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At least 19 recordsLinked to original sources

PubMed1991

Advantages of pressurized canister metered dose inhalers.

Metered dose inhalers (MDI) have provided a versatile, reliable, instantly available, self-contained, portable, low cost medical aerosol delivery system for more than 35 years. Currently, most of the drugs commonly used for treating reversible airflow obstruction due to asthma and chronic obstructive pulmonary disease (COPD) are available as MDI and consideration is being given to formulating other potentially useful drugs such as antibiotics, amiloride, and pentamidine in MDI. By means of particle size selective accessory devices, MDI can be used for pulmonary drug targeting which, by further improving the therapeutic ratio inherent to aerosol therapy, reduces local and systemic side effects and should allow application to the pulmonary airways of significantly larger doses of medication than could otherwise be administered safely. Appropriate masks and a variety of adapters have been developed to allow the MDI to be used in infants and children, as well as patients of all ages requiring assisted ventilation. While nebulizers and powder inhalers both have an important role to play in the management of airway and parenchymal disease, there is, as yet, no all-purpose aerosol generation and delivery system to replace the MDI. While the ideal is obviously to develop new environmentally friendly pressurizing liquid/gaseous systems that are chlorofluorocarbon free, this will take a minimum of a decade if, in the final analysis, it can be done at all. In the meantime, patients should be provided with the current formulations until appropriate substitutes become available.

Administration, Inhalation↗

PubMed1994

The influence of age, diagnosis, and gender on proper use of metered-dose inhalers.

Metered dose inhalers (MDIs) are widely used in clinical practice for administering pharmaceuticals targeted to the lung. It is well known that the inhalation technique used with MDIs can substantially influence the clinical response to inhaled medications. To determine the acceptability of MDI maneuvers, we studied 59 subjects (26 females and 33 males; age, 20 to 81 yr; mean age, 38 yr) to determine whether the MDI technique used by these individuals complied with published recommendations for acceptable inhalation technique. Measurements were made with an MDI adapter that contained an unobtrusive, lightweight, miniature sensing system. Inspiratory flow at the moment of MDI actuation (Va), the volume (integrated from airflow) at actuation as a fraction of total inspiratory volume (Va/VI), breath-holding time (tBH), and inspiratory volume as a fraction of FVC (VI/FVC) were determined from 59 uncoached inhalations. We defined an acceptable maneuver, based on published data, by four components: (1) inspiratory flow at actuation (Va) between 25 and 90 L/min; (2) actuation during early inspiration (0 < Va/VI < or = 0.20); (3) adequate breath-holding time (tBH > 4 s), and (4) a deep inhalation (VI/FVC > 0.50). For all subjects, only 25% of inhalation maneuvers met all four criteria for acceptability. We found that a significantly higher proportion of male than female subjects performed an acceptable MDI maneuver (43% versus 4%, p < 0.001). There were no significant differences in technique between younger and older subjects or between patients with a diagnosis of asthma or chronic obstructive pulmonary disease (COPD). We conclude that most patients use their MDIs incorrectly; females of all ages are much more likely to have improper MDI technique than are males.

Adult↗

PubMed1990

[Effect of a spacer device used with metered dose inhaler].

Metered dose inhaler (MDI) is widely used in treatment of bronchial asthma. But adequate efficacy is not obtained if the patients use an improper technique of inhalation. The spacer device was designed to reduce such inhalation errors. Three types of spacers (pear type, tube type, paper spacer) were studied to confirm their usefulness in bronchial asthma. Bronchodilating effect of procaterol (10 micrograms/puff X 2) in conventional MDI or MDI with a spacer was evaluated. There were no significant difference in the effect on the pulmonary function after single inhalation of MDI with or without a spacer for 60 minutes. In regular use of MDI with a spacer for two weeks, PEFR and FEV1.0 were slightly improved. These results suggest that effect of MDI with a spacer may be more effective than MDI alone in regular use.

Administration, Inhalation↗

PubMed2002

Relative lung and total systemic bioavailability following inhalation from a metered dose inhaler compared with a metered dose inhaler attached to a large volume plastic spacer and a jet nebuliser.

OBJECTIVE: To compare the lung and systemic delivery of salbutamol following inhalation from a metered dose inhaler (MDI), a MDI attached to a spacer (MDI+SP) and a nebuliser (NEB) using a urinary pharmacokinetic method. METHOD: Twelve healthy subjects each provided urine samples at 0, 30 min and pooled up to 24 h after the start of 5 x 100 microg salbutamol inhaled from MDI and MDI + SP and after 2.5 mg was delivered by NEB. Following nebulisation, the amount of salbutamol trapped on an exhalation filter together with that remaining in the apparatus was determined. The amount left in the spacer and that leaving the MDI mouthpiece was also determined. Thus, for all the methods, the amount available for inhalation from each study dose was determined. RESULTS: The mean (+/- SD) 30-min urinary excretion amounts of salbutamol for MDI, MDI+SP and NEB were 12.6+/-3.5, 27.1+/-6.0 and 16.1+/-4.6 microg, respectively. The mean ratios (90% confidence intervals) for MDI+SP compared with MDI and NEB were 230.2 (186.7, 273.8) and 183.0 (146.4, 219.7) (both P values<0.001), respectively, while that between MDI and NEB was 134 (110.4, 159.1) (P < 0.05). The mean (+/-SD) 24-h urinary excretion values for salbutamol and its metabolite were 287.0+/-46.5, 198.1+/-34.7 and 253.4+/-138.3 microg, respectively. Following inhalation a mean of 202.9+/-51.5 microg was left in the spacer. Similarly, after nebulisation 1387.7+/-88.9 microg was left in the nebuliser chamber, 26.3+/-8.0 microg in the mouthpiece and 553.8+/-68.5 microg exhaled. The mean emitted dose from the MDI was 88.4+/-6.1 microg per actuation. When normalised for the amounts available for inhalation, the mean amounts of salbutamol excreted in the urine during the first 30 min were 2.86+/-0.78, 9.15+/-1.69 and 3.06+/-0.70% following MDI, MDI + SP and NEB, respectively. CONCLUSION: Five 100-microg doses inhaled from a metered dose inhaler attached to a spacer delivered more to the lungs and less to the systemic circulation than either the same doses from a metered dose inhaler used alone or five times the dose given via a jet nebuliser. Spacers should be routinely used instead of nebulisers to manage patients unless they are short of breath.

Adult↗

PubMed2000

Salmeterol administration by metered-dose inhaler alone vs metered-dose inhaler plus valved holding chamber.

STUDY OBJECTIVE: To determine whether a spacer device designed as a valved holding chamber with a flow signal increases the efficacy of the long-acting beta(2)-agonist, salmeterol, in patients who use incorrect technique with metered-dose inhaler (MDI) alone. DESIGN: Double-blind, randomized, placebo-controlled study. SETTING: University hospital outpatient rooms. PATIENTS: Twenty adult outpatients with stable persistent asthma, receiving a daily anti-inflammatory drug. INTERVENTIONS: Patients were randomized to either salmeterol MDI (incorrect use: 1 s after actuating MDI, inhale rapidly) and placebo plus spacer (correct use: inhale slowly as MDI is actuated, continue to inhale slowly and deeply) or placebo MDI (incorrect use) and salmeterol plus spacer (correct use). The following week, patients received the opposite treatment. The dose was two puffs from each device on each treatment day; each puff was separated by 1 min. MEASUREMENTS AND RESULTS: After baseline peak expiratory flow (PEF), salmeterol was administered and serial PEF determined (0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h). Administration of salmeterol MDI plus spacer resulted in significantly greater increases in PEF from baseline vs MDI at 4 h (44 L/min vs 10 L/min; p < 0.01) and 6 h (49 L/min vs 24 L/min; p < 0.05). Both methods of administration were equally well tolerated. CONCLUSION: We conclude that patients who have poor timing and rapid inhalation with salmeterol MDI alone will have greater increases in PEF at 4 h and 6 h and no additional side effects if the dose is administered with a valved holding chamber that is used correctly. Further study is needed regarding other errors in MDI technique with salmeterol.

Adult↗

PubMed2005

Lower oropharyngeal deposition of inhaled ciclesonide via hydrofluoroalkane metered-dose inhaler compared with budesonide via chlorofluorocarbon metered-dose inhaler in healthy subjects.

OBJECTIVE: Inhaled corticosteroids may cause oropharyngeal side effects if deposited in the oropharynx in active form. Ciclesonide, an inhaled corticosteroid with low glucocorticoid receptor affinity, is activated primarily in the lung by esterases to an active metabolite, desisobutyryl-ciclesonide (des-CIC), with high glucocorticoid receptor affinity. We studied oropharyngeal deposition of ciclesonide, des-CIC, and budesonide. METHODS: In an open-label, randomized, two-treatment (administered in sequence), five-period study, 18 healthy subjects received 800 microg (ex-valve) inhaled ciclesonide via a hydrofluoroalkane-pressurized, metered-dose inhaler followed by 800 microg budesonide (Pulmicort) by a chlorofluorocarbon-pressurized, metered-dose inhaler (four puffs of 200 microg each, ex-valve) or vice versa. Oropharyngeal cavity rinsing was performed immediately, or 15, 30, 45, or 60 min after inhalation (one rinsing per study period), and the solutions were analyzed using liquid chromatography with tandem mass spectrometric detection. RESULTS: Ciclesonide and budesonide were detected in most oropharyngeal wash samples. Maximal concentration of each inhaled corticosteroid was reached immediately post-inhalation; maximal concentrations of ciclesonide and des-CIC were 30% and 0.67%, respectively, of budesonide. Oropharyngeal deposition of ciclesonide and budesonide decreased rapidly within 15 min post-inhalation, and less rapidly thereafter. Less than 10% of the residual ciclesonide in the oropharynx was converted to des-CIC. The molar dose-adjusted amount of des-CIC was 4% of budesonide (P < 0.0001). There were no significant adverse events. CONCLUSION: Oropharyngeal deposition of des-CIC was more than one order of magnitude lower than that of budesonide when administered by the respective metered-dose inhalers. This may explain the low frequency of oropharyngeal side effects of ciclesonide in clinical studies.

Administration, Inhalation↗

PubMed1995

Clinical evaluation of CFC-free metered dose inhalers.

Current metered dose inhalers (MDIs) contain chlorofluorocarbon (CFC) propellants. A new propellant HFA134a, with no effect on ozone, may be a suitable alternative. Four asthma medications, salbutamol, salmeterol, fluticasone propionate (FP) and beclomethasone dipropionate (BDP), currently containing standard CFC propellants, were formulated with HFA134a for investigation. Single doses of salbutamol (200 micrograms) and salmeterol (50 micrograms, 100 micrograms) provided equivalent protection against bronchial provocation, after histamine and methacholine respectively, compared with the current preparation. A double-blind 4 week study comparing the two formulations of salbutamol, used as required in mild to moderate asthma, showed similar effects on morning peak expiratory flow rates (PEFR) and inhaler use. Salmeterol (50 micrograms) twice daily was compared with the current formulation in a 4 week trial. Improvement in morning PEFR was similar for both formulations. A double-blind study compared the two formulations of FP (250 micrograms) twice daily in moderate asthmatics previously taking 400-1,000 micrograms of inhaled corticosteroid daily. Morning PEFR improved in both groups. Safety and tolerability of the HFA134a product were similar to current formulations. The HFA134a formulations of salbutamol, salmeterol and FP provide equivalent efficacy with a similar safety profile to the existing formulations at equivalent doses.

Adult↗

PubMed1995

The continued need for metered dose inhalers.

The metered dose inhaler (MDI) is currently the most widely used device in the treatment of adult asthma. It is the delivery system of choice in general practice throughout the world where both MDIs and powder inhalers are available. Up to 70% of all UK adult asthma prescriptions are for an MDI and worldwide the figures are likely to be higher. The MDI can be used to dispense a variety of medications and is currently the most economical device available. The cost of converting all MDIs to equivalent powder inhalers would be prohibitive. Patients, who have difficulty coordinating the operation of an MDI, can use it with a spacer device. This obviates the need for hand-lung coordination and the requirement for more than minimal inspiratory effort. In acute attacks, there is currently no alternative to an MDI with a spacer device for effective, easily administered, emergency treatment outside the hospital environment. In an emergency, an MDI with a spacer can act more rapidly than a nebulizer because it is quicker to set up and use. The MDI is inexpensive, requires no power source and is easily portable. It is therefore important that the MDI continues to be available.

Asthma↗

PubMed1991

Optimizing drug delivery from metered-dose inhalers.

Metered-dose inhalers (MDIs) are being used with increasing frequency to administer medication used in the treatment of respiratory tract disorders. Inhaled medication is delivered directly to the tracheobronchial tree, allowing for a rapid and predictable onset of action. Studies show that only about ten percent of the dose from an MDI actually reaches the lung. The site of deposition within the lung is influenced by the aerosol characteristics, interpatient variability, and the technique by which the patient uses the inhaler. Spacer devices have been designed to overcome some of the problems encountered with MDIs and may be beneficial in certain groups of patients. The studies reviewed in this article suggest ways to alter the variables affecting inhalation in order to optimize drug delivery so that the patient will obtain the most benefit from the inhaled medication.

Administration, Inhalation↗

PubMed2005

Assessment of different methods of inhalation from salbutamol metered dose inhalers by urinary drug excretion and methacholine challenge.

AIMS: Methods to determine the lung delivery of inhaled bronchodilators from metered dose inhalers include urinary drug excretion 30 min post inhalation and methacholine challenge (PD20). We have compared these two methods to differentiate lung delivery of salbutamol from metered dose inhalers using different inhalation methods. METHODS: In phase 1 of the study, on randomized study days, 12 mild asthmatics inhaled placebo, one and two 100 microg salbutamol doses from a breath actuated metered dose inhaler, in randomized fashion on different days. In phase 2, they inhaled one 100 microg salbutamol dose from a metered dose inhaler using a SLOW (20 l min(-1)) and a FAST (60 l min(-1)) inhalation technique and a slow inhalation delayed until after they had inhaled for 5 s (LATE). Urinary excretion of salbutamol (0-30 min) and PD20 were measured after each dose. RESULTS: Following placebo, one and two 100 microg salbutamol doses, the geometric mean for PD20 was 0.10, 0.41 and 0.86 mg respectively and the mean (SD) urinary drug excretion after one and two doses was 2.25 (0.65) and 5.37 (1.36) microg, respectively. After SLOW, FAST and LATE inhalations the geometric mean for PD20 was 0.50, 0.40 and 0.42 mg, respectively, and mean (SD) salbutamol excretion was 2.67 (0.84), 1.90 (0.70) and 2.72 (0.67) microg, respectively. Only the amount of drug excreted during the FAST compared with the SLOW and LATE inhalations showed a statistical difference (95% confidence interval on the difference 0.12, 1.54 and 0.06, 1.59 microg, respectively). CONCLUSIONS: Urinary salbutamol excretion but not PD20 showed differences between the inhalation methods used. When using a metered dose inhaler slow inhalation is better and co-ordination is not essential if the patient is inhaling when they actuate a dose of the drug.

Administration, Inhalation↗

PubMed1994

Inhaled therapy in asthma: metered-dose inhaler experience.

Metered-dose inhalers are the most widely-used mode of administration of bronchodilators and anti-inflammatory agents in the treatment of asthma. However, their use is complex and about 50% of the patients do not use their metered-dose inhaler(s) properly. The most frequent errors include inadequate coordination between actuation and inspiration, rapid inspiration, absence of breathhold, and actuation of the aerosol on more than one occasion during the same inspiration. The misuse of metered-dose inhalers results in a loss of efficacy of the drug. It is, therefore, recommended that the patient be carefully trained in the proper use of metered-dose inhalers at the time of prescription. If a patient is unable to use a metered-dose inhaler properly, despite education, it may be advisable to employ a different inhalation system.

Aerosols↗

PubMed2001

Randomized comparison of a dry powder inhaler and metered dose inhaler with spacer in management of children with asthma.

OBJECTIVE: Comparison of the clinical efficacy of a transparent, DPI (transparent Rotahaler) with MDI and spacers in childhood asthma. DESIGN: Open, randomized, crossover trial. SETTINGS: Out patient clinic of a referral pediatric center. METHODS: Thirty (mean 6.1 +/-2.7 years) children with moderate persistent asthma were randomized to receive long-term medications by a DPI or a metered dose inhaler with spacer for six weeks and then crossed over to receive the same drugs for another period of six weeks after an initial run in period of one week for training in inhalation techniques. The preventative therapy consisted of inhaled Beclomethasone dipropionate (600 mcg/day) and Salbutamol as per requirement. The patients were monitored by a symptom diary, weekly PEFR, and PEFR variability by the parental record of PEFR measurements at home with Mini Wright s Peakflow meter in accordance with the Consensus guidelines. RESULTS: Comparisons made on weekly symptom scores, PEFR at interval visits, PEFR variability, additional beta sympathomimetic use and acute exacerbations of asthma did not reveal any statistically significant differences during the two treatment periods (>0.05). CONCLUSION: Metered dose inhaler and dry powder inhaler have equal efficacy in anti-inflammatory therapy of bronchial asthma in children.

Anti-Asthmatic Agents↗

PubMed1999

Aerosol characterization of three corticosteroid metered dose inhalers with volumatic holding chambers and metered dose inhalers alone at two inspiratory flow rates.

Inhaled corticosteroids are first-choice drugs in the treatment of chronic asthma. A metered dose inhaler (MDI) equipped with a spacer device is easier to use for patients with a poor inhalatory technique; it favors a reduction in the size of the particles delivered to the patient and thus a reduction in the incidence of local and systemic side effects of these drugs. The aim of this study was to determine the particle characteristics of fluticasone propionate (FP), flunisolide (FLUN), and beclomethasone dipropionate (BDP), each administered at a rate of 250 micrograms per puff and at inspiratory flow rates of 30 and 60 L/min in vitro, to estimate the particle characteristics of these drugs aspirated via an MDI alone and via a large-volume holding chamber (Volumatic). Compared with the MDI alone, at 30 L/min, the Volumatic (Glaxo Wellcome, Ware, UK) significantly reduced the mass median aerodynamic diameter (MMAD) and increased the fine particles (< 5 microns and < 2 microns) generated by all three drugs. At 60 L/min, the MMAD increased and the generation of fine particles decreased with both devices. These data suggest that the inspiratory flow applied by means of the devices may be a determinant for the deposition of the drug in the lower airways in that by increasing the inspiratory flow, the MMAD increases and the percentage of fine particles decreases, probably because of the reaggregation favored by the higher flows.

Aerosols↗

PubMed1994

Relative bioavailability of salbutamol to the lung following inhalation using metered dose inhalation methods and spacer devices.

BACKGROUND: Inhalation aids do not require coordination between actuation of a metered dose inhaler (MDI) with inspiration and reduce oropharyngeal impaction. The delivery of salbutamol to the lung and systemic availability following inhalation with three commonly used spacers and an open mouth technique have been evaluated using a simple noninvasive technique based on urinary excretion 30 minutes and 24 hours after the dose. METHODS: Ten healthy subjects inhaled, on randomised study days, 4 x 100 micrograms from a Ventolin MDI and, subsequently, with the aid of a Volumatic, Bricanyl Spacer, and Nebuhaler spacer device. In addition, an open mouth inhaler technique was evaluated. Urine samples were collected 0-30 minutes and 0.5-24 hours after inhalation. From these samples the relative bioavailability to the lung (urinary salbutamol excretion 30 minutes after dosing) and the systemic bioavailability of the dose (24 hour urinary excretion of salbutamol and its metabolite) for each inhalation method was obtained. RESULTS: The mean (SD) urinary excretion of salbutamol 30 minutes after inhalation using the MDI alone and with the Volumatic, Bricanyl Spacer, Nebuhaler, and open mouth technique was 2.83 (0.78)%, 3.37 (0.69)%, 4.09 (0.91)%, 4.34 (1.60)%, and 3.49 (0.98)%, respectively, expressed as a percentage of the nominal dose. The nebuhaler and Bricanyl Spacer spacer devices were found to increase the relative bioavailability of salbutamol to the lung compared with the MDI alone. Compared with the MDI the inhalation aid increases were much greater than the intra-individual variability of the urinary excretion method. In 11 individuals who each repeated the same inhalation procedure on four separate occasions, the mean (SD) coefficient of variation was 8.24 (2.36)%. The mean (SD) 24 hour urinary excretion of salbutamol and its metabolites was 26.6 (6.79), 27.0 (7.95), and 55.6 (9.74)% of the salbutamol dose for the Volumatic, Nebuhaler, and MDI, respectively. Similar values following the open mouth method and Bricanyl Spacer were 48.9 (10.97)% and 43.8 (11.57)%. These values, representing the systemic availability of the inhaled dose, were lower when inhaling with the aid of the Volumatic and Nebuhaler than inhalation from the MDI alone. CONCLUSIONS: Spacer devices improve pulmonary bioavailability of salbutamol and reduce the systemically available dose.

Administration, Inhalation↗

PubMed1988

Particle size study of nine metered dose inhalers, and their deposition probabilities in the airways.

This study deals with the particle size measurement of nine aerosol metered dose inhalers. Calibration was made possible by the use of a laser particle velocimeter (aerodynamic Particle Sizer from TSI). The count median aerodynamic diameters (CMAD) show little variation, from 0.63 to 0.73 micron, with standard deviations (sigma g) between 1.2 and 1.8. Aerodynamic diameter aerosol diagram analysis showed multimodal mass distribution for all the tested dose inhalers. Calculations for the airway deposition probabilities (extrathoracic, tracheobronchial and alveolar) refer to the studies made by W. Stahlhofen and co-workers. As most aerosol metered dose inhalers have a predominantly bronchial therapeutic destination, the deposition at the bronchial level could be enhanced with the following parameters: inspired volume of 1500 ml, inspiratory time of 2 sec, aerosol mass median aerodynamic diameter (MMAD) of 7.5 microns, with a monodispersed distribution. The respective influences of the excipients and propellents used for the aerosolization of these dose metered inhalers are also discussed.

Aerosol Propellants↗

PubMed1996

Evaluation of an Auditory Feedback Equipped Metered Dose Inhaler.

BACKGROUND: Although metered dose inhalers are one of the most frequently prescribed drug delivery systems for pulmonary disease, patients usually do not employ ideal technique when using these systems. We studied the effect of a new teaching device, the MDI Tutor (MDI Tutor Inc., Palatine, IL), on patients with unsatisfactory inhalation technique. METHODS: Twelve patients with an average of 10 years' experience with metered dose inhalers (mean age, 41 years) were evaluated by two observers. All patients had deficits in their inspiratory technique such as actuation of inhaler coordinating with the beginning of inhalation cycle, uninterrupted inhalation, and incorrect length of inspiration. Following evaluation, the patients were given metered dose inhalers equipped with a MDI Tutor prototype as well as written instructions on how to use the device most effectively. RESULTS: All patients corrected their inspiratory technique deficits. CONCLUSIONS: Equipping a metered dose inhaler with a MDI Tutor allows patients to rapidly recognize correct the errors in their inspiratory technique.

Journal Article↗

PubMed1996

Effect of inhalation flow rate on the dosing characteristics of dry powder inhaler (DPI) and metered dose inhaler (MDI) products.

Both the dose delivered from the device and the particle size of the medication are important parameters for inhalation products because they influence the amount of drug that is delivered to the patient's lung. The inspiratory flow rate may vary from dose to dose in a given patient and between patients. The Marple-Miller Cascade Impactor, a new multistage inertial impactor that operates at two flow rates (30 and 60 liters/min) with comparable particle size cut-offs, provides a means to study the effect of inhalation flow rate on the particle size distributions of inhalation products. The medication delivery, mass median aerodynamic diameter (MMAD), and fine particle mass were determined, in a randomized fashion, for albuterol, beclomethasone, budesonide, and terbutaline in both metered dose inhaler (MDI) and dry powder inhaler (DPI) products as a function of flow rate. In all cases, independent of drug or device used, the MDI products had a more reproducible respirable dose than the breath-actuated DPI products tested as a function of inhalation flow rate.

Administration, Inhalation↗

PubMed1995

Clinical equivalence of a novel multiple dose powder inhaler versus a conventional metered dose inhaler on bronchodilating effects of salbutamol.

In this study the bronchodilating effect of salbutamol (CAS 18559-94-9) after administration a single-dose (100 micrograms) from a novel multiple dose powder inhaler (MDPI; Easyhaler) and from a conventional metered dose inhaler (MDI) was compared. Forty adult asthmatic patients participated in a double-blind, randomized, cross-over, multicenter study with double-dummy technique. The study comprised two study days with a 4-h follow-up period of spirometric indices and measurements of blood pressure and heart rate. Both the powder and aerosol treatments caused a clear increase in spirometric parameters. The mean (SD) maximum forced exspiratory volume in one second (FEV1) after powder delivery was 2.82 (1.13) l and after aerosol 2.77 (1.03) l. The mean percentual change from the baseline in FEV1 was equal after both preparations. The mean area under the curve (AUC) of the absolute FEV1 values was 616 (264) and 609 (240) l x min after the powder and aerosol delivery, respectively. The treatments had no clinically significant effects on blood pressure or heart rate and were equally well tolerated. Thus the clinical effects indicate therapeutical bioequivalence of the powder and aerosol treatments. Furthermore, most patients found the handling of the MDPI device easier than or equal to that of the conventional MDI, which in all probability increase the patient compliance, which is one of the corner stones in the inhalation therapy of bronchial asthma.

Adolescent↗