentthan salbutamol inhaled from the other devices tested. In practise, a smaller total dose of salbutamol from theTaifun is needed to produce a similar bronchodilatory response. All treatments were equally well tolerated.

Administration, Inhalation↗
PubMed2006

Effect of oropharyngeal length in drug lung delivery via suspension pressurized metered dose inhalers.

PURPOSE: To determine the effect of the oropharyngeal length in adults on the lung dose of a suspension pressurized metered dose inhaler, and whether employing small volume spacers can alter this role. METHODS: Depositions of Ventolin Evohaler (100) microg in the oropharyngeal models of two healthy adult subjects with 17.1 cm (short cast) and 19.9 cm (long cast) centerline lengths via three small volume spacers [two spacers with 3 cm effective length but one with 6.5 cm2 (L3) and the other with 24.6 cm2 (L3W) cross sections, and the Optimiser] were studied. RESULTS: Without using spacers, lung dose of the long cast (19.52 +/- 2.32 microg, mean +/- standard deviation) was significantly larger than that for the short cast (8.08 +/- 1.01 microg, p < 0.006). However, using the L3 spacer with the short cast made the lung dose (18.59 +/- 3.33 microg) similar to that for the long cast alone. Lung doses of the short cast (20.43 +/- 1.42 microg) and the long cast (30.81 +/- 1.84 microg) with the L3W spacer were similar to those with the L3 spacer. However, using the Optimiser spacer increased the lung dose for the short cast (22.27 +/- 6.03 microg) and significantly for the long cast (35.61 +/- 2.19 microg, p < 0.006) compared to those for the L3 spacer. Using spacers increased drug deposition in the oropharynx part of the short cast, and this reduced the lung dose compared to that for the long cast. CONCLUSION: The oropharyngeal length in adults may affect the lung dose via the pMDIs, which may not be eliminated by using small volume spacers.

Administration, Inhalation↗
PubMed1994

Protective effect of albuterol delivered via a spacer device (Babyhaler) against methacholine induced bronchoconstriction in young wheezy children.

Nine young asthmatic children aged 2-5 years underwent methacholine challenge after placebo or albuterol administered by metered dose inhaler through a spacer device (Babyhaler) with a face mask in a double-blind, cross-over, randomized study. The methacholine challenge was performed using chest auscultation to define the provocative concentration of methacholine that causes wheezing (PCW). The PCW increased from a geometric mean of 0.28 mg/mL after placebo to 3.59 mg/mL after albuterol (P < 0.0001). The protective effect of albuterol against methacholine-induced bronchospasm was 3.7 +/- 1.2 doubling doses. We conclude that administration of drugs from a metered dose inhaler through the Babyhaler with a face mask is effective. Albuterol causes a major reduction in the bronchial hyperreactivity in young wheezy children shortly after administration.

Albuterol↗
PubMedDate not supplied

Effectiveness of fluticasone propionate in patients with moderate asthma: a dose-ranging study.

This study was undertaken to evaluate the efficacy and safety of fluticasone propionate, an inhaled corticosteroid, in adolescents and adults with moderate asthma who were previously taking inhaled corticosteroids. After a 2-week, open-label screening period, a double-masked, randomized, parallel-group, dose-ranging study was conducted over 12 weeks in 21 outpatient centers throughout the United States. Patients (N = 304) > or = 12 years of age with moderate asthma previously treated with inhaled corticosteroids and beta-sympathomimetic bronchodilators were enrolled. Patients were assigned to receive placebo or fluticasone propionate 100, 250, or 500 micrograms twice daily via a metered-dose inhaler without a spacer device. These doses refer to the amount of fluticasone propionate released from the valve of the metered-dose inhaler; the corresponding doses released from the activator of the metered-dose inhaler are 88 micrograms, 220 micrograms, and 440 micrograms, respectively. Between baseline and end point, mean values of forced expiratory volume in 1 second decreased 0.31 L in the placebo group and improved 0.39 L, 0.30 L, and 0.43 L in patients receiving 100-micrograms, 250-micrograms, and 500-micrograms fluticasone propionate, respectively. The differences between placebo and all treatment groups were statistically significant. More patients were withdrawn from placebo (72%) than from fluticasone propionate (13% to 16%) because of failure to meet predetermined asthma stability criteria. Differences in baseline-to-end point changes in morning peak expiratory flow rate, physician overall assessments and patient-rated assessment of symptoms, and albuterol use for symptom control also significantly favored each fluticasone propionate group over placebo. There were essentially no differences in efficacy among the three fluticasone propionate groups. Treatment-related adverse events occurred in 8% of placebo-treated patients and 13% to 15% of fluticasone propionate-treated patients; these events were mainly localized to the oropharynx/ larynx. A 12-week course of fluticasone propionate (100, 250, and 500 micrograms twice daily) was well tolerated and more effective than placebo based on maintenance of asthma stability, pulmonary function tests, physician and patient assessments, and rescue bronchodilator use. No dose-related effects were observed with the dosages of fluticasone propionate used in this study.

Adolescent↗
PubMed1990

Do large volume spacer devices reduce the systemic effects of high dose inhaled corticosteroids?

When used in high doses, inhaled corticosteroids may cause suppression of the hypothalamo-pituitary-adrenal axis. The influence of the mode of drug inhalation on the degree of this suppression is not clear. Hypothalamo-pituitary-adrenal function was assessed by measurement of 0900 h serum cortisol concentrations, a short tetracosactrin test, and 24 hour urine free cortisol excretion in 48 adults with asthma taking 1500-2500 micrograms beclomethasone dipropionate daily via a metered dose aerosol. Twelve patients had hypothalamo-pituitary-adrenal suppression, as judged by subnormal results from at least two of the three tests or (in one patient) by an abnormal insulin stress test response. These patients then changed to inhaling the same dose of beclomethasone dipropionate through a 750 ml spacer device (Volumatic). The endocrine tests were repeated from nine days to eight weeks later in 10 patients. Comparison with initial values showed that adding the spacing device caused an increase in the median 0900 h cortisol concentration from 126 nmol/l to 398 nmol/l, in the post-tetracosactrin cortisol concentration from 402 nmol/l to 613 nmol/l and in 24 hour urine free cortisol excretion from 54 nmol to 84 nmol. The rise in serum cortisol concentration in response to tetracosactrin did not change. Evidence of persisting hypothalamo-pituitary-adrenal axis suppression was present in only four of the 10 patients; the most pronounced improvements in function tended to occur in those who had never required long term oral corticosteroids. The results from this uncontrolled study suggest that asthmatic patients taking high dose beclomethasone dipropionate may minimise adverse effects by using a large volume spacer device.

Administration, Inhalation↗