subjects will have Global Initiative for Asthma (GINA 2006) clinical features of uncontrolled asthma despite treatment with a minimum dose of 800 µg beclomethasone dipropionate or equivalent inhaled corticosteroid per day plus one or more additional controller i.e. long-acting b-agonist, leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as additional treatment at any dose are acceptable. The dose of inhaled and oral corticosteroids must have been stable within 4 weeks preceding Visit 1 (screening visit) and will be expected to remain stable for the duration of the study. If subjects are on single inhaler combination products at Visit 1 (e.g. fluticasone/salmeterol - Advair/Seretide or Symbicort (budesonide/formoterol) SMART) they must receive the two components as two separate inhaler medications for the purpose of the trial. This will facilitate withholding the long-acting b-agonist component before lung function and challenge testing (see Section 9.5.7). The GINA 2006 [14] levels of asthma control and treatment are described in Appendix 3.
subjects will have Global Initiative for Asthma (GINA 2006) clinical features of uncontrolled asthma despite treatment with a minimum dose of 800 µg beclomethasone dipropionate or equivalent inhaled corticosteroid per day plus one or more additional controller i.e. long-acting b-agonist, leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as additional treatment at any dose are acceptable. The dose of inhaled and oral corticosteroids must have been stable within 4 weeks preceding Visit 1 (screening visit) and will be expected to remain stable for the duration of the study. If subjects are on single inhaler combination products at Visit 1 (e.g. fluticasone/salmeterol - Advair/Seretide or Symbicort (budesonide/formoterol) SMART) they must receive the two components as two separate inhaler medications for the purpose of the trial. This will facilitate withholding the long-acting b-agonist component before lung function and challenge testing (see Section 9.5.7). The GINA 2006 [14] levels of asthma control and treatment are described in Appendix 3.
C0681850 (UMLS CUI 2011AA)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0004096 (UMLS CUI 2011AA)
195967001 (SNOMED CT 2011_0131)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C2698651 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C2348867 (UMLS CUI 2011AA)
C0424093 (UMLS CUI 2011AA)
247756008 (SNOMED CT 2011_0131)
C0004096 (UMLS CUI 2011AA)
195967001 (SNOMED CT 2011_0131)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2348519 (UMLS CUI 2011AA)
C1524031 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0004906 (UMLS CUI 2011AA)
116575004 (SNOMED CT 2011_0131)
MTHU017342 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
CL426883 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0332173 (UMLS CUI 2011AA)
69620002 (SNOMED CT 2011_0131)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0205166 (UMLS CUI 2011AA)
255511005 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0001644 (UMLS CUI 2011AA)
373227004 (SNOMED CT 2011_0131)
C0595726 (UMLS CUI 2011AA)
372517002 (SNOMED CT 2011_0131)
C0039771 (UMLS CUI 2011AA)
372810006 (SNOMED CT 2011_0131)
MTHU004269 (LOINC Version 232)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
C0681850 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0021461 (UMLS CUI 2011AA)
334980009 (SNOMED CT 2011_0131)
INH (HL7 V3 2006_05)
C1947911 (UMLS CUI 2011AA)
C1514468 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0082607 (UMLS CUI 2011AA)
397192001 (SNOMED CT 2011_0131)
C0073992 (UMLS CUI 2011AA)
372515005 (SNOMED CT 2011_0131)
C0965130 (UMLS CUI 2011AA)
C1130494 (UMLS CUI 2011AA)
C1121854 (UMLS CUI 2011AA)
C0054201 (UMLS CUI 2011AA)
395726003 (SNOMED CT 2011_0131)
MTHU017344 (LOINC Version 232)
C0060657 (UMLS CUI 2011AA)
414289007 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1705248 (UMLS CUI 2011AA)
C0443299 (UMLS CUI 2011AA)
263869007 (SNOMED CT 2011_0131)
C0021461 (UMLS CUI 2011AA)
334980009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0024119 (UMLS CUI 2011AA)
23426006 (SNOMED CT 2011_0131)
10025099 (MedDRA 14.1)
MTHU029811 (LOINC Version 232)
C1315011 (UMLS CUI 2011AA)
MTHU000047 (LOINC Version 232)