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  1. Book ; Online ; E-Book: Design and Analysis of Subgroups with Biopharmaceutical Applications

    Ting, Naitee / Cappelleri, Joseph C. / Ho, Shuyen / Chen, (Din) Ding-Geng

    (Emerging Topics in Statistics and Biostatistics,)

    2020  

    Abstract: This book provides an overview of the theories and applications on subgroups in the biopharmaceutical industry. Drawing from a range of expert perspectives in academia and industry, this collection offers an overarching dialogue about recent advances in ... ...

    Author's details edited by Naitee Ting, Joseph C. Cappelleri, Shuyen Ho, (Din) Ding-Geng Chen
    Series title Emerging Topics in Statistics and Biostatistics,
    Abstract This book provides an overview of the theories and applications on subgroups in the biopharmaceutical industry. Drawing from a range of expert perspectives in academia and industry, this collection offers an overarching dialogue about recent advances in biopharmaceutical applications, novel statistical and methodological developments, and potential future directions. The volume covers topics in subgroups in clinical trial design; subgroup identification and personalized medicine; and general issues in subgroup analyses, including regulatory ones. Included chapters present current methods, theories, and case applications in the diverse field of subgroup application and analysis. Offering timely perspectives from a range of authoritative sources, the volume is designed to have wide appeal to professionals in the pharmaceutical industry and to graduate students and researchers in academe and government.
    Keywords Biometry ; Pharmaceutical chemistry ; Biostatistics ; Pharmaceutics
    Subject code 615.10727
    Language English
    Size 1 online resource (404 pages).
    Edition 1st ed. 2020.
    Publisher Springer International Publishing ; Imprint: Springer
    Publishing place Cham
    Document type Book ; Online ; E-Book
    Remark Zugriff für angemeldete ZB MED-Nutzerinnen und -Nutzer
    ISBN 3-030-40105-7 ; 3-030-40104-9 ; 978-3-030-40105-4 ; 978-3-030-40104-7
    DOI 10.1007/978-3-030-40105-4
    Database ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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  2. Article ; Online: A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials.

    Brock, Kristian / Chen, Chen / Ho, Shuyen / Fuller, Greg / Woolfolk, Jared / McShea, Cindy / Penard, Nils

    Pharmaceutical statistics

    2022  Volume 22, Issue 2, Page(s) 378–395

    Abstract: Sponsors have a responsibility to minimise risk to participants in clinical studies through safety monitoring. The FDA Final Rule for IND Safety Reporting requires routine aggregate safety evaluation, including in ongoing blinded studies. We are ... ...

    Abstract Sponsors have a responsibility to minimise risk to participants in clinical studies through safety monitoring. The FDA Final Rule for IND Safety Reporting requires routine aggregate safety evaluation, including in ongoing blinded studies. We are interested in estimating the probability that the true adverse event rate in the experimental arm exceeds that in the control arm. We developed a Bayesian approach that specifies an informative meta-analytic predictive prior on the event probability in the control arm and an uninformative prior on that in the experimental arm. We combined these priors with a mixture likelihood that considers each patient in the ongoing blinded study may belong to the experimental or control arm. This allowed us to estimate the quantity of interest without unblinding. We evaluated our method by simulation, pairing scenarios that differed only in whether a safety signal was present or missing, and quantifying the ability of our model to discriminate using signal detection theory. Our approach shows benefit. It detects safety signals more reliably with greater sample sizes and for common rather than rare events. Performance does not deteriorate markedly when historical studies exhibit heterogeneous hazards or non-constant hazards. Our method will allow us to monitor safety signals in ongoing blinded studies with the goal of earlier identification and risk mitigation. Our method could be adapted to use informative priors on both arms or predictive covariates where pertinent data exist. We stress that ongoing safety monitoring should involve a multi-disciplinary team where statistical methods are paired with medical judgement.
    MeSH term(s) Humans ; Bayes Theorem ; Probability ; Computer Simulation ; Research Design ; Sample Size ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2022-12-12
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2083706-9
    ISSN 1539-1612 ; 1539-1604
    ISSN (online) 1539-1612
    ISSN 1539-1604
    DOI 10.1002/pst.2278
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Addition of a 5-lipoxygenase-activating protein inhibitor to an inhaled corticosteroid (ICS) or an ICS/long-acting beta-2-agonist combination in subjects with asthma.

    Snowise, Neil G / Clements, Diane / Ho, Shu-Yen / Follows, Richard M A

    Current medical research and opinion

    2013  Volume 29, Issue 12, Page(s) 1663–1674

    Abstract: Objective: To investigate the clinical benefits of 'add-on' therapy with GSK2190915 in combination with the inhaled corticosteroid (ICS) fluticasone propionate (FP) and the ICS/long-acting beta 2 agonist (LABA) combination FP/salmeterol in asthmatic ... ...

    Abstract Objective: To investigate the clinical benefits of 'add-on' therapy with GSK2190915 in combination with the inhaled corticosteroid (ICS) fluticasone propionate (FP) and the ICS/long-acting beta 2 agonist (LABA) combination FP/salmeterol in asthmatic subjects.
    Methods: Both studies were cross-over, randomized, double-blind, double-dummy and placebo-controlled in subjects with a forced expiratory volume in 1 second (FEV1) best of >50 and ≤80% of predicted. Add-on to ICS: Subjects (n = 162) aged ≥12 years received FP 100 µg twice daily (BID) plus GSK2190915 100 mg once daily (QD); GSK2190915 300 mg QD; montelukast 10 mg QD; salmeterol 50 µg BID or placebo. Add-on to ICS/LABA: Female subjects (n = 145) aged ≥18 years received FP/salmeterol 250/50 µg BID plus GSK2190915 300 mg QD, montelukast 10 mg QD or placebo. In both studies, the primary endpoint was trough FEV1 at the end of the treatment period. Secondary endpoints included a range of objective and patient-reported measures of efficacy.
    Results: Add-on to ICS: There was no statistically significant difference in the primary endpoint between either dose of GSK2190915 (add-on to FP) and placebo. Nominally statistically significant increases were demonstrated for GSK2190915 300 mg add-on relative to placebo for mean morning peak expiratory flow (p = 0.049), percentage of symptom-free days (p = 0.035) and percentage of symptom-free 24 h periods (p = 0.030). Add-on to ICS/LABA: There were no statistically significant differences on the primary endpoint between treatment regimens. Nominally statistically significant decreases were demonstrated in daytime (p = 0.023), night-time (p = 0.041) and 24 h (p = 0.019) short-acting beta 2 agonist usage with FP/salmeterol + GSK2190915 300 mg vs. FP/salmeterol + placebo.
    Conclusion: There was no clinically significant improvement in the primary endpoint following GSK2190915 add-on treatment; however, improvements in a range of secondary endpoints and biomarker data provided evidence of pharmacological activity. Improvements in response to background treatment may have been a limitation in both studies.
    Trial registration: Clinicaltrials.gov identifiers: NCT01156792 and NCT01248975.
    MeSH term(s) 5-Lipoxygenase-Activating Protein Inhibitors/administration & dosage ; 5-Lipoxygenase-Activating Protein Inhibitors/adverse effects ; Adolescent ; Adrenal Cortex Hormones/administration & dosage ; Adrenal Cortex Hormones/adverse effects ; Adrenergic beta-2 Receptor Agonists/administration & dosage ; Adrenergic beta-2 Receptor Agonists/adverse effects ; Adult ; Albuterol/administration & dosage ; Albuterol/adverse effects ; Albuterol/analogs & derivatives ; Androstadienes/administration & dosage ; Androstadienes/adverse effects ; Anti-Allergic Agents/administration & dosage ; Anti-Allergic Agents/adverse effects ; Asthma/drug therapy ; Child ; Drug Therapy, Combination ; Female ; Fluticasone ; Humans ; Male ; Salmeterol Xinafoate
    Chemical Substances 5-Lipoxygenase-Activating Protein Inhibitors ; Adrenal Cortex Hormones ; Adrenergic beta-2 Receptor Agonists ; Androstadienes ; Anti-Allergic Agents ; Salmeterol Xinafoate (6EW8Q962A5) ; Fluticasone (CUT2W21N7U) ; Albuterol (QF8SVZ843E)
    Language English
    Publishing date 2013-12
    Publishing country England
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 80296-7
    ISSN 1473-4877 ; 0300-7995
    ISSN (online) 1473-4877
    ISSN 0300-7995
    DOI 10.1185/03007995.2013.842163
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Randomized dose-finding study of batefenterol via dry powder inhaler in patients with COPD.

    Crim, Courtney / Watkins, Michael L / Bateman, Eric D / Feldman, Gregory J / Schenkenberger, Isabelle / Kerwin, Edward M / Crawford, Catriona / Pudi, Krishna / Ho, Shuyen / Baidoo, Charlotte / Castro-Santamaria, Ramiro

    International journal of chronic obstructive pulmonary disease

    2019  Volume 14, Page(s) 615–629

    Abstract: Background: Batefenterol is a novel bifunctional muscarinic antagonist β: Patients and methods: Patients aged ≥40 years with COPD and FEV: Results: In the intent-to-treat population (N=323), all batefenterol doses demonstrated statistically and ... ...

    Abstract Background: Batefenterol is a novel bifunctional muscarinic antagonist β
    Patients and methods: Patients aged ≥40 years with COPD and FEV
    Results: In the intent-to-treat population (N=323), all batefenterol doses demonstrated statistically and clinically significant improvements from baseline vs placebo in the primary and secondary endpoints (191.1-292.8 and 182.2-244.8 mL, respectively), with a relatively flat dose-response. In the subgroup reversible to salbutamol, there were greater differences between batefenterol doses. Lung function improvements with batefenterol ≥150 µg were comparable with those with UMEC/VI. Batefenterol was well tolerated and no new safety signals were observed.
    Conclusion: Batefenterol 300 µg may represent the optimal dose for Phase III studies.
    MeSH term(s) Administration, Inhalation ; Adrenergic beta-2 Receptor Agonists/administration & dosage ; Adrenergic beta-2 Receptor Agonists/adverse effects ; Adult ; Aged ; Carbamates/administration & dosage ; Carbamates/adverse effects ; Dose-Response Relationship, Drug ; Double-Blind Method ; Dry Powder Inhalers ; Female ; Forced Expiratory Volume ; Germany ; Humans ; Lung/drug effects ; Lung/physiopathology ; Male ; Middle Aged ; Muscarinic Antagonists/administration & dosage ; Muscarinic Antagonists/adverse effects ; Pulmonary Disease, Chronic Obstructive/diagnosis ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Pulmonary Disease, Chronic Obstructive/physiopathology ; Quinolones/administration & dosage ; Quinolones/adverse effects ; South Africa ; Time Factors ; Treatment Outcome ; United States
    Chemical Substances Adrenergic beta-2 Receptor Agonists ; Carbamates ; Muscarinic Antagonists ; Quinolones ; batefenterol
    Language English
    Publishing date 2019-03-08
    Publishing country New Zealand
    Document type Clinical Trial, Phase II ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 2212419-6
    ISSN 1178-2005 ; 1176-9106
    ISSN (online) 1178-2005
    ISSN 1176-9106
    DOI 10.2147/COPD.S190603
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Efficacy, safety and tolerability of GSK2190915, a 5-lipoxygenase activating protein inhibitor, in adults and adolescents with persistent asthma: a randomised dose-ranging study.

    Follows, Richard M A / Snowise, Neil G / Ho, Shu-Yen / Ambery, Claire L / Smart, Kevin / McQuade, Barbara A

    Respiratory research

    2013  Volume 14, Page(s) 54

    Abstract: Background: GSK2190915 is a high affinity 5-lipoxygenase-activating protein inhibitor being developed for the treatment of asthma. The objective of this study was to evaluate GSK2190915 efficacy, dose-response and safety in subjects with persistent ... ...

    Abstract Background: GSK2190915 is a high affinity 5-lipoxygenase-activating protein inhibitor being developed for the treatment of asthma. The objective of this study was to evaluate GSK2190915 efficacy, dose-response and safety in subjects with persistent asthma treated with short-acting beta2-agonists (SABAs) only.
    Methods: Eight-week multicentre, randomised, double-blind, double-dummy, stratified (by age and smoking status), parallel-group, placebo-controlled study in subjects aged ≥12 years with a forced expiratory volume in 1 second (FEV1) of 50-85% predicted. Subjects (n = 700) were randomised to receive once-daily (QD) oral GSK2190915 (10-300 mg), twice-daily inhaled fluticasone propionate 100 μg, oral montelukast 10 mg QD or placebo. The primary endpoint was mean change from baseline (randomisation) in trough (morning pre-dose and pre-rescue bronchodilator) FEV1 at the end of the 8-week treatment period. Secondary endpoints included morning and evening peak expiratory flow, symptom-free days and nights, rescue-free days and nights, day and night-time symptom scores, day and night-time rescue medication use, withdrawals due to lack of efficacy, Asthma Control Questionnaire and Asthma Quality of Life Questionnaire scores.
    Results: For the primary endpoint, there was no statistically significant difference between any dose of GSK2190915 QD and placebo. However, repeated measures sensitivity analysis demonstrated nominal statistical significance for GSK2190915 30 mg QD compared with placebo (mean difference: 0.115 L [95% confidence interval: 0.00, 0.23], p = 0.044); no nominally statistically significant differences were observed with any of the other doses. For the secondary endpoints, decreases were observed in day-time symptom scores and day-time SABA use for GSK2190915 30 mg QD versus placebo (p ≤ 0.05). No dose-response relationship was observed for the primary and secondary endpoints across the GSK2190915 dose range studied; the 10 mg dose appeared to be sub-optimal. GSK2190915 was associated with a dose-dependent reduction in urinary leukotriene E4. The profile and incidence of adverse events were similar between treatment groups.
    Conclusion: Efficacy was demonstrated for GSK2190915 30 mg compared with placebo in day-time symptom scores and day-time SABA use. No additional improvement on efficacy endpoints was gained by administration of GSK2190915 doses greater than 30 mg. GSK2190915 was well-tolerated. These results may support further studies with GSK2190915 30 mg.
    Trial registration: Clinicaltrials.gov: NCT01147744.
    MeSH term(s) 5-Lipoxygenase-Activating Protein Inhibitors/administration & dosage ; 5-Lipoxygenase-Activating Protein Inhibitors/adverse effects ; 5-Lipoxygenase-Activating Protein Inhibitors/therapeutic use ; Adolescent ; Adrenergic beta-2 Receptor Agonists/therapeutic use ; Adult ; Aged ; Anti-Asthmatic Agents/administration & dosage ; Anti-Asthmatic Agents/adverse effects ; Anti-Asthmatic Agents/therapeutic use ; Asthma/drug therapy ; Child ; Dose-Response Relationship, Drug ; Double-Blind Method ; Female ; Forced Expiratory Volume ; Humans ; Indoles/administration & dosage ; Indoles/adverse effects ; Indoles/therapeutic use ; Male ; Middle Aged ; Pentanoic Acids/administration & dosage ; Pentanoic Acids/adverse effects ; Pentanoic Acids/therapeutic use ; Smoking/adverse effects ; Treatment Outcome ; Young Adult
    Chemical Substances 3-(3-tert-butylsulfanyl-1-(4-(6-ethoxypyridin-3-yl)benzyl)-5-(5-methylpyridin-2-ylmethoxy)-1H-indol-2-yl)-2,2-dimethylpropionic acid ; 5-Lipoxygenase-Activating Protein Inhibitors ; Adrenergic beta-2 Receptor Agonists ; Anti-Asthmatic Agents ; Indoles ; Pentanoic Acids
    Language English
    Publishing date 2013-05-17
    Publishing country England
    Document type Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2041675-1
    ISSN 1465-993X ; 1465-9921
    ISSN (online) 1465-993X
    ISSN 1465-9921
    DOI 10.1186/1465-9921-14-54
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: Effects of fluticasone propionate and salmeterol hydrofluoroalkane inhalation aerosol on asthma-related quality of life.

    Edin, Heather M / Andersen, Leslie B / Schoaf, Lynne / Scott-Wilson, Catherine A / Ho, Shu-Yen / Ortega, Hector G

    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology

    2009  Volume 102, Issue 4, Page(s) 323–327

    Abstract: Background: Current asthma guidelines emphasize domains of impairment and risk for assessing severity and control, noting the need to consider separately the effects of asthma on asthma quality of life and functional capacity. Proper treatment to ... ...

    Abstract Background: Current asthma guidelines emphasize domains of impairment and risk for assessing severity and control, noting the need to consider separately the effects of asthma on asthma quality of life and functional capacity. Proper treatment to control asthma should result in improvements in patient well-being and functional status.
    Objective: To assess asthma-related quality of life after treatment with combination fluticasone propionate and salmeterol delivered via hydrofluoroalkane 134a metered-dose inhaler compared with the individual components alone.
    Methods: Asthma-related quality of life was assessed as part of two 12-week, randomized, double-blind, placebo-controlled clinical trials comparing the fluticasone propionate-salmeterol combination administered via a single metered-dose inhaler with salmeterol, fluticasone propionate, and placebo administered via traditional chlorofluorocarbon metered-dose inhaler. The Asthma Quality of Life Questionnaire was completed at baseline and end point. Score changes, overall and for the 4 separate domains, were compared within and among the treatment groups.
    Results: A total of 720 of 725 patients completed a baseline Asthma Quality of Life Questionnaire and were included in the analyses. In both studies, all mean scores improved significantly from baseline with the fluticasone propionate-salmeterol combination, with significantly greater improvement in the overall score compared with salmeterol alone, fluticasone propionate alone, and placebo groups. Improvements with the combination were also clinically meaningful compared with changes with salmeterol and placebo in both studies and with fluticasone propionate in study 1.
    Conclusions: Treatment with combination fluticasone propionate and salmeterol delivered via hydrofluoroalkane metered-dose inhaler resulted in significantly greater improvements in asthma-related quality of life compared with individual components and placebo administered via traditional chlorofluorocarbon metered-dose inhaler.
    MeSH term(s) Administration, Inhalation ; Adult ; Aerosol Propellants/administration & dosage ; Albuterol/administration & dosage ; Albuterol/analogs & derivatives ; Androstadienes/administration & dosage ; Asthma/drug therapy ; Bronchodilator Agents/administration & dosage ; Double-Blind Method ; Drug Combinations ; Female ; Fluticasone ; Fluticasone-Salmeterol Drug Combination ; Humans ; Hydrocarbons, Fluorinated/administration & dosage ; Male ; Metered Dose Inhalers ; Quality of Life ; Salmeterol Xinafoate ; Surveys and Questionnaires ; Treatment Outcome ; United States
    Chemical Substances Aerosol Propellants ; Androstadienes ; Bronchodilator Agents ; Drug Combinations ; Fluticasone-Salmeterol Drug Combination ; Hydrocarbons, Fluorinated ; Salmeterol Xinafoate (6EW8Q962A5) ; Fluticasone (CUT2W21N7U) ; Albuterol (QF8SVZ843E) ; apaflurane (R40P36GDK6)
    Language English
    Publishing date 2009-04
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1228189-x
    ISSN 1534-4436 ; 1081-1206 ; 0003-4738
    ISSN (online) 1534-4436
    ISSN 1081-1206 ; 0003-4738
    DOI 10.1016/S1081-1206(10)60338-9
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    Uh III Zs.136: Show issues Location:
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  7. Article: Efficacy and safety of fluticasone propionate/salmeterol HFA 134A MDI in patients with mild-to-moderate persistent asthma.

    Pearlman, David S / Peden, David / Condemi, John J / Weinstein, Steven / White, Martha / Baitinger, Leslie / Scott, Catherine / Ho, Shu-Yen / House, Karen / Dorinsky, Paul

    The Journal of asthma : official journal of the Association for the Care of Asthma

    2004  Volume 41, Issue 8, Page(s) 797–806

    Abstract: The objective of this study was to compare the efficacy and safety of fluticasone propionate (FP) (44 microg)/salmeterol (21 microg) delivered as two inhalations twice daily via a single hydrofluoroalkane (HFA 134a) metered dose inhaler (MDI) (FSC) with ... ...

    Abstract The objective of this study was to compare the efficacy and safety of fluticasone propionate (FP) (44 microg)/salmeterol (21 microg) delivered as two inhalations twice daily via a single hydrofluoroalkane (HFA 134a) metered dose inhaler (MDI) (FSC) with that of placebo HFA 134a (PLA), fluticasone propionate 44 microg chlorofluorocarbon (CFC) alone and salmeterol 21 microg CFC alone (S) in patients (n=360) with persistent asthma previously treated with beta2-agonists (short- or long-acting) or inhaled corticosteroids (ICS). After 12 weeks of treatment, patients treated with FSC had a significantly greater increase (p < or = 0.006) in mean FEV1 AUC(bl) compared with PLA, FP, or S. At end point, mean change from baseline in morning predose FEV1 for FSC (0.58 L) was significantly (p < or = 0.004) greater than PLA (0.14 L), FP (0.36 L), and S (0.25 L). Patients treated with FSC also had a significantly higher probability of remaining in the study without being withdrawn due to worsening asthma (2%) compared with those in the PLA (29%) and S (25%) groups (p < 0.001). Finally, treatment with FSC resulted in significantly (p < or = 0.007) greater improvements in morning and evening peak expiratory flow, need for rescue albuterol, and asthma symptom scores compared with FP, S, and PLA. The safety profile of FSC was also similar to FP or S alone. Initial maintenance treatment of the two main components of asthma, inflammation, and smooth muscle dysfunction (e.g., bronchoconstriction), with FSC results in greater overall improvements in asthma control compared with treatment of either individual component alone.
    MeSH term(s) Adolescent ; Adult ; Aerosol Propellants ; Aged ; Aged, 80 and over ; Albuterol/adverse effects ; Albuterol/analogs & derivatives ; Albuterol/therapeutic use ; Androstadienes/adverse effects ; Androstadienes/therapeutic use ; Anti-Inflammatory Agents/adverse effects ; Anti-Inflammatory Agents/therapeutic use ; Area Under Curve ; Asthma/drug therapy ; Child ; Chlorofluorocarbons ; Double-Blind Method ; Drug Combinations ; Female ; Fluticasone-Salmeterol Drug Combination ; Humans ; Hydrocarbons, Fluorinated ; Male ; Metered Dose Inhalers ; Middle Aged ; Respiratory Function Tests
    Chemical Substances Aerosol Propellants ; Androstadienes ; Anti-Inflammatory Agents ; Chlorofluorocarbons ; Drug Combinations ; Fluticasone-Salmeterol Drug Combination ; Hydrocarbons, Fluorinated ; Albuterol (QF8SVZ843E) ; apaflurane (R40P36GDK6)
    Language English
    Publishing date 2004-11-10
    Publishing country England
    Document type Clinical Trial ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 603816-5
    ISSN 0277-0903
    ISSN 0277-0903
    DOI 10.1081/jas-200038368
    Database MEDical Literature Analysis and Retrieval System OnLINE

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