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PubMed1990

Comparison of the effects of prolonged treatment with low and high doses of inhaled terbutaline on beta-adrenoceptor responsiveness in patients with chronic obstructive pulmonary disease.

Eleven patients with chronic obstructive pulmonary disease (age, 61 +/- 2 yr; FEV1, 1.36 +/- 0.24 L, 46 +/- 7% predicted) were given 4 wk of treatment with either a conventional low dose of inhaled terbutaline (LDT), 500 micrograms four times a day, or a high dose of inhaled terbutaline (HDT), 2,000 micrograms four times a day, delivered by a spacer. A randomized double-blind crossover design was used with 2-wk run-in and washout periods, when ipratropium bromide was substituted for inhaled beta-agonists. Dose response curves (DRC) to cumulative doubling doses of inhaled terbutaline (125 to 4,000 micrograms) were constructed after each treatment period, and baseline spirometry, finger tremor (Tr), plasma potassium (K), plasma cAMP, and ECG (HR and T wave) were measured at each dose step of the DRC. Daily PEFR measurements (A.M. and P.M.) and Holter ECG were performed during run-in and treatment periods. Baseline values for FEV1 were not significantly different during run-in, treatment, or washout periods. There were dose-related increases in FEV1 (p less than 0.0001) with no significant differences between DRC after treatment with HDT compared with those with LDT: delta FEV1 max, 0.46 +/- 0.14 L, 15.5 +/- 3.7% predicted (HDT); 0.50 +/- 0.11 L, 16.0 +/- 3.1% predicted (LDT). There were also no differences between DRC for delta FVC: 1.08 +/- 0.22 L, 31.1 +/- 5.4% predicted (HDT); 0.99 +/- 0.14 L, 28.5 +/- 3.8% predicted (LDT). There were no significant changes in K or HR in response to cumulative doses of terbutaline after either treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Inhalation↗
PubMed1996

Short courses of high-dose inhaled budesonide and serum IgG subclass levels in healthy volunteers.

BACKGROUND: The incidence of systemic side effects of inhaled budesonide increases at doses exceeding 2000 micrograms/day. OBJECTIVE: This study was carried out to investigate whether high-dose inhaled budesonide affects serum IgG subclass concentrations in healthy adult volunteers. METHODS: Two groups of 10 subjects each inhaled 2.4 mg of budesonide per day in a double-blind, crossover study of morning (8:00 AM and noon, group A) and diurnal (8:00 AM and 8:00 PM, group B) dosing schedules for 4 weeks each, separated by a 2-week washout period. The budesonide was inhaled through a pressurized metered-dose inhaler, mounted on a 750 ml Nebuhaler (ASTRA Pharmaceuticals, Lund, Sweden). The IgG subclass levels were determined at baseline and every 2 weeks until the end of the study period (10 weeks). RESULTS: There were no statistically significant changes in the serum IgG subclass concentrations over the 10-week study period in group A, group B, or groups A and B combined. CONCLUSION: Inhalation of budesonide, 2.4 mg/day, through a large-volume spacer for repeated 1-month periods does not influence serum IgG subclass concentrations in healthy adults, suggesting that budesonide does not cause systemic humoral immunosuppression when given at therapeutic doses.

Administration, Inhalation↗
PubMed1997

Effect of oral and inhaled salbutamol in infants with bronchiolitis.

The response of bronchiolitis to bronchodilator drugs is controversial. The present study was designed to evaluate the efficacy of oral or metered dose inhaler (MDI) salbutamol using a coffee cup as a spacer device in bronchiolitis. In the trial, 31 hospitalized patients between 6 and 24 months of age, who exhibited the first episode of acute bronchiolitis without any other predisposing illness such as cystic fibrosis, congenital heart disease etc., were randomly assigned to receive oral salbutamol (n = 11, 0.1 mg/kg per dose, four times a day), or MDI salbutamol (n = 12, 200 micrograms per dose, every 3 h) or formed the control group without any bronchodilator therapy (n = 8). All of the patients were given supplemental oxygen as needed and adequate hydration was maintained. The patients were evaluated with clinical symptom scores. There were no differences in the beneficial or side effects of salbutamol, or the number of days in hospital between the treatment groups and the control group. It was concluded that there is no beneficial effect in using bronchodilators in infants with bronchiolitis. Supplemental oxygen and maintenance of normal hydration may be adequate.

Administration, Inhalation↗
PubMed1996

Pharmacokinetics of inhaled drugs.

1. A high therapeutic ratio for the inhaled route of administration is achieved by delivering doses which achieve a high local concentration in the lung and relatively low levels of systemic absorption. 2. Pharmacokinetic evaluation of drug absorption from the lungs provides an accurate and reproducible method for comparing different inhaler delivery systems, as well as for evaluating bioequivalence of generic drug formulations. 3. The measurement of drug absorption from the lungs may also be applied to assess the effects of inhalation technique on drug delivery in vivo. For example with salbutamol delivered via a large volume spacer, lung bioavailability has been shown to be altered by factors such as the number of actuated puffs, inhalation-actuation delay and washing procedure. 4. Differences in drug delivery to the lungs between dry powder reservoir and pressurised metered-dose aerosol devices translate directly into commensurate differences in clinical efficacy for delivery of both inhaled beta 2-adrenoceptor agonists and corticosteroids. 5. For inhaled corticosteroids, pharmacokinetic evaluation using oral charcoal to obviate alimentary absorption may be applied to quantify the relative gut and lung components of systemic bioavailability. In tandem with information on receptor potency and affinity, drug elimination and distribution, these data may help in part to explain observed differences between different inhaled corticosteroids in terms of their systemic bioactivity profiles. 6. Studies are required to evaluate whether pharmacokinetic evaluation of lung absorption is a suitable way of quantifying delivery of nebulised aminoglycoside antibiotics, as for example in patients with cystic fibrosis. 7. Pharmacokinetic evaluation appears to have an established role in the quantification of drug delivery to the lungs and provides important information which is complimentary to other techniques such as radiolabelled deposition. The next decade of research into pharmacokinetics of established and novel drugs and delivery systems is awaited with keen interest, and will hopefully provide a greater understanding into ways of optimising the benefit-risk ratio for inhaled drugs.

Administration, Inhalation↗
PubMed1991

Effects of albuterol inhalation on the work of breathing during weaning from mechanical ventilation.

The work of breathing is a major determinant of the success of weaning from mechanical ventilation. The aim of this study was to assess whether an inhaled bronchodilator could reduce the mechanical load on the respiratory muscles and diminish the work. For this purpose, 15 intubated patients in the process of weaning from mechanical ventilation inhaled the beta 2-agonist bronchodilator albuterol via a spacer device filled with 1 mg of the drug and connected to the endotracheal tube. During spontaneous breathing, the mean work of breathing diminished significantly after albuterol, from 9.35 +/- 1.05 to 8.33 +/- 1.13 J/min (p less than 0.01), and seven patients exhibited a decrease superior or equal to 15%. This decrease resulted from a marked reduction in lung and airway resistance, from 12.0 +/- 1.7 to 9.8 +/- 1.4 cm H2O.L-1.s (p less than 0.05). No significant changes were observed in the breathing pattern, intrinsic PEEP or arterial blood gas measurements after albuterol, and peripheral cardiovascular effects were not significant. In seven patients, we were able to compare the changes that occurred after albuterol in the work of breathing during weaning from mechanical ventilation with the changes in pulmonary function induced by albuterol after extubation, as assessed by the forced oscillation method. A close correlation was found between the two types of change, further indicating that the reduction in the work of breathing was more likely to occur in patients with the largest bronchodilating effect of albuterol at baseline.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Inhalation↗
PubMed1999

Oral montelukast, inhaled beclomethasone, and placebo for chronic asthma. A randomized, controlled trial. Montelukast/Beclomethasone Study Group.

BACKGROUND: Oral leukotriene receptor antagonists have been shown to have efficacy in chronic asthma. OBJECTIVE: To compare the clinical benefit of montelukast, a once-daily oral leukotriene receptor antagonist; placebo; and inhaled beclomethasone. DESIGN: Randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study. SETTING: 36 sites worldwide. PATIENTS: 895 patients 15 to 85 years of age with chronic asthma and an FEV1 50% to 85% of predicted. INTERVENTIONS: Montelukast, 10 mg once daily at bedtime; inhaled beclomethasone, 200 microg twice daily, administered with a spacer device; or placebo. MEASUREMENTS: Primary end points were daytime asthma symptom score and FEV1. Secondary end points were peak expiratory flow rates in the morning and evening, as-needed beta-agonist use, nocturnal awakenings, asthma-specific quality of life, and worsening asthma episodes. RESULTS: Over the 12-week treatment period, the average percentage change from baseline in FEV1 was 13.1% with beclomethasone, 7.4% with montelukast, and 0.7% with placebo (P < 0.001 for each active treatment compared with placebo; P < 0.01 for beclomethasone compared with montelukast). The average change from baseline in daytime symptom score was -0.62 for beclomethasone, -0.41 for montelukast, and -0.17 for placebo (P < 0.001 for each active treatment compared with placebo; P < 0.01 for beclomethasone compared with montelukast). Each agent improved peak expiratory flow rates and quality of life, reduced nocturnal awakenings and asthma attacks, increased the number of asthma-control days, and decreased the number of days with asthma exacerbations (P < 0.001 for each active treatment compared with placebo for each end point; P < 0.01 for beclomethasone compared with montelukast for each end point). Although beclomethasone had a greater mean clinical benefit than montelukast, montelukast had a faster onset of action and a greater initial effect. The two agents caused similar decreases in peripheral blood eosinophil counts (P < 0.05 for each agent compared with placebo). Both agents had tolerability profiles similar to that of placebo over the 12-week study. CONCLUSIONS: Although beclomethasone had a larger mean effect than montelukast, both drugs provided clinical benefit to patients with chronic asthma. This finding is consistent with the use of these agents as controller medications for chronic asthma.

Acetates↗
PubMed1993

[Efficacy of a powder inhaler (Turbuhaler) in moderate asthmatic crises in children].

The use of a metered dose inhaler can be difficult in children, and requires the juxtaposition of an inhalation chamber. Powder inhalers offer different means of administration and are simpler to use and can be easily carried in the pocket or in a school satchel. The aim of this study is to assess the use of a beta-2-mimetic powder inhaler (Bricanyl Turbuhaler) in children presenting with an exacerbation of asthma. Thirty children aged from 4 to 14 years were included in an open random study in parallel groups. After a baseline measure of pulmonary function, the children inhaled 500 microgram of powdered terbutaline, or with metered dose aerosol attached to a spacer device (Nebuhaler). A significant bronchodilatation was apparent in the two groups of children which was measured at 15 and 30 minutes after the inhalation of the drug (measures of peak flow and forced expiratory volume in one second and of specific airways resistance were made). The bronchodilator response was similar whatever the method of inhalation. Although the inspiratory flow is decreased in an exacerbation this work shows that it is possible to advise the use of a powder inhaler in children presenting with a moderate exacerbation of asthma.

Acute Disease↗
PubMed2002

Antiasthmatic drug delivery in children.

Asthma therapy can be administered to children via a number of routes, including oral, inhaled (via a multiplicity of devices), rectal, intravenous, subcutaneous, and intramuscular. The inhaled route is used most often. This can reduce, but never eliminate, systemic absorption. Swallowed aerosolized medication is subject to hepatic first-pass metabolism, but this metabolic route is bypassed by the drug impacting on the airway, including the pharynx. Although there are a large number of studies from a laboratory setting about drug deposition characteristics, there is very little evidence from community-based studies about what families think actually works well in the everyday treatment of the child. However, it is clear that altering the inhaler device can result in marked changes in the dose administered, and any such change should be part of a review of the dose of prescribed medication. Nebulizers are being used much less frequently, and in particular, all but the most severe exacerbations can be treated at least as effectively with equivalent dosages of beta(2)-adrenoceptor agonists from a large volume spacer.

Absorption↗
PubMed1992

A long-term prospective assessment of home nebulizer treatment.

Forty-nine patients (15 asthma, mean FEV1/FVC 1.3/2.1; 34 COPD, mean FEV1/FVC 0.7/1.8) were referred for consideration of home nebulizer treatment. All were monitored for 2 weeks while using their usual inhaled treatment followed by 2 weeks using a 'Nebuhaler' spacer to deliver 1 mg of terbutaline and 80 micrograms of ipratoropium bromide (IB) four times daily. They then borrowed a System 22 nebulizer to self-administer salbutamol nebulizer solution (5 mg), IB unit dose vials (0.5 mg) or a mixture of these drugs four times daily for 1 month each. Both asthmatic and bronchitic patients had a significant rise in their mean daily peak flow rate (PFR) during home nebulizer treatment (P < 0.03) and the COPD patients also had a significant PFR rise during Nebuhaler treatment (P = 0.0004). The mean daily peak flow rates (PFR 1 min-1 were: baseline 179, Nebuhaler 195, salbutamol nebulizer 200, IB nebulizer 198, mixed nebulizer 216). Four patients failed to respond subjectively or objectively to either Nebuhaler or nebulizer treatment. Five patients responded well to Nebuhaler treatment and did not proceed to a home nebulizer trial. Eight further patients preferred Nebuhaler to nebulizer treatment or could not tolerate nebulizer treatment (two cases). Thirty-two patients requested home nebulizer treatment for long-term use (nine salbutamol, five IB, 18 mixture). Twenty-seven of these patients had an increased mean daily PFR (compared to their usual therapy) while using their chosen nebulized treatment. The mean increase in PFR for all 32 patients was 191 min-1 (11%).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1987

Aerosol corticosteroids for the treatment of asthma.

In an effort to maximize the efficacy of corticosteroid treatment in asthma and minimize the adverse reactions, steroid therapy has evolved to the inhalation route of administration with aerosol compounds having potent topical antiinflammatory activity and minimal systemic effects. Corticosteroids exhibiting these properties that are available in the U.S. include beclomethasone dipropionate, triamcinolone acetonide, and flunisolide. The success or failure of patient response to orally inhaled corticosteroids is often a function of adequate drug delivery rather than the efficacy of the drug itself. Patients who cannot use the inhaler accurately may benefit from the use of a spacer or reservoir device. The three aerosolized corticosteroids have specific pharmacologic differences; however, none of these differences has translated into a clinically significant advantage or disadvantage of one product over the others. These agents should be considered for adjunctive therapy in patients whose asthma is not adequately controlled by beta-agonist bronchodilators, theophylline, or cromolyn sodium.

Adrenal Cortex Hormones↗
PubMed2002

Understanding and use of inhaler medication by asthmatics in specialty care in Trinidad: a study following development of Caribbean guidelines for asthma management and prevention.

STUDY OBJECTIVES: Following the development of the Caribbean Guidelines for Asthma Care, we examined the utilization of inhaled medications in asthmatic patients in Trinidad, West Indies. SETTING: Chest Clinic, Ministry of Health, Trinidad. PARTICIPANTS: Physician-diagnosed asthmatic patients who attended the Chest Clinic between July 1998 and August 2000. MEASUREMENTS AND RESULTS: A consecutive sample of patients who were > 7 years of age (n = 402) was interviewed about compliance with, understanding of, and use of inhaler medication. The inhaler technique of these patients was directly observed. Inhaled steroid therapy was prescribed in 83% of patients but were prescribed the least in elderly patients (63%) and children (62%). Salbutamol was prescribed in 98% of patients, and ipratropium and sodium cromoglycate were selectively prescribed in elderly men and children, respectively. Only 33% of patients used the inhaler correctly, and children and the elderly were the least efficient in its use. The use of a spacer device was advised in 19% of patients, including only 6% of the elderly patients. Explanations for different inhaler therapies were given to 62% of patients, and 53% of patients could describe these reasons. The reported 40% noncompliance rate among patients in the sample was primarily a result of long waiting periods at the pharmacy (58%) and the personal cost incurred on purchasing the medication (52%). CONCLUSIONS: Educating patients, with a focus on children and the elderly, in inhaler techniques and reinforcing understanding of asthma medications can improve asthma management in Trinidad. Asthma caregivers in the Caribbean should ensure the appropriate dissemination of the guidelines and should outline strategies for their implementation.

Adolescent↗
PubMed1997

Metered dose inhalers: current and future uses.

Respiratory disease poses an enormous burden on individuals and society. Asthma and chronic obstructive pulmonary disease (COPD), the diseases discussed here, contribute towards a substantial proportion of ill health and cost to the NHS and the economy. Most health professionals consider the inhaled route to be the best method of delivering drugs to the respiratory system. Four types of inhaled delivery system are in use: pressurised metered dose inhalers (pMDIs); dry powder devices; pMDIs and large volume spacers in combination; and nebulisers. In the UK pMDIs are the cheapest type of device on the market and are usually the method of choice for those patients able to use them. International agreement to phase out CFCs has led to the development of alternative propellants for pMDIs. The role of pMDIs is predicted to increase in the future. Demand for pMDIs to treat asthma is likely to increase as the introduction of clinical guidelines extends best practice, and their use to treat patients with COPD is increasing. Novel drugs for the respiratory system, including gene therapy and drugs for non-respiratory disorders, may well employ pMDIs as a delivery system in the future.

Anti-Asthmatic Agents↗
PubMed1997

Effects of salbutamol delivery from a metered dose inhaler versus jet nebulizer on dynamic lung mechanics in very preterm infants with chronic lung disease.

Treatment of chronic lung disease of prematurity requires effective aerosol delivery of different therapeutic agents. Aerosols can be generated by a metered dose inhaler (MDI) or a jet nebulizer. An MDI combined with a spacer device is easier to use and avoids undesirable effects noted in conjunction with jet nebulization. We compared the clinical effectiveness of 200 micrograms (2 puffs) salbutamol delivered from an MDI in conjunction with a valved spacer device (Aerochamber), and 600 micrograms given via jet nebulizer (PariBaby) on 2 consecutive days, the order being randomized. Thirteen spontaneously breathing very preterm infants [mean (SD) gestational age 27.2 (1.8) weeks; birth weight 0.90 (0.34) kg] were studied at a corrected age of 37 (2.3) weeks. Mean (SD) study weight was 1.83 (0.38) kg. Dynamic lung compliance and resistance were determined from measurements of flows, volumes, and transpulmonary pressures, using a pneumotachometer and a small esophageal microtransducer catheter before and 20 min after salbutamol application. Baseline values before salbutamol administration were similar on both occasions: the mean (SD) compliance was 7.7 (3.0) mL.kPa-1.kg-1 pre-MDI plus-spacer and 8.4 (3.1) pre-jet nebulizer; the resistance was 10.4 (4.0) kPa.L-1.s pre-MDI plus-spacer and 9.7 (3.4) pre-jet nebulizer. Following salbutamol, compliance did not change significantly with either MDI plus spacer or jet nebulizer. Resistance fall significantly with MDI plus spacer (mean -2.2; 99.9% CI -0.35, -4.35) and jet nebulizer (-2.4; 99% CI -0.39, -4.42). We conclude that even in small preterm infants 200 micrograms salbutamol via MDI plus spacer improves dynamic resistance as effectively as 600 micrograms via jet nebulizer and may therefore be a preferable mode of aarosol administration.

Administration, Inhalation↗
PubMed2002

[Influence of asthma inhalers on a breath alcohol test].

BACKGROUND: People and authorities are worried about interferences in breath alcohol measurements. The influence of different inhalers on breath alcohol tests is analysed in this paper. PATIENTS AND METHOD: We included 60 patients treated with different inhalers. They underwent a breath alcohol test before treatment and 1, 2, 3, 5 and 10 min after it. RESULTS: Every medication led to positive readings within the first minutes of its administration. However, all values reached zero at 10 min. Patients administered higher doses and those who did not use a spacer device were found to have higher reading values. CONCLUSIONS: Asthma inhalers, including those without alcohol contents, lead to positive readings of breath alcohol measuring devices within the first minutes. However, these interferences are no longer detected at 10 min.

Alcoholic Intoxication↗
PubMed1998

[Inhaled glucocorticosteroids--distribution, stability, therapy].

In this paper the basic methods of aerosol generation--ultrasonic and pneumatic and problems resulting from their use have been discussed. Nebulisation of the inhaled steroids has been presented together with metered dose inhalers (MDI) and dry powder inhalers (DPI). Special attention has been payed to the role of lung volume chambers (spacers). In the tables the review of steroid preparations and their dosage has been displayed.

Administration, Inhalation↗
PubMed1982

Twice daily inhalation of a new corticosteroid, budesonide, in the treatment of chronic asthma.

The efficacy and side-effects of a new corticosteroid, budesonide, was assessed by comparison with beclomethasone dipropionate in double-blind, cross-over study of 30 patients with chronic asthma. The treatment regimens were budesonide 200 micrograms twice daily by conventional pressurized aerosol with a tube spacer attached and beclomethasone 100 micrograms four times daily via a conventional inhaler. Each treatment was given for four weeks. Results were analyzed using Student's t-test for paired comparisons. No significant differences were found for morning and evening peak flow rates, symptom scores, bronchodilator inhaler usage or forced vital capacity. Forced expiratory volume in one second after 4 weeks on each treatment was significantly higher following budesonide therapy (p less than 0.05), but the absolute changes were small and unlikely to be of clinical relevance. There were no major side-effects during either treatment period, but compared with pre-treatment levels serum creatinine and lactic dehydrogenase levels rose significantly during treatment with budesonide (p less than 0.01 and p less than 0.05 respectively). None of these results reflected clinically important biochemical or haematological changes. There was a significant reduction in neutrophil counts following treatment with beclomethasone (p less than 0.05). In the short term treatment of chronic asthma, budesonide administered twice daily is as effective as four times daily beclomethasone. A twice daily dosage regimen should improve patient compliance with therapy.

Adolescent↗
PubMedDate not supplied

Changes in body water distribution during treatment with inhaled steroid in pre-school children.

PRIMARY OBJECTIVE: The study aimed to examine the changes in water distribution in the soft tissue during systemic steroid activity. RESEARCH DESIGN: A three-way cross-over, randomized, placebo-controlled, double-blind trial was used, including 4 weeks of fluticasone propionate pMDI 200 microg b.i.d. delivered via Babyhaler, budesonide pressurized metered dose inhaler (pMDI) 200 microg b.i.d. delivered via Nebuchamber and placebo. Spacers were primed before use. In total, 40 children aged 1-3 years, with mild intermittent asthma were included. Twenty-five of the children completed all three treatments. At the end of each treatment period body impedance and skin ultrasonography were measured. METHODS AND PROCEDURES: We measured changes in water content of the soft tissues by two methods. Skin ultrasonography was used to detect small changes in dermal water content, and bioelectrical impedance was used to assess body water content and distribution. MAIN OUTCOMES AND RESULTS: We found an increase in skin density of the shin from fluticasone as measured by ultrasonography (p = 0.01). There was a tendency for a consistent elevation of impedance parameters from active treatments compared to placebo although overall this effect was not statistically significant (0.1 < p < 0.2). However, sub-analyses indicated a significant effect on whole-body and leg impedance from budesonide treatment (p < 0.05). CONCLUSION: Decreased growth during inhaled steroid treatment seems to partly reflect generalized changes in body water.

Administration, Inhalation↗
PubMed1999

Early use of inhaled nedocromil sodium in children following an acute episode of asthma.

BACKGROUND: Current guidelines on the treatment of childhood asthma recommend the introduction of an anti-inflammatory drug in children who have persistent symptoms and require regular treatment with a bronchodilator. The efficacy and safety of inhaled nedocromil sodium (Tilade Mint aerosol) administered using a Fisonair spacer at a dose of 4 mg three times daily was compared with placebo in the treatment of asthmatic children aged 6-12 years who are symptomatic and recovering from an acute exacerbation of asthma. METHODS: A group comparative, double blind, placebo controlled trial was performed in children who were recovering from an acute episode of asthma following treatment in the emergency department of the hospital or in children referred from their general practitioner following a wheezing episode and documented evidence of at least two previous episodes of wheezing. A two week baseline period on existing bronchodilator treatment was followed by a 12 week treatment period on either nedocromil sodium (2 mg/puff) or placebo. Both treatments were administered using a Fisonair spacer at a dose of two puffs three times daily. Changes from baseline values in daytime asthma and night time asthma symptom scores, usage of rescue bronchodilators, mean peak expiratory flow (PEF) recorded twice daily on diary cards, patients' opinion of treatment, and withdrawals due to treatment failure were measured during the primary treatment period (last six weeks of treatment). RESULTS: One hundred and forty two children aged 6-12 years entered the baseline period. Sixty three were withdrawn due to failure to meet the entry criteria (18) or the criteria for asthma symptom severity (15) or reversibility (9), because they developed uncontrolled asthma (2), because they took disallowed treatment (2), or for other non-trial related reasons (17). Seventy nine patients (46 boys) of mean age 8. 8 years entered the treatment period. There were significant differences in the changes from baseline values during the last six weeks of treatment in favour of nedocromil sodium compared with placebo in the primary variables of daytime asthma and night time asthma, morning and evening PEF, and the usage of rescue inhaled bronchodilators; 53% of patients reported nedocromil sodium to be very or moderately effective compared with 44% placebo. Improvement in asthma symptoms, PEF, and reduction in use of rescue bronchodilators did not reach statistical significance until after six weeks of treatment. Twenty two patients were withdrawn or dropped out during the treatment phase, 12 due to uncontrolled asthma or persistence of asthma symptoms, four due to suspected adverse drug reactions (nedocromil sodium 3 (headaches 2, angio-oedema/urticaria 1), placebo 1(persistent cough)), and six due to non-treatment related reasons. Seventy one adverse events were reported by 27 patients in the nedocromil group and 75 by 30 patients in the placebo group. CONCLUSIONS: Asthma symptoms, use of bronchodilators, and lung function can be improved significantly in children recovering from an acute exacerbation of asthma or wheeze and currently receiving treatment with bronchodilators alone by the addition of inhaled nedocromil sodium at a dose of 4 mg three times daily administered using a Fisonair holding chamber.

Acute Disease↗