ID

44663

Beschreibung

Alendronate to Prevent Loss of Bronchoprotection in Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02230332

Link

https://clinicaltrials.gov/show/NCT02230332

Stichworte

Versionen (2)
  1. 10.04.16 10.04.16 -
  2. 27.09.21 27.09.21 -
Hochgeladen am

27. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Asthma NCT02230332

Englisch

Eligibility Asthma NCT02230332

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02230332
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical history consistent with moderate asthma for >1 year
Beschreibung

Moderate persistent asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C1960047
asthma is controlled with ics, with an fp dose ≤ 1000mcg/day and >100mcg/day (or equivalent)
Beschreibung

Asthma | inhaled steroids | Fluticasone propionate

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C2065041
UMLS CUI [3]
C0117996
able to perform reproducible spirometry according to ats criteria
Beschreibung

Ability Spirometry

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0037981
baseline fev1 ≥ 50% of predicted and ≥1l.
Beschreibung

FEV1

Datentyp

boolean

Alias
UMLS CUI [1]
C0748133
if fev1 <80%, a minimum 12% increase in fev1 post-bronchodilator or a mch pc20 ≤ 8 mg/ml
Beschreibung

FEV1 post bronchodilator | Methacholine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599594
UMLS CUI [2]
C0600370
if fev1 ≥80%, a mch pc20 ≤ 8 mg/ml
Beschreibung

FEV1 | Methacholine

Datentyp

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C0600370
salmeterol protected mch ≤ 16 mg/ml
Beschreibung

salmeterol | Methacholine

Datentyp

boolean

Alias
UMLS CUI [1]
C0073992
UMLS CUI [2]
C0600370
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled asthma, as suggested by an act score <18 while on high-dose ics (fp daily dose >500mcg or equivalent)
Beschreibung

Asthma Uncontrolled | Asthma control test score | inhaled steroids | Fluticasone propionate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C2733224
UMLS CUI [3]
C2065041
UMLS CUI [4]
C0117996
non-ics controller medication or laba use within 4 weeks of study entry.
Beschreibung

inhaled steroids | Adrenergic beta-2 Receptor Agonists

Datentyp

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C2936789
contraindications to use of bisphosphonates: history of intolerance to bisphosphonates, history of esophageal ulcers, history of hematemesis, uncontrolled gastro-esophageal reflux disease, inability to stay erect for 30 minutes after oral drug, history of osteonecrosis of the jaw, dental extraction or root canal in prior 8 weeks, or anticipated during the study
Beschreibung

contraindications Diphosphonates | intolerance to substance Diphosphonates | Ulcer of esophagus | Hematemesis | Gastroesophageal reflux disease Uncontrolled | Oral drug preparation | Aseptic necrosis of bone of jaw | Tooth Extraction | Root Canal Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079164
UMLS CUI [1,2]
C0012544
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0012544
UMLS CUI [3]
C0151970
UMLS CUI [4]
C0018926
UMLS CUI [5,1]
C0017168
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0304289
UMLS CUI [7]
C2711248
UMLS CUI [8]
C0040440
UMLS CUI [9]
C0035849
calculated gfr of less than 35 ml/min
Beschreibung

Glomerular Filtration Rate Calculated (procedure)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017654
UMLS CUI [1,2]
C0444686
history of smoking (cigarettes, cigars, pipes, marijuana or any other substances) within the past 1 year, or > 10 pack-years total if ≥ 18 years of age
Beschreibung

Smoking History | Cigarette | Cigars | smoking pipe | Marihuana | smoking cigarettes: ____ pack-years history | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C0677453
UMLS CUI [3]
C0678446
UMLS CUI [4]
C0240766
UMLS CUI [5]
C0024808
UMLS CUI [6]
C2230126
UMLS CUI [7]
C0001779
systemic corticosteroid treatment for any condition within 4 weeks of enrollment at visit 1, history of significant asthma exacerbation requiring systemic corticosteroids within 4 weeks of visit 1 or more than five courses of systemic corticosteroids in the past year, history of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years
Beschreibung

Exacerbation of asthma | Therapeutic procedure systemic steroids | Exacerbation of asthma Life Threatening | Intubation | Mechanical ventilation | Hypoxic convulsions

Datentyp

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2825233
UMLS CUI [3,1]
C0349790
UMLS CUI [3,2]
C2826244
UMLS CUI [4]
C0021925
UMLS CUI [5]
C0199470
UMLS CUI [6]
C1843573
history of a respiratory tract infection within 4 weeks of visit 1
Beschreibung

Respiratory Tract Infections

Datentyp

boolean

Alias
UMLS CUI [1]
C0035243
receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment
Beschreibung

hypersensitivity desensitization Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0178702
UMLS CUI [1,2]
C0549178
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Ähnliche Modelle

Eligibility Asthma NCT02230332

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02230332
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Moderate persistent asthma
Item
clinical history consistent with moderate asthma for >1 year
boolean
C1960047 (UMLS CUI [1])
Asthma | inhaled steroids | Fluticasone propionate
Item
asthma is controlled with ics, with an fp dose ≤ 1000mcg/day and >100mcg/day (or equivalent)
boolean
C0004096 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C0117996 (UMLS CUI [3])
Ability Spirometry
Item
able to perform reproducible spirometry according to ats criteria
boolean
C0085732 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
FEV1
Item
baseline fev1 ≥ 50% of predicted and ≥1l.
boolean
C0748133 (UMLS CUI [1])
FEV1 post bronchodilator | Methacholine
Item
if fev1 <80%, a minimum 12% increase in fev1 post-bronchodilator or a mch pc20 ≤ 8 mg/ml
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
C0600370 (UMLS CUI [2])
FEV1 | Methacholine
Item
if fev1 ≥80%, a mch pc20 ≤ 8 mg/ml
boolean
C0748133 (UMLS CUI [1])
C0600370 (UMLS CUI [2])
salmeterol | Methacholine
Item
salmeterol protected mch ≤ 16 mg/ml
boolean
C0073992 (UMLS CUI [1])
C0600370 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Asthma Uncontrolled | Asthma control test score | inhaled steroids | Fluticasone propionate
Item
uncontrolled asthma, as suggested by an act score <18 while on high-dose ics (fp daily dose >500mcg or equivalent)
boolean
C0004096 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C2733224 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
C0117996 (UMLS CUI [4])
inhaled steroids | Adrenergic beta-2 Receptor Agonists
Item
non-ics controller medication or laba use within 4 weeks of study entry.
boolean
C2065041 (UMLS CUI [1])
C2936789 (UMLS CUI [2])
contraindications Diphosphonates | intolerance to substance Diphosphonates | Ulcer of esophagus | Hematemesis | Gastroesophageal reflux disease Uncontrolled | Oral drug preparation | Aseptic necrosis of bone of jaw | Tooth Extraction | Root Canal Therapy
Item
contraindications to use of bisphosphonates: history of intolerance to bisphosphonates, history of esophageal ulcers, history of hematemesis, uncontrolled gastro-esophageal reflux disease, inability to stay erect for 30 minutes after oral drug, history of osteonecrosis of the jaw, dental extraction or root canal in prior 8 weeks, or anticipated during the study
boolean
C0079164 (UMLS CUI [1,1])
C0012544 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0012544 (UMLS CUI [2,2])
C0151970 (UMLS CUI [3])
C0018926 (UMLS CUI [4])
C0017168 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0304289 (UMLS CUI [6])
C2711248 (UMLS CUI [7])
C0040440 (UMLS CUI [8])
C0035849 (UMLS CUI [9])
Glomerular Filtration Rate Calculated (procedure)
Item
calculated gfr of less than 35 ml/min
boolean
C0017654 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
Smoking History | Cigarette | Cigars | smoking pipe | Marihuana | smoking cigarettes: ____ pack-years history | Age
Item
history of smoking (cigarettes, cigars, pipes, marijuana or any other substances) within the past 1 year, or > 10 pack-years total if ≥ 18 years of age
boolean
C1519384 (UMLS CUI [1])
C0677453 (UMLS CUI [2])
C0678446 (UMLS CUI [3])
C0240766 (UMLS CUI [4])
C0024808 (UMLS CUI [5])
C2230126 (UMLS CUI [6])
C0001779 (UMLS CUI [7])
Exacerbation of asthma | Therapeutic procedure systemic steroids | Exacerbation of asthma Life Threatening | Intubation | Mechanical ventilation | Hypoxic convulsions
Item
systemic corticosteroid treatment for any condition within 4 weeks of enrollment at visit 1, history of significant asthma exacerbation requiring systemic corticosteroids within 4 weeks of visit 1 or more than five courses of systemic corticosteroids in the past year, history of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years
boolean
C0349790 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2825233 (UMLS CUI [2,2])
C0349790 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
C0021925 (UMLS CUI [4])
C0199470 (UMLS CUI [5])
C1843573 (UMLS CUI [6])
Respiratory Tract Infections
Item
history of a respiratory tract infection within 4 weeks of visit 1
boolean
C0035243 (UMLS CUI [1])
hypersensitivity desensitization Continuous
Item
receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment
boolean
C0178702 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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