ID

14507

Beschreibung

Study to Evaluate Small Airway Parameters of Fluticasone/Formoterol (Flutiform®) Compared to Fluticasone/Salmeterol in Asthma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02491970

Link

https://clinicaltrials.gov/show/NCT02491970

Stichworte

Versionen (1)
  1. 19.04.16 19.04.16 -
Hochgeladen am

19. April 2016

DOI

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Eligibility Asthma NCT02491970

Englisch

Eligibility Asthma NCT02491970

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02491970
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adult (over 19 years) asthma patients
Beschreibung

Asthma | Adult

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0001675
2. patients who have a history of mild-to-moderate-severe, persistent asthma for at least 6 months prior to screening.
Beschreibung

Mild persistent asthma | Moderate persistent asthma | Severe persistent asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C1960046
UMLS CUI [2]
C1960047
UMLS CUI [3]
C1960048
3. patients who were required to demonstrate a fev1 of ≥ 40 % and ≤ 85% of predicted normal values during screening period following appropriate withholding of asthma medications (if applicable).
Beschreibung

FEV1 | Pharmaceutical Preparations Asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0004096
4. patients who were required to show reversibility of ≥15% fev1 after salbutamol inhalation (2 actuations, 100µg per actuation) from the pre- salbutamol value at screening
Beschreibung

Forced Expiratory Volume in 1 Second Reversibility | Inhaled albuterol preparation

Datentyp

boolean

Alias
UMLS CUI [1]
C3830088
UMLS CUI [2]
C0354688
5. patients who have uncontrolled asthma by seretide® 250/50 defined as act less than 20
Beschreibung

Uncontrolled Asthma | Seretide | Asthma control test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205318
UMLS CUI [1,2]
C0004096
UMLS CUI [2]
C1130494
UMLS CUI [3]
C2733011
6. patients who showed r5-20 more than 0.1 kpa/l/s
Beschreibung

Small airways

Datentyp

boolean

Alias
UMLS CUI [1]
C1862763
7. blood eosinophil count > 300/µl on screening visit
Beschreibung

Eosinophil count procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0200638
8. female patients of childbearing potential must have a negative urine pregnancy test at screening.
Beschreibung

Childbearing Potential | Urine pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0430057
9. patients who are able to use the inhaler
Beschreibung

Ability Use of Inhaler

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0021461
10. patients who is willing to voluntarily sign the study consent form
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have experienced life-threatening asthma within 12 months prior to screening or respiratory infection within 4 weeks prior to screening, or patients who have experienced any emergency visit or hospitalization due to acute asthma symptoms within 4 weeks prior to screening
Beschreibung

Asthma Life Threatening | Respiratory Tract Infections | emergency visit Asthma | Hospitalization Asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0035243
UMLS CUI [3,1]
C0553618
UMLS CUI [3,2]
C0004096
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C0004096
2. patients who have diagnosed as clinically significant disease or non- reversible pulmonary disease or patients who currently have active pulmonary disease (eg. copd, cystic fibrosis, bronchiectasis, active tuberculosis)
Beschreibung

Disease | Lung diseases | Chronic Obstructive Airway Disease | Cystic Fibrosis | Bronchiectasis | Tuberculosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0024117
UMLS CUI [4]
C0010674
UMLS CUI [5]
C0006267
UMLS CUI [6]
C0041296
3. patients who have diagnosed as laryngitis, chronic sinusitis, infectious rhinitis or allergic rhinitis within 4 weeks prior to screening, or patients who have had any symptoms of acute exacerbation or purulent discharge by the disease above within 2 weeks prior to screening
Beschreibung

Laryngitis | Chronic sinusitis | Common Cold | Allergic rhinitis | Patient Outcome - Worsening | Purulent discharge

Datentyp

boolean

Alias
UMLS CUI [1]
C0023067
UMLS CUI [2]
C0149516
UMLS CUI [3]
C0009443
UMLS CUI [4]
C2607914
UMLS CUI [5]
C1546960
UMLS CUI [6]
C0333274
4. current smoker or past smoker defined as below:
Beschreibung

Current Smoker | Former smoker

Datentyp

boolean

Alias
UMLS CUI [1]
C3241966
UMLS CUI [2]
C0337671
current smoker: smoking history within 12 months prior to screening
Beschreibung

Current Smoker Smoking History

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3241966
UMLS CUI [1,2]
C1519384
past smoker: smoking amount ≥10 pack year*
Beschreibung

Former smoker Smoking cigarettes: ____ pack-years history

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C2230126
pack year (py) calculation: average amount of smoking per day (pack) x duration of smoking (year)
Beschreibung

Pack years Calculation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277691
UMLS CUI [1,2]
C1441506
5. patients who currently are pregnant or lactating
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. patient who had taken systemic corticosteroid within 4 weeks prior to screening
Beschreibung

systemic steroids

Datentyp

boolean

Alias
UMLS CUI [1]
C2825233
7. patients who had taken omalizumab within 24 weeks prior to screening
Beschreibung

omalizumab

Datentyp

boolean

Alias
UMLS CUI [1]
C0966225
8. patients who had taken the following medications within 1 week prior to screening:
Beschreibung

Following Pharmaceutical Preparations

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332282
UMLS CUI [1,2]
C0013227
potent cyp3a inhibitors
Beschreibung

Cytochrome P-450 CYP3A Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C3850056
β-blockers
Beschreibung

Adrenergic beta-Antagonists

Datentyp

boolean

Alias
UMLS CUI [1]
C0001645
monoamine oxidase inhibitor
Beschreibung

Monoamine Oxidase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0026457
tca (tricyclic antidepressants)
Beschreibung

Tricyclic Antidepressive Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0003290
quinidine-type anti arrhythmic
Beschreibung

Anti-Arrhythmia Agents Quinidine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0034414
leukotriene anatagonist
Beschreibung

Leukotriene Antagonists

Datentyp

boolean

Alias
UMLS CUI [1]
C0595726
astemizole
Beschreibung

Astemizole

Datentyp

boolean

Alias
UMLS CUI [1]
C0085170
9. patients who are participating or going to participate in any interventional clinical trials
Beschreibung

Study Subject Participation Status | Interventional Study

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
10. qt interval prolongation in ecg result at screening
Beschreibung

Prolonged QT interval

Datentyp

boolean

Alias
UMLS CUI [1]
C0151878
11. patients with hypersensitive to investigational products or to any component of the drug
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Excipient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0015237
12. patients who are judged difficult to participate in this investigation by the investigator
Beschreibung

Study Subject Participation Status Difficult

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0332218
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Ähnliche Modelle

Eligibility Asthma NCT02491970

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02491970
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Asthma | Adult
Item
1. adult (over 19 years) asthma patients
boolean
C0004096 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
Mild persistent asthma | Moderate persistent asthma | Severe persistent asthma
Item
2. patients who have a history of mild-to-moderate-severe, persistent asthma for at least 6 months prior to screening.
boolean
C1960046 (UMLS CUI [1])
C1960047 (UMLS CUI [2])
C1960048 (UMLS CUI [3])
FEV1 | Pharmaceutical Preparations Asthma
Item
3. patients who were required to demonstrate a fev1 of ≥ 40 % and ≤ 85% of predicted normal values during screening period following appropriate withholding of asthma medications (if applicable).
boolean
C0748133 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
Forced Expiratory Volume in 1 Second Reversibility | Inhaled albuterol preparation
Item
4. patients who were required to show reversibility of ≥15% fev1 after salbutamol inhalation (2 actuations, 100µg per actuation) from the pre- salbutamol value at screening
boolean
C3830088 (UMLS CUI [1])
C0354688 (UMLS CUI [2])
Uncontrolled Asthma | Seretide | Asthma control test
Item
5. patients who have uncontrolled asthma by seretide® 250/50 defined as act less than 20
boolean
C0205318 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C1130494 (UMLS CUI [2])
C2733011 (UMLS CUI [3])
Small airways
Item
6. patients who showed r5-20 more than 0.1 kpa/l/s
boolean
C1862763 (UMLS CUI [1])
Eosinophil count procedure
Item
7. blood eosinophil count > 300/µl on screening visit
boolean
C0200638 (UMLS CUI [1])
Childbearing Potential | Urine pregnancy test negative
Item
8. female patients of childbearing potential must have a negative urine pregnancy test at screening.
boolean
C3831118 (UMLS CUI [1])
C0430057 (UMLS CUI [2])
Ability Use of Inhaler
Item
9. patients who are able to use the inhaler
boolean
C0085732 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0021461 (UMLS CUI [1,3])
Informed Consent
Item
10. patients who is willing to voluntarily sign the study consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Asthma Life Threatening | Respiratory Tract Infections | emergency visit Asthma | Hospitalization Asthma
Item
1. patients who have experienced life-threatening asthma within 12 months prior to screening or respiratory infection within 4 weeks prior to screening, or patients who have experienced any emergency visit or hospitalization due to acute asthma symptoms within 4 weeks prior to screening
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0035243 (UMLS CUI [2])
C0553618 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
C0019993 (UMLS CUI [4,1])
C0004096 (UMLS CUI [4,2])
Disease | Lung diseases | Chronic Obstructive Airway Disease | Cystic Fibrosis | Bronchiectasis | Tuberculosis
Item
2. patients who have diagnosed as clinically significant disease or non- reversible pulmonary disease or patients who currently have active pulmonary disease (eg. copd, cystic fibrosis, bronchiectasis, active tuberculosis)
boolean
C0012634 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
C0024117 (UMLS CUI [3])
C0010674 (UMLS CUI [4])
C0006267 (UMLS CUI [5])
C0041296 (UMLS CUI [6])
Laryngitis | Chronic sinusitis | Common Cold | Allergic rhinitis | Patient Outcome - Worsening | Purulent discharge
Item
3. patients who have diagnosed as laryngitis, chronic sinusitis, infectious rhinitis or allergic rhinitis within 4 weeks prior to screening, or patients who have had any symptoms of acute exacerbation or purulent discharge by the disease above within 2 weeks prior to screening
boolean
C0023067 (UMLS CUI [1])
C0149516 (UMLS CUI [2])
C0009443 (UMLS CUI [3])
C2607914 (UMLS CUI [4])
C1546960 (UMLS CUI [5])
C0333274 (UMLS CUI [6])
Current Smoker | Former smoker
Item
4. current smoker or past smoker defined as below:
boolean
C3241966 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
Current Smoker Smoking History
Item
current smoker: smoking history within 12 months prior to screening
boolean
C3241966 (UMLS CUI [1,1])
C1519384 (UMLS CUI [1,2])
Former smoker Smoking cigarettes: ____ pack-years history
Item
past smoker: smoking amount ≥10 pack year*
boolean
C0337671 (UMLS CUI [1,1])
C2230126 (UMLS CUI [1,2])
Pack years Calculation
Item
pack year (py) calculation: average amount of smoking per day (pack) x duration of smoking (year)
boolean
C1277691 (UMLS CUI [1,1])
C1441506 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
5. patients who currently are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
systemic steroids
Item
6. patient who had taken systemic corticosteroid within 4 weeks prior to screening
boolean
C2825233 (UMLS CUI [1])
omalizumab
Item
7. patients who had taken omalizumab within 24 weeks prior to screening
boolean
C0966225 (UMLS CUI [1])
Following Pharmaceutical Preparations
Item
8. patients who had taken the following medications within 1 week prior to screening:
boolean
C0332282 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Cytochrome P-450 CYP3A Inhibitors
Item
potent cyp3a inhibitors
boolean
C3850056 (UMLS CUI [1])
Adrenergic beta-Antagonists
Item
β-blockers
boolean
C0001645 (UMLS CUI [1])
Monoamine Oxidase Inhibitors
Item
monoamine oxidase inhibitor
boolean
C0026457 (UMLS CUI [1])
Tricyclic Antidepressive Agents
Item
tca (tricyclic antidepressants)
boolean
C0003290 (UMLS CUI [1])
Anti-Arrhythmia Agents Quinidine
Item
quinidine-type anti arrhythmic
boolean
C0003195 (UMLS CUI [1,1])
C0034414 (UMLS CUI [1,2])
Leukotriene Antagonists
Item
leukotriene anatagonist
boolean
C0595726 (UMLS CUI [1])
Astemizole
Item
astemizole
boolean
C0085170 (UMLS CUI [1])
Study Subject Participation Status | Interventional Study
Item
9. patients who are participating or going to participate in any interventional clinical trials
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
Prolonged QT interval
Item
10. qt interval prolongation in ecg result at screening
boolean
C0151878 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Excipient
Item
11. patients with hypersensitive to investigational products or to any component of the drug
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
Study Subject Participation Status Difficult
Item
12. patients who are judged difficult to participate in this investigation by the investigator
boolean
C2348568 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
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