Albuterol treatment for children with asthma: A comparison of inhaled powder and aerosol

Kemp, James P.; Furukawa, C.T.; Bronsky, Edwin A.; Grossman, Jay; Lemanske, Robert F.; Mansfield, L E; Murphy, S.; Ratner, Paul H.; Reese, Marshall E.; Rogenes, Paula R.; Spector, Sheldon L.; Tinkelman, David G.

doi:10.1016/0091-6749(89)90085-7

Cited by 25 publications

(8 citation statements)

References 11 publications

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“…AS MDI and Proventil were well tolerated; safety findings were consistent with the known safety profile for albuterol [6,9,10]. Overall, the incidence of TEAEs was low across treatment groups, with no dose-related trends (Table 8).…”

Section: Antorasupporting

confidence: 69%

Dose-Ranging and Cumulative Dose Studies of Albuterol Sulfate MDI in Co-Suspension Delivery™ Technology (AS MDI; PT007) in Patients with Asthma: the ASPEN and ANTORA Trials

et al. 2021

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Background and Objectives Co-suspension Delivery™ Technology has been developed for the administration of albuterol sulfate pressurised inhalation suspension via metered-dose inhaler (AS MDI, PT007). We assessed the efficacy and safety of AS MDI versus Proventil ® in order to determine the optimal dose of AS MDI to take to Phase III clinical trials. Methods ASPEN (NCT03371459) and ANTORA (NCT03364608) were Phase II, randomised, crossover, multicentre studies of AS MDI versus Proventil ® in patients with persistent asthma. In ASPEN, 46 patients received cumulative-dose treatments (90 μg/inhalation using 1 + 1 + 2 + 4 + 8 inhalations at 30-minute intervals) in 1 of 2 possible sequences: AS MDI/Proventil or Proventil/AS MDI. In ANTORA, 86 patients were randomised to one of 10 treatment sequences of AS MDI (90 μg or 180 μg), placebo MDI, or Proventil (90 μg or 180 μg). The primary endpoints were baseline-adjusted forced expiratory volume in 1 second (FEV 1 ) 30 minutes after each cumulative dose (ASPEN) and change from baseline in FEV 1 area under the curve from 0 to 6 h (ANTORA). Safety was assessed in both studies. Results In ASPEN, AS MDI was equivalent to Proventil (within pre-specified bounds of ± 200 mL) following cumulative doses of albuterol up to 1440 μg for the primary endpoint. In ANTORA, 90 μg and 180 μg doses of AS MDI and Proventil were significantly superior to placebo MDI (p < 0.0001), and AS MDI was non-inferior to Proventil at both doses, based on a margin of 100 mL. No new safety concerns were identified. ConclusionThe effects of albuterol delivered via AS MDI and Proventil on bronchodilation were equivalent, supporting the selection of AS MDI 180 µg to be taken into Phase III clinical trials, either alone or in combination with an inhaled corticosteroid. Trial Registration number ASPEN (NCT03371459); Date of registration: 29/12/2017. ANTORA (NCT03364608); Date of registration: 15/12/2017.

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Section: Antorasupporting

confidence: 69%

Dose-Ranging and Cumulative Dose Studies of Albuterol Sulfate MDI in Co-Suspension Delivery™ Technology (AS MDI; PT007) in Patients with Asthma: the ASPEN and ANTORA Trials

et al. 2021

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“…No significant difference was found in the following measured outcomes: FEV 1 , FVC, FEF 25-75% , PEFR, HR, BP, dropout rate or asthma symptom scores. In the long-term study 81 (12 weeks), the number of acute exacerbations requiring medical intervention was significantly higher in the pMDI group.…”

Section: Review B: Delivery Of ß 2 -Agonist Bronchodilators From the mentioning

confidence: 90%

“…Ahlström and colleagues 80 reported significantly (p = 0.046) higher morning PEFR values in comparison with the pMDI group; however, the baseline evening PEFR was significantly (p = 0.03) higher in the Turbuhaler group compared with the pMDI group. Two studies 81,82 compared the pMDI with the Rotahaler. No significant difference was found in the following measured outcomes: FEV 1 , FVC, FEF 25-75% , PEFR, HR, BP, dropout rate or asthma symptom scores.…”

Section: Review B: Delivery Of ß 2 -Agonist Bronchodilators From the mentioning

confidence: 99%

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Comparison of the effectiveness of inhaler devices in asthma and chronic obstructive airways disease: a systematic review of the literature

Brocklebank

Ram

Wright

et al. 2001

Health Technol Assess

353

197

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et al. Comparison of the effectiveness of inhaler devices in asthma and chronic obstructive airways disease: a systematic review of the literature. Health Technol Assess 2001;5(26). Health Technology Assessment is indexed in Index Medicus/MEDLINE and Excerpta Medica/ EMBASE. Copies of the Executive Summaries are available from the NCCHTA website (see opposite). NHS R&D HTA Programme T he NHS R&D Health Technology Assessment (HTA) Programme was set up in 1993 to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and provide care in the NHS. Initially, six HTA panels (pharmaceuticals, acute sector, primary and community care, diagnostics and imaging, population screening, methodology) helped to set the research priorities for the HTA Programme. However, during the past few years there have been a number of changes in and around NHS R&D, such as the establishment of the National Institute for Clinical Excellence (NICE) and the creation of three new research programmes: Service Delivery and Organisation (SDO); New and Emerging Applications of Technology (NEAT); and the Methodology Programme. This has meant that the HTA panels can now focus more explicitly on health technologies ('health technologies' are broadly defined to include all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care) rather than settings of care. Therefore the panel structure has been redefined and replaced by three new panels: Pharmaceuticals; Therapeutic Procedures (including devices and operations); and Diagnostic Technologies and Screening. The HTA Programme will continue to commission both primary and secondary research. The HTA Commissioning Board, supported by the National Coordinating Centre for Health Technology Assessment (NCCHTA), will consider and advise the Programme Director on the best research projects to pursue in order to address the research priorities identified by the three HTA panels. The research reported in this monograph was funded as project number 97/23/02. The views expressed in this publication are those of the authors and not necessarily those of the HTA Programme or the Department of Health. The editors wish to emphasise that funding and publication of this research by the NHS should not be taken as implicit support for any recommendations made by the authors. Criteria for inclusion in the HTA monograph series Reports are published in the HTA monograph series if (1) they have resulted from work commissioned for the HTA Programme, and (2) they are of a sufficiently high scientific quality as assessed by the referees and editors. Reviews in Health Technology Assessment are termed 'systematic' when the account of the search, appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others.

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“…Ideally, dose-response curves should have been used, but this is not feasible in young children. Nevertheless, a number of studies in children and adults with stable asthma have demonstrated up to 20% improvement in forced expiratory flow volumes on spirometry with salbutamol doses of 100 mg [26] and 200 mg [27,28]. Besides, studies that have investigated the effect of bronchodilation on sRaw in young children have demonstrated reversibility with 500 mg of inhaled terbutaline (equivalent to 200 mg of salbutamol) [25,29].…”

Section: Bronchodilator Reversibilitymentioning

confidence: 99%

Repeatability and bronchodilator reversibility of lung function in young children

et al. 2012

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Knowledge of short-and longer-term repeatability of lung function in health and disease is essential to determine bronchodilator reversibility thresholds and to recognise if changes in lung function represent disease progression, therapeutic intervention or normal variability.Multiple-breath washout indices (lung clearance index, conductive ventilation inhomogeneity (Scond)) and specific airway resistance (sRaw) were measured in healthy children and stable wheezers. Measurements were performed at baseline and after 20 min without intervention to assess repeatability and determine bronchodilator reversibility thresholds. Bronchodilator reversibility was assessed by repeating baseline measurements 20 min after inhaled salbutamol. 28 healthy controls, mean¡SD age 6.1¡0.7 years and 62 wheezers 5.4¡0.6 years were tested. Baseline variability in multiple-breath washout indices and sRaw was not significantly different between wheezers and healthy controls. Significant bronchodilator reversibility was only observed in wheezers for Scond (16%), but in both wheezers (37%) and healthy controls (20%) for sRaw. Some wheezers and healthy controls demonstrated increases in multiple-breath washout indices post-bronchodilator.Lung clearance index and sRaw demonstrate low baseline variability in healthy and diseased subjects. Neither multiple-breath washout indices nor sRaw are ideal for assessing bronchodilator reversibility in young children with stable wheeze. These findings will help to interpret the effect of therapeutic interventions in children with respiratory diseases. @ERSpublications Multiple-breath washout indices and sRaw do not reflect bronchodilator reversibility in young children with stable wheeze

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Albuterol treatment for children with asthma: A comparison of inhaled powder and aerosol

Cited by 25 publications

References 11 publications

Dose-Ranging and Cumulative Dose Studies of Albuterol Sulfate MDI in Co-Suspension Delivery™ Technology (AS MDI; PT007) in Patients with Asthma: the ASPEN and ANTORA Trials

Dose-Ranging and Cumulative Dose Studies of Albuterol Sulfate MDI in Co-Suspension Delivery™ Technology (AS MDI; PT007) in Patients with Asthma: the ASPEN and ANTORA Trials

Comparison of the effectiveness of inhaler devices in asthma and chronic obstructive airways disease: a systematic review of the literature

Repeatability and bronchodilator reversibility of lung function in young children

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