Efficacy and safety of ipratropium bromide plus fenoterol inhaled via Respimat® Soft Mist™ Inhaler vs. a conventional metered dose inhaler plus spacer in children with asthma

Berg, Andrea von; Jeena, Prakash; Soemantri, Peter A.; Vertruyen, André; Schmidt, Peter; Gerken, Fronke; Razzouk, H

doi:10.1002/ppul.10428

Cited by 33 publications

(12 citation statements)

References 18 publications

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“…This review focused on identifying the prevalence of the use of different measures for defining asthma exacerbations, as well as the supporting evidence base. A total of 15 NIH-funded studies 18, 20–27, 30, 31, 33, 35–37 and 5 phase III industry-sponsored studies 11, 13, 15–17 was identified that included children aged 5–11 years (with some variation in upper and lower age limits). Six additional studies included children aged 5–11 years together with adolescents.…”

Section: Specific Issues Related To Exacerbations As An Asthma Outcommentioning

confidence: 99%

Asthma outcomes: Exacerbations

Fuhlbrigge

Peden

Apter

et al. 2012

Journal of Allergy and Clinical Immunology

268

203

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Background The goals of asthma treatment include preventing recurrent exacerbations. Yet there is no consensus about the terminology for describing or defining “exacerbation,” or about how to characterize an episode’s severity. Objective National Institutes of Health (NIH) institutes and other federal agencies convened an expert group to propose how asthma exacerbation should be assessed as a standardized asthma outcome in future asthma clinical research studies. Methods We utilized comprehensive literature reviews and expert opinion to compile a list of asthma exacerbation outcomes, and classified them as either core (required in future studies), supplemental (used according to study aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011. Results No dominant definition of “exacerbation” was found. The most widely used definitions included 3 components, all related to treatment, rather than symptoms: (1) systemic use of corticosteroids, (2) asthma-specific emergency department visits or hospitalization, and (3) use of short-acting β-agonists (SABAs) as quick-relief (sometimes referred to as “rescue” or “reliever”) medications. Conclusions The working group participants propose that the definition of “asthma exacerbation” be “a worsening of asthma requiring the use of systemic corticosteroids to prevent a serious outcome.” As core outcomes, they propose inclusion and separate reporting of several essential variables of an exacerbation. Further, they propose the development of a standardized, component-based definition of “exacerbation” with clear thresholds of severity for each component.

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Section: Specific Issues Related To Exacerbations As An Asthma Outcommentioning

confidence: 99%

Asthma outcomes: Exacerbations

Fuhlbrigge

Peden

Apter

et al. 2012

Journal of Allergy and Clinical Immunology

268

203

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“…The cumulative dose study in adults with asthma (Kunkel et al 2000) concluded that IB/FEN delivered by Respimat was as effective as the CFC-pMDI at half the cumulative dose. Two Phase III studies were done comparing IB/FEN via Respimat and CFC-pMDI in adults and children with asthma (Vincken et al 2004; von Berg et al 2004). These studies concluded that delivery by Respimat instead of a CFC-pMDI allows a two- to four-fold reduction in dosage of IB/FEN while achieving similar efficacy.…”

Section: Effectiveness and Safety Of Devicementioning

confidence: 99%

Use of Respimat� Soft Mist? Inhaler in COPD patients

Anderson¹

2006

International Journal of COPD

100

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Events of the past decade have stimulated development of new drug formulations and delivery devices that have improved the efficiency, ease of use, and environmental impact of inhaled drug therapy. Respimat® Soft Mist™ Inhaler is a novel, multidose, propellant-free, hand-held, liquid inhaler that represents a new category of inhaler devices. The aerosol cloud generated by Respimat contains a higher fraction of fine particles than most pressurized metered dose inhalers (pMDIs) and dry powder inhalers (DPIs), and the aerosol spray exits the inhaler more slowly and for a longer duration than with pMDIs. This translates into higher lung drug deposition and lower oropharyngeal deposition, making it possible to give lower nominal doses of delivered drugs without lowering efficacy. In clinical trials in patients with COPD, bronchodilator drugs delivered from Respimat were equally effective at half of the dose delivered from a pMDI. In one study of inhaler preference, Respimat was preferred over the pMDI by patients with COPD and other obstructive lung diseases. Respimat is a valuable addition to the range of inhaler devices available to the patient with COPD.

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“…These characteristics allow a higher proportion of the emitted dose to be delivered to the lungs than with pMDIs [11]. Bronchodilators delivered via Respimat SMI have proven clinical efficacy and safety in patients with asthma or chronic obstructive pulmonary disease (COPD) [12,13,14]. …”

Section: Introductionmentioning

confidence: 99%

Inhaled Ethanolic and Aqueous Solutions via Respimat Soft Mist Inhaler Are Well-Tolerated in Asthma Patients

Patel

Pavia²,

Lowe³

et al. 2006

Respiration

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Background: Respimat^® Soft Mist^™ Inhaler (SMI) is a new-generation inhaler offering improved lung deposition compared with other devices. Bronchodilators administered via Respimat SMI are preserved and stabilized with benzalkonium chloride (BAC) and ethylene diamine tetra-acetic acid (EDTA); both have been reported to cause paradoxical bronchoconstriction if a threshold dose is exceeded. Objective: The aim of this randomized, double-blind, three-period, crossover study was to establish that the safety of inhaled ethanolic and aqueous placebo solutions (containing BAC and EDTA) is equivalent to that of inhaled normal saline solution when administered to asthma patients via Respimat SMI. Methods: Thirty-seven asthma patients with airway hyper-reactivity were randomized to receive four actuations of each of the following three treatments via Respimat SMI, one on each of 3 study days: ethanolic placebo (12 µl 96% ethanol + 0.13 µg EDTA/actuation), aqueous placebo (12 µl water + 5.5 µg EDTA + 1.1 µg BAC/actuation), and normal saline (12 µl 0.9% sodium chloride/actuation). Pulmonary function tests were performed at baseline and at 5, 15, 30, 60, 120 and 180 min after inhalation; the primary endpoint was the lowest FEV₁ recorded between 0 and 30 min. Results: The mean lowest FEV₁ recorded between 0 and 30 min after inhalation minus the study day baseline was –0.090 litres for ethanolic placebo, –0.121 litres for aqueous placebo and –0.094 litres for normal saline (SEM 0.034 litres for all). The mean treatment differences were: ethanolic placebo versus normal saline 0.004 litres (90% CI –0.075–0.083 litres, p = 0.002), and aqueous placebo versus normal saline –0.028 litres (90% CI –0.107–0.052 litres, p = 0.006). Since both 90% CIs fell within the pre-determined equivalence region of ±0.15 litres, both treatments were considered equivalent to normal saline. Conclusion: Ethanolic and aqueous solutions administered via Respimat SMI are safe with regard to paradoxical bronchoconstriction in asthma patients with airway hyper-reactivity.

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Efficacy and safety of ipratropium bromide plus fenoterol inhaled via Respimat® Soft Mist™ Inhaler vs. a conventional metered dose inhaler plus spacer in children with asthma

Cited by 33 publications

References 18 publications

Asthma outcomes: Exacerbations

Asthma outcomes: Exacerbations

Use of Respimat� Soft Mist? Inhaler in COPD patients

Inhaled Ethanolic and Aqueous Solutions via Respimat Soft Mist Inhaler Are Well-Tolerated in Asthma Patients

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