Device use errors with soft mist inhalers: A global systematic literature review and meta-analysis

Navaie, Maryam; Dembek, Carole; Cho-Reyes, Soojin; Yeh, Karen; Celli, Bartolomé R.

doi:10.1177/1479973119901234

Cited by 29 publications

(33 citation statements)

References 74 publications

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“…Here, we did not objectively assess error rates when using the inhalers, which would require a validated metric and definition of critical errors to assess incorrect use [6]. Indeed, assessing critical errors can be flawed and sometimes misleading: one study that specifically looked at the tiotropium/olodaterol SMI included errors that are not applicable to the device [29]. A further limitation may be that patients were assessed in our analysis over a relatively short time period using subjective, self-reported metrics.…”

Section: Discussionmentioning

confidence: 99%

Assessment of Patient Experiences with Respimat® in Everyday Clinical Practice

et al. 2020

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Introduction: Chronic obstructive pulmonary disease (COPD) is a progressive disease requiring maintenance therapy. According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy report, bronchodilation with long-acting muscarinic antagonists (LAMAs) and long-acting b 2-agonists (LABAs), administered via inhalers, is currently the mainstay of COPD treatment. Combined LAMA/LABA therapies have been shown to improve patient health status, lung function and breathlessness. Here, we wanted to report patient satisfaction with the Respimat Ò Soft Mist TM inhaler (SMI). Methods: This was a pooled analysis of SPIRIT Ò (NCT02675517) and OTIVACTO Ò (NCT02719639), two open-label, single-arm, non-interventional studies of physical function in patients with COPD. Patients were treated with tiotropium/olodaterol 5/5 lg for approximately 6 weeks via the SMI. SPIRIT was conducted in Germany; OTIVACTO was conducted in nine European countries. The primary endpoints have been reported previously. Here, we assess patient satisfaction with inhalation and handling, and patient adherence to treatment with the tiotropium/olodaterol SMI in patients with COPD. These were assessed through selfreported questionnaires and physician general assessments. Results: Baseline data were collected from 9180 patients from the SPIRIT and OTIVACTO studies. The majority of patients were GOLD group A (25.59%) or B (46.12%). After 6 weeks of treatment with tiotropium/olodaterol, 85.78% of patients were 'satisfied' or 'very satisfied' with inhaling from the device, and 84.33% of patients were 'satisfied' or 'very satisfied' with the handling of the inhaler. Treating physicians reported patient adherence as 'high' during the study, with 98.57% of patients regularly using the tiotropium/olodaterol SMI. Furthermore, 95.45% of patients expressed a willingness to continue using the tiotropium/olodaterol SMI at the end of the observation period. Conclusion: In this study, over 9000 patients reported satisfaction with respect to inhalation Digital Features To view digital features for this article go to

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Section: Discussionmentioning

confidence: 99%

Assessment of Patient Experiences with Respimat® in Everyday Clinical Practice

et al. 2020

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“…Inhalers are subject to several errors in their use that may result in inadequate symptom relief for patients [10][11][12]. Many patients, especially the elderly, have problems coordinating inhalation with actuation of pMDIs-a critical step for efficient aerosol delivery with pMDIs.…”

Section: Introductionmentioning

confidence: 99%

“…DPIs do, however, require a fast and forceful inhalation for optimal aerosol generation, and generating the inspiratory flow required for effective function of DPIs can be problematic for many patients with COPD [13][14][15]. SMIs provide a slower-moving mist, but hand-breath coordination, hand strength, and breath holding are still needed; errors in SMI use remain common [12]. In contrast, nebulizer therapy is provided with tidal breathing, and hence is less subject to poor inhalation technique; a forceful inhalation is not necessary, and coordination is not an issue.…”

Section: Introductionmentioning

confidence: 99%

Maintenance Therapy with Nebulizers in Patients with Stable COPD: Need for Reevaluation

Terry

Dhand

2020

Pulm Ther

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Patients with stable COPD rely heavily on inhaled bronchodilators and corticosteroids to control symptoms, maximize quality of life, and avoid exacerbations and costly hospitalizations. These drugs are typically delivered by hand-held inhalers or nebulizers. The majority of patients are prescribed inhalers due to their perceived convenience, portability, and lower cost, relative to nebulizers. Unfortunately, poor inhaler technique compromises symptom relief in most of these patients. In contrast to one or two puffs through an inhaler, nebulizers deliver a drug over many breaths, through tidal breathing, and hence are more forgiving to poor inhalation technique. To what extent susceptibility to errors in their use may influence the relative effectiveness of these two types of inhalation device has received little attention in COPD research. In 2005, a systematic review of the literature concluded that nebulizers and inhalers are equally effective in patients who are adequately trained to use their inhalation device. This conclusion was based on two small clinical trials that only examined objective measures of lung function. Since then, additional studies have found that maintenance therapy administered by nebulizers could improve patients’ reported feelings of symptom relief, quality of life, and satisfaction with treatment, compared to therapy administered by inhalers. Because it has been 15 years since the publication of the systematic review, in this article we summarize the results of studies that compared the effectiveness of inhalers with that of nebulizers in patients with stable COPD and discuss their implications for clinical practice and need for future research.

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“…This is due to the fact that, DPIs and pMDIs are breath-actuated and therefore not compatible with animal exposure; whereas for nebulizers modifications are needed in line with the animal model adopted. Thus, our manuscript, which focuses on the potential reduction and replacement of animals studies in OID development, does not discuss the impact of inhalers' performance on the effectiveness of inhalation therapies [34], a current challenge discussed in detail elsewhere [35][36][37][38][39][40][41][42][43][44].…”

Section: Inhalation Therapymentioning

confidence: 99%

Preclinical Development of Orally Inhaled Drugs (OIDs)—Are Animal Models Predictive or Shall We Move Towards In Vitro Non-Animal Models?

Movia

Prina-Mello

2020

Animals

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Respiratory diseases constitute a huge burden in our society, and the global respiratory drug market currently grows at an annual rate between 4% and 6%. Inhalation is the preferred administration method for treating respiratory diseases, as it: (i) delivers the drug directly at the site of action, resulting in a rapid onset; (ii) is painless, thus improving patients’ compliance; and (iii) avoids first-pass metabolism reducing systemic side effects. Inhalation occurs through the mouth, with the drug generally exerting its therapeutic action in the lungs. In the most recent years, orally inhaled drugs (OIDs) have found application also in the treatment of systemic diseases. OIDs development, however, currently suffers of an overall attrition rate of around 70%, meaning that seven out of 10 new drug candidates fail to reach the clinic. Our commentary focuses on the reasons behind the poor OIDs translation into clinical products for the treatment of respiratory and systemic diseases, with particular emphasis on the parameters affecting the predictive value of animal preclinical tests. We then review the current advances in overcoming the limitation of animal animal-based studies through the development and adoption of in vitro, cell-based new approach methodologies (NAMs).

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Device use errors with soft mist inhalers: A global systematic literature review and meta-analysis

Cited by 29 publications

References 74 publications

Assessment of Patient Experiences with Respimat® in Everyday Clinical Practice

Assessment of Patient Experiences with Respimat® in Everyday Clinical Practice

Maintenance Therapy with Nebulizers in Patients with Stable COPD: Need for Reevaluation

Preclinical Development of Orally Inhaled Drugs (OIDs)—Are Animal Models Predictive or Shall We Move Towards In Vitro Non-Animal Models?

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