Terbutaline in COPD comparison between turbuhaler® and chlorofluorocarbon (CFC) inhaler Comparison of inhaled terbutaline administered by either the Turbuhaler dry powder inhaler or a metered-dose inhaler with spacer in preschool children with asthma. Sample sizes for comparative inhaled corticosteroid trials with emphasis on showing therapeutic equivalence Bricanyl Turbuhaler in the treatment of asthma: a six week multi-centre study carried out in Sweden, the United Kingdom, Denmark, Norway and Finland. Dry powder inhalers are bioequivalent to metered-dose inhalers. A study using a new urinary albuterol (salbutamol) assay technique. Salbutamol by Powder or Spray Inhalation in Childhood Asthma A multiple dose powder inhaler (Turbuhaler) compared with a conventional aerosol. An acceptance study in asthmatics. Effect of terbutaline on mucociliary clearance in asthmatic and healthy subjects after inhalation from a pressurised inhaler and a dry powder inhaler. Terbutaline via pressurised metered dose inhaled (P-MDI) and Turbuhaler in highly reactive asthmatic patients. A new multiple dose powder inhaler, (Turbuhaler), compared with a pressurized inhaler in a study of terbutaline in asthmatics. Albuterol aerosol versus albuterol Rotacaps in exercise-induced bronchospasm in children. Comparison of inhaled salbutamol powder and aerosol in asthmatic patients with low peak expiratory flow level A comparison of terbutaline inhaled by Turbuhaler® and by a chlorofluorocarbon (CFC) inhaler in children with exercise‐induced asthma Kinetics of action of salbutamol inhaled from a metered dose inhaler (MDI) and a “diskhaler” Turbuhaler®: a new device for dry powder terbutaline inhalation Comparison of salbutamol Rotahaler with conventional pressurized aerosol Clinical equivalence of a novel non-chlorofluorocarbon-containing salbutamol sulfate metered-dose inhaler and a conventional chlorofluorocarbon inhaler in patients with asthma. Comparison of terbutaline and placebo from a pressurised metered dose inhaler and a dry powder inhaler in a subgroup of patients with asthma. Cumulative dose-response study of non-CFC propellant HFA 134a salbutamol sulfate metered-dose inhaler in patients with asthma. Dose potency relationship of terbutaline inhaled via Turbuhaler or via a pressurized metered dose inhaler. Long-term comparison of salbutamol powder with salbutamol aerosol in asthmatic out-patients. Comparison of a new multidose powder inhaler with a pressurized aerosol in children with asthma. Treatment of asthma in pre‐school children with inhalation of terbutaline in Turbuhaler compared with Nebuhaler A double‐blind comparison between a new multi‐dose powder inhaler (Turbuhaler®) and metered dose inhaler in children with asthma Salbutamol: comparison of bronchodilating effect of inhaled powder and aerosol in asthmatic subjects. Albuterol treatment for children with asthma: a comparison of inhaled powder and aerosol. The inhalation device influences lung deposition and bronchodilating effect of terbutaline. Evaluation of a Breath Operated Powder Inhaler
Patients with chronic obstructive pulmonary disease ( COPD ) often subjectively benefit from inhaled R2-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 β2-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 r and omized 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 We compared the bronchodilator response of terbutaline delivered either by a dry powder inhaler , the Turbuhaler , or by a metered-dose inhaler attached to a Nebuhaler inhaler in 10 children with stable asthma who were 3 to 6 years of age . The bronchodilator response did not differ between the two inhalational devices . The dry powder inhaler Turbuhaler is a suitable alternative to a metered-dose inhaler in the delivery of terbutaline to preschool children with stable asthma if adequate inhalational technique is used In the near future it is to be expected that many new inhaled corticosteroids or formulations of these drugs will be compared with older ones , to discover whether they are therapeutically equivalent or not . The statistical evaluation of these trials differs from the classic methods . When two averages are similar or differ only slightly , power is very low . The regulatory bodies dem and a power of at least 80 % . This problem was initially solved by using the so-called power approach . Research ers included enough volunteers to enable them to detect a predefined difference , considered to be without any clinical significance , with a power of 80 % . This approach , however , has been shown to be incorrect and has been replaced by the two one-sided tests procedure , where a new sample size equation is derived . Important elements of this new equation are the coefficient of variation of the parameter measured , the difference between the averages of the two groups and the equivalence limit ( the difference between the means still tolerable ) . This equation was used in the present study to estimate the number of volunteers needed in a parallel inhaled corticosteroids equivalence trial . The end points chosen were the changes in FEV1 and PC20 due to the corticosteroid effect . Calculations were performed by extracting data from published placebo-controlled trials , and defining a range of equivalence limits and differences between the group averages . It was shown that a huge number of volunteers ( 500–1000 ) will be needed , as a result of the small corticosteroid effect and the high variance . In the case of inhaled corticosteroids , the equivalence limit is not known and needs defining to avoid discussion s on the outcome . Due to the high number of patients who need to be included , the trial will most probably be multicentre and take place in several countries . Such a trial will suffer from several sources of bias . For instance , the definition of asthma can differ from country to country and from research er to research er , result ing in non-comparable groups of patients . The many sources of bias will make the outcome difficult to interpret . Therefore alternative methods to establish therapeutic equivalence are proposed and discussed Two hundred and fifty eight adult patients with bronchial asthma participated in an open , parallel group study of 8 wks duration . During a 2 wk run-in period the beta 2-agonist terbutaline ( 0.5 mg q.i.d ) was delivered via a pressurized freon aerosol , Bricanyl metered dose inhaler ( MDI ) . During the following 6 wks , one third of the patients continued with MDI and two thirds with the same dose of terbutaline in the form of dry powder , Bricanyl Turbuhaler . There were no statistically significant differences in the increases in peak expiratory flow rate ( PEFR ) after inhalation between the two treatment groups . The asthma symptom scores decreased in the Turbuhaler group during the study but remained the same in the MDI group . No difference in use of extra trial medication during the day was found . During the night , the difference was statistically significant in favour of Turbuhaler ( p less than 0.05 ) . Turbuhaler was well accepted and easy to use . As compared with the MDI used during run-in , 50 % of the patients in the Turbuhaler group preferred to use  Turbuhaler and 26 % MDI , whilst 24 % had no preference . In conclusion , Turbuhaler was at least as effective as MDI during the whole Turbuhaler life-span ( 6 wks ) Metered-dose inhalers ( MDIs ) are extensively used to deliver drugs to the lungs but are driven by chlorofluorocarbon ( CFC ) propellants . The worldwide phasing out of CFCs within the next 5 to 10 years presents difficulties to the pharmaceutical industry . The mean + /- SD relative lung bioavailability of albuterol  to the lung following inhalation of 400 micrograms of albuterol from an MDI , the Rotahaler and Diskhaler in 10 well-trained volunteers , was 2.83 ( 0.78 ) , 1.72 ( 0.99 ) , and 2.64 (1.23)% , respectively , expressed as a percentage of the nominal dose . The delivery of albuterol to the lungs from the MDI and Diskhaler was similar . In nine asthmatic subjects , the relative lung bioavailability of albuterol  following inhalation with the MDI and Diskhaler was 1.19 ( 0.79 ) and 2.38 (1.46)% , respectively , expressed as a percentage of the nominal dose . There was no difference in reversibility 30 min after administration of the dose by the two methods . Similar lung deposition from the Diskhaler in volunteers probably is due to efficient MDI technique , which was absent in the asthmatic subjects . The Diskhaler does not rely on coordination during inhalation and therefore is easier to use Forty‐three children from 3‐16 years of age suffering from moderate bronchial asthma completed a double‐blind cross‐over study on the clinical effect of inhaled salbutamol ( Ventoline ® ) powder ( 0.2 mg/dosis ) compared with spray ( 0.1 mg/dosis ) over two 4‐week periods . Both administrations gave significant improvement in air flow meter ( AFM ) results . There was no significant difference between the periods on active powder or spray regarding daily symptom scores , adjuvant medication or AFM values . The powder caused cough in four children but in 12 of 28 children it was considered as easy or easier to accept as the spray ; nine of these 12 children were younger than 10 years of age . It is concluded that salbutamol inhaled as a powder is a useful alternative when using a spray is difficult or unwanted Nineteen patients with asthma completed an open , r and omized , crossover study in which 0.5 mg terbutaline sulphate was administered either via Turbuhaler or via the metered dose inhaler ( MDI ) for 2-week periods . The clinical effect of the two treatment forms was comparable ; both provided adequate bronchodilator therapy . Patients also considered  Turbuhaler and MDI equally effective , with a small preference for the MDI . Turbuhaler seems to be a valuable alternative to bronchodilator MDI therapy BACKGROUND : beta Agonists have been shown to increase mucociliary clearance in some studies but not all . Whether the formulation of beta agonists affects mucociliary clearance is not known but may be important as the use of dry powder inhalers increases . METHODS : The effect of different methods of administration of inhaled terbutaline on mucociliary clearance and forced expiratory volume in one second ( FEV1 ) was assessed in 10 patients with asthma and 10 healthy subjects .  Terbutaline ( 1 mg ) was administered through a metered dose inhaler with a spacer ( Nebuhaler ) or a dry powder inhaler ( Turbuhaler ) , or both treatments were given , in a four way double blind , double dummy trial . Mucociliary clearance was measured by bronchoscintigraphy . RESULTS : Clearance of radioactivity from the lobar bronchi increased in the asthmatic patients by a median of 32 % after terbutaline was given by metered dose inhaler and 55 % after a combined dose of 2 mg from both inhalers ( 1 mg from each ) compared with placebo but by only 9 % after 1 mg of terbutaline was given by a dry powder inhaler . In the healthy subjects  mucociliary clearance increased by 51 % when terbutaline was given by a dry powder inhaler , by 66 % when given by a metered dose inhaler , and by 66 % when given by both inhalers combined . The effect of terbutaline on FEV1 was the same with each of the inhalers . CONCLUSION : Despite similar changes in FEV1 with the two formulations terbutaline increased mucociliary clearance significantly in asthmatic and healthy subjects when inhaled from a metered dose inhaler whereas when it was inhaled from a dry powder inhaler its effect was significant only in healthy subjects . The reason for the difference in asthmatic subjects is unclear , but may be associated with differences in the deposition of terbutaline There is some concern over the environmental consequences of chlorofluorocarbons ( CFCs ) used in pressurized metered-dose inhalers ( p-MDIs ) . Turbuhaler was design ed to deliver a drug as a dry powder without administering additives directly to the airways . The aim of this study was to evaluate the comparative irritant and bronchodilating effects of the same dose of terbutaline delivered by a p-MDI and via Turbuhaler .  Ten symptomatic , asthmatic patients , with highly reactive airways ( provocative concentration of methacholine producing a 20 % fall in forced expiratory volume in one second ( PC20 ) < 0.2 mg.ml-1 ) , inhaled , on separate days , 0.25 mg terbutaline via p-MDI or Turbuhaler . Changes in airway calibre were followed as specific airways conductance ( sGaw ) . On a third day , patients inhaled from a placebo p-MDI containing all constituents except terbutaline . The study was conducted in a single-blind fashion and in r and om order . There were no significant differences in baseline sGaw on any of the study days . Inhalation of terbutaline from the p-MDI produced a transient percentage fall in sGaw at 1 min , reaching a mean maximum + /- SD of 17 + /- 8 % at 10 s and then returning to baseline value after 20 s , followed by a progressive increase in sGaw to a maximum of 39 + /- 45 % above baseline at 45 min . In contrast , inhalation of terbutaline via Turbuhaler caused no significant bronchoconstriction ( fall in sGaw , 3 + /- 16 % ) at 10 s and achieved a greater increase in sGaw , reaching 63 + /- 51 % at 45 min , although just failing to reach statistical significance compared to terbutaline p-MDI inhalation . ( ABSTRACT TRUNCATED AT 250 WORDS Twelve adult asthmatic patients participated in an open , r and omized , cross-over comparison between cumulatively increasing doses of terbutaline sulphate administered via the multiple dose powder inhaler ( Turbuhaler ) or via a pressurized inhaler . Turbuhaler and the pressurized inhaler showed equipotency both with respect to bronchodilatation and side effects . Both treatments produced a significant increase in pulmonary function measurements , forced expiratory volume in one second ( FEV1 ) and forced vital capacity ( FVC ) . No increase in pulse rate was seen with either treatment but there was an increase in tremor at higher doses with both treatments . Inhalation of beta-agonists via Turbuhaler seems to be an effective way of treating asthma The purpose of this study was to determine the safety and effectiveness of albuterol aerosol 180 micrograms and albuterol powder 200 micrograms in the prevention of  exercise-induced bronchospasm in children . Forty-six patients aged 4 - 11 years with asthma and exercise-induced bronchospasm were enrolled in this r and omized , double-blind , single-dose , three-way crossover study comparing albuterol aerosol , albuterol powder , and placebo . Exercise challenge was performed at the screening visit for qualifying and baseline determinations of pulmonary function and then 15 min after drug administration at each of three visits . Prevention of exercise-induced bronchospasm was assessed by comparing across all treatment groups the percentage change in FEV1 from pre- to postexercise , the percentage of patients protected by treatment , postexercise minimum FEV1 , and postexercise change in FEV1 . Safety was assessed by observation of clinical adverse events , laboratory tests , physical examination , electrocardiogram and rhythm strips , vital signs , and pulmonary auscultation .  Forty-four patients completed the study .  Mean postexercise FEV1 decreased 6 % from preexercise values when patients were treated with either albuterol formulation ; FEV1 decreased 23 % when patients were treated with placebo .  Exercise-induced bronchospasm was prevented in 95 % of patients when treated with albuterol powder , in 91 % treated with albuterol aerosol , and in 57 % treated with placebo . Patients maintained significantly higher mean minimum FEV1 values after treatment with albuterol powder and albuterol aerosol than when treated with placebo . Treatment with either albuterol formulation produced a significantly smaller decrease in mean FEV1 from pre- to postexercise than treatment with placebo . No drug-related adverse events were reported , and safety assessment s were within normal limits . ( ABSTRACT TRUNCATED AT 250 WORDS Summary The short-term bronchodilator effects of dry salbutamol powder and a pressurized salbutamol aerosol were compared in 22 patients with severe asthma , on 3 consecutive mornings , in a double-dummy cross-over study . Only patients with peak expiratory flow ( PEF ) rate lower than 250 l/min , were recruited .  PEF measurement was employed to assess changes in ventilatory function induced by inhalation of the drugs . No significant difference was found between the PEF changes induced by the dry salbutamol powder ( 400 µg ) and the pressurized aerosol ( 200 µg ) . Both forms of the drug produced a significant rise in mean PEF values . The study shows that even in asthmatic patients with poor ventilation , a dry powder inhaler and pressurized aerosol are effective means of drug delivery to the lungs Svenonius E , Arborelius M , Wiberg R , Ståhl E , Svensson M. A comparison of  terbutaline inhaled by Turbuhaler ® and by a chlorofluorocarbon ( CFC ) inhaler in children with exercise‐induced asthma Summary In a double-blind cross-over study , 12 patients with reversible airways obstruction were treated with 200 μg salbutamol base in aerosol or 400 μg of powder following methacholine-induced bronchoconstriction . Salbutamol was inhaled either from a conventional metered dose inhaler ( MDI ) or from an inhaler ( Diskhaler ® ) utilizing the powdered form of the drug . The efficacy of both forms was identical whether assessed in terms of FEV1 or vital capacity . The ratio of the increase in FEV1 or vital capacity after bronchodilatation to the decrease during the prior bronchoconstriction was 1.4 , indicating that both FEV1 and vital capacity improved over baseline following bronchodilatation . In six subjects , the onset of action of the powder form was more rapid , and in four the MDI acted more rapidly . In the group as a whole , the mean time constant for the action of salbutamol was identical ( 3.8 min ) for the two forms . It is concluded that salbutamol powder has a similar efficacy and time course of action as the aerosol , probably because both formulations produce similar sized particles of the drug The aim of this study was to compare bronchodilator response and adverse effects of terbutaline when administered with the metered dose inhaler ( MDI ) Bricanyl ® and with the dry powder inhaler Bricanyl Turbuhaler ® ( BT ) .  Nine adult patients with bronchial asthma participated . The study was of an open crossover design . At 30–min intervals the patients inhaled increasing doses of terbutaline ( 0.25 mg to 5.0 mg cumulated ) from either the conventional MDI or from the BT . After each inhalation FEV1 , FVC , heart rate , muscle tremor and adverse effects were recorded . Both treatments , BT and MDI , result ed in a dose‐related increase in lung function , without any statistical difference . Taste sensation , muscle tremor and increase in heart rate were observed in both groups . Because of the design of the BT one may assume that inhalation failure can be avoided Salbutamol in a powder aerosol from the Rotahaler insufflator was compared , with equal doses of the conventional pressurized aerosol by dose‐response curves and in a 1 month open trial , in the treatment of asthma patients with good inhalation technique . Results were not significantly different in either study . A further group of asthma patients , who were known to be incapable of using pressurized aerosols effectively , were shown to benefit from treatment with the Rotahaler . This device should increase the value of the sympathomimetic drugs to the minority of asthma patients who can not use conventional aerosols correctly BACKGROUND New formulations of non-chlorofluorocarbon-containing propellants for pressurized metered-dose inhaler delivery systems must be developed in response to the forthcoming ban on chlorofluorocarbon ( CFC ) production . OBJECTIVE This study compared the bronchodilator effects of 100 , 200 , and 300 micrograms ( base equivalent ) of salbutamol in a novel CFC-free propellant system ( Airomir in the 3 M CFC-Free System ; 3 M Pharmaceuticals , St. Paul , Minn. ; 108 micrograms of salbutamol sulfate or 90 micrograms of salbutamol base equivalent per inhalation ) with that of 100 and 200 micrograms of salbutamol base in a conventional CFC propellant system ( Ventolin , CFC-11/12 ; Allen and Hanburys , Division of Glaxo Inc. , Research Triangle Park , N.C. ; 90 micrograms of salbutamol base per inhalation ) and placebo . METHODS Twenty-six patients with chronic , stable asthma , who had a forced expiratory volume in 1 second ( FEV1 ) between 50.0 % and 75.0 % of predicted normal value , entered this r and omized , double-blind , double-dummy , 6-period , crossover study . FEV1 was measured before and at multiple time points ( ranging from 10 to 480 minutes ) after administration of one , two , and three inhalations of salbutamol/CFC-free ( 100 , 200 , and 300 micrograms ) ; one and two inhalations of salbutamol/CFC ( 100 and 200 micrograms ) ; and placebo . Safety parameters included adverse events , heart rate , blood pressure , physical examinations , electrocardiograms , and clinical laboratory tests . Parametric analysis of variance models appropriate for a 6-period crossover design were used , along with multiple comparisons according to Tukey 's method . RESULTS All active treatments produced significantly ( p < 0.0001 ) greater bronchodilation than placebo . The bronchodilator effect , as measured by FEV1 ( peak percent change , peak as a percent of predicted value , duration , and area under the curve ) after two inhalations of salbutamol/CFC-free was clinical ly comprable to two inhalations of salbutamol/CFC , with no clinical ly meaningful differences in safety parameters between the two delivery systems or between different dose levels . CONCLUSION These results suggest that salbutamol/CFC-free may offer a suitable alternative for salbutamol/CFC when the need arises to change from CFC-containing salbutamol products BACKGROUND --Reversibility after administration of an inhaled bronchodilator is not always demonstrable in patients with asthma . Bronchodilator aerosol-induced bronchoconstriction has also been reported to occur in some patients . METHODS --Fifteen selected patients showing < 10 % improvement in forced expiratory volume in one second ( FEV1 ) when tested with four doses of salbutamol ( 0.1 mg/dose ) or terbutaline ( 0.25 mg/dose ) from a pressurised metered dose inhaler ( MDI ) participated in two r and omised , double blind studies . They received 2.0 mg terbutaline ( 4 x 2 doses of 0.25 mg ) or a corresponding placebo from an MDI connected to a 750 ml spacer , and 1.0 mg ( 2 x 0.5 mg ) terbutaline or placebo from a multidose dry powder inhaler free of additives ( Turbohaler ) . RESULTS --Inhalation of placebo MDI result ed in a mean ( SD ) decrease in FEV1 of 20.5 (14.1)% ( range -42.9 % to + 2.6 % ) . In 14 patients inhalation of 2.0 mg terbutaline MDI with spacer result ed in < 10 % improvement ( mean increase 3.1 (6.0)% ) . One mg of terbutaline via a Turbohaler result ed in improvements in FEV1 of > 15 % in eight patients ( mean increase 16.0 (9.7)% ) . The improvement was < 10 % in four patients . Use of placebo Turbohaler did not affect airway calibre ( mean change 0.2 (2.9)% ) . CONCLUSIONS --Additives of MDIs may cause bronchoconstriction in some patients with asthma . In these patients inhalation from a pressurised metered dose inhaler is more likely to decrease the bronchodilator response than inhalation from an additive-free inhaler . The frequency of this phenomenon is unknown STUDY OBJECTIVE This study compares the safety and efficacy of HFA 134a salbutamol sulfate ( Airomir in the 3 M CFC-free system [ 3 M Pharmaceuticals ] ) and CFC 11/12 salbutamol ( Ventolin [ Allen & Hanburys ] ) in a cumulative dose-response ( 1 , 1 , 2 , 4 , 8 inhalations at 30-min intervals ) study in asthmatic patients . DESIGN R and omized , single-blind , two-period cross-over study . PARTICIPANTS Twenty-four stable mild to moderate asthmatics . MEASUREMENTS AND RESULTS At all cumulative inhalations , the changes in FEV1 ( absolute , percent , and percent predicted ) and FVC were equivalent . There was also no significant difference in heart rate , serum potassium level , BP , 12-lead ECG , Holter monitor recordings , or adverse events . Both HFA 134a salbutamol sulfate and CFC 11/12 salbutamol displayed a significant dose-response for FEV1 , FEF25 - 75 % , FVC , serum potassium , heart rate , and systolic BP . CONCLUSIONS HFA 134a salbutamol sulfate and CFC 11/12 salbutamol produced clinical ly and statistically similar airway responses and side effects . These results indicate that HFA 134a salbutamol sulfate would be a safe and effective substitute for CFC 11/12 salbutamol OBJECTIVE The relative dose potency of cumulative doses of terbutaline sulfate inhaled via Turbuhaler and via a pressurized metered dose inhaler was estimated with respect to lung efficacy and systemic effect . METHODS The study was an open , crossover , r and omized , multicenter study including 31 adult patients with asthma [ forced expiratory volume in one second ( FEV1 ) , 65 % of predicted ] . The patients inhaled terbutaline doses of 0.125 , 0.125 , 0.25 , 0.5 , 1.0 , and 2.0 mg ( a total of 4 mg ) at 30-minute intervals . Lung function [ FEV1 , forced vital capacity ( FVC ) , forced expiratory flow at 75 % of FVC ( FEF75 % ) , and peak expiratory flow ( PEF ) ] , and systemic effect variables ( serum potassium , tremor , pulse , blood pressure ) were monitored prior to the first inhalation and 15 to 25 minutes after each inhaled dose . RESULTS The mean relative dose potency of terbutaline inhaled via Turbuhaler compared with pressurized metered dose inhaler was 1.5 ( 95 % confidence interval : 1.2 to 1.8 ) with respect to FEV1 and serum potassium , respectively . The corresponding relative dose potencies for PEF , FVC , and FEF75 % were 1.0 , 1.2 , and 1.6 , respectively , with no statistically significant difference between the two devices . No differences between the devices were evident with regard to blood pressure and pulse . CONCLUSION The results suggest that Turbuhaler is more efficient in the delivery of inhaled terbutaline to the lungs compared with the conventional pressurized metered dose inhaler Salbutamol dry powder was compared with salbutamol aerosol in 38 asthmatic patients . The study was double-blind and took place over six months . Salbutamol powder in a dose of 200 micrograms per capsule was able to control asthma as well as the aerosol , but some patients needed to increase the frequency of dosage when using the powder . The device used for powder administration , the Rotahaler , was well accepted and was preferred to the pressurized aerosol by one-third of patients . Dry powder administered by Rotahaler allows salbutamol to be given by inhalation to many patients previously using aerosols inefficiently Thirteen children with asthma were treated with cumulative doses of terbutaline delivered as a pressurized aerosol and from a new multidose powder inhaler ( Turbuhaler ) in a r and omized cross-over dose-response study . The cumulative dose of terbutaline was 2 mg on each study day . All children used a correct aerosol inhalation technique . At no time was there any difference in forced expiratory volume in 1 s ( FEV1 ) , forced midexpiratory flow , forced vital capacity , peak expiratory flow rate , or percent increase in these parameters between the two inhalers . The mean total increases in FEV1 after 2 mg terbutaline were 60 % ( aerosol ) and 62 % ( Turbuhaler ) ; 90 % of these increases were measured after a cumulative dose of 0.5 mg terbutaline . One milligram of terbutaline inhaled from a Nebuhaler at the end of each study day did not result in additional increase of pulmonary functions , indicating that maximal bronchodilation had been achieved with both inhalers . After a cumulative dose of 2 mg terbutaline from the aerosol seven children complained of tremor and one of restlessness . No side effects were reported when the Turbuhaler was used ( P less than 0.02 ) . 1989 ; 7:00 - 00 The aim of this study was to evaluate the efficacy , safety and preference of pre‐school children with regard to two different devices for treatment of bronchial asthma with terbutaline . Turbuhaler , a powder inhaler preloaded with pure terbutaline for inhalation , was compared with a pressurized metered dose inhaler , attached to a Nebuhaler . The study had an open , cross‐over r and omized design . Each treatment period consisted of 2 weeks . Diary cards were filled in every morning and evening by the parents regarding PEF , asthma symptoms , extra inhalations of terbutaline , and side effects .  Twenty‐one children ( mean age 3.9 years ) were included in the study . A highly significant ( P < 0.001 ) increase in peak expiratory flow ( PEF ) was obtained after inhalation with both devices . The PEF values in the mornings after inhalation of terbutaline with Turbuhaler were significantly higher ( P= 0.046 ) than those with Nebuhaler . Further , the PEF baseline values in the evenings before inhalation were also significantly higher ( P= 0.03 ) with Turbuhaler .  No difference was found in asthma symptoms and extra medication between the two devices . Side effects were mild and few with both devices . The parents found Turbuhaler easier to h and le and 19 of 21 preferred this device for future use Turbuhaler ® is a ready‐loaded multiple dose inhaler which does not require co‐ordination between release of dose and inhalation . 57 children with asthma participated in this clinical trial to compare the clinical effect and acceptance of terbutaline sulphate via Turbuhaler with that of metered dose inhaler ( MDI ) . The trial consisted of two parts . In the first part of the study , which made use of a double‐blind cross‐over design , the clinical effect and number of treatment occasions with Turbuhaler were compared with those of MDI . In the second part , which was open , all patients were treated with Turbuhaler for 2 weeks . At the end of this period the patients were asked to make a subjective assessment of effect and to state their preference . There was no difference in clinical effect and number of treatment occasions between Turbuhaler and MDI . A majority of the patients thought Turbuhaler had the best effect and was easy to use In the treatment of asthma  salbutamol can be administered as an aerosol with a metered-dose inhaler or as a powder with a breath-actuated device ( Rotahaler ) . The two forms of the drug were compared in a double-blind placebo-controlled study involving 10 asthmatic adults who were known to respond to salbutamol .  The bronchodilating effect of the aerosol and the powder at doses of 200 micrograms and of the powder at doses of 200 and 400 micrograms was compared , bronchodilation being measured in terms of forced expiratory volume and vital capacity . The response was far greater to salbutamol than to placebo , but there was no significant difference between the two forms of the drug or between the lower and higher doses of powder . No side effects were observed A dose-ranging study and a 12-week treatment study were conducted in children with asthma , aged 4 to 12 years , to assess the efficacy and safety of albuterol inhaled as either an aerosol or as dry powder . Both studies were double-blind and placebo-controlled with r and omized assignment to treatment . The dose-ranging study in 30 patients indicated that similar single doses of albuterol aerosol and powder had comparable effects with the intermediate doses ( i.e. , 180 micrograms of aerosol and 200 micrograms of powder ) providing effective bronchodilation with minimal adverse effects . In the subsequent 12-week , parallel-group study , 204 children received  albuterol as either aerosol , 180 micrograms , or powder , 200 micrograms four times a day . Both formulations were equally effective with no untoward cardiovascular effects and only one incident of mild tremor . Among those children who expressed a preference for one of the delivery systems , significantly more children preferred the powder ( 44 % versus 26 % , p less than 0.01 ) . Albuterol taken four times a day as either aerosol or dry powder is both effective and well tolerated in children with asthma The development of new inhalation devices for asthma drugs raises the issue of the relationship between pulmonary deposition and therapeutic effect of inhaled drugs in patients with obstructive lung diseases . We thus conducted a r and omized , double-blind and double-dummy , four-period crossover study in 13 patients with moderate asthma ( mean age 36 yr ; FEV1 59 % of predicted ) , who inhaled 0.25 and 0.5 mg terbutaline sulphate on separate occasions either via a pressurized metered dose inhaler ( pMDI ) or Turbuhaler ( TBH ) . Pulmonary deposition was 8.1 + /- 2.7 % and 8.3 + /- 2.3 % , respectively , of the nominal dose for pMDI and 19.0 + /- 7.3 % , and 22.0 + /- 8.1 % for TBH . The FEV1 increase after 0.25 mg terbutaline sulphate via TBH was significantly greater than after 0.25 mg via pMDI . No significant differences in FEV1 increase were observed between 0.25 mg via TBH , 0.5 mg via pMDI , or 0.5 mg via TBH . Other lung function variables showed similar dose- and device-related changes . We concluded that : ( 1 ) the dose of terbutaline sulphate deposited in the lungs is dependent on which inhalation system is used ; ( 2 ) TBH delivers about twice the amount of drug to the lungs as the pMDI ; and ( 3 ) the observed difference in deposition is reflected in the bronchodilating effect A r and omized , double-blind , double-dummy crossover study on 42 asthmatics was carried out to compare the single dose effects of salbutamol administered from the widely used metered dose inhaler and a breath operated system ( Diskhaler ® ) . The bronchodilator response ( change in forced expiratory volume in the first second ) was almost identical for the two systems . The Diskhaler ® system however , since it is breath operated , obviates the need for h and –breath coordination
BACKGROUND To study the transition from metered dose inhalers using chlorofluorocarbons as propellants ( CFC-MDIs ) to non-CFC containing devices , a systematic review was conducted of clinical trials which compared the delivery of salbutamol and terbutaline via CFC-MDIs and non-CFC devices .