Abstract：
:The present study aimed at assessing the pharmacokinetics (PK) and safety pharmacodynamics (PD) of 24 microg formoterol delivered via a Novolizer and via an Aerolizer in healthy subjects. This was a randomized, open-label, crossover study. Beside PK, serum potassium, and glucose profiles, vital signs, and ECG were recorded. Twenty-nine subjects (15 males) were enrolled. The inhalation maneuver had to be repeated by 19 subjects using the Aerolizer and 1 subject using a Novolizer. While eight (28%) subjects completely failed to inhale correctly via the Aerolizer (four were identified by the investigators immediately after inhalation, another four by bioanalytics later), all did it correctly via the Novolizer. The bioanalytical evaluation indicated two distinct serum peaks. The shapes of serum concentration-time profiles were more homogeneous after inhaling via the Novolizer than via the Aerolizer. After adjusting for the delivered dose the Cmax of formoterol predicting pulmonary absorption was higher after the Novolizer than after the Aerolizer, while the average AUC0-infinity levels indicating total systemic exposure were equivalent. There was no evidence for different pharmacodynamic behavior with respect to serum potassium and glucose profiles, vital signs, and ECG. The Novolizer yields higher pulmonary absorption of formoterol than the Aerolizer and equivalent safety profiles. Considering the lower variability of PK profiles and the higher proportion of correct inhalations, formoterol is more reliably inhaled via Novolizer.
journal_name
J Aerosol Med Pulm Drug Delivjournal_title
Journal of aerosol medicine and pulmonary drug deliveryauthors
Petzold U,Kremer HJ,Nguyen DT,Munzel U,Dietrich H,Maus Jdoi
10.1089/jamp.2008.0690subject
Has Abstractpub_date
2008-09-01 00:00:00pages
309-19issue
3eissn
1941-2711issn
1941-2703journal_volume
21pub_type
杂志文章,随机对照试验abstract：BACKGROUND:The site of deposition in the respiratory tract for aerosolized, inhaled therapeutic drugs depends on both the particles' aerodynamic size and the patient's breathing pattern. METHODS:In 21 healthy subjects with normal lung function, we evaluated an extremely slow inhalation of a large 9.5-μm MMAD particle ...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2008.0711
更新日期：2010-12-01 00:00:00
abstract：:Exhaled breath condensate (EBC) consists mainly of water, but also contains semivolatile and nonvolatile compounds. The aim of this study was to develop a system in which two condensers are simultaneously used in series to clarify the mechanisms of EBC condensation. Two aliquots of EBC (EBC1 and EBC2) were collected f...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2007.0644
更新日期：2008-03-01 00:00:00
abstract：BACKGROUND:Currently bronchial provocation testing (BPT) using mannitol powder cannot be performed in children under 6 years. A primary reason is it is challenging for children at this age to generate a consistent inspiratory effort to inhale mannitol efficiently from a dry powder inhaler. A prototype system, which doe...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2015.1208
更新日期：2015-12-01 00:00:00
abstract：BACKGROUND:Small rodents continue to be the mainstay for the assessment of pharmacological and toxicological data of inhaled therapeutics. For meaningful interpretation of the results information about deposition of aerosol particles in the respiratory tract is warranted, but not trivial to obtain for animals with nose...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2011.0902
更新日期：2012-06-01 00:00:00
abstract：: Background: Inhalation of medications is the cornerstone in the treatment of patients with lung diseases. A variety of inhalation devices exists and each device has specific requirements to achieve optimum inhalation of the drug. The goal of this study was to establish a c...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2017.1376
更新日期：2018-12-01 00:00:00
abstract：BACKGROUND:Researchers, using checklists, have identified that 30%-90% of patients make errors in inhaler use. It is not certain whether these errors affect the delivery of medication. We have developed an electronic monitor (INCA™) that records audio each time an inhaler is used, providing objective information on inh...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2016.1334
更新日期：2017-08-01 00:00:00
abstract：:This article provides a concise review of the use of magnetic resonance imaging (MRI) for measurement of regional aerosol deposition in the lungs. Basic aspects of MRI and its use in lung imaging and measurement of regional ventilation are introduced. Imaging of hydrogen protons (water) and inhaled hyperpolarized gase...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章,评审
doi：10.1089/jamp.2011.0897
更新日期：2012-04-01 00:00:00
abstract：BACKGROUND:Model predictions of regional deposition in the respiratory tract are useful in assessing factors that influence the effectiveness of aerosol delivery. Regional deposition models have previously been coupled with models of mucous production and clearance to estimate initial concentrations of drug deposited i...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2017.1377
更新日期：2018-02-01 00:00:00
abstract：: Background: Salvia miltiorrhiza polyphenolic acid (SMPA) is effective in the treatment of cardiovascular diseases and currently it is administered orally or intravenously. However, SMPA is poorly absorbed orally and quickly eliminated in vivo. A long-term frequent intraveno...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2019.1538
更新日期：2020-04-01 00:00:00
abstract：BACKGROUND:Vitamin A (VA) is crucial for lung growth and development. In premature infants, inadequate VA levels are associated with an increased risk of bronchopulmonary dysplasia (BPD). Intramuscular VA supplementation has been shown to decrease the incidence of BPD, but is not widely used in the clinical setting due...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2017.1438
更新日期：2018-12-01 00:00:00
abstract：:The available toxicity data of benzalkonium chloride (BKC) clearly shows that it is toxic; however, the weight of evidence favors the view that at doses encountered in nasally and orally inhaled pharmaceutical preparations it is well tolerated. The adverse toxicological data predominantly come from in vitro and animal...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章,评审
doi：10.1089/jamp.2017.1390
更新日期：2018-02-01 00:00:00
abstract：BACKGROUND:Understanding the regional partition of deposition of inhaled particles within the lung is important for improving targeted delivery of inhaled aerosolized drugs. One factor affecting regional deposition is gravity. As the lung deforms under its own weight, changes in lung volume, in airway geometries, and i...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2014.1189
更新日期：2015-12-01 00:00:00
abstract：BACKGROUND:Mechanically ventilated patients commonly suffer from ventilator-associated pneumonia, hypoxemia, and other lower respiratory tract infection as a result of pathogen colonization and poor sputum clearance. Consequently, there is a high rate of morbidity and mortality in these patients. Dry powder mannitol in...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2016.1320
更新日期：2017-04-01 00:00:00
abstract：BACKGROUND:Inhaled alpha1-antitrypsin (AAT) is being developed for treatment of cystic fibrosis to protect the lungs from excessive free elastase. High drug costs mandate a very efficient aerosol system to deliver a high payload to the airways. The I-neb Adaptive Aerosol Delivery (AAD) System is a portable, electronic,...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2009.0793
更新日期：2010-04-01 00:00:00
abstract：BACKGROUND:Remote inhaler monitoring is an emerging technology that enables the healthcare team to monitor the time and location of a patient's inhaler use. We assessed the feasibility of remote inhaler monitoring for chronic obstructive pulmonary disease (COPD) patients and the pattern of albuterol inhaler use associa...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2017.1383
更新日期：2018-06-01 00:00:00
abstract：BACKGROUND:Particle size and velocity are two of the most significant factors that impact the deposition of pressurized metered-dose inhaler (pMDI) sprays in the mouth cavity. pMDIs are prominently used around the world in the treatment of patients suffering from a variety of lung diseases such as asthma and chronic ob...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2015.1264
更新日期：2016-12-01 00:00:00
abstract：BACKGROUND:The effectiveness of metered-dose inhalers (MDIs) in delivering medication to the lungs highly depends on its correct usage technique. Current guidelines state optimal technique for high lung deposition should include a slow inhalation (>5 seconds) at an inspiratory flow rate of 30 L/min and inhaler actuatio...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2015.1278
更新日期：2017-08-01 00:00:00
abstract：BACKGROUND:The unit dose dry powder inhaler (UD-DPI) is being considered as an alternative inhaler platform that, if developed, has the potential to improve access to inhaled respiratory medicines in developing countries. AIM:This study compared the systemic exposure of fluticasone furoate after delivery from the UD-D...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章,随机对照试验
doi：10.1089/jamp.2016.1322
更新日期：2017-10-01 00:00:00
abstract：BACKGROUND:To validate the 'Test of Adherence to Inhalers' (TAI), a 12-item questionnaire designed to assess the adherence to inhalers in patients with COPD or asthma. METHODS:A total of 1009 patients with asthma or COPD participated in a cross-sectional multicenter study. Patients with electronic adherence ≥80% were ...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章,多中心研究
doi：10.1089/jamp.2015.1212
更新日期：2016-04-01 00:00:00
abstract：BACKGROUND:Dyspnea significantly impacts quality of life and is one of the most common symptoms in advanced illness. Systemically-administered opioids and benzodiazepines have been the most studied and utilized pharmacologic treatments for refractory dyspnea. Less attention has been given to the use of these medication...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章,评审
doi：10.1089/jamp.2014.1136
更新日期：2015-02-01 00:00:00
abstract：BACKGROUND:Programmed cell death 4 (PDCD4), a protein that binds to eukaryotic initiation factor 4A (eIF4A), inhibits the initiation of translation. Although a number of tumor suppressors target transcription, Pdcd4 is the first suppressor targeting protein translation, and has also been suggested to function as a tumo...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2009.0778
更新日期：2010-10-01 00:00:00
abstract：:Flexhaler is a multiple-dose, inspiratory flow-driven dry powder inhaler that is a newer version of Turbuhaler, and is identical to the Symbicort Turbuhaler. Sustained performance is of the utmost importance to ensure consistent drug delivery throughout the lifespan of the inhaler. We report functionality testing resu...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2008.0700
更新日期：2008-12-01 00:00:00
abstract：BACKGROUND:Secondary lung infections are the primary cause of morbidity associated with cystic fibrosis lung disease. Aerosolized antibiotic inhalation is potentially advantageous but has limited effectiveness due to altered airway aerodynamics and deposition patterns that limit drug access to infected regions. One pot...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2017.1412
更新日期：2018-08-01 00:00:00
abstract：BACKGROUND:The delivery of antitubercular drugs through direct lung targeting can lead to reduction in the dose as well as side effects of the drug. In the present investigation, carrier (lactose)-based dry-powder inhaler of rifampicin was prepared to achieve direct targeting of the drug into the lungs. METHODS:The dr...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2017.1379
更新日期：2017-12-01 00:00:00
abstract：:The success of inhalation therapy is not only dependent upon the pharmacology of the drugs being inhaled but also upon the site and extent of deposition in the respiratory tract. Similarly, the toxicity of environmental and industrial particulate matter is affected not only by the nature of the dust but also by the am...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2020.29029.cd
更新日期：2020-08-01 00:00:00
abstract：BACKGROUND:High flow nasal cannula oxygen therapy (HFT) is increasingly used in intensive and emergency care departments. Patients suffering from respiratory failure, who are likely to benefit from HFT, may require aerosolized bronchodilators; therefore, combining nebulization with HFT may be relevant. This study aimed...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2015.1219
更新日期：2016-04-01 00:00:00
abstract：PURPOSE:The objective of this study was to determine optimal aerosol delivery conditions for a full-term (3.6 kg) infant receiving invasive mechanical ventilation by evaluating the effects of aerosol particle size, a new wye connector, and timing of aerosol delivery. METHODS:In vitro experiments used a vibrating mesh ...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2013.1077
更新日期：2014-10-01 00:00:00
abstract：BACKGROUND:Predicting local lung tissue pharmacodynamic (PD) responses of inhaled drugs is a longstanding challenge related to the lack of experimental techniques to determine local free drug concentrations. This has prompted the use of physiologically based pharmacokinetic (PBPK) modeling to potentially predict local ...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2017.1436
更新日期：2019-02-01 00:00:00
abstract：: Background: The photo reflection method (PRM) is used to measure light reflected from particles released from dry powder inhalers (DPIs). This simple method depicts time trajectories of released drugs; however, it underestimates the number of particles at high peak inhalat...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2020.1610
更新日期：2020-11-04 00:00:00
abstract：PURPOSE:Many methods have been developed to evaluate dry powder inhalation techniques and their efficiency for disease control in asthma patients. However, it is difficult to apply these methods to clinical practice and research. In this study, we introduce a simple new method that can be applied to dry powder inhalati...
journal_title：Journal of aerosol medicine and pulmonary drug delivery
pub_type： 杂志文章
doi：10.1089/jamp.2014.1193
更新日期：2016-10-01 00:00:00
