Pressurized Metered-dose Inhaler Research Articles

The Climate is Changing for Metered-Dose Inhalers and Action is Needed.

Increases in global temperature are already having a significant impact on our climate. The hydrofluorocarbon (HFC) propellants used today in pressurized metered-dose inhalers (pMDIs) have global warming potential (GWP) many times that of carbon dioxide. Their use, together with all other emissive uses of HFCs, is being phased down under the Montreal protocol. This has prompted calls to switch patients to dry powder inhalers (DPIs). This paper presents a new analysis of the top 15 respiratory drug markets by drug class. It shows that a switch to DPIs would be economically feasible for most countries and most drugs. However, a wholesale switch of reliever medications, notably short-acting β-agonists, would lead to significant increases in the cost of these life-saving medications. Reviewing the evidence, whilst most patients are capable of using DPIs, the very young, very old and those undergoing an acute exacerbation still require a pMDI. Thus, there is a clinical and economic need to have both pMDIs and DPIs available. At the same time, it is projected that the reduction in non-medical uses of propellants is likely to give rise to a 5-fold increase in their cost for pMDI uses and is likely to hit the Western world in 2025. This may lead to a price increase in reliever medication that will make it unaffordable for the poorer communities in some markets. At the same time, opportunities to save money by developing new formulations using propellants with lower GWP, such as HFC 152a or HFO 1234ze(E), are described. Two companies have made this commitment, but neither currently have a strong presence in reliever medication. For them, or other companies, now is the time to act; 2025 is not far away in terms of product development timescales and the climate cannot wait.

Influence of Actuator Nozzle Angle on the Flow Characteristics in Pressurized-Metered Dose Inhaler Using CFD

Influence of Actuator Nozzle Angle on the Flow Characteristics in Pressurized-Metered Dose Inhaler Using CFD

Consequences of not-shaking and shake-fire delays on the emitted dose of some commercial solution and suspension pressurized metered dose inhalers

ABSTRACT Background Pressurized metered-dose inhalers (pMDIs) include hydrofluoroalkane (HFA) propellant to generate a drug aerosol upon actuation and drugs can be formulated as solution or suspension. Suspended particles can cream or sediment depending on density differences between drug and propellant and shaking the pMDI is an essential step to ensure a uniform drug dose release. Research design and methods The effect of the delay (0, 10, 30, 60 seconds) in pMDI actuation after shaking and the effect of no-shaking during the canister life on the emitted dose (ED) for commercial solution and suspension pMDIs was investigated. Results The ED for solutions was unaffected by no-shaking or by the progressive increasing delay in actuation after shaking (between 77% and 97%). For all the suspension products, shaking was demonstrated to be critical to assure the close to nominal drug delivery. In detail, the actuation delay after shaking led to an increase up to 380% or a drop to 32% of ED in relation to the label claim with high variability. Conclusion The drug delivered can vary widely for no-shaking and over different shake-fire delays with suspension pMDIs while solution formulations appear to remain stable.

Inhaled therapy for asthma

Inhaled therapy is key to the successful treatment of asthma. National guidelines provide us with the aim of asthma management, which is to maintain control of the disease. The correct combination of drug and device can be individually tailored to the patient. Drugs consist of bronchodilators and anti-inflammatories. Devices consist of aerosol inhalers, also known as pressurised metered dose inhalers, and dry powder inhalers. Both the drug and the device need to be prescribed if the treatment is to be clinically effective. A combination of inhaled steroid with long-acting B2 agonist is one of the most clinically effective ways of delivering asthma treatment. This can be prescribed either as a fixed daily dose with a concomitant short-acting B2 agonist as a reliever, or as maintenance and reliever therapy, which has been shown to improve asthma control and reduce exacerbations.

The Relationship Between Clinical Trial Participation and Inhaler Technique Errors in Asthma and COPD Patients.

BackgroundIncorrect inhaler use is associated with poorer health outcomes, reduced quality of life, and higher healthcare utilisation in patients with asthma and COPD.MethodsWe performed an observational study of pressurized metered-dose inhaler technique in patients with asthma or COPD. Patients were assessed using a six-point inhaler checklist to identify common critical inhaler technique errors. An inadequate inhaler technique was defined as the presence of one or more critical errors. A multivariate logistic regression model was used to determine the odds of an inadequate inhaler technique.ResultsDuring the 14-month study period, 357 patients were enrolled. At least one critical error was executed by 66.7% of participants, and 24.9% made four or more critical errors. The most common errors were failure to exhale completely prior to pMDI activation and inhalation (49.6%), failure to perform a slow, deep inhalation following device activation (48.7%), and failure to perform a breath-hold at the end of inspiration (47.3%). The risk of a critical error was higher in COPD patients (aOR 2.25, 95% CI 1.13–4.47). Prior training reduced error risk specifically when trained by a doctor (aOR 0.08, 95% CI 0.1–0.57) or a pharmacist (aOR 0.02, 95% CI 0.01–0.26) compared to those with no training. Previous clinical trial participation significantly reduced error risk and rate: <3 trials (aOR 0.35, 95% CI 0.19–0.66) and ≥3 trials (aOR 0.17, 95% CI 0.07–0.42). The rate of critical errors was not significantly associated with age, sex, or prior pMDI experience.ConclusionThis study found a high rate of critical inhaler technique errors in a mixed population of asthma and COPD patients; however, prior training and, in particular, multiple previous clinical trial participation significantly reduced the risk of errors.

Technical Evaluation of Soft Mist Inhaler Use in Patients with Chronic Obstructive Pulmonary Disease: A Cross-Sectional Study.

BackgroundProper inhaler technique is highly relevant to the effective management of chronic obstructive pulmonary disease (COPD). The tiotropium bromide spray (TBS) (Spiriva® Respimat®) is a soft mist inhaler (SMI) preferred by patients to pressurized metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs) because of its convenience in use. However, the technique of using TBS inhaler in the real world is unclear.ObjectiveTo evaluate techniques in using TBS inhaler and investigate the association between the patient characteristics and the correct use of TBS inhaler.MethodsThis cross-sectional study enrolled 74 COPD patients who used TBS inhaler device for more than 3 months. The sociodemographic and clinical characteristics of the patients were recorded. The technique of using TBS inhaler was evaluated step by step. Incorrect use was defined as the patient’s inability to complete the key steps in the inhalation manoeuvre. The percentage of incorrect use was compared between the groups. Risk factors related to incorrect use were analyzed by logistic regression analysis.ResultsOf the 74 participants, only 2 (2.7%) patients completed all the steps correctly, and 48 (64.9%) patients misused the key steps in the inhalation manoeuvre. Incorrect preparation of the TBS inhaler for the first use was the most frequently misused step, accounting for 77.0%. Factors associated with misuse of TBS inhaler included the educational background (p=0.010), living state (p=0.031) and COPD assessment test (CAT) score (p=0.005) of the patients. Additionally, logistic regression analysis showed that the COPD duration was significantly associated with the incorrect use (p=0.019). Compared with patients with a higher educational background, patients with an elementary school background [OR 11652.99, CI: 22.72–5975697.72], junior high school background [OR 7187.78, CI: 16.41–3146787] and high school background [OR 1563, CI: 4.27–572329.67] were more likely to misuse TBS inhaler. Patients living with their spouses alone were also more likely to commit errors in using TBS inhaler as compared with those living with their children [OR 12.29, CI of 1.14–1.96]. Clinical factors like the COPD symptoms were relative to the technical use of the device. Better technique was accompanied by a lower CAT score [OR 1.49, CI of 1.14–1.96].ConclusionThe incorrect use of TBS inhaler was common in COPD patients. Healthcare providers should not only teach the patients about the drug preparation but help them use the inhaler correctly. Special attention should be paid to patients with a short COPD duration and a low educational background and those who live without the company of their children. Proper use of TBS inhaler can significantly improve the symptom control of COPD patients.

Amid COVID-19 drug shortages: proposed plan for reprocessing and reusing salbutamol pressurized metered dose inhalers (pMDIs) for shared use.

Amid COVID-19 drug shortages: proposed plan for reprocessing and reusing salbutamol pressurized metered dose inhalers (pMDIs) for shared use.

ATTACHED, DETACHED and WITHOUT inhaler technique coaching tools to optimize pMDI use competence, asthma control and quality-of-life in asthmatic adults.

BackgroundPoor pressurized metered dose inhaler (pMDI) technique is prevalent, which will diminish treatment gains. In a two-visit study, two novel pMDI training devices with feedback mechanisms; Trainhaler (THR) and Flo-Tone CR (FTCR), were evaluated alongside the traditional verbal inhaler training (VT) in asthma outpatients.MethodsOn visit 1, 18–60 year-old asthmatics with incorrect pMDI use [including peak inhalation flow (PIF) >60 L/min] signed consent and baseline pMDI technique, lung function, asthma control and quality-of-life were measured. Participants were randomized to receive pMDI technique training using VT, THR or FTCR. One hour post-training, the pMDI coordination and PIF were re-assessed. The THR and FTCR patients were given their assigned tools to take home to facilitate regular training. All outcomes were re-evaluated 6–8 weeks later (visit 2).ResultsNinety-two asthmatics completed visit 1 (46 attended visit 2). Pre-training, 61.3% (VT), 61.5% (THR) and 65.0% (FTCR) patients similarly made ≥2 pMDI errors with mean PIFs 175.2, 187.1 and 158.9 L/min, respectively. pMDI use was significantly improved 1 h post-training. The subjects that completed visit 2 had significantly, yet equally, maintained the improved inhaler use; only 28.0% (VT), 26.2% (THR) and 21.7% (FTCR) patients made ≥2 pMDI errors with PIF improvements; 115.3, 94.6 and 96.1 L/min, respectively. Clinical outcomes remained comparable.ConclusionsVT improves the overall pMDI technique, however patients gradually forget their VT. The THR and FTCR devices are retained by the patients as their self-monitoring, all-time personal trainers that boost and maintain their VT between routine clinic visits.

Deep CNN Sparse Coding for Real Time Inhaler Sounds Classification

Effective management of chronic constrictive pulmonary conditions lies in proper and timely administration of medication. As a series of studies indicates, medication adherence can effectively be monitored by successfully identifying actions performed by patients during inhaler usage. This study focuses on the recognition of inhaler audio events during usage of pressurized metered dose inhalers (pMDI). Aiming at real-time performance, we investigate deep sparse coding techniques including convolutional filter pruning, scalar pruning and vector quantization, for different convolutional neural network (CNN) architectures. The recognition performance has been assessed on three healthy subjects following both within and across subjects modeling strategies. The selected CNN architecture classified drug actuation, inhalation and exhalation events, with 100%, 92.6% and 97.9% accuracy, respectively, when assessed in a leave-one-subject-out cross-validation setting. Moreover, sparse coding of the same architecture with an increasing compression rate from 1 to 7 resulted in only a small decrease in classification accuracy (from 95.7% to 94.5%), obtained by random (subject-agnostic) cross-validation. A more thorough assessment on a larger dataset, including recordings of subjects with multiple respiratory disease manifestations, is still required in order to better evaluate the method’s generalization ability and robustness.

Knowledge, practice pattern and attitude toward asthma management amongst physicians from Nepal, Malaysia, Lebanon, Myanmar and Morocco

Objective This survey aimed to understand the physicians’ practice pattern and challenges faced while treating their patients with asthma in five countries-Malaysia, Nepal, Myanmar, Morocco and Lebanon. Methods Questionnaire-based data was gathered from internal medicine doctors (209), general practitioners (206), chest physicians (152) and pediatricians (58) from 232 locations from across the five countries. Results Of the 816 physicians, 374 physicians encountered at least 5 asthma patients daily. Approximately, 38% physicians always used spirometry for diagnosis and only 12% physicians always recommended Peak flow meter (PFM) for home-monitoring. Salmeterol/fluticasone (71%) followed by formoterol/budesonide (38%) were the most preferred ICS/long-acting beta2-agonists (LABA); Salbutamol (78%) was the most preferred reliever medication. 60% physicians said >40% of their patients were apprehensive to use inhalers. 72% physicians preferred a pressurized metered-dose inhaler (pMDI) to a dry powder inhaler (DPI) with only a third of them using a spacer with the pMDI. 71% physicians believed that using similar device for controller and reliever can be beneficial to patients. Skipping medicines in absence of symptoms (64%), incorrect inhaler technique (48%) and high cost of medication (49%) were considered as major reasons for non-adherence by most physicians. Incorrect inhaler technique (66%) and nonadherence (59%) were considered the most common causes of poor asthma control. Conclusions There are opportunities to improve the use of diagnostic and monitoring tools for asthma. Non-adherence, incorrect inhaler technique and cost remain a challenge to achieve good asthma control. Asthma education, including correct demonstration of inhaler, can potentially help to improve inhaler adherence.

What drives inhaler prescription for asthma patients? Results from a real-life retrospective analysis.

The choice of inhaler device for asthma patients depends upon multiple attributes. We investigated factors that may drive general practitioners (GPs) and respiratory specialists in the prescription of inhaler devices for asthma patients who initiated inhalation therapy. We retrospectively analysed prescriptions by GPs and respiratory specialists to asthma patients commencing inhaled corticosteroid/long-acting β2-agonist combination therapy available as both pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs). Patient characteristics were compared by device and multivariate analysis was used to model the likelihood of receiving a pMDI as opposed to a DPI in order to identify drivers for prescription. A sample of the respiratory specialists completed an ad-hoc survey of their perceived success in achieving asthma control in their patients and barriers to attaining full control. Prescription of a particular inhaler device was unrelated to the characteristics of the patients. Multivariate analysis revealed that the main driver for the choice of inhaler device was the medication (Odds Ratio and 95% Confidence Interval, respectively for GPs and specialists: 0.19 [0.16-0.23]; 0.17 [0.08-0.37]). Specialists perceived asthma as being inadequately controlled in 41% of their patients, and considered patients' difficulties in using DPIs and pMDIs as instrumental in this, citing a need for a novel, more effective inhaler technology. Physicians choose inhaler devices according to the prescribed drugs and not to the characteristics of the individual patient. This may reflect a lack of confidence in existing inhaler devices and underlines the need for technologies, which are more reliable and easier to use by patients.

The pharmacists’ ability to use pressurized metered-dose inhalers with a spacer device and factors affecting it

Objective: The aim of this study is to evaluate the pharmacists’ ability to use pMDIs with a spacer device and the factors that affect this ability.Method: Face to face interviews were conducted with the pharmacists. A nine item questionnaire was completed and the checklist for how to use pMDIs with a spacer device was filled out.Results: A total of 307 pharmacists voluntarily participated in this study. Fifty-six (18.2%) of the pharmacists stated that they did not know how to use pMDIs with a spacer device. These pharmacists were excluded and remaining 251 pharmacists included in the study. Only 100 (39.8%) pharmacists demonstrated all of the inhaler spacer device usage steps correctly. The step in which pharmacists made the most mistakes was “take 5–6 deep and slow breaths, hold for 10 s and slow breaths.” Those pharmacists who were more likely to correctly use pMDIs with a spacer device were younger (p = 0.023), had dispensed more asthma medications per day (p < 0.001), had dispensed more asthma medications per day for patients younger than six years of age (p = 0.016), and sold inhaler spacer devices at their pharmacy (p = 0.042).Conclusion: Approximately one third of the pharmacists in the current study were able to correctly demonstrate all of the steps for proper usage of pMDIs with a spacer device, which indicates that pharmacists should be included in the training program and be provided continuous training on the use of pMDIs with a spacer device.

Green respiratory healthcare: need for proportionality

The Montreal Protocol on Substances That Deplete the Ozone Layer was an example of an amazing international collaboration that has already led to improvements in the ozone layer, although the...

In Vitro Evaluation of Aerosol Performance and Delivery Efficiency During Mechanical Ventilation Between Soft Mist Inhaler and Pressurized Metered-Dose Inhaler

Soft mist inhalers (SMIs) generate aerosols with a smaller particle size than pressurized metered-dose inhalers (pMDIs). However, the whole-span particle size distribution (PSD) of SMIs and the optimal delivery method of SMIs during mechanical ventilation have not been fully investigated. This study aimed to measure the PSD of the SMI alone and the SMI coupled to an inhalation aid (eg, a spacer, a valved holding chamber), as well as the delivery efficiency of SMI in different actuation timings and circuit positions during mechanical ventilation. As a suitable comparison, the pMDI was chosen for the same measurement. SMIs (2.5 μg/actuation of tiotropium) were compared with pMDIs (100 μg/actuation of salbutamol). A microorifice uniform deposit impactor was utilized for the particle sizing of drug aerosols generated by inhalers alone, inhalers with a spacer, and inhalers with a valved holding chamber. To optimize the delivery efficiency of both inhalers during mechanical ventilation, the operating parameters included the circuit positions and actuation timings in the ventilator circuit. Particle sizes and inhaled doses were measured with an optical particle sizer and filters used to collect and quantify the drug, respectively. The SMI generated a smaller mass medium aerodynamic diameter (MMAD) than that from the pMDI. The extrafine-particle fraction (EFPF, < 1 μm) of the SMI was significantly higher than that of the pMDI. With the use of either inhalation aid, the MMAD of both inhalers decreased, and both inhalers with inhalation aid showed significant increases in EFPF. During mechanical ventilation, the optimum way to deliver the SMI and pMDI was at 15 cm from the Y-piece and actuated at the end of expiration and the onset of inspiration, respectively. The SMI with an inhalation aid showed marginal improvement on the PSD. The inhaler type, actuation timing, and position within the circuit also played important roles in delivery efficiency during mechanical ventilation.

Air Trapping Correlates With Increased Frequency of Albuterol Use and Severity of Wheeze in Persistent Asthma.

Symptoms of asthma have been shown to correlate poorly with spirometric variables of obstruction. We hypothesized that lung volume measurements might correlate with symptoms and frequency of rescue inhaler use in asthma. Patients with persistent asthma on treatment for ≥12 months were enrolled from university-based clinics. The association between lung volumes, spirometry, asthma symptoms, and rescue inhaler use were explored by using linear modeling. Among the 120 subjects, 76% were women. The mean age ± SD was 52 ± 15 y. With regard to ethnicity, 64% of the subjects were caucasian, 23% were Hispanic, and 13% were African-American. Twenty-one percent of the subjects reported chest pain. There was no significant correlation between asthma symptoms or rescue inhaler use to spirometry indices of obstruction. The residual volume percent of predicted showed a significant association with the wheeze score (r = 0.32, P = .001) and frequency of rescue inhaler use (r = 0.35, P ≤ .001). Linear contrast analysis showed that the mean wheeze score (P = .003) and frequency of rescue inhaler (P = .007) use increased linearly from the lowest to the highest quartiles of residual volume. Furthermore, multiple regression analysis showed an association only to the residual volume percent predicted value to the pressurized metered-dose inhaler score and the wheeze score. Frequent albuterol use and wheezing may be a sign of unrelieved air trapping. Chest pain is a unique symptom in persistent asthma, and the pathogenesis requires further studies. Lung volume measurement added to routine spirometry can help identify patients with asthma and with air trapping.

Budesonide/formoterol therapy: effective and appropriate use in asthma and chronic obstructive pulmonary disease.

Aim: Quality, real-world comparative effectiveness (CE) studies of asthma and chronic obstructive pulmonary disease therapy efficacy are scarce. We identified and evaluated peer-reviewed CE and appropriate-use evaluations of budesonide/formoterol combination (BFC) maintenance therapy. Materials & methods: Analyses were limited to retrospective, real-world utilization studies of BFC delivered by pressurized metered-dose inhalers. Results: In a CE study of BFC versus fluticasone/salmeterol combinations (FSC)in asthma, BFC users had fewer total exacerbations. In appropriate-use studies of asthma treatment, BFC patients were consistently more likely to meet treatment escalation recommendations. BFC comparisons with FSC or tiotropium for chronic obstructive pulmonary disease found differences in exacerbation rates and rescue inhaler use. Conclusion: We found available, good quality BFC CE and appropriate-use articles; however, all had limitations.

Formulation development and in-vitro evaluation of montelukast sodium pressurized metered dose inhaler

Montelukast is used as alternative treatment for asthma. However, some adverse drug reactions have been reported for the oral dosage form of montelukast. To counter this issue, the drug was formulated into a pressurized metered-dose inhaler (pMDI), which delivered montelukast directly to the lower regions of the lungs. Montelukast sodium, mixed with either HFA 134a propellant or a mixed propellant (HFA-134a and HFA227), was formulated into a pMDI with other excipients. The canister was prepared using a pressurized filling method, followed by disk sampling to assess content per spray and content uniformity. The effects of ethanol and polyethylene glycol (PEG) 400 on the fine particle fraction (FPF) and mass median aerodynamic diameter (MMAD) of the formulation were evaluated. In vitro cytotoxicity of the developed montelukast pMDIs was tested in lung airway cell lines. Their effects on the levels of inflammatory nitric oxide (NO), tumor necrosis factor-α (TNF-α), and interleukin-1β (IL-1β), generated from NR8383 alveolar macrophage (AM) cells, were also evaluated. All selected formulations had a FPF >46%, whereas the formulation containing 20% v/v ethanol and 1% v/v PEG 400 showed the highest FPF. The MMADs of all formulations were within 1–5 μm. The montelukast pMDI formulations were found to be non-toxic to lung airway cell lines and did not induce inflammatory NO, TNF-α, or IL-1β production in NR8383 cells.

Is "Slow Inhalation" Always Suitable for Pressurized Metered Dose Inhaler?

To achieve adequate inhalation therapy, a proper inhalation technique is needed in clinical practice. However, there is limited information on proper inhalation flow patterns of commercial inhalers. Here, we quantitatively estimated airway deposition of two commercial pressurized metered dose inhalers (pMDIs) to determine their optimal inhalation patterns. Sultanol® inhaler (drug particles suspended in a propellant, suspension-pMDI) and QVAR™ (drug dissolved in a propellant with ethanol, solution-pMDI) were used as model pMDIs. Aerodynamic properties of the two pMDIs were determined using an Andersen cascade impactor with human inhalation flow simulator developed by our laboratory. As indices of peripheral-airway drug deposition, fine particle fractions (FPFPA) at different inhalation flow rates were calculated. The time-dependent particle diameters of sprayed drug particles were determined by laser diffraction. On aerodynamic testing, FPFPA of suspension-pMDI significantly decreased depending on the increasing inhalation flow rate, while solution-pMDI achieved higher and constant FPFPA in the range of the tested inhalation flow rates. The particle diameter of solution-pMDI markedly decreased from 5 to 3μm in a time-dependent manner. Conversely, that of suspension-pMDI remained at 4μm during the spraying time. Although "slow inhalation" is recommended for pMDIs, airway drug deposition via solution-pMDI (extra-fine particles) is independent of patients' inhalation flow pattern. Clinical studies should be performed to validate instruction for use of pMDIs for each inhaler for the optimization of inhalation therapy.

Is Inhaler Technique Associated with Quality of Life in Patients with Chronic Obstructive Pulmonary Disease?

Inhalers are the mainstay of treatment for patients suffering from chronic obstructive pulmonary disease. However, incorrect inhaler technique is a considerable challenge. We aimed to evaluate inhaler technique and its association with quality of life in a sample of patients with chronic obstructive pulmonary disease. This cross-sectional study included patients with confirmed chronic obstructive pulmonary disease who were prescribed at least 1 inhaler medication on a regular basis. Patients were recruited from the outpatient pulmonary clinic of a hospital in Tehran. Inhaler technique was assessed according to a validated checklist. Patients' quality of life was evaluated using Chronic Obstructive Pulmonary Disease Assessment Test. One hundred seventy-five patients with mean (SD) age of 59.0 (10.1) years were included. Patients' devices were 192 (62.3%) pressurized metered-dose inhalers (including pressurized metered-dose inhalers plus spacer) and 116 (37.7%) dry powder inhalers. Unfortunately, only 2.86% of patients used their inhalers completely correct. The highest rate of errors was committed by patients who used metered-dose inhalers plus spacer. Patients with a higher educational degree had significantly lower rate of errors on average (P = 0.001). The most frequent errors made by patients using pressurized metered-dose inhalers or Turbuhaler was priming the inhaler before the first administration in 90.6% and 78.3% of patients, respectively. Chronic Obstructive Pulmonary Disease Assessment Test scores in patients using different inhaler devices were not significantly different. However, in patients with lower quality of life, significantly more patients had poor inhaler technique (P = 0.0001). There is still considerable need for interventions to optimize inhaler technique. We also noted that appropriate inhaler technique is associated with better quality of life. (Curr Ther Res Clin Exp. 2020; 81:XXX-XXX).

Efficacy and Safety of a Pressurized Metered-Dose Inhaler in Older Asthmatics: Comparison to a Dry Powder Inhaler in a 12-Week Randomized Trial.

PurposeAsthma control in older asthmatics is often less effective, which may be attributed to small airway dysfunction and poor inhalation technique. We compared the efficacy of 2 inhalers (fluticasone propionate/formoterol treatment using a pressurized metered-dose inhaler [p-MDI group] vs. fluticasone propionate/salmeterol treatment using a dry powder inhaler [DPI group]) in older asthmatics.MethodsWe conducted a 12-week, randomized, open-label, parallel-designed trial in older patients (over 55 years old) with moderate-to-severe asthma, and compared the efficacy and safety for asthma control between the 2 groups. Subgroup analyses on disease duration and air trapping were performed. Clinical parameters, including changes in lung function parameters, inhaler technique and adherence, were compared with monitoring adverse reactions between the 2 groups.ResultsA total of 68 patients underwent randomization, and 63 (30 in the p-MDI group and 33 in the DPI group) completed this study. The p-MDI group was non-inferior to the DPI group with regard to the rate of well-controlled asthma (53.3% vs. 45.5%, P < 0.001; a predefined non-inferiority limit of 17%). In subgroup analyses, the proportion of patients who did not reach well-controlled asthma in the p-MDI group was non-inferior to that in the DPI group; the difference was 12.7% among those with a longer disease duration (≥ 15 years) and 17.5% among those with higher air-trapping (RV/TLC ≥ 45%), respectively (a predefined non-inferiority limit of 17%, P < 0.001). No significant differences were observed in lung function parameters, inhalation techniques, adherence and adverse reactions between the 2 groups.ConclusionThese results suggest that the p-MDI group may be comparable to the DPI group in the management of older asthmatics in aspects of efficacy and safety.