Standard Metered-dose Inhaler Research Articles

Efficacy and safety of levosalbutamol in patients with mild to moderate asthma compared with racemic salbutamol: results of a crossover placebo-controlled study

Aim. Effectiveness and safety of levosalbutamol metered dose inhaler (MDI) in comparison with placebo and salbutamol. Materials and methods. In this multicenter, randomized, placebo-controlled, 3-period crossover study, all asthma patients (n=91) received levosalbutamol (90 mcg), salbutamol (180 mcg), and placebo using standard MDI. Pulmonary function testing – forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) – was performed 45 and 15 minutes before and 5, 10, 15, 30, 60, 90, 120, 180, 240, 300 and 360 minutes after dosing. The primary efficacy endpoint was the baseline-corrected area under FEV1 curve from 0 to 6 hours (AUC(0–6h)). Secondary endpoints were the baseline adjusted FEV1 and FVC peak values, as well as the onset of drug action. Results. The FEV1 AUC0–6 hours analysis confirmed similar bronchodilatory levosalbutamol and salbutamol effect (p=0.595), significantly improved compared with placebo (p0.001). The peak values of FEV1 and FVC after levosalbutamol or salbutamol dosing were similar (p=0.643) and significantly higher compared with placebo group (p0.001). The active therapy effect was observed 5 minutes after dosing and throughout the entire observation period up to 6 hours, however, there was some tendency towards a longer duration of action of levosalbutamol compared to salbutamol. Levosalbutamol was well tolerated by patients; after levosalbutamol dosing twiсе fewer adverse reactions were observed compared to salbutamol. Conclusion. Levosalbutamol at a 90-mcg dose showed efficacy similar to that of salbutamol at a dose of 180 mcg, assosiated with a good safety profile.

A Novel, Portable MESH Nebulizer-An Alternative to Metered Dose Inhaler: Efficacy and Usability in Preschool Wheezers.

Introduction and Objectives: Wheezing episodes are the first causes of doctor's consultation in preschool age. Treatment is usually administered with a metered dose inhaler (MDI) spacer. At variance, many parents and doctors prefer to use a compressor nebulizer, which cannot be easily carried. The study is aimed at testing whether a pocket mesh nebulizer has similar efficacy and acceptability than a standard MDI device.Materials and Methods: The IPAC study was a randomized, controlled, non-inferiority trial (number: 1616/2018, Ospedale Pediatrico Bambino Gesu'—IRCCS). The study had two arms: cases, using MicroAIR U100, and controls, using MDI+spacer device. Both devices were adopted for long-term treatment and for exacerbations. Follow-up was organized with clinical visits and a daily e-diary connected to an application for mobile phone.Results: One hundred patients were enrolled. The frequency of asthmatic symptoms showed a non-inferiority for MicroAIR U100 group vs. MDI. Accordingly, no significant difference was found in the average % of days with cough, wheezing, breathlessness after exercise, days lost at school, and not-programmed visits. Considering only patients with >1 day with symptoms, no significant sdifferences were found in the number of exacerbations nor in the cumulative days with symptoms. The acceptance and usability of both devices have been favorable. However, the MDI+AeroChamber® device showed better acceptability.Conclusions: Our study shows that MicroAIR U-100, a mesh nebulizer, has similar clinical efficacy but lower acceptance and usability than an MDI plus Aerochamber® in delivering therapy in preschool wheezers. Therefore, MicroAIR U-100 might be a valuable second choice, when the delivery of medication with an MDI plus Aerochamber® is not accepted, or wrongly used by the parents.

Inhaled Corticosteroid Metered-Dose Inhalers: How Do Variations in Technique for Solutions Versus Suspensions Affect Drug Distribution?

To assess the literature that evaluates how variations in metered-dose inhaler (MDI) technique affect lung distribution for inhaled corticosteroids (ICSs) formulated as MDI suspensions and solutions. PubMed (up to November 2012) and Cochrane Library (up to November 2012) were searched using the terms metered-dose inhalers, HFA 134a, Asthma/*drug therapy, and inhaled corticosteroids. In addition, reference citations from publications identified were reviewed. All articles in English from the data sources that assessed MDI technique comparing total lung distribution (TLD) of MDI solutions or suspensions formulated with ICSs were included in the review. Five relevant studies were identified. Five controlled studies compared how variations in MDI technique affect TLD for ICS MDI solutions with suspensions. MDI solutions resulted in greater TLD compared with larger particle MDI suspensions. Delayed or early inspiration upon device actuation of MDI solutions resulted in less TLD than coordinated actuation, but with a 3- to 4-times greater TLD than MDI suspensions inhaled using a standard technique. A sixth study evaluated inspiratory flow rates (IFR) for small, medium, and large particles. Rapid and slow IFRs resulted in similar TLD for small particles, while far fewer particles reached the airways with medium and large particles at rapid, rather than slow, IFRs. Based on the literature evaluated, standard MDI technique should be used for ICS suspensions. ICS MDI solutions can provide a higher average TLD than larger-particle ICS suspensions using standard technique, discoordinated inspiration and medication actuation timing, or rapid and slow IFRs. ICS MDI solutions allow for a more forgiving technique, which makes them uniquely suitable options for patients with asthma who have difficultly with MDI technique.

A pilot study of nicotine delivery to smokers from a metered-dose inhaler

The present study generated preliminary data on the acceptability and pharmacokinetics of nicotine administered by a simple metered-dose inhaler (MDI). We conducted a nonrandomized, open-label cross-over trial of 10 current smokers. On Day 1, a single cigarette was smoked ad libitum. On Day 2, participants took 10 puffs (20 inhalations) of 50 microg nicotine/puff through the inhaler, and on Day 3, they took 10 puffs (20 inhalations) of 100 microg nicotine/puff, each over 5 min. Nicotine pharmacokinetics, changes in heart rate and blood pressure, and the acceptability of the inhalers were measured and recorded. Nicotine administered by an MDI produced a median maximum plasma concentration that was about 50% of that obtained by smoking a cigarette (12.5 vs. 25.9 ng/ml) and took twice the time to reach that concentration, 6 versus 3 min. Self-rated satisfaction and reduced urge to smoke were similar for the MDIs and a cigarette. The results suggest that nicotine can be delivered effectively by the pulmonary route using a standard MDI. The inhaler appears to provide a satisfaction level and reduction in the urge to smoke relatively similar to that provided by smoking a cigarette. These conclusions require verification in a larger controlled study.

Efficacy, Safety, and Acceptance of Beclomethasone Dipropionate Administered via a New Dry Powder Inhaler or a Standard CFC Metered-Dose Inhaler in Asthma Patients

Background/Objectives: The mechanical aerosol generator, MAGhaler^®, is a new chlorofluorocarbon-free inhalation device. The objective of this trial was to show equivalent efficacy and safety of beclomethasone dipropionate (BDP) delivered via the MAGhaler^® and the metered-dose inhaler (MDI) in patients with mild to moderate bronchial asthma. Moreover, user-friendliness and acceptance of the two devices were compared. Methods: This was a double-blind, reference-controlled, 12-week trial in 171 patients with asthma receiving BDP (1,000 µg/day) delivered via either the MAGhaler^® or the conventional MDI. Respiratory function parameters, clinical symptoms, concomitant intake of salbutamol or fenoterol, adverse events (AEs), laboratory values, and concomitant medications and diseases were recorded. The primary efficacy parameter was mean forced expiratory volume in 1 s (FEV₁), measured after 4, 8, and 12 weeks of therapy. Results: The equivalence of the two devices was confirmed (p = 0.003) on the basis of the ratios of the mean FEV₁ in weeks 4 to 12. Mean (± SD) FEV₁ (MAGhaler^®) was 2.24 ± 0.60 l (baseline), 2.61 ± 0.90 litres (week 4), and 2.62 ± 0.87 litres (weeks 4–12). Mean FEV₁ (MDI) was 2.28 ± 0.59 litres (baseline), 2.53 ± 0.82 litres (week 4), and 2.56 ± 0.77 litres (weeks 4–12). In total, 33 AEs occurred in 26 (30.2%) patients (MAGhaler^®) and 51 AEs in 36 (42.4%) patients (MDI). Most of the AEs were of mild or moderate intensity. The relationship to treatment could not be excluded for 11 AEs in 11 patients (MAGhaler^®) and 23 AEs in 18 patients (MDI). Three serious AEs, all unrelated to treatment, occurred in 3 patients (MAGhaler^®: 2, MDI: 1). There were no clinically relevant changes in other safety parameters. Most patients either preferred the MAGhaler^® or rated the two devices as equally acceptable. Conclusion: The new MAGhaler^® was equivalent to the standard MDI in terms of the safety and efficacy of BDP. The improved user-friendliness and acceptance of the MAGhaler^® over the conventional MDI represent an important advance in the clinical management of bronchial asthma.

Ability to learn inhaler technique in relation to cognitive scores and tests of praxis in old age

Clinical observations have shown that some older patients are unable to learn to use a metered dose inhaler (MDI) despite having a normal abbreviated mental test (AMT) score, possibly because...

The Spacehaler ™ for delivery of salbutamol: a comparison with the standard metered-dose inhaler plus Volumatic ™ spacer device

The Spacehaler ™ is a new, compact, pressurized aerosol device that uses the same canister as a conventional metered-dose inhaler (MDI). Its design, however, reduces the velocity of the aerosol cloud that emerges from the inhaler, thereby reducing the amount of the non-respirable fraction of the drug delivered to the patient. Large volume spacers achieve a similar effect, but they are bulky and therefore inconvenient to use and carry around. This study compared the bronchodilator effect of 200 μg salbutamol delivered by the Spacehaler ™ to that of an MDI used with a Volumatic ™ spacer (MDI plus spacer) in patients with reversible obstructive airways disease. Twenty-five patients with asthma, having a forced expiratory volume in 1 s (FEV 1) between 50 and 90% predicted and a reversibility of ≥15% to 200 μg salbutamol given by the conventional (standard) MDI entered the study. On two separate study days, they inhaled 200 μg salbutamol either via the Spacehaler ™ or the MDI plus spacer. To maintain blinding, they received placebo on both study days via the alternate device. Their FEV 1, forced vital capacity (FVC) and peak expiratory flow (PEF) were measured before and at regular intervals for 6 h after inhalation. Assessment of equivalence between the two devices was based on whether the 90% confidence interval for the difference between the weighted mean FEV 1 was within ±0·251. Patient preference was assessed by a questionnaire at the end of the second study day. Twenty-four patients completed the study. Both devices produced a significant improvement in FEV 1 ( P<0·02). The upper and lower 90% confidence limits for the difference in weighted mean FEV 1 between the devices was ±0·041, and the 99% confidence limits were +0·061 and −0·071. The weighted means for FVC and PEF, and the duration of effect and peak responses for FEV 1, FVC and PEF also showed no difference between the two devices. Patients found no difficulty in using the Spacehaler ™, and 20 out of 24 patients (83·3%) preferred it to the MDI plus spacer. The bronchodilator effect of 200 μg salbutamol administered by a Spacehaler ™ was equivalent to that produced by an MDI plus spacer in this group of patients with reversible airways obstruction. The majority of patients preferred it to a large volume spacer.

Design and characteristics of a portable breath actuated, particle size selective medical aerosol inhaler

A new medical aerosol inhaler comprising a pressurized canister or metered dose inhaler (MDI), an aerosol holding chamber and a one-way valve system has been designed. Coordination of inhalation with actuation of the canister is no longer necessary as the valve ensures that aerosol is delivered only upon inspiration. The optimum chamber dimensions were found experimentally to be a cylinder approx. 11 cm in length by 3.5 cm diameter. It was deduced that the large particles from the MDI, which usually deposit in the upper airway during standard metered dose inhaler use, impacted in the holding chamber and the remainder evaporated to smaller size particles. These smaller particles (< 2.8 μ) remain suspended in the holding chamber, available for inhalation.