Formoterol indications
P. Ewing1, P. Gerde1, 3, P. Andersson2, S. Eirefelt2, A. Blomgren2 and A. Ryrfeldt1. 1Environmental medicine, Karolinska Institute, Stockholm, Sweden, 2 Discovery DMPK, Astra Zeneca Pharmaceuticals Ltd., Lund, Sweden and 3DustGun Technologies AB, Stockholm, Sweden. When rats are exposed nose-only to aerosols of solutes, disposition in the respiratory tract proceeds along several routes; absorption through the air blood barrier, mucociliary clearance with swallowing, macrophage engulfment of slow dissolving particles and various systemic effects. These overlaying processes tend to obscure the key process of solute absorption through the air blood barrier. Our aim was to create a model for measuring the pulmonary absorption of inhaled solutes in great detail. Hence, one important task is to link the systemic concentration profile with the dosimetry of the exposed tissue; primarily the air blood barrier of the peripheral lung. The isolated and perfused rat lung IPL ; has been widely used to study deposition, absorption and metabolism of inhaled drugs and toxicants. However few options have been available for exposing the IPL to dry powder aerosols in a controlled way. The recently developed DustGun aerosol technology can reproducibly expose the IPL to a respirable dry powder aerosol. We studied the pulmonary absorption of three generical drugs by exposing distal regions of the IPL to respirable aerosols of budesonide, formoterol and terbutaline. The IPL was perfused in a single pass mode and repeated samples of the perfusate were taken up to 80 min post exposure. The concentration of drug in perfusate and in lung extracts was measured using LC-MS MS. An overall mass balance was established by summing up cumu.
Goal: Complete the genomic sequencing of representative members and strains of the VHFs, and compare them to detect differences in pathogenesis and virulence. NIAID has made a significant investment in the genomic sequencing of microorganisms considered agents of bioterrorism. As a result of a coordinated federal effort with the Department of Energy, the CDC, United States Department of Agriculture, and the National Science Foundation, and international partners including the Sanger Center.
A CL1, CL2, DH-P, and DH-N were short-term CD4 T cell lines. DH-P and DH-N were sorted sublines of CD28 and CD28null cells, respectively. b Cells were cultured on plastic-immobilized anti-CD3 for at least 18 h, washed, and immunostained with the anti-Fas mAb CH11 followed by FITC-conjugated antimouse Ab, and subsequently stained with PE-conjugated anti-CD28 and PerCP-conjugated anti-CD4. Fas-expressing cells were distinguished by a distinct FITC-fluorescence shift over the isotype control.
Fig. 1. Mean dose-response curves to inhaled salbutamol construction 2 h after inhaling placebo ; , formoterol 24 g , salmeterol 50 g , or oxitropium 200 g for forced expiratory volume in one second FEV1.
P3841 Is the hypoxemic effect of formoterol really linked to a shunt-like effect? S. Centanni 1 , F. Di Marco 1 , P. Santus 1 , M. Verga 1 , A. Pistone 1 , M. Cazzola 2 . 1 Unit of Pneumology, Univ of Milan, S Paolo Hosp, Milan, Italy; 2 Unit of Pneumology, Cardarelli Hosp, Naples, Italy The administration of 2 -agonists to patients with airways obstruction often results in a transient decrease in PaO2 despite concomitant bronchodilation. This has been attributed to the pulmonary vasodilator action of these agents, increasing blood flow to poorly ventilated lung regions and thus increasing ventilationperfusion inequality, a shunt-like effect. We have investigated the acute effects of formoterol on the arterial blood gas tensions of 30 patients with COPD. Sixty min after the inhalation of formoterol 12 g, P A-a ; O2 rose significantly 4.50 mmHg ; and, as expected, showed a highly significant negative correlation r -0.91; p 0.001 ; with the fall in PaO2 -4.79 mmHg ; . This finding was not linked to hypoventilation because PaCO2 was not elevated. The expected raise in FEV1 0.19 L ; elicited by formoterol showed a significant negative correlation with the fall in PaO2 r -0.36; p 0.04 ; , whereas the changes in IC 0.37 L ; and TGV -0.73 L ; did not correlate with the changes in PaO2 IC: r 0.017, p 0.93; TGV: r -0.014, p 0.94 ; . Also DLCO , VA, and DL VA rose from baseline 1.48 mL min-1 mmHg, 0.25 L, and 0.11 mL min-1 mmHg, respectively ; , although their raises were not correlated with the fall in PaO2 DLCO : r 0.09, p 0.63; VA: r 0.10, p 0.59; DL VA: r 0.11, p 0.58 ; . These findings suggest a primary true shunt effect in inducing the hypoxemic effect of formoterol, although the contribution of an impairment of the ventilationperfusion cannot be excluded.
Formoterol indications
Exacerbations of COPD, however, are primarily driven by eosinophils, which are sensitive to corticosteroids." "In order to be eligible for Symbicort treatment, the patient must demonstrate a forced expiratory volume in 1 second FEV1 ; of less than 50% of the predicted normal value and a history of repeated exacerbations." "Symbicort offers additional benefits compared with either budesonide or formoterol alone. Specifically, the reduction in the rate of severe exacerbations appeared to be mainly attributable to the corticosteroid component, whereas lung function was primarily improved by the long-acting 2-agonist." "Compared with all other treatments, Symbicort prolonged the time to first exacerbation and reduced the risk of having an exacerbation." "Symbicort offers short-term and sustained improvements in lung function and healthrelated quality of life to a greater extent than either monotherapy or placebo. This superiority also extended to the rate of exacerbations of COPD." "Symbicort and Seretide offer comparable efficacy in improving lung function in COPD." "Administration of budesonide and formoterol together as Symbicort does not introduce any additional adverse events other than those reported when the two drugs are administered as monotherapies." "In those patients for whom concurrent formoterol and budesonide therapy is advised, it is more cost-effective to prescribe Symbicort than the two component monotherapies and forteo.
Of InTPP. Photoxidation did not occur when a lower concentration of Photofrin was used 0.35 mol L-1 ; . Table 2 shows that there was a reduction in t 50 when the concentration of InTPP was increased from 0.26 to 6.4 mol L-1. However, there was almost no change in t50 when the concentration of InTPP was increased from 6.4 to 20.0 mol L-1, possibly due to the formation of larger oligomers at higher InTPP concentrations in the presence of RBC. There was also a decrease in the maximum percentage hemolysis from 100% to around 82% when higher concentrations of InTPP 6.4 and 20 mol L-1 ; were used in the experiment. No changes were observed in the maximum percentage hemolysis when higher Photofrin concentrations were used. Grossweiner et al.57 reported that, in porphyrin-binding experiments with RBC, the bound sensitizer fraction decreased as the total sensitizer concentration increased. This suggests that increases in the porphyrin concentration favor the aggregation of its molecules. Therefore, it is possible that the microenvironment of erythrocytes does not change the aggregation state of Photofrin, but favors the formation of InTPP aggregates, which decreases the percentage hemolysis to around 82%. Determination of the parameters n and K of equation 13 and using the data shown in Figure 7 showed that there are four cooperative binding sites per cell, with association constants of 2.40 0.05 ; 107 L mol-1 and 7.2 0.2 ; 104 L mol-1 for InTPP and Photofrin, respectively. These results show that InTPP has a higher affinity for erythrocytes than Photofrin. The differences in the observed efficiencies could be associated with the affinity of the sensitizers for the erythrocyte membrane. Photodynamic activity of phthalocyanines was also observed to correlate with the affinity of the dye for the cell.59 The DavsonDanielli principle states that the ease with which a compound passes through the cellular membrane is proportional to its lipophilic character. 60 Therefore, the higher polarity of Photofrin molecules weakens their interaction with the membrane. Our results indicate that, because of the higher affinity of InTPP for RBC compared with that of Photofrin, a lower light.
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4: 44 4: upon completion of this session, participants should be able to: discuss the evidence supporting adjustable maintenance dosing with budesonide formoterol for management of moderate or severe persistent asthma and the potential risks associated with this treatment approach; describe the evidence supporting the therapeutic utility of daily inhaled corticosteroid for mild persistent asthma and recent evidence supporting the alternatives of inhaled corticosteroid on an intermittent schedule and anti-leukotriene monotherapy and fortovase.
Missing data. By checking the appropriate box on the study case report form, each investigator provided the qualitative categories of the ECG criteria for each patient that form the basis for these analyses. This classification was used to evaluate a simple and practical approach toward clinical categorization of general ECG abnormalities. The patients were divided into 4 groups on the basis of the ECG findings at presentation: 1 ; isolated T-wave inversions of more than 0.1 mV including the normalization of a known negative T-wave 2 ; ST-segment elevation of at least 0.05 mV in at least 2 contiguous leads; 3 ; ST-segment depression of greater than 0.05 mV alone or with concomitant T-wave inversion and 4 ; the combination of ST-segment elevation and depression. The 145 patients with new or previously unknown left bundle branch block were included in the group with ST-segment elevation. Of the randomized patients, 2723 22% ; had Twave inversion alone, 3369 28% ; had ST-segment elevation, 4263 35% ; had ST-segment depression, and 1769 15% ; had a combination of ST-segment elevation and depression!
Without hesitation I would acknowledge that combination products with fixed doses of long-acting b-adrenoceptor agonists and inhaled corticosteroids are an established therapeutic option for asthma in patients with moderate and severe disease. These drugs have changed conceptual views of asthma treatment and may have simplified asthma management, which is probably one of their greatest merits! There is a reasonable scientific basis for the use of combination therapy [1] that convinced us that the fixed combination of bronchodilators with inhaled steroids is the treatment of choice, at least for patients that are not sufficiently controlled with a short-acting b-agonist and an inhaled steroid. I still find it puzzling that the same doses of drugs given in one inhaler should have a greater effect in these patients compared to the single components at least in the first weeks of treatment ; , but that9s the data and all published studies irrespective of sponsorship come to the same conclusion. As this is the evidence, I happy to adopt this strategy. But chronic obstructive pulmonary disease COPD ; ? We have all witnessed the heated discussions around inhaled steroids in COPD and have seen and read the data that confirm that asthma and COPD are completely different diseases, clinically and biologically. I can see the role of longacting bronchodilators for the treatment of COPD, an issue that is already addressed in the updated Global Initiative for Chronic Obstructive Lung Disease GOLD ; guidelines [2], but the use of inhaled steroids and combination therapy as in asthma? Is this a "one size fits all" strategy that is driven by commercial interests? And, were we all wrong, does this mean we no longer need to differentiate between asthma and COPD since the treatment will be the same in the end? At this point the available evidence should probably be considered. In this issue of the European Respiratory Journal, P. Calverley and co-authors [3] yes, the TRISTAN P. Calverley [4] ; present the second large clinical study of 2003 that demonstrates that maintenance treatment with a fixed dose of an inhaled steroid budesonide ; and long-acting bagonists formoterol ; in COPD improves lung function, quality of life and delays the time to first exacerbation and that this effect is more pronounced with the combination therapy than in either component alone. One-thousand and twenty-two COPD patients with 629 or 62% completing the study ; with a mean forced expiratory volume in one second FEV1 ; of 36% predicted were included in this multicentre trial and were randomised to receive either budesonide or formoterol or the combination of both or placebo, with terbutaline as rescue medication. Randomisation followed a run-in period of 2 weeks during which patients were treated with 30 mg oral prednisolone and formoterol b.i.d., and terbutaline as rescue medication. The primary outcomes of and fosamprenavir.
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Respir med 2001; 5-512 18 o'byrne pm, barnes pj, rodriguez-roisin r, et al low dose inhaled budesonide and formoterol in mild persistent asthma: the optima randomized trial.
Chen Z, Chen GQ, Shen ZX, Sun GL, Tong JH, Wang ZY, Chen SJ. Expanding the use of arsenic trioxide: leukemia and beyond. Seminars in Hematology 39: 22-26, 2002. Dai MS, Chevallier N, Stone S, Heinrich MC, McConnell M, Reuter T, Broxmeyer HE, Licht JD, Lu L, Hoatlin ME. The effects of the Fanconi anemia zinc finger FAZF ; on cell cycle, apoptosis, and proliferation are differentiation stage-specific. J. Biol. Chem. 277: 26327-26334, 2002. Davison K, Mann KK, Miller WH Jr. Arsenic trioxide: mechanisms of action. Seminars in Hematology 39, Supplement 1: 3-7, 2002. Dong S, Tweardy DJ. Interactions of STAT5b-RARa a novel acute promyelocytic leukemia fusion protein, with retinoic acid receptor and STAT3 signaling pathways. Blood 99: 2637-2646, 2002. Fahrner JA, Eguchi S, Herman JG, Baylin SB. Dependence of histone modifications and gene expression on DNA hypermethylation in cancer. Cancer Research 62: 72137218, 2002. Fang J, Chen SJ, Tong JH, Wang ZG, Chen GQ, Chen J. Treatment of acute promyelocytic leukemia with ATRA and arsenic trioxide. Cancer Biology & Therapy 1: 6, 614-620, Gopalkrishnan RV, Su Z-z, Kang D-c, Sarkar D, Sauane M, Leszczyniecka M, Lebedeva IV, Sivo F, Goldstein NI, Fisher PB. DISH-Differentiation induction subtraction hybridization. In: Analysing Gene Expression, Lorkowski S, Cullen P Eds. ; Wiley-VCH Verlag GmbH, Germany, Ch. 3.2.4.1, pg. 178-185, 2002. Grant S, Fisher PB, Dent P. The role of signal transduction pathways in drug and radiation resistance. Cancer Treat. Res. 112: 89-108, 2002 and fosrenol.
Where I sat, even in the rainiest weather. The Harivansa says, "An abode without birds is like a meat without seasoning." Such was not my abode, for I found myself suddenly neighbor to the birds; not by having imprisoned one, but having caged myself near them. I was not only nearer to some of those which commonly frequent the garden and the orchard, but to those smaller and more thrilling songsters of the forest which never, or rarely, serenade a villager -- the wood thrush, the veery, the scarlet tanager, the field sparrow, the whip-poor-will, and many others. I was seated by the shore of a small pond, about a mile and a half south of the village of Concord and somewhat higher than it, in the midst of an extensive wood between that town and Lincoln, and about two miles south of that our only field known to fame, Concord Battle Ground; but I was so low in the woods that the opposite shore, half a mile off, like the rest, covered with wood, was my most distant horizon. For the first week, whenever I looked out on the pond it impressed me like a tarn high up on the side of a mountain, its bottom far above the surface of other lakes, and, as the sun arose, I saw it throwing off its nightly clothing of mist, and here and there, by degrees, its soft ripples or its smooth reflecting surface was revealed, while the mists, like ghosts, were stealthily withdrawing in every direction into the woods, as at the breaking up of some nocturnal conventicle. The very dew seemed to hang upon the trees later into the day than usual, as on the sides of moun.
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Awarded Research Grant by Novartis Pharmaceuticals Corporation Awarded 4 Research Grants by the Pacific Vascular Research Foundation, San Francisco, CA Presidential Task Force Medal Recipient, from President Bush, DC Awarded Academic Scholarship to U.C. Santa Cruz, from A.M.I. Intl. Awarded "Outstanding Young Men of America", by Jaycees U.S. Selected to Deliver Two Research Papers to National Conference of Professional Psychologists, Pepperdine University, Malibu, Ca and fragmin.
Used for a similar length of time, reproducibility has been of the same order. Interference by drugs commonly administered to Parkinsonian patients is negligible Table 1 ; . This list is not exhaustive, but we have not experienced any difficulties owing to interference from other drugs taken by the 15 patients who have participated in our studies during the past 18 months. The progressive increase in strip-test values that occurred in the early stages of therapy roughly correlated with the clinical progress of the patient. Two patients, for example, who obtained excellent clinical results from L-DOPA therapy exhibited a very marked and prompt rise in strip test values with relatively low doses of L-DOPA. The two patients who demonstrated the least clinical response to L-DOPA therapy exhibited only a very slow rise in strip test values. A more complete correlation between various phases of clinical progress and specific metabolites will be included in a separate paper covering the clinical aspects of this study. This screening test for L-DOPA and its metabolites provides a method of monitoring L-DOPA therapy in Parkinson's disease patients.
Adverse effects - beta-agonist: are we really protected by concomitant ICS? See Sears et al., 1990 - ICS: total dose of ICS used in the study by Rabe et al., increased by only 163 g day but what about the high users? Economic cost - The cost of substituting Symbicort PRN for SALBUTAMOL 3 evaluated and published. salbutamol PRN needs to CENTS PER DOSE The possibility of using Ventide PRN needs to be TERBUTALINE 9 CENTS PER DOSE explored further Educational cost BUDESONIDE 50 CENTS PER DOSE FORMOTEROL - There will be a need to re-educate patients regarding self-management and frova.
60. Shrewsbury S, Pyke S, Britton M. Meta-analysis of increased dose of inhaled steroid or addition of salmeterol in symptomatic asthma MIASMA ; . BMJ 2000; 320 7246 ; : 1368-73. 61. Woolcock A, Lundback B, Ringdal N, Jacques LA. Comparison of addition of salmeterol to inhaled steroids with doubling of the dose of inhaled steroids. J Respir Crit Care Med 1996; 153 5 ; : 1481-8. 62. Greening AP, Ind PW, Northfield M, Shaw G. Added salmeterol versus higher-dose corticosteroid in asthma patients with symptoms on existing inhaled corticosteroid. Allen & Hanburys Limited UK Study Group. Lancet 1994; 344 8917 ; : 219-24. 63. Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA, et al. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. J Respir Crit Care Med 2004; 170 8 ; : 836-44. 64. Lalloo UG, Malolepszy J, Kozma D, Krofta K, Ankerst J, Johansen B, et al. Budesonide and formoterol in a single inhaler improves asthma control compared with increasing the dose of corticosteroid in adults with mild-to-moderate asthma. Chest 2003; 123 5 ; : 1480-7. 65. Kips JC, O'Connor BJ, Inman MD, Svensson K, Pauwels RA, O'Byrne PM. A long-term study of the antiinflammatory effect of low-dose budesonide plus formoterol versus high-dose budesonide in asthma. J Respir Crit Care Med 2000; 161 3 Pt 1 ; 996-1001. 66. Stoloff SW, Stempel DA, Meyer J, Stanford RH, Carranza Rosenzweig JR. Improved refill persistence with fluticasone propionate and salmeterol in a single inhaler compared with other controller therapies. J Allergy Clin Immunol 2004; 113 2 ; : 245-51. 67. Rabe KF, Pizzichini E, Stallberg B, Romero S, Balanzat AM, Atienza T, et al. Budesonide formoterol in a single inhaler for maintenance and relief in mild-to-moderate asthma: a randomized, double-blind trial. Chest 2006; 129 2 ; : 246-56. 68. O'Byrne PM, Bisgaard H, Godard PP, Pistolesi M, Palmqvist M, Zhu Y, et al. Budesonide formoterol combination therapy as both maintenance and reliever medication in asthma. J Respir Crit Care Med 2005; 171 2 ; : 129-36. 69. Scicchitano R, Aalbers R, Ukena D, Manjra A, Fouquert L, Centanni S, et al. Efficacy and safety of budesonide formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Curr Med Res Opin 2004; 20 9 ; : 1403-18. 70. Vogelmeier C, D'Urzo A, Pauwels R, Merino JM, Jaspal M, Boutet S, et al. Budesonide formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005; 26 5 ; : 819-28. 71. Nelson JA, Strauss L, Skowronski M, Ciufo R, Novak R, McFadden ER, Jr. Effect of long-term salmeterol treatment on exercise-induced asthma. N Engl J Med 1998; 339 3 ; : 141-6. 72. Palmqvist M, Persson G, Lazer L, Rosenborg J, Larsson P, Lotvall J. Inhaled dry-powder formoterol and salmeterol in asthmatic patients: onset of action, duration of effect and potency. Eur Respir J 1997; 10 11 ; : 2484-9 and formoterol.
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LPS was administered intraperitoneally 4 h after implanting osmotic pumps containing formoterol solution. Values represent the mean SEM n 5 or mice ; . The numbers of live fetuses in uteri are shown in parentheses and frovatriptan.
Compass, being a double-blind study, now shows that budesonide formoterol maintenance and reliever therapy is a more effective treatment than a higher maintenance dose of either budesonide formoterol or salmeterol fluticasone combination plus reliever medication.
Revealed: Hb: 8.4 g dl, PLT: 35 109 L, WBC: 105 109 L and blasts 51%. Bone marrow aspiration showed hypercellularity with an excess of blasts 88% ; that had a positive immunophenotype for myeloperoxydase MPO ; , CD14, CD13, and CD33. Chromosomal analysis of the marrow revealed trisomy 8. A bone marrow biopsy showed diffuse infiltration by leukemic blast cells that were positive for MPO, lysozyme, and CD68. Accordingly, a diagnosis of AML M4 subtype ; was made and the patient received three courses of systemic chemotherapy with aracytin and idarubicin. Three months later, although she had normal blood tests and normal bone marrow aspiration, multiple red, painless nodules developed on her upper and lower limbs Fig 1 ; . A skin nodule from the right arm was then excised and sent for histopathological examination. After a histological diagnosis of skin infiltration by AML blasts was made, the patient received another course of systemic che and fudr
Grove A, Lipworth BJ. Bronchodilator subsensitivity to salbutamol after twice daily salmeterol in asthmatic patients. Lancet 1995; 346: 201206. Wagner J, Reinhardt D, Schumann HJ. Comparison of the bronchodilator and cardiovascular actions of isoprenaline, Th 1165a, terbutaline and salbutamol in cats and isolated organ preparations. Res Exp Med 1974; 162: 4962. Lindn A, Bergendal A, Ullman A, Skoogh B-E, Lfdahl C-G. Salmeterol, formoterol, and salbutamol in the isolated guinea pig trachea: differences in maximum relaxant effect and potency but not in functional antagonism. Thorax 1993; 48: 547553. Smyth ET, Pavord ID, Wong CS, Wisniewski AFZ, Williams J, Tattersfield AK. Interaction and dose equivalence of salbutamol and salmeterol in patients with asthma. Br Med J 1993; 306: 543545. Dougall IG, Harper D, Jackson DM, Leff P. Estimation of the efficacy and affinity of the 2-adrenoceptor agonist salmeterol in guinea-pig trachea. Br J Pharmacol 1991; 104: 10571061. Naline E, Zhang Y, Qian Y, et al. Relaxant effects and durations of action of formoterol and salmeterol on the isolated human bronchus. Eur Respir J 1994; 7: 914 Klestrm B-L, Sjberg J, Waldeck B. The interaction between salmeterol and 2-adrenoceptor agonists with higher efficacy on guinea-pig trachea and human bronchus in vitro. Br J Pharmacol 1994; 113: 687692. Grove A, Lipworth BJ. Evaluation of the 2-adrenoceptor agonist antagonist activity of formoterol and salmeterol. Thorax 1996; 51: 5458. Grove A, Lipworth BJ. Effects of prior treatment with salmeterol and formoterol on airway and systemic 2 responses to fenoterol. Thorax 1996; 51: 585589. Cazzola M, Matera MG, Santangelo G, Vinciguerra A and forteo.
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