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PubMed2003

Inhaled corticosteroids with/without long-acting beta-agonists reduce the risk of rehospitalization and death in COPD patients.

INTRODUCTION: In patients with COPD who have recently been hospitalized for their disease, we examined whether treatment with inhaled corticosteroids without or with long-acting beta-adrenoceptor agonists (beta-agonists) reduced rehospitalization and mortality. STUDY DESIGN: Retrospective cohort analysis in the UK General Practice Research Database. METHODS: We compared rehospitalization for a COPD-related medical condition or death within 1 year after first hospitalization, in 3636 COPD patients receiving prescriptions for inhaled corticosteroids or long-acting beta-agonists compared with 627 reference patients with COPD who were prescribed short-acting bronchodilators only. RESULTS: Rehospitalization within a year occurred in 13.2% of the reference COPD patients, 14.0% of users of long-acting beta-agonists only, 12.3% of users of inhaled corticosteroids only, and 10.4% of users of inhaled corticosteroids and long-acting beta-agonists. Death within a year occurred in 24.3% of the reference COPD patients, 17.3% of users of long-acting beta-agonists only, 17.1% of users of inhaled corticosteroids only, and in 10.5% of users of inhaled corticosteroids and long-acting beta-agonists. In multivariate analyses the risk of rehospitalization or death was reduced by 10% in users of long-acting beta-agonists only (NS), by 16% in users of inhaled corticosteroids only, and by 41% in users of combined inhaled corticosteroids and long-acting beta-agonists (both p < 0.05). CONCLUSION: Use of inhaled corticosteroids with/without long-acting beta-agonists was associated with a reduction of rehospitalization or death in COPD patients.

Administration, Inhalation↗
PubMed2003

Clinical efficacy of inhaler devices containing beta(2)-agonist bronchodilators in the treatment of asthma: cochrane systematic review and meta-analysis of more than 100 randomized, controlled trials.

BACKGROUND: A number of different inhaler devices are available to deliver beta(2)-adrenoceptor agonist (beta(2)-agonist) bronchodilators in asthma. These include hydrofluoroalkane or chlorofluorocarbon (CFC)-free propelled pressurized metered-dose inhalers (pMDIs), many dry powder inhalers and breath-actuated inhalers. OBJECTIVE: To determine the clinical efficacy of all available hand-held inhaler devices compared with the standard CFC-containing pMDI for the delivery of short-acting beta(2)-agonist bronchodilators in nonacute asthma in both children and adults. METHODOLOGY: A systematic review and meta-analysis was carried out of all available randomized, controlled trials (RCTs) using the standard pMDI compared with any other hand-held inhaler device, delivering short-acting beta(2)-agonist bronchodilators in patients with stable asthma. RESULTS: One hundred and eighteen RCTs were included in this review. No clinical differences were found between the standard CFC-containing pMDI and 12 other hand-held inhaler devices for most outcome measures. We found no evidence of clinical differences between studies using either a 1 : 1 (pMDI: another inhaler) or a 2 : 1 dosing ratio. CONCLUSIONS: In patients with stable asthma, short-acting beta(2)-agonist bronchodilators in standard CFC-pMDIs are as effective as any other hand-held inhaler device; therefore the cheapest available device that the patient is able to use should always be considered. Pharmaceutical companies should in future submit to regulatory authorities clinical outcome data (as opposed to in vitro data) in support of any dosing schedules greater than 1 : 1 when compared with the standard pMDI. Clinical effectiveness studies that use an intention-to-treat analysis and report more patient-centered outcomes are required.

Administration, Inhalation↗
PubMed1997

Actual use of inhaled corticosteroids and risk of hospitalisation: a case-control study.

BACKGROUND: The relationship between therapy and adverse outcome in asthma is debated especially for naturally occurring situations. This is due in part to insufficient information regarding actual use of medications. OBJECTIVE: This study was conducted to clarify the relationship between actual intake of anti-asthma drugs and asthma hospitalisation, considered as an outcome. METHODS: A case-control study was performed. Patients hospitalised for an asthma exacerbation were matched to community controls identified in surrounding general practices. Patients were questioned to identify prior use of anti-asthma medications, level of use of inhaled corticosteroids and attitude towards therapy. RESULTS: Twenty-three cases and 31 matched controls were interviewed. Cases tended to have more severe asthma than controls, as judged by more frequent use of oral corticosteroids. Cases tended to make more frequent use of oral xanthines and inhaled anticholinergics, but the proportion of patients using inhaled beta 2-adrenoceptor agonists and inhaled corticosteroids was similar in both groups. Use of lower doses of inhaled corticosteroids was associated with an increased risk of hospitalisation, while higher dosage was associated with decreased risk. Cases and controls differed as to their answers to a questionnaire concerning attitudes: cases expressed less interest in optimal usage of inhaled corticosteroids than controls; they also expressed more confidence in inhaled beta 2-agonists. When both risks were combined, overconfidence in beta 2-agonists and suboptimal use of inhaled steroids, the relationship with hospitalisation was significant (OR 5.5, 95% CI 1.1; 26.1). CONCLUSION: The results suggest that patients' attitudes to inhaled corticosteroids and actual consumption of these medications are directly related to adverse outcome in asthma.

Administration, Inhalation↗
PubMedDate not supplied

Effects of early intervention with inhaled sodium cromoglycate in childhood asthma.

International and Japanese guidelines classify childhood asthma as mild, moderate, or severe, and recommend treatment with "as needed" bronchodilators, inhaled sodium cromoglycate, and inhaled corticosteroids, respectively. Alternatively, some investigators proposed inhaled corticosteroids as first-line therapy to prevent airway inflammatory obstruction. This article describes a clinical study assessing the effect of early intervention with inhaled sodium cromoglycate in childhood asthma. This was a retrospective study of 189 asthmatic children treated with inhaled sodium cromoglycate for five years and whose age of onset of asthma was six year of age or younger. An end-of-study questionnaire completed the examination. Children administered oral or inhaled corticosteroids simultaneously with sodium cromoglycate, were excluded. Asthma scores as defined by the Japanese Pediatric Allergic Committee, were reduced continuously during the five years after the start of sodium cromoglycate treatment. The frequency of emergency department visits and hospitalizations also decreased. Significant between-period intervention differences showed improvement of clinical outcomes for children with severe asthma during the five years of sodium cromoglycate inhalation. The early intervention regime of starting sodium cromoglycate inhalation within two years of the onset of asthma shows a large improvement in the long-term prognosis of childhood asthma, especially for children with severe asthma. It is possible that starting inhaled sodium cromoglycate earlier than the present recommendation of corticosteroids could further improve clinical outcomes, but a prospective study should be performed to verify our results.

Administration, Inhalation↗
PubMed1996

The effect of inhaled K+ channel openers on bronchoconstriction and airway microvascular leakage in anaesthetised guinea pigs.

Since orally administered K+ channel openers may have cardiovascular side effects, it is possible that inhaled administration would be preferred for the treatment of asthma. We have investigated whether inhaled levcromakalim and HOE 234 inhibit histamine-induced bronchoconstriction and airway plasma exudation in anaesthetised guinea pigs. We have also investigated whether inhaled HOE 234 inhibits the bronchoconstriction and plasma exudation induced by vagus nerve stimulation, which is due to the release of tachykinins from sensory nerves. Lung resistance was measured by airway resistance (RL) computed from airway and transpulmonary pressures and plasma exudation by measurement of Evans blue dye extravasation. Inhaled levcromakalim (25 mu g/ml) had a short duration of action, being effective against histamine-induced bronchoconstriction 2 min after pretreatment, but not at 10 min. Inhaled HOE 234 (25 mu g/ml) was similarly effective against histamine-induced bronchoconstriction but had a longer duration of action. Inhaled levcromakalim partially attenuated histamine-induced plasma extravasation in small airways, but not in the trachea or main bronchi, whereas inhaled HOE 234 had no effect. HOE 234 protected against non-adrenergic non-cholinergic nerve-induced bronchoconstriction, but had no effect on neurogenic- or substance P-induced plasma extravasation in the airway. Inhaled K+ channel openers protect against induced bronchoconstriction, but provide little or no protection against plasma exudation, possibly because of an increase in airway blood flow. In addition, inhaled HOE 234 had no effect on neurogenic leakage, suggesting that its vagal inhibitory effect on bronchoconstriction was on airway smooth muscle, rather than on release of neuropeptides from sensory nerves.

Administration, Inhalation↗
PubMed1986

Comparison of subcutaneous injection and high-dose inhalation of epinephrine--implications for self-treatment to prevent anaphylaxis.

The plasma concentrations of epinephrine were determined in healthy subjects administered epinephrine by subcutaneous injection of 0.5 mg or inhalation of 1.5 to 4.5 mg (10 to 30 inhalations from a metered-dose aerosol). The absorption of injected epinephrine was variable and in several cases very slow. The individual maximum values for epinephrine in plasma were 4.65 +/- 1.09 (range 0.74 to 8.31) nmol/L, and these maxima were attained 5 to 120 minutes after injection. Inhaled epinephrine was rapidly and dose dependently absorbed. Ten inhalations resulted in 2.72 +/- 0.84 (0.75 to 5.67) nmol/L within 5 minutes and 20 inhalations resulted in 7.19 +/- 1.78 (2.10 to 13.83) nmol/L with rapid increases and maxima within 20 minutes in seven of eight subjects. Gastrointestinal side effects were dose limiting when epinephrine was administered by inhalation. Our results indicate that inhalation of 2 to 3 mg of epinephrine produces rapid increases of epinephrine concentrations in plasma to levels that have previously been demonstrated to counteract bronchoconstriction induced by inhaled allergen in subjects with asthma. Inhalation has several advantages over injection for self-administration of epinephrine, e.g., in patients who are allergic to insect (Hymenoptera) stings. Apart from the absorption being more rapid, the locally high concentrations of epinephrine in the airways should be advantageous, since bronchoconstriction is one of the life-threatening phenomena of the anaphylactic reaction. This route of administration is also simple for the patient.

Administration, Inhalation↗
PubMed2005

Combined administration of intravenous dipyridamole and inhaled nitric oxide to assess reversibility of pulmonary arterial hypertension in potential cardiac transplant recipients.

BACKGROUND: Irreversible, severe pulmonary hypertension (PH) can produce right heart failure and early mortality after cardiac transplantation. We hypothesized that dipyridamole, an inhibitor of Type 5 phosphodiesterase, would augment the ability of inhaled nitric oxide (NO) to identify reversibility of PH. METHODS: In 9 patients with congestive heart failure (CHF) and severe PH who were breathing 100% oxygen during right heart catheterization, we administered inhaled NO (80 ppm) alone and in combination with intravenous dipyridamole (0.2-mg/kg bolus, with an infusion of 0.0375 mg/kg/min). RESULTS: Compared with breathing oxygen alone, NO inhalation decreased pulmonary artery pressure and pulmonary vascular resistance (PVR) (by 10 +/- 4% and 26 +/- 12% [mean +/- SEM], respectively; both p < 0.05). The combination of NO and dipyridamole reduced PVR (43 +/- 7%; p < 0.05) to a greater extent than did administration of NO alone, and increased the duration of pulmonary vasodilation produced by NO inhalation. Combined administration of inhaled NO and intravenous dipyridamole increased cardiac index (by 23 +/- 10%) and reduced SVR (by 19 +/- 6%, both p < 0.05) without changing systemic arterial pressure. NO inhalation reduced PVR to <200 dyne x s/cm5 in 3 of 7 patients who had a PVR of >200 dyne x s/cm5 when breathing oxygen alone, whereas the combination of NO and dipyridamole decreased PVR to <200 dyne.s/cm(5) in 2 additional patients. CONCLUSIONS: Intravenous dipyridamole augments and prolongs the pulmonary vasodilator effects of inhaled NO in CHF patients with severe PH and, when administered in combination with NO inhalation, can identify PH reversibility in potential cardiac transplant recipients in whom a pulmonary vasodilator response to inhalation of NO alone is not observed.

Administration, Inhalation↗
PubMed2004

Use of inhaled steroids by pregnant asthmatic women does not reduce intrauterine growth.

BACKGROUND: Inhaled steroids are recommended for the treatment of persistent asthma during pregnancy, but their potential effects on intrauterine growth have been inadequately evaluated. OBJECTIVE: The purpose of this study was to evaluate the association between maternal use of specific inhaled steroids and inhaled steroid dose during pregnancy and the incidence of infants who are small for gestational age (SGA) and mean birth weight. METHODS: Pregnant asthmatic women being treated with inhaled steroids were enrolled in the study before delivery by their managing allergists. Information regarding the specific inhaled steroid and daily dose used, requirement for oral steroids, occurrence of acute asthmatic episodes, maternal race, birth weight, gestational age, and congenital malformations was obtained for each patient. SGA was defined through use of a published normative sample of American births. RESULTS: A total of 474 women were enrolled in the study; of the 451 enrolled participants whose pregnancy ended in a singleton live birth, 396 (88%) completed the study. The incidence of infants with low birth weight, preterm births, and congenital malformations in this cohort was not greater than expected in the general population. The incidence of SGA was 7.1% (95% CI, 5.0% to 10.1%). No significant relationships between specific inhaled steroid or dose of inhaled steroid used and either SGA or mean birth weight were observed. CONCLUSION: These data suggest that the use of inhaled steroids by pregnant asthmatic women does not reduce intrauterine growth and supports the recommendation that inhaled steroids should be used in the management of persistent asthma during pregnancy.

Administration, Inhalation↗
PubMed2005

Acute LPS inhalation in healthy volunteers induces dendritic cell maturation in vivo.

BACKGROUND: We have been studying the innate immune response of airways cells of healthy human volunteers to inhaled LPS, a Toll-like receptor 4 (TLR4) ligand, and have shown that macrophage phagocytic capacity is blunted. OBJECTIVE: Because a primary feature of dendritic cell (DC) maturation is a loss of phagocytic capacity, we sought to determine whether acute LPS inhalation in healthy volunteers promotes DC maturation in vivo. METHODS: Phagocytosis (IgG-opsonized zymosan particles) and cell-surface phenotypes were analyzed by flow cytometry of induced sputum cells obtained before and 6 hours after Clinical Center Reference Endotoxin (CCRE; 20,000 EU) inhalation in 9 healthy volunteers. RESULTS: Neutrophils were elevated in the airways after CCRE inhalation (67% +/- 6% vs 37% +/- 6%; P < .05). Phagocytosis (monocytes, macrophages) was blunted (73%, 46%; P < .05) and negatively correlated with PMN influx ( R = -0.73; P < .05) after CCRE inhalation. GM-CSF and IL-1beta, potent DC maturation agents, were elevated after versus before CCRE inhalation (217 pg/mL +/- 103 pg/mL vs 722 pg/mL +/- 202 pg/mL; 83 pg/mL +/- 24 pg/mL vs 148 pg/mL +/- 37 pg/mL, respectively; P < .05). Markers of DC maturation (CD80, CD86, HLA-DR) were upregulated on monocytes and macrophages ( P < .05), and discrete populations of mature DC were observed ( P < .05) after CCRE inhalation. CONCLUSION: Inhaled LPS, directly through TLR4 stimulation of immature DC and/or indirectly through stimulation of GM-CSF and IL-1beta, induces pulmonary DC maturation in vivo . Inhaled LPS may enhance allergic airways responses to air pollution through its ability to induce DC maturation.

Administration, Inhalation↗
PubMed2004

Inhaled prostacyclin is safe, effective, and affordable in patients with pulmonary hypertension, right heart dysfunction, and refractory hypoxemia after cardiothoracic surgery.

BACKGROUND: The purpose of this study was to describe our institutional experience in using inhaled prostacyclin as a selective pulmonary vasodilator in patients with pulmonary hypertension, refractory hypoxemia, and right heart dysfunction after cardiothoracic surgery. METHODS: Between February 2001 and March 2003, cardiothoracic surgical patients with pulmonary hypertension (mean pulmonary artery pressure >30 mm Hg or systolic pulmonary artery pressure >40 mm Hg), hypoxemia (PaO(2)/fraction of inspired oxygen <150 mm Hg), or right heart dysfunction (central venous pressure >16 mm Hg and cardiac index <2.2 L.min(-1).m(-2)) were prospectively administered inhaled prostacyclin at an initial concentration of 20,000 ng/mL and then weaned per protocol. Hemodynamic variables were measured before the initiation of inhaled prostacyclin, 30 to 60 minutes after initiation, and again 4 to 6 hours later. RESULTS: One hundred twenty-six patients were enrolled during the study period. At both time points, inhaled prostacyclin significantly decreased the mean pulmonary artery pressure without altering the mean arterial pressure. The average length of time on inhaled prostacyclin was 45.6 hours. There were no adverse events attributable to inhaled prostacyclin. The average cost for inhaled prostacyclin was 150 US dollars per day. Compared with nitric oxide, which costs 3000 US dollars per day, the potential cost savings over this period were 681,686 US dollars. CONCLUSIONS: Inhaled prostacyclin seems to be a safe and effective pulmonary vasodilator for cardiothoracic surgical patients with pulmonary hypertension, refractory hypoxemia, or right heart dysfunction. Overall, inhaled prostacyclin significantly decreases mean pulmonary artery pressures without altering the mean arterial pressure. Compared with nitric oxide, there is no special equipment required for administration or toxicity monitoring, and the cost savings are substantial.

Administration, Inhalation↗
PubMed2005

Inhaled endotoxin in healthy human subjects: a dose-related study on systemic effects and peripheral CD4+ and CD8+ T cells.

BACKGROUND: Inhaled endotoxin or lipopolysaccharide (LPS) is implicated in the pathogenesis of pulmonary diseases. We investigated the inhalation effects of two different doses of LPS in healthy human subjects. METHODS: Eighteen healthy non-atopic human subjects inhaled either 15 microg (n=10) or 50 microg (n=8)Escherichia coli LPS in an open study. As control, each subject had isotonic saline inhalation 1 week before (baseline) and after LPS inhalation. Data collected included those of clinical parameter, induced sputum and peripheral blood CD4+ and CD8+ T cells. RESULTS: Acute flu-like symptoms and pyrexia were significantly greater in the 50 microg than 15 microg LPS group. Similarly, the increase in sputum and blood total cell and neutrophil counts at 6h following inhaled LPS were greater in the 50 microg group. Myeloperoxidase, human neutrophil elastase and interleukin-8 in sputum sol, but not blood, showed a trend towards greater increase following 50 microg LPS. All these changes were resolved at one week. In the 50 microg dose group alone, there was a reduction in the proportion of peripheral blood interferon (IFN)-gamma-producing CD4+ and CD8+ T cells at 6h followed by an increase at 1 week after inhaled LPS. CONCLUSIONS: The airway and systemic effects of inhaled LPS are dose-related and predominantly neutrophilic. The changes in the proportions of circulating CD4+ and CD8+ T cells suggests preferential recruitment of IFN-gamma-producing T cells into tissue from inhaled 50 microg LPS, followed by reappearance of these cells in blood 1 week later.

Administration, Inhalation↗
PubMed1995

Bone mineral density and the risk of fracture in patients receiving long-term inhaled steroid therapy for asthma.

To determine whether high-dose or prolonged inhaled steroid therapy for asthma increases a patient's risk of osteoporosis and fracture, we measured bone density in 26 men and 43 women (41 postmenopausal, all of whom had received supplemental estrogen therapy) after treatment with an inhaled steroid for 10.1 +/- 5.5 years and oral prednisone for 10.7 +/- 9.7 years (mean +/- SD). Most had stopped receiving prednisone since commencing the inhaled steroid therapy. We found that bone densities (adjusted for age and sex to yield a z score) were lower in association with higher daily doses of inhaled steroid (p = 0.013 ANCOVA) and with the duration of past prednisone therapy (p = 0.032). Larger cumulative inhaled steroid doses were associated with higher bone densities (p = 0.002) and a reduction in the numbers of patients at risk of fracture. Bone density also increased with the amount of supplemental estrogen therapy (p = 0.058) and, at equivalent levels of inhaled and oral steroid use, women showed higher bone density z scores than did men. Women with a lifetime dose of inhaled steroid greater than 3 gm had normal bone density regardless of the amount of past or current prednisone use or the current dose of inhaled steroid. These data indicate that the daily dose, but not the duration, of inhaled steroid therapy may adversely affect bone density, and that estrogen therapy may offset this bone-depleting effect in postmenopausal women.

Administration, Inhalation↗
PubMed1995

Steroid-sparing effect of inhaled lysine acetylsalicylate and furosemide in high-dose beclomethasone-dependent asthma.

BACKGROUND: Inhaled lysine acetylsalicylate and furosemide exert a mutually potentiating protective activity on experimentally induced bronchoconstriction in asthma. OBJECTIVE: Our purpose was to investigate the clinical effectiveness of combined treatment of asthma with inhaled lysine acetylsalicylate and furosemide. METHODS: We performed a randomized, double-blind, crossover study in nine patients with chronic asthma requiring a high dose (2 mg/day) of inhaled beclomethasone for clinical control. Patients were treated with a combination of 720 mg inhaled lysine acetylsalicylate and 40 mg furosemide twice daily, or with matched placebo in addition to inhaled steroids. The dose of inhaled steroids was reduced by half every 15 days and eventually suspended unless a patient's respiratory condition worsened. RESULTS: During treatment with placebo, all patients had worsening of asthma at dosages of 1 or 0.5 mg/day beclomethasone (mean +/- SE, 833 +/- 83 micrograms/day). During combined treatment complete suspension of inhaled steroids in two patients and reduction to 0.5 to 0.25 mg in the remaining seven patients (mean, 250 +/- 72 micrograms/day) was achieved, with a mean reduction of 71% +/- 7%. Forced expiratory volume in 1 second, weekly peak expiratory flow rate, symptom score, and bronchodilator intake remained significantly better with combined treatment than with placebo. CONCLUSIONS: Treatment with inhaled lysine acetylsalicylate and furosemide allows a considerable sparing of inhaled steroids without significant side effects in patients with severe asthma.

Administration, Inhalation↗
PubMed1997

Time course of changes in adenosine 5'-monophosphate airway responsiveness with inhaled heparin in allergic asthma.

BACKGROUND: Recent studies have shown that inhaled heparin exerts a protective effect against various bronchoconstrictor stimuli in asthma, possible through an inhibition of mast cell activation. OBJECTIVE: Because adenosine 5'-monophosphate (AMP) elicits bronchoconstriction by augmenting mast cell mediator release, we have investigated the effect of inhaled heparin (15,000 units USP/ml, 4 ml) on the bronchoconstrictor response to this agonist and to methacholine in a randomized, double-blind, placebo-controlled study of 10 subjects with asthma. We also carried out a separate randomized, double-blind study in seven additional volunteers with asthma to examine in more detail the time-course of change in bronchial reactivity to inhaled AMP after treatment with nebulized heparin. RESULTS: Inhaled heparin significantly increased the provocative concentration of AMP causing a 20% decrease in forced expiratory volume in 1 second (PC20 FEV1-AMP) from the postplacebo treatment value of 22.3 mg/ml (range, 5.7 to 68.9 mg/ml) to 48.1 mg/ml (range, 5.1-196.8 mg/ml) (p < 0.01). When compared with placebo, inhaled heparin failed to alter the airway responsiveness to methacholine; the mean (range) PC20 methacholine values were 1.00 mg/ml (0.44 to 4.76 mg/ml) and 1.08 mg/ml (0.46 to 5.08 mg/ml), respectively. After placebo administration, the PC20 AMP values at 15, 60, and 180 minutes did not differ significantly from each other; their geometric mean (range) values were 26.1 mg/ml (5.9 to 85.8 mg/ml), 26.6 mg/ml (6.3 to 87.8 mg/ml), and 24.9 mg/ml (5.2 to 80.2 mg/ml), respectively. When compared with placebo, the PC20 values for AMP after administration of inhaled heparin were significantly increased up to 57.3 mg/ml (14.7 to 176.0 mg/ml) and to 52.7 mg/ml (13.9 to 90.8 mg/ml) at 15 minutes and 60 minutes, respectively. At 180 minutes, inhaled heparin failed to affect AMP airway responsiveness; the PC20 AMP was not significantly different from that of placebo, with a value of 30.6 mg/ml (4.8 to 93.3 mg/ml). CONCLUSION: Heparin administered by inhalation is effective in attenuating the airway response to AMP but not to methacholine. The time course of change in bronchial reactivity to AMP has a peak effect at 15 minutes and lasts up to 60 minutes. It is possible that the mechanism(s) underlying the protective effects of inhaled heparin in asthma may be related to an inhibitory modulation of mast cell activation.

Adenosine Monophosphate↗
PubMed1999

Clinical use of nebulized budesonide inhalation suspension in a child with asthma.

Childhood asthma contributes to significant morbidity among patients and significantly impacts the quality of life and daily routines of their caregivers. The parents or caregivers assume responsibility for tasks that children are too young to perform; this often includes daily administration of controller medications and nightly administration of reliever medications. Most young children do not have the coordination or understanding to effectively use pressurized metered-dose inhalers or inhalation-driven devices; thus nebulizer therapy often is preferred for children younger than 4 years of age. Budesonide inhalation suspension will be the first inhaled corticosteroid available for children younger than 4 years of age and the first inhaled corticosteroid for delivery by nebulization in the United States. This is a case report of a 3-year-old boy who received budesonide inhalation suspension as part of several double-blind and open-label studies evaluating the drug. Before study entry, the boy was experiencing more breakthrough wheezing episodes at night than the parents were used to, resulting in an increase in nighttime awakenings that required nebulizer therapy. These nighttime awakenings had a substantial impact on the quality of life of the entire family and interfered with the parents' ability to function at work. Even though they wanted to have more children, this situation discouraged them from doing so. Budesonide inhalation suspension improved overall asthma control and was well tolerated. The boy had a decrease in nighttime symptoms and an increase in both height and weight percentiles for his age. Importantly, use of budesonide inhalation suspension in this boy eased the management of severe asthma and improved the quality of life of the entire family. The parents subsequently decided to have a second child. Budesonide inhalation suspension represents a major breakthrough for infants and young children by providing a formulation that, on approval, can be delivered reliably by nebulizer for effective maintenance treatment of persistent asthma.

Administration, Inhalation↗
PubMed2000

Inhaled corticosteroid use and bone-mineral density in patients with asthma.

BACKGROUND: Inhaled corticosteroids are absorbed into the systemic circulation, but the extent to which they have adverse effects on bone is uncertain. The question is important since 3% of the European population take an inhaled corticosteroid regularly and may do so for many years. METHODS: We studied the dose-response relation between cumulative inhaled corticosteroid dose and bone-mineral density at the lumbar spine and proximal femur in 196 adults (119 women) with asthma aged 20-40 years. Patients had taken an inhaled corticosteroid regularly for at least 6 months, and had had limited exposure to systemic steroids. Cumulative dose of inhaled corticosteroid was calculated from questionnaires and computerised and written general-practice records, and its effect on bone-mineral density was estimated by multiple regression analysis. FINDINGS: Median duration of inhaled corticosteroid treatment was 6 years (range 0.5-24), and median cumulative dose was 876 mg (87-4380). There was a negative association between cumulative dose of inhaled corticosteroid and bone-mineral density at the lumbar spine (L2-L4), femoral neck, Ward's triangle, and trochanter, both before and after adjustment for the effects of age and sex. A doubling in dose of inhaled corticosteroid was associated with a decrease in bone-mineral density at the lumbar spine of 0.16 SD (95% CI 0.04-0.28). Similar decreases were found at the femoral neck, Ward's triangle, and trochanter. Adjustment for potential confounding factors including physical activity and past oral, nasal, dermal, and parenteral corticosteroids did not weaken the associations. INTERPRETATION: This study provides evidence of a negative relation between total cumulative dose of inhaled corticosteroid and bone-mineral density in patients with asthma.

Absorptiometry, Photon↗
PubMed1998

The comparison of early fluid therapy in extensive flame burns between inhalation and noninhalation injuries.

Over the last half century, advances in treatment have changed the principal cause of death in burn patients from burn shock and wound sepsis to pulmonary sepsis, of which inhalation injury has always played a key role in morbidity and mortality. Even though Navar et al., Am. J. Surg. 1985;150:716-720 have noted that patients with inhalation injury had a mean fluid requirement of 5.8 ml/kg/% burn to achieve resuscitation from early burn shock, while patients without inhalation injury required only a mean fluid of 4.0 ml/kg/% burn, to achieve successful resuscitation in inhalation injured patients with minimum but adequate fluid has always been a challenge. To further define the difference of early fluid therapy between inhalation and noninhalation in extensively burned patients, a retrospective analysis was carried out in the Tri-Service General Hospital. Sixty-two flame burned patients (aged from 16 to 81 years-old with a mean age of 33.2+/-15.1 years: with burn size ranging from 30% to 98% TBSA with a mean burn size of 60.5+/-22.7%; 26 with inhalation injury; noninhalation 36) were reviewed during a 5-year period. The Parkland formula is the initial choice of fluid regimen with 4 ml/kg/% burn and the amount of replacement is monitored by urine output and is titrated to maintain urine output between 0.5 and 1.0 ml/kg/h. The mean amounts of fluid requirements of both inhalation and noninhalation burned patients were 3.1 +/- 1.0 and 2.3+/-0.8 ml/kg/% burn respectively (p < 0.05). Our study showed less fluid requirement for both inhalation and noninhalation injured patients in comparison with the Navar study and Parkland predictions in the first 24 h postburn. Furthermore, the inhalation injured patients definitely required volumes of fluid in excess of those required in noninhalation injured cases.

Adolescent↗
PubMed1996

Inhaled prostacyclin for treatment of pulmonary hypertension after cardiac surgery or heart transplantation: a pharmacodynamic study.

OBJECTIVE: To study the effects of incremental concentrations of inhaled aerosolized prostacyclin (PGI2) on pulmonary and systemic hemodynamics after cardiac surgery or heart transplantation. DESIGN: Pharmacodynamic dose-response study. SETTING: Cardiothoracic intensive care unit (ICU) at a university hospital. PARTICIPANTS: Nine patients with pulmonary hypertension after cardiac surgery or heart transplantation and an elevated pulmonary vascular resistance (PVR) (> 20 dynes.sec.cm-5) treated in the ICU with inotropic support were studied. INTERVENTIONS: Inhaled prostacyclin was administered at concentrations of 2.5, 5.0, and 10.0 micrograms/mL using conventional systems for nebulization. MEASUREMENTS AND MAIN RESULTS: Pulmonary and systemic hemodynamics as well as right ventricular (RV) function variables (n = 3) were measured before, during, and 10 and 20 minutes after inhalation of PGI2. Inhaled PGI2 induced a dose-dependent decrease in PVR and the transpulmonary gradient (which decreased by -29% and -26%, respectively) at an inhaled concentration of 10 micrograms/mL. Inhaled PGI2 caused no changes in systemic vascular resistance. Central venous pressure decreased during PGI2 inhalation with no change in stroke volume, indicating an improvement in RV performance, which was particularly obvious in one patient with RV failure after heart transplantation. Twenty minutes after discontinuation of inhaled PGI2, hemodynamic variables returned to baseline. CONCLUSIONS: Inhaled PGI2 induces a dose-dependent selective pulmonary vasodilation and may improve RV performance after cardiac surgery complicated by pulmonary hypertension and RV failure.

Administration, Inhalation↗