ID

39274

Description

Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01070888

Link

https://clinicaltrials.gov/show/NCT01070888

Keywords

Versions (1)
  1. 12/16/19 12/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Exercise Induced Asthma NCT01070888

English

Eligibility Exercise Induced Asthma NCT01070888

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients aged 12 to 50 years with a diagnosis of asthma for at least 6 months before screening
Description

Age | Asthma Disease length

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C0872146
baseline fev1 of 60% to >100% of predicted
Description

Percent predicted FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0730561
demonstrate a decrease in fev1 of 15% or greater from baseline after standardized stepped exercise challenge testing
Description

FEV1 decreased Percentage | Status post Exercise challenge

Data type

boolean

Alias
UMLS CUI [1,1]
C4272903
UMLS CUI [1,2]
C0439165
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1293901
taking a constant dose of low-medium dose inhaled steroids for at least 30 days before screening of either:
Description

Inhaled steroids Low dose Medium

Data type

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C0445550
UMLS CUI [1,3]
C0439536
1. fluticasone, 88 - 440 mcg/d via mdi or 100 to 500 mcg/d via dpi
Description

Fluticasone Dose Metered Dose U/day Inhaler | Fluticasone Dose U/day Dry Powder Inhaler

Data type

boolean

Alias
UMLS CUI [1,1]
C0082607
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
UMLS CUI [1,4]
C0993596
UMLS CUI [2,1]
C0082607
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
UMLS CUI [2,4]
C1967611
2. beclomethasone hfa 80 to 480 mcg/day
Description

Beclomethasone Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0004905
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
3. budesonide dpi 180 to 1200 mcg/ d
Description

Budesonide Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0054201
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
4. flunisolide 500 to 2000 mcg/d
Description

Flunisolide Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0060501
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
5. flunisolide hfa 320 to 640 mcg/d
Description

Flunisolide HFA Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C1569761
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
6. mometasone 200 to 800 mcg/d
Description

Mometasone Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0360564
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
7. triamcinolone acetonide 300 to 1500 mcg/ d
Description

Triamcinolone Acetonide Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0040866
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients already on labas, systemic corticosteroids, or other combination inhaled steroids/laba medications.
Description

Adrenergic beta-Agonists Long-term Active | CORTICOSTEROIDS FOR SYSTEMIC USE | Combined Modality Therapy | inhaled steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0001644
UMLS CUI [1,2]
C0443252
UMLS CUI [1,3]
C0205177
UMLS CUI [2]
C3653708
UMLS CUI [3]
C0009429
UMLS CUI [4]
C2065041
patients not able to safely complete an exercise challenge due to physical constraints outside of their respiratory status.
Description

Exercise challenge Completion Unable | Etiology Constraint Physical

Data type

boolean

Alias
UMLS CUI [1,1]
C1293901
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0443288
UMLS CUI [2,3]
C0205485
patients who are pregnant or plan to become pregnant during the study period.
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
patients with a history of hypersensitivity reaction to either formoterol or budesonide.
Description

Allergic Reaction Formoterol | Budesonide allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0060657
UMLS CUI [2]
C0571620
patients with any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study.
Description

Disease Study Subject Participation Status At risk | Disease Influence Research results | Disease Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0439801
patients with planned hospitalization during the study
Description

Hospitalization Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1301732
current smokers or those with a history of 10 pack years of tobacco use or more.
Description

Tobacco use | Smoking cigarettes: ____ pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C2230126
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Similar models

Eligibility Exercise Induced Asthma NCT01070888

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Asthma Disease length
Item
male or female patients aged 12 to 50 years with a diagnosis of asthma for at least 6 months before screening
boolean
C0001779 (UMLS CUI [1])
C0004096 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Percent predicted FEV1
Item
baseline fev1 of 60% to >100% of predicted
boolean
C0730561 (UMLS CUI [1])
FEV1 decreased Percentage | Status post Exercise challenge
Item
demonstrate a decrease in fev1 of 15% or greater from baseline after standardized stepped exercise challenge testing
boolean
C4272903 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1293901 (UMLS CUI [2,2])
Inhaled steroids Low dose Medium
Item
taking a constant dose of low-medium dose inhaled steroids for at least 30 days before screening of either:
boolean
C2065041 (UMLS CUI [1,1])
C0445550 (UMLS CUI [1,2])
C0439536 (UMLS CUI [1,3])
Fluticasone Dose Metered Dose U/day Inhaler | Fluticasone Dose U/day Dry Powder Inhaler
Item
1. fluticasone, 88 - 440 mcg/d via mdi or 100 to 500 mcg/d via dpi
boolean
C0082607 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0993596 (UMLS CUI [1,4])
C0082607 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C1967611 (UMLS CUI [2,4])
Beclomethasone Dose U/day
Item
2. beclomethasone hfa 80 to 480 mcg/day
boolean
C0004905 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Budesonide Dose U/day
Item
3. budesonide dpi 180 to 1200 mcg/ d
boolean
C0054201 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Flunisolide Dose U/day
Item
4. flunisolide 500 to 2000 mcg/d
boolean
C0060501 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Flunisolide HFA Dose U/day
Item
5. flunisolide hfa 320 to 640 mcg/d
boolean
C1569761 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Mometasone Dose U/day
Item
6. mometasone 200 to 800 mcg/d
boolean
C0360564 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Triamcinolone Acetonide Dose U/day
Item
7. triamcinolone acetonide 300 to 1500 mcg/ d
boolean
C0040866 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Adrenergic beta-Agonists Long-term Active | CORTICOSTEROIDS FOR SYSTEMIC USE | Combined Modality Therapy | inhaled steroids
Item
patients already on labas, systemic corticosteroids, or other combination inhaled steroids/laba medications.
boolean
C0001644 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,3])
C3653708 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C2065041 (UMLS CUI [4])
Exercise challenge Completion Unable | Etiology Constraint Physical
Item
patients not able to safely complete an exercise challenge due to physical constraints outside of their respiratory status.
boolean
C1293901 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0443288 (UMLS CUI [2,2])
C0205485 (UMLS CUI [2,3])
Pregnancy | Pregnancy, Planned
Item
patients who are pregnant or plan to become pregnant during the study period.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Allergic Reaction Formoterol | Budesonide allergy
Item
patients with a history of hypersensitivity reaction to either formoterol or budesonide.
boolean
C1527304 (UMLS CUI [1,1])
C0060657 (UMLS CUI [1,2])
C0571620 (UMLS CUI [2])
Disease Study Subject Participation Status At risk | Disease Influence Research results | Disease Study Subject Participation Status Limited
Item
patients with any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study.
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
Hospitalization Planned
Item
patients with planned hospitalization during the study
boolean
C0019993 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Tobacco use | Smoking cigarettes: ____ pack-years history
Item
current smokers or those with a history of 10 pack years of tobacco use or more.
boolean
C0543414 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
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