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40 results on '"Brealey, Noushin"'

8. Reply to Suissa and Ariel: The FULFIL Trial

Author

Lipson, David A., Barnacle, Helen, Birk, Ruby, Brealey, Noushin, Locantore, Nicholas, Lomas, David A., Ludwig-Sengpiel, Andrea, Mohindra, Rajat, Tabberer, Maggie, Zhu, Chang-Qing, and Pascoe, Steven J.

Published
2018
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12. Late Breaking Abstract - Dose responses for topical efficacy and systemic activity, dose equivalence and relative therapeutic index for fluticasone furoate (FF), fluticasone propionate (FP) and budesonide (BUD) in asthmatic subjects

Author

Daley-Yates, Peter, primary, Brealey, Noushin, additional, Kumar, Bharath, additional, Thomas, Sebin, additional, Austin, Daren, additional, Shabbir, Shaila, additional, Harrison, Tim, additional, Singh, Dave, additional, and Barnes, Neil, additional

Published
2019
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13. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD

Author

Lipson, David A., Barnhart, Frank, Brealey, Noushin, Brooks, Jean, Criner, Gerard J., Day, Nicola C., Dransfield, Mark T., Halpin, David M. G., Han, MeiLan K., Jones, C. Elaine, Kilbride, Sally, Lange, Peter, Lomas, David A., Martinez, Fernando J., Singh, Dave, Tabberer, Maggie, Wise, Robert A., Pascoe, Steven J., Lipson, David A., Barnhart, Frank, Brealey, Noushin, Brooks, Jean, Criner, Gerard J., Day, Nicola C., Dransfield, Mark T., Halpin, David M. G., Han, MeiLan K., Jones, C. Elaine, Kilbride, Sally, Lange, Peter, Lomas, David A., Martinez, Fernando J., Singh, Dave, Tabberer, Maggie, Wise, Robert A., and Pascoe, Steven J.

Published
2018

14. Therapeutic index of inhaled corticosteroids in asthma: A dose–response comparison on airway hyperresponsiveness and adrenal axis suppression.

Author

Daley‐Yates, Peter, Brealey, Noushin, Thomas, Sebin, Austin, Daren, Shabbir, Shaila, Harrison, Tim, Singh, Dave, and Barnes, Neil

Subjects
*FLUTICASONE propionate, *CORTICOSTEROIDS, *ASTHMA, *GLUCOCORTICOID receptors, *HYDROCORTISONE, *FLUTICASONE, *BRONCHIAL spasm
Abstract

Aims: To compare the airway potency, systemic activity and therapeutic index of three inhaled corticosteroids that differ in glucocorticoid receptor binding affinity, physicochemical and pharmacokinetic properties. Methods: This escalating‐dose, placebo‐controlled, cross‐over study randomised adults with asthma to 1 or 2 treatment periods with ≥25 days washout in‐between. Each treatment period comprised five 7‐day dose escalations (μg/d): fluticasone furoate (FF; 25 → 100 → 200 → 400 → 800), fluticasone propionate (FP; 50 → 200 → 500 → 1000 → 2000), budesonide (BUD; 100 → 400 → 800 → 1600 → 3200) or placebo. Airway hyperresponsiveness to adenosine‐5'‐monophosphate (AMP PC20) was assessed on day 8. Plasma cortisol was assessed on day 1 (predose baseline) and from pre‐PM dose on day 6 to pre‐PM dose day 7 (24‐h weighted mean). Results: Fifty‐four subjects were randomised. FF showed greater airway potency than FP and BUD (AMP PC20 dose at which 50% of the maximum effect is achieved [ED50] values: 48.52, 1081.27 and 1467.36 μg/d, respectively). Systemic activity (cortisol suppression) ED50 values were 899.99, 1986.05 and 1927.42 μg/d, respectively. The therapeutic index (ED50 cortisol suppression/ED50 AMP PC20) was wider for FF (18.55) than FP (1.84) and BUD (1.31). FF 100 μg/d and 200 μg/d were both comparable in terms of airway potency with high doses of FP (≥1000 μg twice daily [BID]) and BUD (≥1500 μg/BID). The systemic activity of FF 100 μg/d and 200 μg/d (cortisol suppression: 7.41% and 14.28%, respectively) was comparable with low doses of FP (100 μg/BID and 250 μg/BID) and BUD (100 μg/BID and 200 μg/BID). Conclusion: This study provides evidence that FF can provide more protection against airway hyperresponsiveness, with less systemic activity, than FP or BUD. This suggests that all inhaled corticosteroids are not therapeutically similar and may differ in their therapeutic index. (203162; NCT02991859). [ABSTRACT FROM AUTHOR]

Published
2021
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16. Comparison of LAMA/LABA vs ICS/LABA in high risk COPD patients: Pre-specified analysis on lung function and health status from the IMPACT trial

Author

Lipson, David A, primary, Barnhart, Frank, additional, Boucot, Isabelle, additional, Crim, Courtney, additional, Brealey, Noushin, additional, Criner, Gerard J, additional, Dransfield, Mark, additional, Halpin, David M.G, additional, Kilbride, Sally, additional, Han, Meilan K, additional, Lange, Peter, additional, Lomas, David A, additional, Martinez, Fernando J, additional, Singh, Dave, additional, Naya, Ian Naya, additional, Jones, Christine Elaine, additional, and Wise, Robert, additional

Published
2018
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17. FF/UMEC/VI versus FF/VI and UMEC/VI in the ELLIPTA device in patients with COPD: Subgroup analyses from the IMPACT trial

Author

Singh, Dave, primary, Barnhart, Frank, additional, Brealey, Noushin, additional, Criner, Gerard, additional, Dransfield, Mark, additional, Halpin, David M G, additional, Han, Meilan K, additional, Jones, C Elaine, additional, Kilbride, Sally, additional, Lange, Peter, additional, Lomas, David A, additional, Martinez, Fernando J, additional, Mouneimne, Dalal, additional, Wise, Robert, additional, and Lipson, David A, additional

Published
2018
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18. Exacerbation outcomes with LAMA/LABA and ICS/LABA in high risk COPD patients in the IMPACT trial

Author

Lipson, David A, primary, Barnhart, Frank, additional, Boucot, Isabelle, additional, Crim, Courtney, additional, Brealey, Noushin, additional, Criner, Gerard J, additional, Dransfield, Mark, additional, Halpin, David M.G, additional, Kilbride, Sally, additional, Han, Meilan K, additional, Lange, Peter, additional, Lomas, David A, additional, Martinez, Fernando J, additional, Singh, Dave, additional, Naya, Ian Naya, additional, Jones, Christine Elaine, additional, and Wise, Robert, additional

Published
2018
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20. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD

Author

Lipson, David A., primary, Barnhart, Frank, additional, Brealey, Noushin, additional, Brooks, Jean, additional, Criner, Gerard J., additional, Day, Nicola C., additional, Dransfield, Mark T., additional, Halpin, David M.G., additional, Han, MeiLan K., additional, Jones, C. Elaine, additional, Kilbride, Sally, additional, Lange, Peter, additional, Lomas, David A., additional, Martinez, Fernando J., additional, Singh, Dave, additional, Tabberer, Maggie, additional, Wise, Robert A., additional, and Pascoe, Steven J., additional

Published
2018
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21. Reply to Morice and Hart: Increased Propensity for Pneumonia with Fluticasone in Chronic Obstructive Pulmonary Disease

Author

Lipson, David A., primary, Barnacle, Helen, additional, Birk, Ruby, additional, Brealey, Noushin, additional, Locantore, Nicholas, additional, Lomas, David A., additional, Ludwig-Sengpiel, Andrea, additional, Mohindra, Rajat, additional, Tabberer, Maggie, additional, Zhu, Chang-Qing, additional, and Pascoe, Steven J., additional

Published
2018
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35. Effect of Disease Severity in Asthma and Chronic Obstructive Pulmonary Disease on Inhaler-Specific Inhalation Profiles Through the ELLIPTA® Dry Powder Inhaler

Author

Prime, David, primary, de Backer, Wilfried, additional, Hamilton, Melanie, additional, Cahn, Anthony, additional, Preece, Andrew, additional, Kelleher, Dennis, additional, Baines, Amanda, additional, Moore, Alison, additional, Brealey, Noushin, additional, and Moynihan, Jackie, additional

Published
2015
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37. Effect of severe renal impairment on umeclidinium and umeclidinium/vilanterol pharmacokinetics and safety: a single-blind, nonrandomized study

Author

Mehta,Rashmi, Hardes,Kelly, Brealey,Noushin, Tombs,Lee, Preece,Andrew, Kelleher,Dennis, Mehta,Rashmi, Hardes,Kelly, Brealey,Noushin, Tombs,Lee, Preece,Andrew, and Kelleher,Dennis

Abstract

Rashmi Mehta,1 Kelly Hardes,2 Noushin Brealey,3 Lee Tombs,4 Andrew Preece,2 Dennis Kelleher1 1Respiratory Medicines Development Center, GSK, Research Triangle Park, NC, USA; 2Clinical Pharmacology Science and Study Operations, 3Respiratory Medicines Development Centre, GSK, Stockley Park, UK; 4Statistics and Programming, Synergy, Slough, Berkshire, UKBackground: Umeclidinium and vilanterol, long-acting bronchodilators for the treatment of chronic obstructive pulmonary disease, are primarily eliminated via the hepatic route; however, severe renal impairment may adversely affect some elimination pathways other than the kidney.Objectives: To evaluate the effect of severe renal impairment on the pharmacokinetics of umeclidinium and umeclidinium/vilanterol.Methods: Nine patients with severe renal impairment (creatinine clearance <30 mL/min) and nine matched healthy volunteers received a single dose of umeclidinium 125 µg; and after a 7- to 14-day washout, a single dose of umeclidinium/vilanterol 125/25 µg.Results: No clinically relevant increases in plasma umeclidinium or vilanterol systemic exposure (area under the curve or maximum observed plasma concentration) were observed following umeclidinium 125 µg or umeclidinium/vilanterol 125/25 µg administration. On average, the amount of umeclidinium excreted in 24 hours in urine (90% confidence interval) was 88% (81%–93%) and 89% (81%–93%) lower in patients with severe renal impairment compared with healthy volunteers following umeclidinium 125 µg and umeclidinium/vilanterol 125/25 µg administration, respectively. Treatments were well tolerated in both populations.Conclusion: Umeclidinium 125 µg or umeclidinium/vilanterol 125/25 µg administration to patients with severe renal impairment did not demonstrate clinically relevant increases in systemic exposure compared with healthy volunteers. No dose adjustment f

Published
2014

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