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Deposition and pharmacokinetics of an HFA formulation of triamcinolone acetonide delivered by pressurized metered dose inhaler.
Novel formulations of asthma drugs contained in pressurized metered dose inhalers (pMDIs) are being developed containing hydrofluoroalkane (HFA) propellants. The objectives of this study were to assess the deposition in the lungs and oropharynx of triamcinolone acetonide (TAA; Azmacort, Aventis Pharma, Collegeville, PA) delivered by pMDI formulated with HFA-134a, together with the pharmacokinetic profile of TAA, and to determine the extent to which the Azmacort spacer improves targeting of TAA to the lungs. The deposition of TAA, labelled with 99mTc, was assessed by gamma scintigraphy in 10 patients with mild to moderate asthma (mean forced expiratory volume in one second [FEV1] 76% predicted), who received in randomized order three delivered (ex-device) doses of 75 microg TAA via pMDI coupled to an Azmacort spacer (TAA-spacer), and three delivered doses of 230 microg TAA via the same device, but with the spacer removed (TAA-no spacer). Mean lung deposition expressed as mass of drug was similar for each regimen (TAA-no spacer 175 microg; TAA-spacer 188 microg), but when expressed as percentage delivered dose, lung deposition was higher for TAA-spacer (53.8%) versus TAA-no spacer (26.0%), indicating superior drug targeting for TAA-spacer. The spacer reduced oropharyngeal deposition. The pharmacokinetic data showed higher plasma levels of drug for TAA-no spacer, resulting from higher oropharyngeal deposition. "Pharmacoscintigraphic" data showed proof of concept for a novel HFA delivery system for an inhaled corticosteroid based on pulmonary targeting of drug.
[Asthma follow-up after treatment of status asthmaticus in ICU Pneumonology Department in Warsaw Medical University].
Asthmatic patients who were treated in ICU because of exacerbation of asthma must be in close contact with doctors. They need steroid therapy, regular PEF measurements and should take part in educational programs for asthmatic. The 87 (60f, 27m) patients after treatment of status asthmaticus in our ICU were answered to the questionnaire about next hospitalisation, factors causing exacerbation, treatment, spacers, electrical nebulizators, PEF-meters and asthma educational program. Eight men (29.6%) and 13 woman (21.6%) needed next hospitalisation. Airway infection, exercise and cool air are the common cause of asthma exacerbation. Oral steroid was used continuously by 44.8% of patients and 68.9% inhaled steroid. Inhaled beta-agonists were taken by 71.2% of patients, oral theophylline by 70.1%, inhaled ipratropium bromide by 26.9%, 11.1% cromolyn and leucotriene receptor antagonists by 16.1%. At home 27.5% of patients have electrical nebulizator and 75.8% spacer. PEF-meters are utilized by 42.5% of patients but they did not use it correctly. A large number of patients (47%) did not take part in educational program for asthmatic patients. Our data show that patients after status asthmaticus in our ICU mainly treat exacerbations but they not prevent asthma attacks.
Ipratropium bromide for symptomatic preterm infants.
Twelve preterm infants, median gestational age 31.5 weeks, were entered into a randomised, placebo-controlled trial of bronchodilator therapy. Their postnatal age was a median of 17.5 months and all suffered from recurrent respiratory symptoms. The infants received either inhaled placebo or 40 micrograms of ipratropium bromide (active therapy) three times a day utilising a coffee cup as a spacer device. Each therapy was administered for 2 weeks. The symptom score during the active period was reduced by 59% compared to the placebo period (P less than 0.01) and this was associated with 38% improvement in lung function in the active period compared to a 20% change in functional residual capacity over the placebo period (P less than 0.01). We conclude inhaled ipratropium bromide appears to be an effective treatment for symptomatic infants at follow up.
Fluticasone propionate 750 micrograms/day versus beclomethasone dipropionate 1500 micrograms/day: comparison of efficacy and adrenal function in paediatric asthma.
BACKGROUND: Previous studies have suggested a 2:1 efficacy advantage of fluticasone propionate (FP) over beclomethasone dipropionate (BDP) in adults on high dose inhaled steroids and children on low dose inhaled steroids. The lower doses of FP required to provide equivalent efficacy to BDP also appear to have fewer systemic effects as measured by adrenal function. METHODS: The efficacy and safety of FP 750 micrograms/day and BDP 1500 micrograms/day were compared in 30 children with persistent asthma (requiring 1000-2000 micrograms/day of inhaled corticosteroids) in a 12 week randomised double blind crossover study. Medication was delivered by a spacer device in two divided doses. Primary efficacy variables were peak expiratory flows (PEF). Adrenal function was assessed by 24 hour urinary free cortisol levels at eight and 12 weeks and ACTH and low dose synacthen tests (LDST) at 12 weeks. The results were adjusted for sequence and period differences. RESULTS: There was no difference in the primary efficacy variables over the two 12 week treatment periods (difference in adjusted means for morning PEF 1.3 l/min (95% CI -6.1 to 8.8), p = 0.112) and symptom scores (cough, tachypnoea, wheeze, shortness of breath; difference in adjusted means of night time scores: -0.06 (95% CI -0.14 to 0.03); p = 0.136). Similar degrees of mild adrenal dysfunction were found during BDP and FP treatment phases. Identical height gain velocities were shown during the corresponding periods. CONCLUSIONS: FP 750 micrograms/day is as effective as BDP 1500 micrograms/day in children with persistent asthma. At these very high doses we were unable to demonstrate a safety advantage of FP over BDP as assessed by adrenal function. However, measures of adrenal function may have been influenced by concurrent and previous systemic steroid usage, and possibly by effects of disease activity.
Errors in inhalation technique and efficiency in inhaler use in asthmatic children.
256 asthmatic children receiving regular inhalation therapy demonstrated how they used their inhalers. Pulmonary function measurements (PFM) were made before and after the demonstrations, and errors in technique were recorded. 242 children had reversible airway obstruction on the day of study. In only 109 (45%) did the inhalation result in an increase in FEV1 greater than or equal to 15% (efficient technique). An efficient inhalation technique was found in 46% of children who demonstrated a pressurized aerosol, 59% who demonstrated a tube spacer aerosol and 46% who demonstrated a rotahaler, and the frequency of efficient technique varied from 17% to 84% between six different groups of instructors. 87% of children controlled and 25% not controlled with PFM at the time of prescription had an efficient technique. Children under 6 years had a more inefficient and a more faulty technique than older children, but otherwise age did not influence the result. Neither was time since instruction of any importance for efficiency or number of errors. The errors recorded that seem to influence efficiency most were: coordination problems, rapid inspirations, ceasing to inspire when the aerosol was fired, and inhalation through the nose. The results emphasize the paramount importance of clear instructions and control of inhalation technique at the time the treatment is prescribed.
Evaluation of particle size distribution of albuterol sulfate hydrofluoroalkane administered via metered-dose inhaler with and without valved holding chambers.
BACKGROUND: Administration of inhaled medications via metered-dose inhaler (MDI) to pediatric patients younger than 4 years usually requires use of a holding chamber or spacer with an attached face mask. OBJECTIVE: To determine the particle size distribution and overall dose of albuterol from the albuterol sulfate hydrofluoroalkane delivered in conjunction with 2 US-marketed valved holding chambers (VHCs) compared with the dose delivered via MDIs without VHCs. METHODS: Cascade impaction methods with high-performance liquid chromatography were used to evaluate the fine particle mass (FPM) of albuterol administered without and with the use of 2 commercially available VHCs. RESULTS: Particle size distributions for the 2 VHCs and the control were similar. The mean FPM values for the 2 VHCs and the control were 32, 28, and 30 microg, respectively. Statistical comparison of the FPM shows a similar profile when differences from the albuterol hydrofluoroalkane without a spacer were evaluated. CONCLUSIONS: In vitro results obtained under these test conditions demonstrate that all the FPM values for the VHCs tested were within 15% of the control range, a difference that is unlikely to be clinically meaningful. These results do not warrant a change in the recommended dose of albuterol hydrofluoroalkane administered when using the VHCs tested. The use of an MDI in conjunction with a VHC provides a reasonable therapeutic approach for administration of albuterol hydrofluoroalkane to young children and other patients who have difficulty administering the MDI alone.
Spacers in childhood asthma--is there one for all occasions?
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Large and small airway responses to procaterol hydrochloride administered through different extension devices in asthmatic patients.
The effects of spacer devices on the magnitude and velocity of large and small airway bronchodilator responses in asthmatic patients who can correctly operate a metered dose inhaler (MDI) remain unclear. According to a double-blinded, randomized, crossover protocol, 14 asthmatic patients were studied on seven separate occasions. On each occasion, patients inhaled doubling methacholine concentrations until forced expiratory volume in 1 second (FEV1) had fallen by 20% of baseline. Changes in forced expiratory flow between 25% and 75% of vital capacity (FEF25-75) were also evaluated. Subsequently, patients were administered 20 or 50 micrograms of procaterol from an MDI either alone or in conjunction with a small- or large-volume spacer device. Changes in FEV1 and FEF25-75 corrected for baseline forced vital capacity (isoFEF25-75) were assessed at 3-minute intervals for 15 minutes and at 30 minutes. Spontaneous recovery was similarly evaluated. The time required to attain significant increases in both FEV1 and isoFEF25-75 was calculated in bronchodilator trials. With 20 micrograms of procaterol, both spacers allowed larger and faster FEV1 increases than the MDI alone (P < 0.01); with 50 micrograms, the velocity and magnitude of FEV1 increases were further enhanced in trials with the MDI alone. The lower procaterol dose via the large-volume spacer determined larger and faster isoFEF25-75 increases than the higher dose via both the small-volume spacer and the MDI alone (P < 0.01). Spacers enhance bronchodilation even in patients using MDIs optimally. Compared with both the small-volume device and the MDI alone, the large-volume spacer allows faster and larger small airway dilation with less than half of the procaterol dose.
Albuterol delivery by metered-dose inhaler in a mechanically ventilated pediatric lung model.
OBJECTIVES: To assess albuterol delivery by metered-dose inhaler in a mechanically ventilated pediatric lung model and to determine the influence of the following variables on albuterol delivery: endotracheal tube diameter; type of spacer; humidification; and pulmonary mechanics. DESIGN: Prospective, in vitro, laboratory study. SETTING: Research laboratory. INTERVENTIONS: A model, consisting of a volume-cycled ventilator, pediatric breathing circuit, 4.0- or 6.0-mm endotracheal tube, and lung simulator, was assembled. Ventilator settings were: tidal volume 250 mL; FIO2 0.5; inspiration/expiration ratio 1:3; respiratory rate 25 breaths/min; positive end-expiratory pressure 3 cm H2O; temperature 35 degrees C; and a decelerating flow pattern, using dry and humidified air. Lung simulator compliance and resistance values were consistent with those values reported for healthy childeren (20 mL/cm H2O and 40 cm H20/L/sec) and children with pulmonary disease (10 mL/cm H2O and 60 cm H2O/L/sec). Pulmonary mechanics were verified with a pulmonary function diagnostic system. Ten metered-dose inhaler canisters were used to administer 2000 micrograms of albuterol, using either a collapsible or a rigid spacer. A circuit filter placed immediately proximal to the test lung collected drug exiting the endotracheal tube. The filter was rinsed with water and albuterol concentrations were determined by high-performance liquid chromatography. Each variable was tested in triplicate. MEASUREMENTS AND MAIN RESULTS: Albuterol delivery was significantly (p < or = .05) greater for the 6.0-mm endotracheal tube, rigid spacer, dry air, and pulmonary disease mechanics by multifactor analysis of variance. Drug delivery in humidified air with pulmonary disease mechanics using the rigid chamber was 2.5 =/- 0.27% and 6.3 =/- 0.99% for the 4.0- and 6.0-mm endotracheal tubes, respectively. CONCLUSIONS: These in vitro results suggest that pulmonary disease mechanics and a 6.0-mm endotracheal tube improve albuterol delivery. Future clinical investigations in intubated pediatric patients with pulmonary disease are needed to address the clinical significance of these results.
Local side-effects during 4-year treatment with inhaled corticosteroids--a comparison between pressurized metered-dose inhalers and Turbuhaler.
Local side-effects, such as hoarseness and oropharyngeal candidiasis, are often seen during treatment of patients with inhaled corticosteroids (ICS). We investigated whether changing from pressurized metered-dose inhalers (pMDI) to Turbuhaler influenced the type and frequency of local side-effects. Local side-effects were recorded for a 2-year period in which 154 patients used ICS pMDI with a spacer device. They were followed for an equally long period of time (26.2 +/- 5.7 months) while using Turbuhaler, as were 90 patients who received Turbuhaler as their first ICS preparation. After inhalation, all patients rinsed out their mouths with water. In experienced pMDI-users, the frequency of local side-effects decreased from 21% to 6%. The reduction was due to a lower incidence of hoarseness. Candidiasis or hoarseness was not seen in patients given Turbuhaler as their first ICS device. Our fear of an increased incidence of local side-effects when giving ICS in Turbuhaler was unwarranted.
Prevention of viral induced asthma attacks using inhaled budesonide.
Thirty two preschool children were entered into a double blind, placebo controlled study using intermittent budesonide to treat viral induced wheeze. Active treatment was either 800 micrograms twice a day via a spacer or 1600 micrograms twice a day via a spacer and facemask in those children too young to use a mouthpiece. Treatment was started at the onset of an upper respiratory tract infection and continued for seven days or until symptoms had resolved for 24 hours. Each child remained in the study until they had completed using one pair of budesonide and placebo inhalers in random order without the need for additional oral prednisolone. Twenty five children completed 28 treatment pairs. All 25 families were asked to express a preference after completing their first treatment pair: 12 preferred budesonide and six preferred placebo; seven had no preference. Symptom scores were compared in 17 treatment pairs that were completed without the need for oral prednisolone. Mean day and night time wheeze in the first week after infection were significantly lower in those receiving budesonide. Intermittent inhalation of budesonide can modify the severity of wheezing in preschool children developing asthma after viral respiratory infections but improvements were modest with the doses used in this study.
Approach to aerosol therapy in management of asthma at primary care level.
Present day management of bronchial asthma focuses on use of inhaled drugs. To find out the acceptability of aerosol therapy at primary care level, a questionnaire survey was conducted on practical acceptance of aerosol therapy in management of asthma. Seven clinically relevant questions were asked regarding management modalities followed in bronchial asthma. Amongst the group of general practitioners (n = 60) studied, it was found that in treatment of chronic stable asthma inhaled steroids are used by only 50% and inhaled bronchodilators by 86.7%, whereas 93.3% use oral bronchodilators and 60% use oral steroids to treat the same. During exacerbation injectable bronchodilators are preferred to inhaled drugs. Poor compliance to aerosol therapy was reported by 33.3%. Reasons for non-compliance are discussed, important ones are cost and technique. Spacer was reported to be useful by 20% and lung functions are carried out occasionally by only 5% of practitioners.
Comparison of inhaled terbutaline and inhaled terbutaline plus ipratropium bromide in acute asthmatic children.
Twenty asthmatic children, aged 4 to 15 years, consisting of 14 boys and 6 girls, were studied during acute episodes of asthmatic attacks. A group of 10 children each received either inhaled terbutaline 0.5 mg or inhaled terbutaline 0.5 mg followed by ipratropium bromide 0.04 mg 15 minutes later through a 750-ml volumetric spacer. Significant increases in FEV1 over the baseline were observed from 2 minutes to 2 hours and from 2 minutes to 6 hours following the first and second regimen respectively. A slightly greater increase and longer duration in FEV1 were observed in the combined drug treatment and very slight decreases in systolic and diastolic blood pressure below the base-line were observed. Neither regimen showed any serious adverse effect on the heart rate and respiratory rate.
Pharmacological factors that influence the choice of inhaled corticosteroids.
Local therapeutic effect relative to the risk of adverse effects of inhaled drugs, i.e. airway selectivity, is determined by the efficiency of the delivery system and the physicochemical and pharmacokinetic properties of the drug molecule. For the inhaled corticosteroid formulations, many of the pharmacokinetic prerequisites for airway selectivity have been fulfilled, but there are still differences that may influence the choice of treatment regimens. This choice should be based on disease severity, age, inhalation technique, preference and expected compliance, together with a knowledge of individual features of different corticosteroid formulations. Simple to use, hand-held pressurised or breath-actuated inhalers have favourable lung deposition properties and are appropriate for most patients. For small children or severely ill patients, nebulised treatment or spacers may be advocated. A corticosteroid formulation with a high intrinsic activity and long duration of action allows for once-daily administration in some patient groups. These properties may also partly compensate for noncompliance when more frequent administration schemes are used. The risk of adverse effects is reduced if systemic exposure is held to a minimum by rapid elimination and low tissue distribution.
The presence of emphysema does not affect the systemic bioactivity of inhaled fluticasone in severe chronic obstructive pulmonary disease.
AIMS: To assess the systemic bioactivity of fluticasone proprionate (FP) 2000 micro g daily on sensitive adrenal and bone markers in severe chronic obstructive pulmonary disease (COPD) patients with or without significant emphysema. METHODS: Ten patients without emphysema (COPD group: age 55 years, FEV(1) 51% predicted and DL(CO) 83% predicted) and 10 patients with emphysema (COPDE group: age 59 years, FEV(1) 43% predicted and DL(CO) 49% predicted) received FP 2000 micro g daily via a spacer for 2 weeks. There was a 1-week washout period prior to FP treatment where patients were given salmeterol and oxitropium, after stopping their usual inhaled corticosteroids for the duration of the study. Measurements including overnight 10 h urinary cortisol excretion corrected for creatinine (OUCC) and serum osteocalcin concentrations were performed at baseline following washout and after 2 weeks of FP. RESULTS: Values for OUCC and serum osteocalcin concentrations pre- and post-FP were not significantly different between the COPD and COPDE groups. There was significant suppression of OUCC (nmol mmol(-1)) by FP treatment within the COPD group (P = 0.03): 7.86 vs 4.64 (95% CI on the difference 0.47, 5.98), and within the COPDE group (P = 0.006): 7.13 vs 4.27 (95% CI on the difference: 1.03, 4.69). Likewise, there was significant suppression of osteocalcin concentration (nmol l(-1)) by FP treatment within the COPD group (P = 0.04): 7.24 vs 6.34 (95% CI on the difference: 0.01, 1.78), and within the COPDE group (P = 0.03): 6.92 vs 5.72 (95% CI on the difference: 0.12, 2.29). CONCLUSIONS: Severe COPD patients who are receiving high dose FP are susceptible to the development of systemic adverse effects, irrespective of the presence of emphysema.
Cumulative dose-response study comparing terbutaline pressurized aerosol administered via a pearshaped spacer and terbutaline in a nebulized solution.
The bronchodilator effects of cumulative doses of terbutaline 0.125 mg, 0.125 mg and 0.250 mg administered as a pressurized aerosol via a pear shaped spacer were compared with those of terbutaline 1.25 mg, 1.25 mg and 2.50 mg administered as a nebulized solution via a PARI-inhaler Boy. FEV1.0 and flow-volume curves in 13 patients were measured. Initial placebo treatment of both groups resulted in a significant increase in FEV1.0, especially when it was given in nebulized form. The increase after active drug was significant after 15 min, with only minor changes during the rest of the trial. The log-dose/increase in FEV1.0 showed that equipotent doses of pressurized and nebulized terbutaline were in the ratio 1 to 4. Administration by nebulization offered no clear advantage over use of a pressurized aerosol with a pearshaped spacer.
The continued need for metered dose inhalers.
The metered dose inhaler (MDI) is currently the most widely used device in the treatment of adult asthma. It is the delivery system of choice in general practice throughout the world where both MDIs and powder inhalers are available. Up to 70% of all UK adult asthma prescriptions are for an MDI and worldwide the figures are likely to be higher. The MDI can be used to dispense a variety of medications and is currently the most economical device available. The cost of converting all MDIs to equivalent powder inhalers would be prohibitive. Patients, who have difficulty coordinating the operation of an MDI, can use it with a spacer device. This obviates the need for hand-lung coordination and the requirement for more than minimal inspiratory effort. In acute attacks, there is currently no alternative to an MDI with a spacer device for effective, easily administered, emergency treatment outside the hospital environment. In an emergency, an MDI with a spacer can act more rapidly than a nebulizer because it is quicker to set up and use. The MDI is inexpensive, requires no power source and is easily portable. It is therefore important that the MDI continues to be available.