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PubMed1999

The use of inhalers in patients with tracheal stomas or tracheostomy tubes.

Patients with chronic obstructive airways disease (COAD) or asthma who have a tracheostomy tube or tracheal stoma have difficulty using metered dose inhalers (MDIs) because of a failure to achieve a good seal between the tracheostomy tube or stoma and the MDI or spacer device mouthpiece. Many such patients therefore utilize nebulizers. MDIs in comparison to nebulizers have the advantages of being more compact, portable, easy to use, less time-consuming, and cheaper. We present the case of a 74-year-old man who underwent a laryngectomy with tracheal stoma formation who had a poor response with nebulizers and required oral steroids. He was subsequently, with the help of a number of attached devices, able to use his MDIs to good effect. We describe a number of devices and adaptors to enable patients with laryngectomy stomas or tracheostomy tubes to utilize MDIs and undergo respiratory function tests. We recommend that all such patients should have the benefit of a consultation with a dedicated respiratory nurse who can provide the appropriate MDIs, devices and adaptors to optimize the treatment of their lower respiratory tract condition.

Administration, Inhalation↗
PubMed2006

In vitro validation of 99mTc-HFA-FP delivered via pMDI-spacer.

The purpose of the study was to label Flixotide (fluticasone propionate [FP] with HFA propellant), with technetium-99m and validate that (99m)Tc acts as a suitable marker for FP when delivered via pMDI-spacer. Sodium pertechnetate was mixed with 5 mL of butanone. (99m)Tc was extracted into butanone and transferred into an empty canister. The (99m)Tc lined canister was heated, and the butanone evaporated to dryness. A supercooled commercial Flixotide canister was decrimped, and the contents transferred to the (99m)Tc lined canister and recrimped. The particle size distribution of FP and (99m)Tc from 10 radiolabeled canisters was measured using an Anderson cascade impactor calibrated to 28.3 L/min, and compared to commercial FP. The drug (FP) content of each particle size fraction was measured using ultraviolet spectrophotometry and the (99m)Tc level in each fraction was measured using an ionization chamber. The percentage of particles in the fine particle fraction (<;4.7 microm) and the percentage of (99m)Tc from commercial and radiolabeled canisters were compared. The mean (SD) % FP in the fine particle fraction, before and after label was 43.2 (1.8) % and 43.9 (2.6) %, respectively. The mean (SD) % (99m)Tc in the fine particle fraction was 42.1 (5.1) %. The mean %FP exiting spacer at (<4.7 microm) before labeling was not significantly different from the mean % FP exiting spacer at (<4.7 microm) after labeling (p > 0.05). The mean % (99m)Tc attached to particles at (<4.7 microm) after radiolabeling was not significantly different from the mean % FP levels (p > 0.05). The validation in this study indicates that (99m)Tc can act as a suitable marker for HFAFP, delivered via pMDI-spacer.

Administration, Inhalation↗
PubMed2001

Investigation of some commercially available spacer devices for the delivery of glucocorticoid steroids from a pMDI.

Five commercially available spacers were investigated to determine their influence on the percentage of drug retained in the spacer device, percentage fine particle fraction (FPF), percentage deposited in the induction port, mass median aerodynamic diameter (MMAD), and geometric standard deviation (GSD). Betamethasone valerate (BMV) and triamcinolone acetonide (TAA) were used as model drugs in the pressurized metered dose inhaler (pMDI) formulations containing the propellant HFA 134a. The BMV was dissolved in an ethanol/HFA 134a system, and the TAA was suspended in HFA 134a using ethanol as a dispersing agent. The metering chamber volume of the valve was either 50 microl or 150 microl. The spacer devices investigated included the ACE, Aerochamber, Azmacort, Easivent, and Ellipse spacers. Each spacer device was attached to an Andersen Cascade Impactor powered by a vacuum pump. Cascade impaction data were used to derive the percentage drug deposited in the induction port, MMAD, GSD, and FPF. The BMV particles emitted from the spacers were finer than the TAA particles because the dissolved drug precipitated as the cosolvent evaporated. The TAA particles had significantly larger MMADs because many undissolved drug particles were contained within each droplet following actuation. After evaporation of the liquid continuous phase, the suspended drug aggregated to form larger agglomerates than those particles precipitated from the BMV pMDI solution droplets. The addition of a spacer device lowered the MMAD to less than 4.7 microm for particles from both the BMV pMDI solution and the TAA pMDI suspension. The addition of a spacer device also lowered the percentage drug deposited in the induction port. The FPF was significantly increased when a spacer device was used. The MMAD significantly decreased when a spacer device was added for the two model drugs when using the 150-microl metering valves, but the difference was not statistically significant when the 50-microl valves were used (P < .05). The GSD was not influenced by the use of a spacer device. The use of a spacer device will enhance pMDI therapy by reducing the amount of drug deposited in the oropharyngeal region, which will lead to fewer instances of local and systemic side effects. In addition, the spacer devices investigated will allow a higher dose of drug to reach the deep lung, which may permit the use of lower dosage regimens with increased therapeutic efficacy.

Administration, Inhalation↗
PubMed2002

Flunisolide HFA.

Flunisolide is a synthetic corticosteroid approved for the treatment of persistent asthma and delivered by means of a metered-dose inhaler (MDI). A new formulation of flunisolide, using hydrofluoroalkane (HFA) as a propellant, has been developed to comply with the mandated worldwide phase-out of ozone-depleting chlorofluorocarbon (CFC) propellants. Aerosol particle size in the new flunisolide HFA solution is smaller than the flunisolide CFC suspension (1.2 vs 3.8 microm mass median aerodynamic diameter). Aerosol particle size is a key element in determining lung deposition and the regional distribution of inhaled medication within the lung. In addition, the flunisolide HFA MDI has been redesigned to include a built-in spacer. These features have improved distal lung deposition. Flunisolide HFA, at one-third the dosage (170 and 340 microg twice daily), had similar efficacy to flunisolide CFC (500 and 1000 microg twice daily) and significantly greater efficacy than placebo in a randomized, double-blind, placebo-controlled, 12-week study in patients with mild to moderate asthma. Flunisolide HFA was well tolerated in all trials. A long-term study found no suppression of adrenal function and minimal systemic effects were observed both in adults and children.

Aerosol Propellants↗
PubMed2005

Instruction of hospitalized patients by respiratory therapists on metered-dose inhaler use leads to decrease in patient errors.

BACKGROUND: Hospitalized patients have been shown to make several errors in using metered-dose inhalers (MDIs), which can lead to poor medication delivery. METHODS: This study was designed to look at the potential benefit of a respiratory therapist (RT) giving instruction on the use of MDIs to hospitalized patients with obstructive lung disease. A baseline group of 58 patients was observed by a physician while performing 2 actuations of their MDI and the number of errors they committed, based on the National Institutes of Health's recommended 8 steps for proper MDI use, was recorded. After a program of MDI instruction (which included encouragement to use a spacer) by an RT was performed, a second group of hospitalized patients was again observed by a physician to determine if their error rate was reduced. RESULTS: The baseline error rate was 6.72 (out of 15 possible) errors per patient, and improved to 2.43 errors per patient after RT-provided instruction (p < 0.001). This improvement was still significant after controlling for an increased use of spacers in the post-instruction group of patients (27.6% and 91.7% spacer use before and after education). CONCLUSIONS: Instruction of hospitalized patients with obstructive lung disease by an RT improves their correct use of MDIs and increases their use of spacers while in the hospital.

Administration, Inhalation↗
PubMed1991

Delivery of propellant soluble drug from a metered dose inhaler.

The deposition of particulate suspensions delivered from a metered dose inhaler has been investigated extensively. The distribution of propellant, delivered from a metered dose inhaler, was studied by radiolabelling it with technetium-99m hexamethylpropyleneamine oxime. Andersen sampler measurements indicated that half of the dose was associated with particles in the size range 0.5-5 microns diameter. The preparation was administered to healthy subjects by inhalation and deposition was monitored with a gamma camera. Each lung image was divided into an inner, mid, and peripheral zone. The effects on deposition of varying the size of the delivery orifice (0.46, 0.61, and 0.76 mm internal diameters) and the effect of attaching a spacer were assessed. Lung deposition was independent of the orifice size within the actuator. Without the spacer the average dose deposited in the lungs was 39%, with 15% penetrating into the peripheral part of the lungs. Attachment of the spacer to the mouth-piece increased the mean lung deposition to 57% and reduced oropharyngeal deposition. The study has shown that propellant soluble drugs can be delivered efficiently to the lungs from a metered dose inhaler.

Administration, Inhalation↗
PubMed2001

Deposition and pharmacokinetics of flunisolide delivered from pressurized inhalers containing non-CFC and CFC propellants.

Our objective was to assess the deposition and pharmacokinetics of a novel formulation of flunisolide (Aerobid, Forest Laboratories) in hydrofluoroalkane (HFA) 134a delivered by pressurized metered dose inhaler (pMDI). The design was a two-way crossover investigation in 12 healthy male subjects comparing HFA-134a flunisolide by pMDI versus pMDI plus 50 mL spacer device. Four of these subjects also took part in a two-way crossover investigation comparing chlorofluorocarbon (CFC) flunisolide pMDI versus pMDI plus Aerochamber holding chamber. The imaging technique of gamma scintigraphy was used to quantify total and regional lung deposition of flunisolide. Plasma levels of flunisolide and its major metabolite (6beta-OH flunisolide) were also determined. The spacer and Aerochamber reduced oropharyngeal deposition dramatically for both the HFA and CFC products (mean 59.8 to 14.9% (p < 0.01) of ex-valve (metered) dose for HFA product; 66.3 to 12.3% (p < 0.01) of ex-valve dose for CFC product) owing to deposition of part of the dose on the walls of the add-on devices themselves. Lung deposition averaged 22.6 and 40.4% (p < 0.01) of the ex-valve dose for the HFA formulation used with pMDI alone and with pMDI plus spacer. Mean lung deposition of the CFC formulation delivered via the Aerochamber (mean 23.4%) was higher than that for the CFC pMDI alone (mean 17.0%), but this difference was not statistically significant. Lung deposition expressed as percentage ex-device (delivered) dose averaged 68.3% for HFA pMDI plus spacer and 19.7% for CFC pMDI. Plasma levels of flunisolide were higher for the pMDI plus spacer than for pMDI alone, reflecting higher lung deposition via the spacer, but plasma levels of the 6beta-OH flunisolide metabolite were higher for the pMDI alone as a consequence of higher oropharyngeal deposition. When delivered via the spacer, pulmonary targeting of the flunisolide HFA formulation was improved compared with the CFC formulation, which should benefit patients by providing satisfactory asthma therapy from a much-reduced delivered dose of flunisolide.

Administration, Inhalation↗
PubMed1997

[Perioral dermatitis in children under steroid inhalation therapy].

Topically applied corticosteroid is a known provoking factor in perioral dermatitis. In recent years inhaled corticosteroids have become first line therapy for asthma in children. We present two characteristic cases of perioral dermatitis that developed during asthma treatment with budesonide using either a nebulizer or a spacer connected with a mask. In severe cases treatment with oral erythromycin or topical metronidazole gel may be considered. The eruption should not be confused with atopic eczema.

Administration, Inhalation↗
PubMed1997

Efficacy of metered-dose inhaler administration of albuterol in intubated infants.

STUDY OBJECTIVE: To compare the safety and efficacy of metered-dose inhaler (MDI) albuterol to nebulized (NEB) albuterol administration. DESIGN: A randomized, triple-blinded, crossover study. SETTING: A pediatric ICU in a tertiary care children's hospital. PATIENTS: Eleven intubated infants with bronchiolitis. INTERVENTIONS: Subjects received four puffs of MDI albuterol (360 microg) and 3 mL of NEB saline solution placebo or 0.3 mL of NEB albuterol (1.5 mg) and MDI saline solution placebo. Each set of albuterol and saline solution placebo was administered after direct attachment of delivery device to the endotracheal tube and bag-valve system. Subjects received the opposite sequence 4 h after the initial sequence. The second sequence was given first the next day, and the first sequence was administered 4 h later. MEASUREMENTS AND RESULTS: Respiratory system compliance and resistance were measured at baseline and 30 min, 1 h, 2 h, and 4 h after each set of placebo and albuterol. There was an appreciable improvement in compliance and resistance for up to 2 h following both methods of administration. However, the degree of improvement was not significantly different (p>0.05) between the two methods. Neither method caused a significant change in resistance when measured at 4 h after albuterol/placebo administration. No evidence of toxicity was detected. CONCLUSIONS: MDI-administered albuterol is as safe and efficacious as nebulized-administered albuterol in intubated infants with bronchiolitis. Generalizability of these results is limited by differences in drug delivery with different brands of nebulizers and spacers and sites of attachment.

Administration, Inhalation↗
PubMed2004

Investigation of pulmonary deposition of a nebulized radiopharmaceutical agent in awake cats.

OBJECTIVE: To determine whether conscious, unsedated cats will inhale a nebulized material administered via a facemask and whether this material will reach the lower airways. ANIMALS: 20 healthy adult cats. PROCEDURE: Technetium Tc 99m-diaminetriaminopentaacetic acid (99mTc-DTPA) was nebulized into a spacer and administered to the cats via a closely fitting facemask. By use of a gamma camera, images were then immediately obtained to determine the distribution of 99mTc-DTPA within the lower airways. RESULTS: Images obtained by use of the gamma camera revealed that all 20 cats had inhaled 99mTc-DTPA from the facemask. In each cat, deposition of the radiopharmaceutical agent was evident throughout the lung fields. CONCLUSIONS AND CLINICAL RELEVANCE: Awake cats that were not used to the application of a facemask did inhale substances from such a device. Aerosolization of medications may be a feasible route of administration for cats with lower airway disease.

Administration, Inhalation↗
PubMed2006

National Heart, Lung, and Blood Institute guidelines and asthma management practices among inner-city pediatric primary care providers.

BACKGROUND AND OBJECTIVE: Most surveys of pediatric outpatient asthma management obtain information from parents and caregivers. Studies based on surveys of primary health-care providers are sparse. Suboptimal outpatient management may play a role in the high hospitalization rates among inner-city asthmatic children. Asthma management practices were compared between hospital-based and community-based primary care providers (PCPs). Adherence to National Heart, Lung, and Blood Institute (NHLBI) guidelines was evaluated, along with practices not clearly defined in the guidelines such as use of oral cough medicines and albuterol suspension. DESIGN/METHODS: An 8-point questionnaire was administered to 48 community-based and 32 hospital-based PCPs practicing in inner-city neighborhoods. The questionnaire addressed three "positive" practices (classification of asthma severity, use of asthma action plan, and use of a spacer) and three "negative" practices (use of cough syrup, use of albuterol suspension, and preferential use of leukotriene modifiers instead of inhaled corticosteroids as the first line of preventive therapy). Response options were as follows: never, rarely, sometimes, and always, scored from 0 to 3. The two physician groups were compared on score means for the positive and negative practices using a t test with statistical significance set at p < 0.05. RESULTS: Overall, the rate of adherence to the positive practices was high, with no significant difference between the two groups. Negative practices, while present in both the groups, were reported significantly more often by the community-based group, particularly the use of cough suppressants and albuterol suspension. CONCLUSIONS: Greater emphasis is needed to increase the awareness among PCPs of the NHLBI guideline recommendations, as suboptimal outpatient asthma management may contribute to the disproportionately higher hospitalization rates among inner-city asthmatic children. Clarification on the use of potentially harmful medications and those of doubtful value need to be incorporated in the guidelines. The extent to which these negative practices contribute to the elevated pediatric hospitalization rates warrants further investigation.

Adult↗
PubMed1997

Current therapies for asthma. Promise and limitations.

Effective treatments for asthma exist, but morbidity and mortality have continued to climb. Many attempts have been made to refine rather than change therapy over the past 20 years. Drugs currently used to treat asthma include beta 2-agonists, glucocorticoids, theophylline, cromones, and anticholinergic agents. For acute, severe asthma, the inhaled beta 2-agonists are the most effective bronchodilators. Short-acting forms give rapid relief; long-acting agents provide sustained relief and help nocturnal asthma; and serious adverse effects are rare when these drugs are used properly. First-line therapy for chronic asthma is inhaled glucocorticoids, the only currently available agents that reduce airway inflammation. Their side effects can be reduced by rinsing the mouth or by using large-volume spacers. Theophylline is a bronchodilator that is useful for severe and nocturnal asthma, but recent studies suggest that it may also have an immunomodulatory effect. Although theophylline is inexpensive, monitoring its plasma concentrations is both expensive and inconvenient. Cromones work best for patients who have mild asthma: they have few adverse effects, but their activity is brief, so they must be given four times daily. The anticholinergic bronchodilators are more useful for treating COPD than for chronic asthma. These drugs have virtually no side effects, and their onset is slower and their action longer than inhaled beta 2-agonists. The new direction in treating asthma will be orally administered medication that has few side effects and is targeted specifically to the pathogenesis of asthma.

Adrenergic beta-Agonists↗
PubMed1996

[Concerns about adverse effects of inhaled corticosteroids].

Inhaled corticosteroids (ICS) are mainstay in controlling the symptoms of asthma. Previous studies have demonstrated that ICS have minimal systemic effects, at doses of up to 400 micrograms per day for children and up to 1000 micrograms per day for adults. At higher doses some systemic effects can be seen. But to date there is no convincing evidence that this gives rise to any of the well known clinical sequelae of corticosteroid excess. To determine the dosage of ICS, it is important to weigh up the potential benefits and risks in each patient. The use of spacer devices and mouth rinsing may reduce local and systemic adverse effects.

Administration, Inhalation↗
PubMed2002

Impact of Fluticasone Diskhaler on health-related quality of life in asthmatic patients.

OBJECTIVE: To assess effect of a breath-actuated inhaled steroid, Fluticasone Diskhaler (Flutide) on health-related quality of life in asthmatic patients using Hyland's living with asthma questionnaire (LWAQ). SUBJECTS AND METHODS: Randomly selected asthmatic patients filled out the LWAQ (the first study). Then, the eight physicians switched inhaled steroid from pressurelized metered-dose inhaler of beclomethasone (BDI) to Flutide according to their own decision. Consequently some patients were switched their prescriptions and others were not. In 12 weeks after the first study, all the patients again filled out the LWAQ (the second study). RESULTS: The patients treated with Flutide were 87 and without were 159. The scale scores of the Flutide group (mean, 1.900) were significantly higher than those of the BDI-group (mean, 1.789). In the second study, there was no significant difference between the scale scores in the two groups (mean, 1.782 vs. 1.705). Among the 8 domains, only medication score significantly decreased by Flutide therapy. More than 80% of the patients favored easy handling of Flutide including no necessity of the spacer. CONCLUSIONS: Flutide therapy significantly improved quality of life in asthmatic patients. The possible mechanisms are the stronger effectiveness of fluticasone propionate and improvement of adherence to inhaled steroid.

Adult↗
PubMed2005

[Nebulisation in childhood asthma].

The inhaled route way, which directly brings an appropriate amount of drug in the right place, is at the present time the recommended route for asthma treatments. The development of spacer devices, easier to use, has reduced the indications of nebulised treatments, but these are still essential in some situations. Nebulisation of short acting beta-2-agonists, which usually requires oxygen administration, is still the first line treatment of a severe acute asthma attack. Ipratropium bromide can be added in the nebulisation, depending on the severity of the attack and the response to beta-2-agonists. Sodium cromoglycate is not used in the prophylactic treatment of childhood asthma any more, but nebulised budesonide is still very useful in moderate to severe persistent asthma in children under 5 years of age, after failure of a treatment with a spacer device. The quality of nebulisation is fully dependent on the equipment used, and on the practical conditions of its realization. It is of most extreme importance to use a compressor/nebulizer couple which is validated for the delivered drug, and that the child breathes, depending on age, via a mouth peace or a facial mask.

Administration, Inhalation↗
PubMed2006

Rural and urban children with asthma: are school health services meeting their needs?

OBJECTIVE: Children with asthma spend a large portion of their day in school, and the extent to which public schools are prepared to meet their health needs is an important issue. The objective of this study was to identify asthma policies and practices in rural and urban school settings and to compare them with current National Heart, Lung, and Blood Institute recommendations. METHODS: A stratified random sample of school nurses who represented each of the 500 active Pennsylvania school districts were surveyed in 2004 concerning nurse staffing patterns, availability of asthma monitoring and treatment-related equipment, emergency preparedness, availability of asthma-related support and case management services, school-specific procedures including identification of children with asthma and accessibility of inhaler medication during school hours, presence and content of written asthma management plans, and perceived obstacles to asthma management in the school setting. Sampling weights were incorporated into the analyses to take the survey design into account. RESULTS: The overall response rate was 76%, with a total of 757 surveys analyzed. In more than half of secondary schools and three quarters of elementary schools, nurses were present < 40 hours per week. Nearly 1 in 5 schools reported that staff who know what to do for a severe asthma attack were not always available. In 72% of rural schools, children were allowed to self-carry rescue inhalers, as compared with 47% of urban schools. Asthma management plans were on file for only 1 quarter of children with asthma, and important information often was omitted. Approximately half of the schools were equipped with peak flow meters and nebulizers, and spacers were available in 1 third of schools. CONCLUSIONS: Improvements are needed to bring schools into compliance with current recommendations, including more consistent availability of knowledgeable staff, improved access to asthma monitoring and treatment-related equipment, more universal use of asthma management plans, and greater access to inhalers while at school, including increasing the proportion of children who are allowed to carry and self-administer inhaler medication.

Adolescent↗