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PubMed1994

Terbutaline in COPD comparison between Turbuhaler and chlorofluorocarbon (CFC) inhaler.

Patients with chronic obstructive pulmonary disease (COPD) often subjectively benefit from inhaled beta 2-agonists in spite of little or no demonstrable effect in forced expiratory volume in 1 second (FEV1.0). A comparison between the effects of terbutaline administered via a dry powder inhaler (Turbuhaler) and via a chlorofluorocarbon (CFC) inhaler in conjunction with a spacer device (Nebuhaler) was performed in patients with regard to FEV1.0, forced expiratory capacity (FVC), residual volume (RV), and specific conductance (s-Gaw). Fifteen hospitalised patients (11 male) with COPD were studied, each of whom had a diurnal variation in peak expiratory flow (PEF) not exceeding 15% and with a demonstrated volume response to inhaled beta 2-agonists in FVC and/or RV of at least 15%. Patients were administered each of the following five treatments on a single occasion in a randomized order (latin square) in intervals of at least 2 days: placebo, terbutaline via Turbuhaler (1.0 and 2.5 mg) and terbutaline via a CFC inhaler (1.0 mg without and 2.5 mg with Nebuhaler). Inhalation of terbutaline in different doses and from different devices induced a decrease in RV, an increase in FVC, and s-Gaw and a less pronounced increase in FEV1.0. No statistically significant differences between the four terbutaline treatments were seen, but all were significantly different from the placebo. These findings indicate that while patients with COPD may benefit from inhaled terbutaline through decreased hyperinflation, the choice of inhalation device seems to be of little importance for its efficacy.

Administration, Inhalation↗
PubMed1997

Holding chambers for pMDI use.

Spacer devices for pressurized metered-dose inhalers (pMDI) are needed to slow down the aerosol jet and hence to reduce oropharyngeal deposition as well as to overcome coordination problems. A new spacer, JET (Chiesi, Italy), which is less cumbersome to carry, was tested on five healthy volunteers. They inhaled with a slow inspiratory vital capacity maneuver 2 x 100 micrograms doses of the beta 2-agonist salbutamol, labelled with 99mTc, via a pMDI (Butovent, Chiesi) with and without the new JET spacer. The percentage of total delivered activity to the lungs increased with the JET from 14.3 +/- 4.5% to 22.3 +/- 4.1%, while the extrapulmonary deposition (oropharynx and stomach) was reduced from 39.8 +/- 12.2% to 11.0 +/- 3.4%. These results show that the optimal application of the JET can improve therapeutic efficacy by reducing extrapulmonary drug deposition while increasing the drug delivery to the lungs. Use of holding chambers as reservoirs should be avoided as well as frequent cleaning of the spacer.

Administration, Inhalation↗
PubMed1999

[Current strategy of bronchodilator therapy for chronic obstructive pulmonary disease (COPD)].

The COPD is slowly but progressive disease, the main purpose of the treatment for COPD is considered to produce a significant bronchodilating effect for maintaining lung functions for long period. Inhaled anticholinergic drug is currently used as the first-line therapy of patients with COPD. The beta 2-adrenergic agonists used be the other choice of bronchodilator for treatment of COPD. The benefit of inhalational steroid on the treatment of COPD is still a matter of debate. The accurate procedure of inhalational device and appropriate use of spacer are particularly important for older patients with COPD. The older patients with COPD can be better treated by the inhaled anticholinergic drug or its combination with beta 2-adrenergic agents.

Administration, Inhalation↗
PubMedDate not supplied

[Errors in the technique of using measured-dose inhalers in asthmatic children and adolescents].

BACKGROUND: The MDI's are widely used in the treatment of asthma and are relatively easy to use. The response to this medicament is influenced by several facts that include the physical characteristics of the container and the technique used by the patient. OBJECTIVE: To identify the mistakes made by asthmatic children and teenagers in the use of the MDI's. MATERIAL AND METHODS: This paper was a descriptive and observational study in 57 asthmatic patients who were between 5 to 17 years. For the evaluation of the inhalation technique we used a placebo without a spacer. There are 5 steps for the correct use of the inhaled medications: 1) opening, 2) agitation, 3) coordination between inhalation and the shoot of the MDI's, 4) a deep breath and holding it for at lest 6 seconds. RESULTS: 20 of the 57 patients (35%) followed all the steps correctly. The most frequent mistake was to take the deep breath, which was perform only by 20 (35%) out of the children. The second mistake we found in this study was the up holding inspiration at least for 6 seconds, which was done properly only by 31 patients (54%). CONCLUSIONS: The implantation of inhaled therapy programs directed and performed by specialists is recommended.

Administration, Inhalation↗
PubMed2003

The formulation and evaluation of a CFC-free budesonide pressurised metered dose inhaler.

Although dry powder inhalers are well established for the delivery of corticosteroids, the pressurised metered dose inhaler remains the preferred and most cost effective presentation. To design an HFA solution formulation which matched marketed CFC products (Pulmicort and Desonac DA) two elements of the Chiesi Modulite system, the addition of a non-volatile component and the actuator orifice diameter, were varied. These variables, which were shown by in vitro tests to influence the fine particle dose and its mean particle size in different ways, could be permuted to give an aerosol cloud with size characteristics very close to the comparator products. The likelihood that this would confer clinical equivalence is reinforced by a pharmacokinetic analysis which showed that the chosen HFA solution formula gave similar systemic absorption from the lung as Pulmicort. The equivalence in aerosol characteristics was sustained when the pressurised metered dose inhalers (pMDIs) were used with spacers. The Chiesi Jet and the AstraZeneca Nebuhaler, when used with their respective pMDIs, reduced likely oropharyngeal deposition to the same extent and gave a similar increase in the fine particle dose.

Administration, Inhalation↗
PubMed1997

Bronchodilator therapy for chronic obstructive pulmonary disease.

Chronic obstructive pulmonary disease (COPD) is a heterogeneous group of diseases characterized by cough, sputum production, dyspnoea, airflow limitation and bronchial hyperreactivity. The airflow limitation declines progressively and is irreversible or partially reversible. Bronchodilator therapy is prescribed to relieve the symptoms, reverse airway obstruction and hopefully slow the rate of disease progression and decelerate the decline in pulmonary function. During acute exacerbation, inhalation of beta2-agonists remain the therapy of choice. The usefulness of anticholinergic inhalation in acute attacks is investigated in order to determine if a higher dose and more frequent administration have same benefit as beta2-agonists inhalation. Theophylline is usually given orally as a sustained release formulation for chronic maintenance therapy. Some patients may benefit from theophylline infusion during an acute phase when appropriately used; however, sympathomimetic agents fail to produce adequate bronchodilation. During interim periods of stability, inhalation of ipratropium bromide has increased in popularity as a regular long-term bronchodilator therapy. Although ipratropium and beta2-agonists are equally efficacious when the dosage is adequate enough, a combination of both provides a rapid onset of action of the adrenergic agents and a prolonged action of the anticholinergic. Furthermore, this combination can be given in a reduced dose, thereby avoiding side-effects. Inhalation techniques can influence the efficacy of bronchodilator therapy. For severe dyspnoeic patients or patients with poor technique of co-ordination with metered-dose inhaler (MDI), attachment of a spacer to the MDI or using a nebulizer will overcome these difficulties. Bronchodilator therapy can not prevent the development of COPD or slow down the decline of pulmonary function, other interventions should be included in a comprehensive management programme.

Administration, Inhalation↗
PubMed1995

Inhaled frusemide and exercise-induced bronchoconstriction in children with asthma.

BACKGROUND: Nebulised frusemide has been shown to be protective against bronchoconstricting stimuli in adult asthmatic subjects and against cold air challenge in children. Animal studies suggest that inhaled frusemide may be more effective in the young. METHODS: A double blind placebo, controlled, crossover study on the effect on exercise of pretreatment with frusemide (20 mg) from a metered dose inhaler via a large volume spacer (Volumatic) was performed in 12 asthmatic children. Exercise testing consisted of eight minutes of running on a treadmill in an environmentally controlled laboratory. RESULTS: Deterioration in lung function was less after frusemide than after the placebo exercise tests. The mean (95% CI) maximum percentage falls in forced expiratory volume in one second (FEV1) were 14.4% (7.7 to 21.0) for placebo and 5.7% (2.3 to 9.0) for frusemide. CONCLUSIONS: Inhaled frusemide via a metered dose inhaler reduces exercise-induced bronchoconstriction in children.

Administration, Inhalation↗
PubMed1996

Incorrect use of metered dose inhaler by pediatric residents.

Currently press-and-breath metered dose inhalers (MDIs) are widely prescribed but are often difficult for many patients to properly use. However many medical personnel cannot use the MDIs correctly. We administered a question and observed usage of a placebo metered dose inhaler with ad-on spacer (Nebuhaler) among 127 second year pediatric residents. Forty-eight per cent of the residents performed at least six of nine steps correctly. The two most common errors made by participants were not to place mouthpiece tightly between teeth and lips (64%) and failure to breath out to functional residual capacity before actuation (55.3%). Of the residents with improper timing of actuation (49%) all actuated the canister before starting inhalation. (5 seconds or longer time). We conclude that (1) pediatricians should have additional instruction in proper MDIs usage and practice with the asthmatic child and (2) routine assessment of MDIs technique should be instituted as standard practice care.

Administration, Inhalation↗
PubMed1992

A new baby-spacer device for aerosolized bronchodilator administration in infants with bronchopulmonary disease.

The response of salbutamol (Ventolin, Glaxo), topically administered from a metered dose inhaler (MDI) through a new baby-spacer-device (Babyhaler, Glaxo) was studied in 14 infants (8 wheezy infants, 3 infants with cystic fibrosis and 3 infants after respiratory distress syndrome), age 2.9-18.8 months. Changes in thoracic gas volume (TGV) as an estimate of pulmonary hyperinflation and changes in airway conductance (Gaw) as an estimate of bronchial obstruction were assessed by whole-body plethysmography. After baseline measurements, 1 puff of 100 micrograms salbutamol was given repeatedly at 5 min intervals until 600 micrograms have been inhaled and TGV and Gaw were measured after each inhalation at 5, 10, 15, 20, 25 and 30 min. Significant improvement in lung function was achieved in 57.1% of infants after 400 micrograms and in 92.9% of infants after 600 micrograms salbutamol. The study shows usefulness of bronchodilator treatment in infants with bronchopulmonary disease by a system with a MDI and baby-spacer-device. However a special dose-time relationship must be respected.

Albuterol↗
PubMed1997

Clinical and physiological improvement after inhalation of low-dose beclomethasone dipropionate and salbutamol in wheezy infants.

UNLABELLED: Twenty-nine of initially 42 infants with recurrent wheeze (20 male and 9 female) with an age range of 2.1-25.2 months were randomly assigned to receive either 100 micrograms beclomethasone dipropionate (BDP) combined with 200 micrograms salbutamol (group BDP-S, n = 9), 200 micrograms salbutamol (group S, n = 8), or placebo (group P, n = 6) 3 times daily for a 6 weeks' treatment period. Six infants had to be treated openly with BDP-S (group O, n = 6) because of deterioration in the disease state. Ten babies were excluded because of incomplete data and poor drug compliance and further 3 because of needed rescue medication. The drugs were inhaled from a metered dose inhaler through a baby-adapted spacer device, the Babyhaler. Control was assessed by symptom diaries, and infant whole-body plethysmography. Values of thoracic gas volume (TGV), airway conductance (Gaw) and specific airway conductance (sGaw) were calculated numerically independent of age and body length in percent predicted and in standard deviation scores using regression equations taken from healthy infants previously evaluated. Functional improvement was considered to have occurred when either TGV, and/or Gaw improved more than 2 SD from baseline. There was a significant improvement in the symptom score (p < 0.05), particularly concerning cough, in addition to a significant decrease in pulmonary hyperinflation (TGV: p < 0.05) and improvement of Gaw (p < 0.01) and sGaw (p < 0.01) in the BDP-S group when compared to the P group. No significant differences were found between the BDP-S and S group and/or between the S and P groups. CONCLUSIONS: In wheezy infants BDP improves clinical status and lung function, when given in combination with salbutamol by a baby-adapted spacer device.

Administration, Inhalation↗
PubMed2005

Principles of metered-dose inhaler design.

The pressurized metered-dose inhaler (pMDI) was introduced to deliver asthma medications in a convenient and reliable multi-dose presentation. The key components of the pMDI device (propellants, formulation, metering valve, and actuator) all play roles in the formation of the spray, and in determining drug delivery to the lungs. Hence the opportunity exists to design a pMDI product by adjusting the formulation, metering-valve size, and actuator nozzle diameter in order to obtain the required spray characteristics and fine-particle dose. Breath-actuated pMDIs, breath-coordinated pMDIs, spray-velocity modifiers, and spacer devices may be useful for patients who cannot use a conventional press-and-breathe pMDI correctly. Modern pMDI devices, which contain non-ozone-depleting propellants, should allow inhalation therapy via pMDI to extend well into the 21st century for a variety of treatment indications.

Administration, Inhalation↗
PubMed1994

Volumatic usage: some generic salbutamol metered dose inhalers can be used.

BACKGROUND: The 30 minute and 24 hour post-inhalation urinary excretion of salbutamol represents the relative amount of drug deposited in the lungs and total systemic absorption, respectively. Using this method two metered dose inhalers used with a Volumatic (Allen and Hanburys Ltd, UK) large volume spacer have been compared. METHOD: Eleven healthy volunteers inhaled 4 x 100 micrograms salbutamol from either a generic salbutamol (Baker Norton, UK) or Ventolin (Allen and Hanburys Ltd, UK) metered dose inhaler with a Volumatic. The order of administration was randomised with a seven day washout period. Urine samples were collected for 0-30 minutes and then pooled up to 24 hours after inhalation. RESULTS: The mean (SD) urinary salbutamol excretion 30 minutes after inhalation with the metered dose inhalers used with the Volumatic was 22.22 (4.63) and 21.30 (5.91) micrograms for the Baker Norton and Ventolin respectively, with a mean difference (95% confidence interval (CI)) of 0.92 (-0.65 to 2.49) micrograms. Similar amounts were excreted up to 24 hours after the dose with a mean (SD) urinary excretion of 116.1 (24.3) micrograms and 114.8 (22.3) micrograms, respectively, and a mean difference (95% CI) of 1.22 (-20.39 to 22.84) micrograms. CONCLUSION: Inhalations from generic salbutamol (Baker Norton) and Ventolin metered dose inhalers with a Volumatic inhalation aid deliver similar amounts of drug to the lungs and the total systemic absorption from the two products is the same.

Administration, Inhalation↗
PubMed2002

What is the optimal treatment strategy for chronic obstructive pulmonary disease exacerbations?

The present study aims to determine whether treating chronic obstructive pulmonary disease (COPD) exacerbations with intravenous steroids and aerosol bronchodilators (group I) is superior to oral steroids and multiple dose inhaler (MDI) bronchodilators with a spacer (group II). Group I received 40 mg methylprednisolone x day(-1) intravenously with a decrease to 20 mg after 10 days and a further decrease of 4 mg x 4 days(-1). Aerosol therapy consisted of 10 mg salbutamol and 1 mg ipratropiumbromide x day(-1). Group II received 32 mg methylprednisolone orally for 1 week followed by 24 mg x day(-1) for 4 days and a subsequent decrease of 4 mg x week(-1). Duovent MDI with a spacer was given at a dose of 1.6 mg fenoterol and 640 microg ipratropiumbromide x day(-1). In group I (n=19) forced expiratory volume in one second (FEV1) rose from 0.82+/-0.46 to 0.91+/-0.47 L and average dyspnoea decreased from 6.0+/-1.9 to 4.1+/-2.6 within 10 days. The Chronic Respiratory Disease Index Questionnaire (CRQ) score increased from 78+/-24 to 90+/-24 points after 4 weeks. In group II (n=18) FEV1 increased from 0.70+/-0.27 to 0.90+/-0.29 L, dyspnoea regressed from 6.2+/-2.4 to 2.7+/-2.6 and CRQ from 67+/-17 to 86+/-20. Both groups showed similar results in dropout rate, length of hospital stay and patient satisfaction. In conclusion, the two treatment strategies appear equally effective in treating chronic obstructive pulmonary disease exacerbations, although oral steroids and metered dose inhaler bronchodilators appear associated with a higher risk of hospital re-admission.

Acute Disease↗
PubMed1997

Adrenocortical activity with repeated twice daily dosing of fluticasone propionate and budesonide given via a large volume spacer to asthmatic school children.

BACKGROUND: In a previous single dosing study in asthmatic school children fluticasone propionate produced significantly greater suppression of overnight urinary cortisol excretion than budesonide at high doses of 800 micrograms/day or greater. The aim of this study was to assess whether conventional lower doses of both drugs cause adrenal suppression when given at steady state twice daily by large volume spacer on a microgram equivalent basis in asthmatic school children. METHODS: Eight school children of mean age 12.1 years with stable asthma of mild to moderate severity (forced expiratory volume in one second (FEV1) 78.6% predicted, mid forced expiratory flow rate (FEF25-75) 72.5% predicted), on 400 micrograms/day or less of inhaled corticosteroid, were studied in a single blind (investigator blind), placebo controlled, crossover design comparing inhaled budesonide and fluticasone propionate 100 micrograms bid and 200 micrograms bid. Each dose was given at 08.00 hours and 20.00 hours for four days by metered dose inhaler via their respective large volume spacers with mouth rinsing. Measurements were made of overnight urinary cortisol and creatinine excretion after the eighth dose. RESULTS: Neither drug produced significant suppression of overnight urinary cortisol or cortisol/creatinine excretion compared with pooled placebo and there were no differences between the drugs. Only one subject with each drug at 200 micrograms twice daily had abnormally low urinary cortisol excretion of < 10 nmol/12 hours. Ratios for the fold difference between active treatment versus placebo for urinary cortisol excretion were (as means and 95% confidence intervals for difference): budesonide 100 micrograms b.i.d 1.03 (95% CI 0.46 to 1.61), budesonide 200 micrograms b.i.d 1.04 (95% CI 0.62 to 1.46); fluticasone 100 micrograms b.i.d 1.11 (0.45 to 1.77), fluticasone 200 micrograms b.i.d 1.12 (0.78 to 1.47). Likewise, there were no significant differences in overnight urinary cortisol/creatinine excretion. CONCLUSIONS: With repeated twice daily administration at steady state across a dose range of 200-400 micrograms/day no evidence of significant adrenal suppression was found using the sensitive marker of overnight urinary cortisol excretion for either fluticasone propionate or budesonide given via a large volume spacer. These results emphasise the good safety profile in children of these inhaled steroids at conventional dose levels, which have proven antiasthmatic efficacy.

Adrenal Cortex↗
PubMed1999

Short-term dose-response relationships for the relative systemic effects of oral prednisolone and inhaled fluticasone in asthmatic adults.

AIMS: To determine the systemic dose-response relationships with oral prednisolone and inhaled fluticasone propionate administered in a putative 11:1 mg equivalent basis, in terms of effects on adrenal, bone and haematological markers. METHODS: Twelve asthmatic patients mean (s.e.) age, 28.8 [3.3] years, FEV1 94.7 [3.6]% predicted, FEF(25-75) 65.5 [6.1]% predicted were studied in a double-blind, double dummy randomised crossover design comparing placebo, inhaled fluticasone propionate via volumatic spacer given twice a day (ex actuator dose 0.44 mg day-1, 0.88 mg day-1, 1.76 mg day-1 ) and oral prednisolone given once daily (5 mg day-1, 10 mg day-1, 20 mg day-1 ). All treatments were for 4 days at each dose level with a 7-day washout at crossover. Measurements were made at 08.00 h after the last dose of each dose level for plasma cortisol, serum osteocalcin and blood eosinophil count. RESULTS: There were significant dose-related effects for suppression of all three endpoints with both prednisolone and fluticasone propionate. Parallel slope analysis revealed a calculated dose ratio for relative potency of 8. 5:1 mg (95% CI 5.7-11.2) comparing Pred with FP for morning cortisol. The magnitude of suppression with FP was less for osteocalcin and eosinophils than for cortisol. CONCLUSIONS: Systemic tissues exhibit different dose-response relationships for the effects of inhaled and oral corticosteroids with suppression of cortisol being greater than osteocalcin or eosinophils. For cortisol suppression we observed an 8.5:1 mg relative potency ratio comparing prednisolone with fluticasone propionate. Patients taking high dose inhaled fluticasone propionate should therefore be screened for evidence of impaired adrenal reserve.

Administration, Inhalation↗
PubMed1992

[Inhaled corticosteroids in the treatment of childhood asthma].

During the last fifteen years, inhaled corticosteroids were increasingly used for prophylaxis in childhood asthma. The development of inhaled corticosteroids with a high ratio of topical vs systemic potency, now makes possible their use in large doses which are needed to control the most severe forms of the disease, in order to avoid long term oral corticosteroid treatment for these patients. The efficacy of inhaled corticosteroids depends on an optimal pulmonary deposition of the drug which is obtained with children by inhaling the drug via a large volume spacer. Beyond their beneficial effects on the clinical condition of the patients and on pulmonary function, inhaled corticosteroids should improve the long term prognosis of asthma, by reducing chronic inflammation in the airways and the associated bronchial hyperreactivity. At usual dosages, inhaled corticosteroids are free of harmful side effects. However, caution and close observation of adrenal function and growth development are required when prescribing inhaled corticosteroids at high dosages for a long period. Nevertheless, inhaled corticosteroids present very few serious side effects compared with those induced by long term oral corticosteroid treatment.

Administration, Inhalation↗
PubMed1990

Effective bronchodilator treatment by a simple spacer device for wheezy premature infants.

Ten preterm infants with recurrent respiratory symptoms (median gestational age 30 weeks) were entered into a non-randomised placebo controlled trial of bronchodilator treatment at 12.5 months of age. The infants had coughed or wheezed, or both, on at least four days a week for the past month. The infants received either placebo or 500 micrograms terbutaline from an inhaler using a coffee cup as a spacer device. Each treatment was maintained for two weeks, first placebo then active drug. The symptom score was reduced by 65% during the active treatment period compared with the placebo period and this was associated with a 32% improvement in lung function, reflected in an increase in functional residual capacity. We conclude that inhaled bronchodilator treatment given with a simple spacer device is useful for preterm infants with recurrent respiratory symptoms in the first two years of life.

Bronchodilator Agents↗
PubMed1999

Efficacy of inhaled steroids (beclomethasone dipropionate) for treatment of mild to moderately severe asthma in the emergency department: a randomized clinical trial.

STUDY OBJECTIVE: To examine the efficacy of an inhaled steroid, when added to a standard regimen of beta-agonist therapy, in the treatment of patients with mild to moderately severe asthma in the emergency department. METHODS: A convenience sample of adult patients with asthma (FEV1 % predicted 40% to 69%) presenting to the ED was randomly assigned in a double-blind fashion into 2 treatment groups. The first group received 2.5 mg nebulized salbutamol plus 1 mg (4 puffs) of beclomethasone dipropionate (BDP) at baseline, 30 minutes, and at 1, 2, and 4 hours, delivered by a metered-dose inhaler (MDI) attached to a spacer device (Vent-AH-aler, Glaxo). The second group was given the same salbutamol regimen plus MDI placebo through the Vent-AH-aler. The primary endpoint was improvement in FEV1 %predicted at 6 hours. RESULTS: Of 54 patients enrolled, 28 were assigned to the BDP group and 26 to the placebo group. Spirometry improved significantly in both groups over the 6 hours compared with baseline (ANOVA, P <.001). At 6 hours, the mean absolute improvement in FEV1 % predicted for BDP was 18% versus 17% for placebo (95% confidence interval for the absolute difference of 1% [-8% to 10%]). The proportion of patients in the BDP group who were hospitalized was 7% compared with 19% for patients in the placebo group (95% confidence interval for the difference of 12% [-6%, 30%]). CONCLUSION: In this group of patients with mild to moderately severe asthma, 5 mg BDP delivered by MDI during the initial 4 hours of an emergency visit was of no added benefit over standard therapy, as measured by improvement in FEV1 % predicted at 6 hours. However, a trend toward a difference in admission favoring BDP was observed. [Afilalo M, Guttman A, Colacone A, Dankoff J, Tselios C, Stern E, Wolkove N, Kreisman H: Efficacy of inhaled steroids (beclomethasone dipropionate) for treatment of mild to moderately severe asthma in the emergency department: A randomized clinical trial.

Administration, Inhalation↗