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PubMed1988

Clinical interpretation of airway response to a bronchodilator. Epidemiologic considerations.

Airways responsiveness to a bronchodilator is frequently measured to assist in determining the cause of respiratory symptoms. Clinically, a greater than 15% improvement in the FEV1 is often used to define the "increased" response indicative of asthma. However, unlike other tests of lung function, reference standards derived from "healthy" members of a general population sample have never been reported. As part of a health survey carried out in Alberta, Canada, 2,609 subjects completed a standardized respiratory symptom questionnaire and had FEV1 measured before and 20 min after inhaling terbutaline sulfate via a 750-ml spacer device. Among asymptomatic never-smoking subjects with a FEV1 greater than 80% of predicted, the upper 95th percentile of bronchodilator response (BDR), when expressed as 100 x (FEV1 postBDR - FEV1 preBDR)/predicted baseline FEV1 averaged 9%. This value remained remarkably stable across gender, age (7 to 75 yr), and height groups, and deviated to 6% only when baseline FEV1 was greater than 120% of predicted. Consistent with other respiratory function variables, in which the upper limit of normal is often defined as the upper 95th percentile, our population-derived reference values provide a conceptual definition of BDR that can easily be applied to define "increased" response in the clinical setting.

Adolescent↗
PubMed2006

[Asthma related knowledge among parents of asthmatic children at the moment of admission to a specialized service].

OBJECTIVE: To assess asthma related knowledge among parents of asthmatic children at the moment of admission to a specialized service. METHODS: This was a descriptive study. Parents of 93 asthmatic children (aged from 29-18 yr) were interviewed, at the moment of admission to the Pediatric Pulmonary Outpatient Service of a university hospital, using a questionnaire to assess their asthma related knowledge. The assessment focused on understanding of the nature, prognosis and treatment of asthma. Only the data from parents of 87 children aged from 29 days to 10 years were analyzed. RESULTS: Upon self-assessment, 93.1% of the parents considered their asthma related knowledge insufficient and 88.5% showed interest in obtaining more information. With regard to understanding of the nature, prognosis and treatment of asthma, 96.6% of the parents did not know the role of airway inflammation on synthesis of symptoms and 51.7% believed in a cure for the disease. Among the parents whose children use a home nebulizer, 80.6% used it incorrectly; all of the parents whose children use spray without a spacer were not familiar with the correct inhalation technique; 65.5% of the parents were unaware of the importance of environmental control. Presence of allergic sources and of smokers was found in 77.0% and 68.9% of families respectively. CONCLUSIONS: This study shows an insufficient asthma related knowledge among parents of asthmatic children at the moment of admission to a specialized service, characterized by ignorance about the nature and prognosis of the disease, inadequate technique to use inhaled drugs and unawareness of home environmental control.

Asthma↗
PubMed1999

Washing plastic spacers in household detergent reduces electrostatic charge and greatly improves delivery.

Ionic detergents reduce electrostatic charge on plastic spacers, thereby improving in vitro drug delivery. The aim of this study was to gain practical information on the use of detergents and to evaluate the relevance of this information on in vivo drug deposition. Measurement of electrostatic charge and salbutamol particle size distribution was carried out on detergent-coated and noncoated plastic spacers. The efficiency of four household detergents was compared, and the influence of dilution and the duration of the antistatic effect were studied. In addition, the level of radiolabelled salbutamol deposition in the lungs of eight healthy adults was compared after inhalation through a new versus a detergent-coated spacer. In vitro, all tested detergents reduced the electrostatic charge on the spacer surface. This resulted in a mean increase of 37.4% (range 33.5-41.2) in small particle (<6.8 microm) salbutamol output compared with water-rinsed/drip-dried spacers. Dilution had no influence on the results and the effect lasted for at least four weeks. In vivo, the mean lung deposition of radiolabelled salbutamol in healthy subjects was 45.6% (range 43.4-49.5) through a detergent-coated spacer compared to 11.5% (range 7.6-17.9) through a static spacer (p<0.001). In conclusion, household detergents offer a simple and practical solution to the problem of static on plastic spacers and significantly improve both in vitro and in vivo delivery of salbutamol.

Administration, Inhalation↗
PubMed1986

High-dose inhaled budesonide in treatment of severe steroid-dependent asthma.

Forty-five steroid-dependent asthmatic outpatients were treated twice daily for 51 weeks with a new inhalation steroid, budesonide (BUD), using a 750 ml spacer. During the initial 15 weeks the prednisone-sparing effects of a high daily dose (1600 micrograms) and a conventional dose (400 micrograms per day) were compared in a double-blind randomized trial including 50 patients. During the remaining 36 weeks 45 patients were treated openly with 1600 micrograms daily. All patients used other antiasthmatic drugs which were maintained throughout the study, except for inhalations of beta-2 agonists that could be used whenever needed. All patients but 2 were able to reduce the daily dose of oral prednisone. The mean daily dose decreased from 13.9 mg to 5.3 mg. Eighteen patients (40%) were able to discontinue oral prednisone. Adrenal gland function improved considerably as prednisone intake decreased. Oropharyngeal thrush frequency showed no change. No severe side effects were observed.

Administration, Oral↗
PubMed1993

Efficacy and safety of inhaled corticosteroids in asthma. Report of a workshop held in Eze, France, October 1992.

Inhaled glucocorticosteroids have now become first-line therapy for the treatment of chronic asthma in many countries. They are the most effective asthma therapy currently available, and numerous studies have documented their long-term efficacy in asthma control in adults and in children. Inhaled steroids suppress inflammation in asthmatic airways, although their precise molecular mechanism of action is not yet certain. It is likely that steroids affect the transcription of several steroid-responsive genes, and, of particular importance, they may inhibit cytokine gene transcription and cytokine effects, thereby reducing the chronic inflammation in asthmatic airways. Inhaled steroids are now used at a much earlier stage in asthma therapy, and there is a strong argument for their early introduction in both adults and children to prevent asthma morbidity and mortality and possibly the structural changes resulting from uncontrolled chronic inflammation, which may lead to irreversible airflow obstruction in some patients. Of paramount importance is the question of safety as inhaled steroids are likely to be required for a long time. Local side effects caused by oropharyngeal deposition of the inhaled steroid may be reduced by the use of spacer devices and mouthwashing. Systemic side effects caused by gastrointestinal absorption of the fraction deposited in the oropharynx may also be reduced by these devices. There are differences in the systemic bioavailability of the different inhaled steroids currently in use, and inhaled steroids with the lowest bioavailability should be chosen when high doses of inhaled steroids are required for asthma control. Systemic side effects are usually observed only when daily doses of > 800 micrograms are inhaled, and whether effects on very sensitive biochemical indices are relevant to long-term deleterious effects is not yet certain. There is now overwhelming evidence that the doses of inhaled steroids required to control asthma in the majority of adults and children are safe and without systemic side effects. It is important to control asthma with the minimum dose of inhaled steroids possible, however. In the future it may be possible to develop inhaled steroids with even fewer systemic effects if the fraction absorbed from the respiratory tract can be rapidly metabolized in the bloodstream.

Administration, Inhalation↗
PubMed1997

Emergency treatment of acute asthma with albuterol metered-dose inhaler plus holding chamber: how often should treatments be administered?

STUDY OBJECTIVE: To determine the optimal treatment interval for administering albuterol metered-dose inhaler (MDI) with a holding chamber to patients presenting to the emergency department (ED) with acute asthma. DESIGN: Prospective, randomized, double-blind study. SETTING: EDs of two affiliated teaching hospitals in the Bronx, NY. PATIENTS: One hundred adult patients with acute asthma and FEV1 <60% predicted of normal. INTERVENTIONS: At entry (T=0 min), eligible patients all openly received inhaled albuterol (six puffs) via MDI with a spacer. Subsequently, in a double-blind fashion, they received six puffs of albuterol or placebo with new MDIs and spacers at 30, 60, and 90 min such that group 1 (n=34) received albuterol every 30 min, group 2 (n=33) every 60 min, and group 3 (n=33) at 120 min only. FEV1 and vital signs were measured at T=0 and at 15, 30, 60, 90, and 120 min following initial treatment. Potassium levels were measured at T=0 and 120 min. Adverse events, the use of additional inhaled beta-agonists or systemic corticosteroids, and hospitalization rates were recorded. MEASUREMENTS AND RESULTS: At T=0, the groups did not differ in age, FEV1, or prescribed asthma medications. All groups showed significant improvement in FEV1 (p<0.05; T=120 vs 0 min). The conditions of groups 1 and 2 improved significantly more than those of group 3, but did not differ compared to each other. The mean+/-SEM change in FEV1 (T=120 vs 0 min) was 0.993+/-0.108, 0.858+/-0.135, and 0.321+/-0.056 L, respectively, for the three groups. Separate analysis for patients with FEV1% <40% or >40% predicted showed similar results. However, patients who initially were low responders to albuterol treatment (<15 percentage point increase at 15 min) improved significantly with 30-min treatments compared to the other two treatment regimens. Patients who initially responded with >15 percentage point increase in FEV1 at 15 min following initial albuterol inhalation benefited equally from 30- or 60-min treatments compared to 120 min. Potassium levels did not change significantly during the study. Adverse events and hospitalization rates were equivalent. After the conclusion of the study, group 3 patients required a greater number of beta-agonist treatments prior to eventual discharge from the ED. CONCLUSIONS: For acute asthma, albuterol MDI with a holding chamber can be given optimally at 60-min intervals with minimal adverse effects for the majority of patients. However, patients who initially demonstrate a low or poor bronchodilator response to albuterol should be given subsequent treatments at 30-min intervals. This will optimize care and conserve resources for patients who will benefit the most.

Administration, Inhalation↗
PubMed2000

[New aspects of use inhaled steroids in treatment of children with bronchial asthma].

The development of potent glucocorticoids (GC) delivered topically via metered dose inhalers (MDI) have revolutionized the way we care for asthmatic children. Steroids can improve asthma symptoms, baseline pulmonary function, and reduce bronchial hyperresponsiveness (BHR) to the extent no other asthma medication can. In addition, the fact that small quantities of GC are delivered topically, the incidence of adverse effects is greatly diminished. Inhaled GC therapy has become first line therapy for all children even with mild persistent asthma, and their early use in life is known as "early intervention". The results from many studies suggest that the longer the time from the initiation of symptoms, and subsequent treatment with inhaled GC, the less effective this form of therapy may be. Also, early intervention and long-term therapy may offer the potential to effect long-term outcome. Unfortunately, systemic absorption does occur, and with that comes the potential for adverse effects. Growth suppression and bone metabolism effects remain the most feared, controversial, and inadequately addressed issues facing long-term inhaled GC therapy. In general, the development of adverse effects from inhaled GC therapy is dependent on the dose and the frequency with which the inhaled GC is given. They can also be minimized by using a spacer device, turbuhaler, mouth rinsing. It is important to define maximally safe and effective doses of the available inhaled GC and corresponding delivery systems.

Administration, Inhalation↗
PubMed2002

Inhaler devices for asthma: do we follow the guidelines?

BACKGROUND: Despite national guidelines for asthma treatment, many children have troublesome symptoms. AIM: To assess the extent to which the use of inappropriate inhaler devices contributes to this problem. METHODS: Of 14 813 questionnaires distributed to schoolchildren, 6996 (47%) were returned identifying 1444 children using asthma inhalers. Inhalers were categorised as age appropriate or inappropriate according to national guidelines and were compared with those used by 75 patients attending a hospital clinic. RESULTS: A total of 35% of "schools" and 4% of "clinic" children reported using an inappropriate inhaler device. Most were using metered dose inhalers alone. Twenty four per cent of "schools" children < or = 5 years old did not use a spacer. Both children and parents overestimated the child's ability to use their inhaler. CONCLUSIONS: Large numbers of children are given inhalers they cannot use. To improve asthma care we must ensure that prescriptions reflect the age and ability of the child. Recent recommendations by the Department of Health in England and Wales stress the importance of seamless care between primary and secondary services. As the management of childhood asthma is guided primarily by secondary care providers, it is therefore imperative that general paediatricians know the difficulties and issues which are occurring in the community. This will enable them to lead and support necessary change.

Administration, Inhalation↗
PubMed1984

Cumulative dose response study comparing clinical effects of two doses of terbutaline sulphate administered via a 750 ml spacer to asthmatic patients.

Thirteen out-patients suffering from chronic reversible bronchial obstruction were treated on two separate days with two doses of terbutaline aerosol, administered with a 750 ml spacer interposed between the actuator and the mouth, in order to evaluate whether clinical responses showed a dose dependency during a 4-h period. On each day the two different doses (65 micrograms versus 250 micrograms) were inhaled three times at 15-min intervals. Fifteen minutes after the first dose there was a significant difference in FEV1 increase between the small dose and the normal dose, FEV1 being higher after 250 micrograms, but no significant differences in increase after the 2nd and 3rd inhalations. This study indicates that the bronchodilating effect of terbutaline administered via the spacer is dose-dependent at the first inhalation, and that succeeding inhalations show no dose-response effects.

Adult↗
PubMed1998

Lung delivery of non-CFC salbutamol via small volume metal spacer and large volume plastic spacer devices compared with an open vent jet nebulizer.

AIMS: To compare the lung delivery of salbutamol from a commonly used constant output open vent jet nebuliser (Sidestream) with use of both a conventional large volume plastic spacer (Volumatic) and a novel small volume metal spacer (NebuChamber). This was assessed using the early lung absorption profile of salbutamol over the first 20 min after inhalation. METHODS: Twelve healthy volunteers were studied in a randomized single (investigator) blind crossover design. Single 1200 microg nominal doses salbutamol from a CFC-free metered-dose inhaler (12 sequential 100 microg puffs of Airomir) were delivered via the Volumatic and NebuChamber spacers. A single 1200 microg nominal dose of salbutamol was given as a 4 ml fill volume from a Sidestream nebuliser with mouthpiece. Mouth rinsing was performed after each drug sequence. Plasma salbutamol was measured at 5, 10, 15 and 20 min after the last dose of each inhalation sequence, with calculation of maximal concentration (Cmax) and average concentration over 20 min (C[av]). Systemic beta2-responses were measured as plasma potassium, tremor and heart rate. RESULTS: Both the Volumatic and the NebuChamber spacers produced significantly greater salbutamol concentration than the Sidestream nebuliser. For C(av) this amounted to a 7.34-fold difference (95%CI 5.31 to 9.38) between Volumatic vs Sidestream, and a 7.04-fold difference (95%CI 4.91 to 9.17) for NebuChamber vs Sidestream. Similar differences were found for the extrapulmonary beta2-responses. There were no significant differences in either salbutamol concentration or extrapulmonary beta2-responses between the Volumatic and NebuChamber spacers. CONCLUSIONS: We found that, in vivo, both the Volumatic and the NebuChamber spacers produced seven-fold greater lung delivery of salbutamol than the Sidestream nebuliser when comparing microgram equivalent nominal doses, in terms of the early lung absorption profile.

Administration, Inhalation↗
PubMed2002

Differences in inhaled fluticasone bioavailability between holding chambers in children with asthma.

STUDY OBJECTIVE: To determine if differences between holding chambers in previous in vitro aerosol studies would agree with the bioavailability of inhaled fluticasone propionate between the same holding chambers in children with asthma. DESIGN: Double-blind, randomized, crossover study SETTING: University of Florida Clinical Research Center. PATIENTS: Eight children (aged 5-9 yrs) with stable asthma. INTERVENTION: Under observation, the children inhaled two 110-microg puffs of fluticasone twice/day through the InspirEase or E-Z Spacer holding chamber. MEASUREMENTS AND MAIN RESULTS: Blood samples were collected at baseline and then at 0.5, 1, 1.5, 2, 4, and 6 hours after the last dose of fluticasone. Primary outcome measures were peak fluticasone steady-state plasma concentration (Cmax) and area under the fluticasone plasma concentration-time curve from 0-6 hours (AUC0-6). The fluticasone plasma concentrations were determined by high-performance liquid chromatography-mass spectrometric assay. Mean +/- SD Cmax from InspirEase (245 +/- 77 pg/ml) was 18% higher than that after E-Z Spacer (199 +/- 58 pg/ml, p < 0.05). Mean +/- SD AUC0-6 from InspirEase (1103 +/- 305 pg x hr(-1) x ml(-1) was 22% higher than that delivered from E-Z Spacer (863 +/- 258 pg x hr(-1) x ml(-1), p = 0.06). CONCLUSION: Differences in inhaled fluticasone bioavailability between these holding chambers in children with asthma corroborate differences reported in earlier in vitro aerosol studies.

Administration, Inhalation↗
PubMed1999

New formulation metered dose inhaler increases breath alcohol levels.

A new, chlorofluorocarbon-free metered dose inhaler containing salbutamol, with small amounts of ethanol as a co-solvent, has recently been released. We evaluated the effect on breath alcohol levels of two inhalations from this metered dose inhaler. In 10 volunteers, breath alcohol levels rose to 17.9 micrograms 100 ml-1 breath after an inhalation with a good technique, and to 35 micrograms 100 ml-1 breath (the current legal limit for driving in the UK) after a poor inhalation. Breath alcohol levels were reduced by the use of a spacer device, and in all cases fell to near zero after 2 min. In patients who have just used this type of metered dose inhaler, breath alcohol measurements should be defferred for at least 2 min.

Adult↗
PubMed1994

Comparison of terbutaline and placebo from a pressurised metered dose inhaler and a dry powder inhaler in a subgroup of patients with asthma.

BACKGROUND: Reversibility after administration of an inhaled bronchodilator is not always demonstrable in patients with asthma. Bronchodilator aerosol-induced bronchoconstriction has also been reported to occur in some patients. METHODS: Fifteen selected patients showing < 10% improvement in forced expiratory volume in one second (FEV1) when tested with four doses of salbutamol (0.1 mg/dose) or terbutaline (0.25 mg/dose) from a pressurised metered dose inhaler (MDI) participated in two randomised, double blind studies. They received 2.0 mg terbutaline (4 x 2 doses of 0.25 mg) or a corresponding placebo from an MDI connected to a 750 ml spacer, and 1.0 mg (2 x 0.5 mg) terbutaline or placebo from a multidose dry powder inhaler free of additives (Turbohaler). RESULTS: Inhalation of placebo MDI resulted in a mean (SD) decrease in FEV1 of 20.5 (14.1)% (range -42.9% to +2.6%). In 14 patients inhalation of 2.0 mg terbutaline MDI with spacer resulted in < 10% improvement (mean increase 3.1 (6.0)%). One mg of terbutaline via a Turbohaler resulted in improvements in FEV1 of > 15% in eight patients (mean increase 16.0 (9.7)%). The improvement was < 10% in four patients. Use of placebo Turbohaler did not affect airway calibre (mean change 0.2 (2.9)%). CONCLUSIONS: Additives of MDIs may cause bronchoconstriction in some patients with asthma. In these patients inhalation from a pressurised metered dose inhaler is more likely to decrease the bronchodilator response than inhalation from an additive-free inhaler. The frequency of this phenomenon is unknown.

Albuterol↗
PubMed1988

Cumulative dose response relationship of terbutaline delivered by three different inhalers.

In a controlled, open cross-over study 15 asthmatic children received increasing doses of terbutaline (0.125 mg + 0.125 mg + 0.25 mg + 0.5 mg + 0.1 mg) delivered by a pressurized aerosol alone or with a tube spacer or a nebuhaler attached. At no time was there any significant difference in measured FEV1 or percent increase in FEV1 between the three inhalers. However, when eight patients with bronchodilation greater than 50% on all tests days were studied separately, a significantly greater improvement in FEV1 was seen after the first three inhalations of terbutaline when a nebuhaler or a tube spacer was used compared with the response after the pressurized aerosol (P less than 0.05) Bronchodilation measurements did not differ after use of the two spacers. There was no statistically significant difference in side effects between the three inhalers, but there was a trend towards a higher occurrence of side effects when the pressurized aerosol was used alone.

Adolescent↗
PubMed2004

Inhalation technique and variables associated with misuse of conventional metered-dose inhalers and newer dry powder inhalers in experienced adults.

BACKGROUND: Pressurized metered-dose inhalers (pMDIs) are often poorly used, but little information is available concerning use of the newer dry powder inhalers (DPIs). OBJECTIVE: To estimate the inhalation technique and variables associated with the misuse of pMDIs and newer DPIs in clinical practice. METHODS: A multicenter, observational survey was used to evaluate the inhalation technique in 1,404 experienced outpatients aged 15 to 88 years affected mostly by asthma (47%) and chronic obstructive pulmonary disease (39%). A total of 1,056 patients were using pMDIs, 190 in conjunction with a large volume spacer (LVS); regarding DPIs, 230 patients were using the Aerolizer Inhaler, 524 were using the Turbuhaler, and 475 were using the Diskus. In each center, a trained observer recorded patients' inhalation techniques for each inhaler used against a standardized step-by-step checklist. RESULTS: Twenty-four percent and 3% of patients used pMDIs poorly, alone or with an add-on LVS, respectively. Failure to correctly perform essential steps for reliable lung delivery with the Aerolizer Inhaler, Turbuhaler, and Diskus was found in 17%, 23%, and 24% of patients, respectively. There was no difference in most variables correlated with poor inhalation between patients using pMDIs and those using DPIs. CONCLUSIONS: The use of DPIs is associated with a similar percentage of inadequate inhalation technique as the use of pMDIs in clinical practice. The addition of an LVS to a pMDI and education from health care personnel, rather than simply changing inhalers, represent the best strategies for minimizing poor inhalation technique.

Administration, Inhalation↗
PubMed1991

Adrenocortical suppression following treatment with beclomethasone and budesonide.

The study was carried out to compare the adrenocortical suppression caused by inhaled beclomethasone dipropionate (BDP) with the suppression caused by budesonide (Bu). The study was of an open cross-over design. Sixteen children with asthma were treated with high-dose inhaled BDP and Bu via a 750 ml spacer (Nebuhaler). Each drug was used for periods of 6 weeks. The 24-hr urinary cortisol excretion was unchanged in 11 subjects. A reproducible suppression of the urinary cortisol excretion was shown in three subjects following BDP and in two subjects following treatment with Bu. The results of the study indicate the occurrence of interpersonal variations of the sensitivity to the adrenocortical suppressive effect of BDP and Bu.

Adolescent↗