ArticleJournal of aerosol medicine and pulmonary drug delivery2014
Evaluation of in vitro and in vivo flow rate dependency of budesonide/formoterol Easyhaler(®).
Article in Journal of aerosol medicine and pulmonary drug delivery, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
20 citing papers in PubMed.
- In Vitro Flow Rate Dependency of Delivered Dose and Fine Particle Dose of Salmeterol/Fluticasone Propionate Easyhaler and Seretide Diskus with Patient Flow Rates Collected in a Randomized Controlled Trial.Journal of aerosol medicine and pulmonary drug delivery · 2019Trial
- Equivalent Lung Dose and Systemic Exposure of Budesonide/Formoterol Combination via Easyhaler and Turbuhaler.Journal of aerosol medicine and pulmonary drug delivery · 2015Trial
- Inspiratory Flow Parameters Through Dry Powder Inhalers in Healthy Volunteers and Patients with Chronic Obstructive Pulmonary Disease (COPD): Device Resistance Does Not Limit Use in COPD.International journal of chronic obstructive pulmonary diseaseTrial
- Peak Inspiratory Flow Capability for Simulated Dry Powder Inhaler Resistances in Asthma Patients Prescribed Pressurized Metered-Dose Inhalers with Valved Holding Chambers: The USE-DPI Study.Journal of clinical medicine · 2026Article
- Inspiratory Profiles Through Easyhaler Dry Powder Inhaler During Acute Bronchoconstriction.Journal of aerosol medicine and pulmonary drug delivery · 2025Article
- Scale-Up and Postapproval Changes in Orally Inhaled Drug Products: Scientific and Regulatory Considerations.Journal of aerosol medicine and pulmonary drug delivery · 2025Review
- The effect of exhalation before the inhalation of dry powder aerosol drugs on the breathing parameters, emitted doses and aerosol size distributions.International journal of pharmaceutics: X · 2023Article
- Inhalable Nanoparticle-based Dry Powder Formulations for Respiratory Diseases: Challenges and Strategies for Translational Research.AAPS PharmSciTech · 2023Review
- Switching to the Dry-Powder Inhaler EasyhalerPulmonary therapy · 2021Review
- Patients with asthma or chronic obstructive pulmonary disease (COPD) can generate sufficient inspiratory flows via EasyhalerJournal of thoracic disease · 2021Article
- Patient Inspiratory Maneuver Performance; Peak Lungpower, Acceleration and Volume.Journal of aerosol medicine and pulmonary drug delivery · 2020Article
- Effectiveness and Patient Satisfaction with Budesonide/Formoterol EasyhalerPulmonary therapy · 2019Article
- Understanding Dry Powder Inhalers: Key Technical and Patient Preference Attributes.Advances in therapy · 2019Review
- A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol TurbuhalerAdvances in therapy · 2019Observational
- EasyhalerDrugs in context · 2019Review
- Dose uniformity of budesonide Easyhaler® under simulated real-life conditions and with low inspiration flow rates.Chronic respiratory disease · 2018Article
- Clinical Effectiveness of Budesonide/Formoterol Fumarate EasyhalerAdvances in therapy · 2018Observational
- Routine Use of Budesonide/Formoterol Fixed Dose Combination in Elderly Asthmatic Patients: Practical Considerations.Drugs & aging · 2017Review
- Measuring Peak Inspiratory Flow in Patients with Chronic Obstructive Pulmonary Disease.International journal of chronic obstructive pulmonary diseaseReview
- What to consider before prescribing inhaled medications: a pragmatic approach for evaluating the current inhaler landscape.Therapeutic advances in respiratory diseaseReview
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Easyhaler(®) (EH) device-metered dry powder inhaler containing budesonide and formoterol is being developed for asthma and chronic obstructive pulmonary disease (COPD). As a part of product optimization, a series of in vitro and in vivo studies on flow rate dependency were carried out.
methodsInspiratory flow parameters via EH and Symbicort(®) Turbuhaler(®) (TH) inhalers were evaluated in 187 patients with asthma and COPD. The 10(th), 50(th), and 90(th) percentile flow rates achieved by patients were utilized to study in vitro flow rate dependency of budesonide/formoterol EH and Symbicort TH. In addition, an exploratory pharmacokinetic study on pulmonary deposition of active substances for budesonide/formoterol EH in healthy volunteers was performed.
resultsMean inspiratory flow rates through EH were 64 and 56 L/min in asthmatics and COPD patients, and through TH 79 and 72 L/min, respectively. Children with asthma had marginally lower PIF values than the adults. The inspiratory volumes were similar in all groups between the inhalers. Using weighted 10(th), 50(th), and 90(th) percentile flows the in vitro delivered doses (DDs) and fine particle doses (FPDs) for EH were rather independent of flow as 98% of the median flow DDs and 89%-93% of FPDs were delivered already at 10(th) percentile air flow. Using±15% limits, EH and TH had similar flow rate dependency profiles between 10(th) and 90(th) percentile flows. The pharmacokinetic study with budesonide/formoterol EH in healthy subjects (n=16) revealed a trend for a flow-dependent increase in lung deposition for both budesonide and formoterol.
conclusionsComparable in vitro flow rate dependency between budesonide/formoterol EH and Symbicort TH was found using the range of clinically relevant flow rates. The results of the pharmacokinetic study were in accordance with the in vitro results showing only a trend of flow rate-dependant increase in lung deposition of active substances with EH.
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