Tag: Efficacy

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Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects

Condition:   Asthma
Interventions:   Drug: Fluticasone furoate (FF) Dry Powder Inhaler;   Drug: Fluticasone propionate (FP) Dry Powder Inhaler;   Drug: Budesonide (BUD) Turbuhaler;   Drug: Placebo (ELLIPTA or DISKUS)
Sponsor:   GlaxoSmithKline
Not yet recruiting – verified December 2016

View full post on ClinicalTrials.gov: asthma | Studies received in the last 14 days

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Efficacy and Safety Study of Mepolizumab in Subjects With Severe Hypereosinophilic Syndrome (HES)

Condition:   Hypereosinophilic Syndrome
Interventions:   Drug: Mepolizumab 300 mg;   Drug: Placebo matching mepolizumab;   Drug: Active OCS capsules (5 mg prednisolone or prednisone);   Drug: Placebo matching OCS capsules
Sponsor:   GlaxoSmithKline
Not yet recruiting – verified July 2016

View full post on ClinicalTrials.gov: asthma | Studies received in the last 14 days

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Study of Safety and Efficacy of Mometasone Furoate Used in Combination With Formoterol Fumarate Compared With Mometasone Furoate in Children (5 to 11 Years of Age) With Persistent Asthma (MK-0887A-087)

Condition:   Asthma
Interventions:   Drug: MK-0887A 100/10 mcg;   Drug: MK-0887 100 mcg;   Drug: Albuterol/Salbutamol;   Drug: Prednisone/Prednisolone
Sponsor:   Merck Sharp & Dohme Corp.
Not yet recruiting – verified April 2016

View full post on ClinicalTrials.gov: asthma | received in the last 14 days

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Effect of smoking status on the efficacy of the SMART regimen in high risk asthma.

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Effect of smoking status on the efficacy of the SMART regimen in high risk asthma.

Respirology. 2016 Feb 21;

Authors: Pilcher J, Patel M, Reddel HK, Pritchard A, Black P, Shaw D, Holt S, Weatherall M, Beasley R

Abstract
BACKGROUND AND OBJECTIVE: The optimal management of people with asthma with a significant smoking history is uncertain. The aim of this study was to determine whether the efficacy/safety profile of single combination inhaled corticosteroid (ICS)/long acting beta-agonist (LABA) inhaler maintenance and reliever therapy is influenced by smoking status.
METHODS: We undertook secondary analyses from an open-label 24-week randomized study of 303 high risk adult asthma patients randomized to budesonide/formoterol 200/6-µg-metred dose inhaler for maintenance (two actuations twice daily) and either budesonide/formoterol 200/6-µg-metred dose inhaler one actuation (‘single ICS/LABA maintenance and reliever therapy (SMART)’ regimen) or salbutamol 100?µg 1-2 actuations for symptom relief (‘Standard’ regimen). Smoking status was classified in to three groups, as ‘current’, ‘ex’ or ‘never’, and a smoking/treatment interaction term tested for each outcome variable. The primary outcome variable was number of participants with at least one severe exacerbation.
RESULTS: There were 59 current, 97 ex and 147 never smokers included in the analyses. The smoking status/treatment interaction term was not statistically significant for any of the outcome measures. With adjustment for smoking status, the number of participants with severe exacerbations was lower with the SMART regimen (OR 0.45, 95% CI: 0.26-0.77, P?=?0.004; P value for interaction between smoking status and treatment 0.29).
CONCLUSION: We conclude that the favourable safety/efficacy profile of the SMART regimen applies to patients with high risk asthma, irrespective of smoking status.

PMID: 26897389 [PubMed – as supplied by publisher]

View full post on pubmed: asthma