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Asthma control in patients receiving inhaled corticosteroid and long-acting beta2-agonist fixed combinations. A real-life study comparing dry powder inhalers and a pressurized metered dose inhaler extrafine formulation
Veronika Müller, Gabriella Gálffy, Noemi Eszes, Gy?rgy Losonczy, Andrea Bizzi, Gabriele Nicolini, Henry Chrystyn, Lilla Tamási
BMC Pulmonary Medicine , 2011, DOI: 10.1186/1471-2466-11-40
Abstract: This real-life study had a cross-sectional design. Patients using fixed combinations of ICS and LABA had their asthma control and spirometry assessed during regular visits.111 patients were analyzed: 53 (47.7%) received maintenance therapy of extrafine beclomethasone-formoterol (BDP/F) pressurized metered dose inhaler (pMDI), 25 (22.5%) fluticasone-salmeterol (FP/S) dry powder inhaler (DPI), and 33 (29.7%) budesonide-formoterol (BUD/F) DPI. Severity of asthma at time of diagnosis, assessed by the treating physician, was comparable among groups. Asthma control was achieved by 45.9% of patients; 38.7% were partially controlled and 15.3% were uncontrolled. In the extrafine BDF/F group, asthma control total score, daytime symptom score and rescue medication use score were significantly better than those using fixed DPI combinations (5.8 ± 6.2 vs. 8.5 ± 6.8; 1.4 ± 1.8 vs. 2.3 ± 2.1; 1.8 ± 2.2 vs. 2.6 ± 2.2; p = 0.0160; p = 0.012 and p = 0.025, respectively) and the mean daily ICS dose were significantly lower.pMDI extrafine BDP/F combination demonstrated better asthma control compared to DPIs formulated with larger particles. This could be due to the improved lung deposition of the dose or less reliance on the optimal inhalation technique or both.While asthma represents a global public health issue due to high prevalence rates in the general population (ranging from 1% to 18% of the population in different Countries), several studies now indicate that the impact on public health is even more severe due to the difficulty in achieving full disease control with available therapies [1,2]. Indeed, achieving and maintaining asthma control is the major goal of asthma care. Based on the Global Initiative for Asthma (GINA) 2009 guidelines, asthma control can be assessed by taking into consideration different characteristics including daytime symptoms, nocturnal awakenings, need of rescue medication, limitation of physical activity, and lung function [2]. Randomized clinical trial
Onset of relief of dyspnoea with budesonide/formoterol or salbutamol following methacholine-induced severe bronchoconstriction in adults with asthma: a double-blind, placebo-controlled study
René E Jonkers, Theo A Bantje, René Aalbers
Respiratory Research , 2006, DOI: 10.1186/1465-9921-7-141
Abstract: In this randomised, double-blind, placebo-controlled, cross-over study, 32 patients with asthma underwent a methacholine provocation test leading to a fall in forced expiratory volume in 1 second (FEV1) of ≥30% at enrolment (Visit 1) and three subsequent study visits (Visits 2–4). Immediately after each provocation at Visits 2–4, patients received one of three test treatments: one inhalation of budesonide/formoterol 160/4.5 μg (via Turbuhaler?), two inhalations of salbutamol 100 μg (via a pressurised metered-dose inhaler [pMDI]) or placebo. All patients received each of the test treatments in a randomised order, after separate methacholine provocations. The effect of treatment on FEV1 and breathlessness (using the Borg scale) was measured at 1, 3, 5, 10, 15, 20, 25 and 30 minutes after test treatment.Following methacholine provocation, Borg score increased from a baseline value of below 0.5 to 3.03, 3.31 and 3.50 before treatment with budesonide/formoterol, salbutamol and placebo, respectively. Budesonide/formoterol and salbutamol reversed methacholine-induced dyspnoea (breathlessness) rapidly. At 1 minute after inhalation, statistically significant decreases in Borg score were observed for budesonide/formoterol and salbutamol (p = 0.0233 and p < 0.0001, respectively, versus placebo), with similar rapid increases in FEV1 (both active treatments p < 0.0001 versus placebo). The median time to 50% recovery in Borg score after methacholine provocation was 3 minutes with budesonide/formoterol, 2 minutes with salbutamol and 10 minutes with placebo. All treatments and procedures were well tolerated.Single doses of budesonide/formoterol and salbutamol both provided rapid relief of dyspnoea and reversal of severe airway obstruction in patients with asthma with experimentally induced bronchoconstriction. The perception of relief, as confirmed by objective lung function assessment, provides evidence that budesonide/formoterol can be used as reliever medication in asthma.For ma
Budesonide/formoterol combination in COPD: a US perspective
Amir Sharafkhaneh, Amarbir S Mattewal, Vinu M Abraham, et al
International Journal of Chronic Obstructive Pulmonary Disease , 2010, DOI: http://dx.doi.org/10.2147/COPD.S4215
Abstract: udesonide/formoterol combination in COPD: a US perspective Review (7382) Total Article Views Authors: Amir Sharafkhaneh, Amarbir S Mattewal, Vinu M Abraham, et al Published Date October 2010 Volume 2010:5 Pages 357 - 366 DOI: http://dx.doi.org/10.2147/COPD.S4215 Amir Sharafkhaneh1,2, Amarbir S Mattewal1, Vinu M Abraham1, Goutham Dronavalli1, Nicola A Hanania1 1Section of Pulmonary, Critical Care Medicine and Sleep Medicine, Department of Medicine, Baylor College of Medicine, Houston, Texas, USA; 2Section of Pulmonary, Critical Care Medicine and Sleep Medicine, Medical Care Line, Michael E DeBakey VA Medical Center, Houston, Texas, USA Abstract: Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease of the lung caused primarily by exposure to cigarette smoke. Clinically, it presents with progressive cough, sputum production, dyspnea, reduced exercise capacity, and diminished quality of life. Physiologically, it is characterized by the presence of partially reversible expiratory airflow limitation and hyperinflation. Pathologically, COPD is a multicomponent disease characterized by bronchial submucosal mucous gland hypertrophy, bronchiolar mucosal hyperplasia, increased luminal inflammatory mucus, airway wall inflammation and scarring, and alveolar wall damage and destruction. Management of COPD involves both pharmacological and nonpharmacological approaches. Bronchodilators and inhaled corticosteroids are recommended medications for management of COPD especially in more severe disease. Combination therapies containing these medications are now available for the chronic management of stable COPD. The US Food and Drug Administration, recently, approved the combination of budesonide/formoterol (160/4.5 μg; Symbicort , AstraZeneca, Sweden) delivered via a pressurized meter dose inhaler for maintenance management of stable COPD. The combination also is delivered via dry powder inhaler (Symbicort and Turbuhaler , AstraZeneca, Sweden) but is not approved for use in the United States. In this review, we evaluate available data of the efficacy and safety of this combination in patients with COPD.
Budesonide/formoterol combination in COPD: a US perspective  [cached]
Amir Sharafkhaneh,Amarbir S Mattewal,Vinu M Abraham,et al
International Journal of COPD , 2010,
Abstract: Amir Sharafkhaneh1,2, Amarbir S Mattewal1, Vinu M Abraham1, Goutham Dronavalli1, Nicola A Hanania11Section of Pulmonary, Critical Care Medicine and Sleep Medicine, Department of Medicine, Baylor College of Medicine, Houston, Texas, USA; 2Section of Pulmonary, Critical Care Medicine and Sleep Medicine, Medical Care Line, Michael E DeBakey VA Medical Center, Houston, Texas, USAAbstract: Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease of the lung caused primarily by exposure to cigarette smoke. Clinically, it presents with progressive cough, sputum production, dyspnea, reduced exercise capacity, and diminished quality of life. Physiologically, it is characterized by the presence of partially reversible expiratory airflow limitation and hyperinflation. Pathologically, COPD is a multicomponent disease characterized by bronchial submucosal mucous gland hypertrophy, bronchiolar mucosal hyperplasia, increased luminal inflammatory mucus, airway wall inflammation and scarring, and alveolar wall damage and destruction. Management of COPD involves both pharmacological and nonpharmacological approaches. Bronchodilators and inhaled corticosteroids are recommended medications for management of COPD especially in more severe disease. Combination therapies containing these medications are now available for the chronic management of stable COPD. The US Food and Drug Administration, recently, approved the combination of budesonide/formoterol (160/4.5 μg; Symbicort , AstraZeneca, Sweden) delivered via a pressurized meter dose inhaler for maintenance management of stable COPD. The combination also is delivered via dry powder inhaler (Symbicort and Turbuhaler , AstraZeneca, Sweden) but is not approved for use in the United States. In this review, we evaluate available data of the efficacy and safety of this combination in patients with COPD.Keywords: inhaled steroid, bronchodilator, 2-agonist, lung function, quality of life, COPD exacerbations
Comparison of the systemic bioavailability of mometasone furoate after oral inhalation from a mometasone furoate/formoterol fumarate metered-dose inhaler versus a mometasone furoate dry-powder inhaler in patients with chronic obstructive pulmonary disease
Kosoglou T, Hubbell J, Xuan F, Cutler DL, Meehan AG, Kantesaria B, Wittmer BA
International Journal of Chronic Obstructive Pulmonary Disease , 2013, DOI: http://dx.doi.org/10.2147/COPD.S36592
Abstract: mparison of the systemic bioavailability of mometasone furoate after oral inhalation from a mometasone furoate/formoterol fumarate metered-dose inhaler versus a mometasone furoate dry-powder inhaler in patients with chronic obstructive pulmonary disease Original Research (421) Total Article Views Authors: Kosoglou T, Hubbell J, Xuan F, Cutler DL, Meehan AG, Kantesaria B, Wittmer BA Published Date March 2013 Volume 2013:8 Pages 107 - 116 DOI: http://dx.doi.org/10.2147/COPD.S36592 Received: 01 August 2012 Accepted: 12 September 2012 Published: 07 March 2013 Teddy Kosoglou,1 James Hubbell,2 Fengjuan Xuan,3 David L Cutler,1 Alan G Meehan,4 Bhavna Kantesaria,5 Bret A Wittmer6, 1Clinical Pharmacology, 2Exploratory Drug Metabolism, 3Early Development Statistics, 4Medical Communications, 5Drug Metabolism/Pharmacokinetics, Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA; 6Commonwealth Biomedical Research, LLC, Madisonville, KY, USA Dr Bret A Wittmer passed away on May 9, 2012. Background: Coadministration of mometasone furoate (MF) and formoterol fumarate (F) produces additive effects for improving symptoms and lung function and reduces exacerbations in patients with asthma and chronic obstructive pulmonary disease (COPD). The present study assessed the relative systemic exposure to MF and characterized the pharmacokinetics of MF and formoterol in patients with COPD. Methods: This was a single-center, randomized, open-label, multiple-dose, three-period, three-treatment crossover study. The following three treatments were self-administered by patients (n = 14) with moderate-to-severe COPD: MF 400 μg/F 10 μg via a metered-dose inhaler (MF/F MDI; DULERA /ZENHALE ) without a spacer device, MF/F MDI with a spacer, or MF 400 μg via a dry-powder inhaler (DPI; ASMANEX TWISTHALER ) twice daily for 5 days. Plasma samples for MF and formoterol assay were obtained predose and at prespecified time points after the last (morning) dose on day 5 of each period of the crossover. The geometric mean ratio (GMR) as a percent and the corresponding 90% confidence intervals (CI) were calculated for treatment comparisons. Results: Systemic MF exposure was lower (GMR 77%; 90% CI 58, 102) following administration by MF/F MDI compared to MF DPI. Additionally, least squares geometric mean systemic exposures of MF and formoterol were lower (GMR 72%; 90% CI 61, 84) and (GMR 62%; 90% CI 52, 74), respectively, following administration by MF/F MDI in conjunction with a spacer compared to MF/F MDI without a spacer. MF/F MDI had a similar adverse experience profile as that seen with MF DPI. All adverse experiences were either mild or moderate in severity; no serious adverse experience was reported. Conclusion: Systemic MF exposures were lower following administration by MF/F MDI compared with MF DPI. Additionally, systemic MF and formoterol exposures were lower following administration by MF/F MDI with a spacer versus without a spacer. The magnitude of these differences with respe
Comparison of the systemic bioavailability of mometasone furoate after oral inhalation from a mometasone furoate/formoterol fumarate metered-dose inhaler versus a mometasone furoate dry-powder inhaler in patients with chronic obstructive pulmonary disease  [cached]
Kosoglou T,Hubbell J,Xuan F,Cutler DL
International Journal of COPD , 2013,
Abstract: Teddy Kosoglou,1 James Hubbell,2 Fengjuan Xuan,3 David L Cutler,1 Alan G Meehan,4 Bhavna Kantesaria,5 Bret A Wittmer6, 1Clinical Pharmacology, 2Exploratory Drug Metabolism, 3Early Development Statistics, 4Medical Communications, 5Drug Metabolism/Pharmacokinetics, Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA; 6Commonwealth Biomedical Research, LLC, Madisonville, KY, USA Dr Bret A Wittmer passed away on May 9, 2012.Background: Coadministration of mometasone furoate (MF) and formoterol fumarate (F) produces additive effects for improving symptoms and lung function and reduces exacerbations in patients with asthma and chronic obstructive pulmonary disease (COPD). The present study assessed the relative systemic exposure to MF and characterized the pharmacokinetics of MF and formoterol in patients with COPD.Methods: This was a single-center, randomized, open-label, multiple-dose, three-period, three-treatment crossover study. The following three treatments were self-administered by patients (n = 14) with moderate-to-severe COPD: MF 400 μg/F 10 μg via a metered-dose inhaler (MF/F MDI; DULERA /ZENHALE ) without a spacer device, MF/F MDI with a spacer, or MF 400 μg via a dry-powder inhaler (DPI; ASMANEX TWISTHALER ) twice daily for 5 days. Plasma samples for MF and formoterol assay were obtained predose and at prespecified time points after the last (morning) dose on day 5 of each period of the crossover. The geometric mean ratio (GMR) as a percent and the corresponding 90% confidence intervals (CI) were calculated for treatment comparisons.Results: Systemic MF exposure was lower (GMR 77%; 90% CI 58, 102) following administration by MF/F MDI compared to MF DPI. Additionally, least squares geometric mean systemic exposures of MF and formoterol were lower (GMR 72%; 90% CI 61, 84) and (GMR 62%; 90% CI 52, 74), respectively, following administration by MF/F MDI in conjunction with a spacer compared to MF/F MDI without a spacer. MF/F MDI had a similar adverse experience profile as that seen with MF DPI. All adverse experiences were either mild or moderate in severity; no serious adverse experience was reported.Conclusion: Systemic MF exposures were lower following administration by MF/F MDI compared with MF DPI. Additionally, systemic MF and formoterol exposures were lower following administration by MF/F MDI with a spacer versus without a spacer. The magnitude of these differences with respect to systemic exposure was not clinically relevant.Keywords: mometasone furoate, chronic obstructive pulmonary disease, pharmacokinetics, systemic exposure, metered-
PROCESS VALIDATION OF METERED DOSE INHALER: A REVIEW  [PDF]
Kaur Gaganpreet,Rana A.C.,Seth Nimrata,Bala Rajni
International Research Journal of Pharmacy , 2012,
Abstract: The purpose of this work is to present an introduction and general overview on process validation of Metered dose inhaler.The word validation simply means, “Assessment of validation or action of proving effectiveness”. The most common dosage form for inhalation is the metered-dose inhaler (MDI), by which the drug is delivered from a pressurized container using a liquefied gas propellant.Inhalation is the convenient way to deliver drugs to respiratory tract in treatment of respiratory disease like ASTHMA.The process validation process parameters are derived from the specifications for the device, component or other entity to be produced by the process. The process is developed in such a way that the required parameters are achieved and it ensures that the output of the process will consistently meet the required parameters during routine production, the process is validated. A manufacturer can assure through careful design of the device, processes, process controls and packaging that all manufactured units will meet specifications and have uniform quality. However, in-process and finished product testing still play an important role in assuring that products meet specifications Validation is defined as a collection and evaluation of data , from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. MDI is pocket-sized, hand-held, pressurise multiple-dose inhalation delivery system. It delivers small, precisely measured therapeutic doses, greatly minimizing the risk of adverse side effects. A metered dose inhaler (MDI) is a device that delivers a specific amount of medication to the lungs in the form of a short burst of aerosolized medicine that is inhaled by the patient. Three consecutive batches of metered dose inhaler shall be taken up for process validation. Based on the results of all the 3 batches, suitable conclusions will be drawn with respect to the suitability of proposed method of manufacture for metered dose inhaler. This review covers need of validation, elements of validation, principles of Validation, Types of validation; brief introduction on MDI includes uses, components, materials and manufacturing.
Bronchodilatory effect of inhaled budesonide/formoterol and budesonide/salbutamol in acute asthma: a double-blind, randomized controlled trial
Jenish J Arun, Rakesh Lodha, Sushil K Kabra
BMC Pediatrics , 2012, DOI: 10.1186/1471-2431-12-21
Abstract: We did not observe any significant differences in the % predicted FEV1 and MPIS between formoterol and salbutamol at various time points from 1 min to 60 min post drug administration. There was significant improvement in FEV1 (% predicted) from baseline in both the groups as early as 1 min after drug administration.Salbutamol or formoterol delivered along with inhaled corticosteroid by metered dose inhaler with spacer in children between 5-15 years of age with mild acute exacerbation of asthma had similar bronchodilatory effects.ClinicalTrials.gov: NCT00900874Bronchial asthma is one of the commonest chronic respiratory illnesses encountered in clinical practice in both adults and children. Asthma therapeutics can be broadly divided into long-term controllers and short-term reliever medications. Among inhaled bronchodilators, short acting beta agonists (SABA) like salbutamol and terbutaline are preferred in acute asthma exacerbations while inhaled corticosteroids (ICS) are the mainstay for long term treatment of asthma [1]. In moderate to severe persistent asthma, long acting beta agonists (LABA) like salmeterol and formoterol are added to ICS [1]. Efficacy and safety of LABA has been demonstrated in both adult and young asthmatics [2].It is desirable to have a single inhaled medication that can be used as both reliever and controller; formoterol is likely to be one such agent as it has both rapid onset and long lasting action [3]. This will facilitate use of a single formulation (ICS + Formoterol) in children with persistent asthma. Few studies performed in adults with acute asthma exacerbation have demonstrated that formoterol was as efficacious and well tolerated as salbutamol [4-6]. Rodrigo et al. identified nine randomized controlled trials (576 patients; 3 trials included children) comparing formoterol with SABAs in acute exacerbation [4]; no significant difference was detected between formoterol and salbutamol in clinical and spirometric parameters.In a system
FORMULATION AND QUALITY CONTROL OF METERED DOSE INHALER: A REVIEW  [PDF]
Ramteke K.H.,Gunjal S.S,Sharma Y.P
Journal of Pharmaceutical and Scientific Innovation , 2012,
Abstract: The MDI is now established as the principal dosage form of inhalation drug therapy for bronchial asthma and chronic obstructive pulmonary disease (COPD). Metered dose inhalers (MDIs) are pharmaceutical delivery systems designed for oral or nasal use, which deliver discrete doses of aerosolized medicament to the respiratory tract. The MDI contains the active substance, dissolved or suspended in a liquefied propellant system held in a pressurized container that is sealed with a metering valve. In general, MDI formulations can take the form of either suspensions or solutions. Traditionally the preferred route has been to formulate a suspension of the micronized drug substance in the liquid propellant (CFC or HFA). In some cases, additional excipients (e.g., surfactants and/or co- solvents) have been added to improve the quality of the dispersion. Quality control testing of MDI batches is applied to the individual inhaler components prior to manufacture, as in-process controls during the manufacturing, and to the finished product. An exhaustive search for new propellants was made at the time of the switch away from CFCs, and it is unlikely that new ones will be found with the necessary physicochemical properties combined with an excellent safety profile.
Development of room temperature stable formulation of formoterol fumarate/beclomethasone HFA pMDI  [cached]
Purohit D,Trehan A,Arora V
Indian Journal of Pharmaceutical Sciences , 2009,
Abstract: The primary aim of present investigation was to develop and formulate room temperature stable formulation of formoterol fumarate and beclomethasone dipropionate with extra fine part size of hydrofluoroalkane pressurized metered dose inhalers. Particle size distribution of hydrofluoroalkane pressurized metered dose inhalers was evaluated using Twin Stage Glass Impinger and Anderson Cascade Impactor. A tetrafluoroethane and/or heptafluoropropane were evaluated for preparation of hydrofluoroalkane pressurized metered dose inhalers. The fine particle fractions delivered from hydrofluoroalkane propellant suspension pressurized metered dose inhalers can be predicted on the basis of formulation parameters and is dependent of metering chamber of valve and orifice size of actuators. The results presented in investigation showed the importance of formulation excipients with formulation of pressurized metered dose inhalers viz, canister, valve and actuators used in formulations.
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