ID

14392

Beskrivning

Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00529529

Länk

https://clinicaltrials.gov/show/NCT00529529

Nyckelord

Versioner (1)
  1. 2016-04-13 2016-04-13 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

13 april 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00529529

Engelsk

Eligibility Asthma NCT00529529

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00529529
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female patients aged ≥ 12 years (or ≥ 18 years depending upon regulatory and/or institutional review board/independent ethics committee/research ethics board [irb/iec/reb] approval) who have signed an informed consent form.
Beskrivning

age and informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
2. patients with moderate to severe persistent asthma, diagnosed according to the global initiative for asthma (gina) guidelines (updated 2006) and who additionally meet the following criteria:
Beskrivning

moderate to severe persistent asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C1960047
UMLS CUI [2]
C1960048
patients who have used treatment with a bronchodilator, either regularly or on-demand, and who had used a daily dose of at least 100 μg beclomethasone dipropionate (or equivalent) for at least 1 month prior to screening.
Beskrivning

bronchodilator and beclomethasone dipropionate

Datatyp

boolean

Alias
UMLS CUI [1]
C0006280
UMLS CUI [2,1]
C0004906
UMLS CUI [2,2]
C2348070
UMLS CUI [3]
C0040223
patients whose forced expiratory volume in 1 second (fev1) is ≥ 50% of the predicted normal value.
Beskrivning

fev1

Datatyp

boolean

Alias
UMLS CUI [1]
C0748133
patients with documented (in the previous 6 months) or who demonstrate (prior to randomization) a ≥ 12% and at least 200 ml increase in fev1, after inhaling 200
Beskrivning

fev1 post-bronchodilator

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599594
μg salbutamol.
Beskrivning

salbutamol

Datatyp

boolean

Alias
UMLS CUI [1]
C0001927
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or nursing (lactating) women and women of child-bearing potential unless they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception.
Beskrivning

pregnant or nursing (lactating) women and women of child-bearing potential unless they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4]
C0700589
UMLS CUI [5]
C0232970
2. patients who have used tobacco products within the 12 month period prior to screening, or who have a smoking history of greater than 10 pack years.
Beskrivning

smoking history

Datatyp

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C1277691
3. patients who suffer from chronic obstructive pulmonary disease (copd) as diagnosed by the global initiative for chronic obstructive lung disease (gold) guidelines (2006).
Beskrivning

copd

Datatyp

boolean

Alias
UMLS CUI [1]
C0024117
4. patients who have had emergency room treatment for an acute asthma attack in the 6 weeks prior to screening or who have been hospitalized for an acute asthma attack in the 6 months prior to screening, or at any time between screening and week 1.
Beskrivning

emergency room or hospitalization for asthma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0583237
UMLS CUI [1,2]
C0347950
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0347950
5. patients with diabetes type i or those with uncontrolled diabetes type ii including patients with a history of blood glucose levels consistently outside the normal range or glycosylated hemoglobin (hba1c) > 8.0% measured at screening.
Beskrivning

diabetes mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0202042
UMLS CUI [3]
C0019018
6. patients who, in the judgment of the investigator or the responsible novartis personnel, have a clinically significant condition or a clinically relevant laboratory abnormality that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
Beskrivning

comorbidity limiting study protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
7. patients with a history of long qt syndrome, or whose qtc interval (bazett's formula) is prolonged to > 450 ms (males) or > 470 ms (females).
Beskrivning

long qt syndrome or whose qtc interval (bazett's formula) is prolonged

Datatyp

boolean

Alias
UMLS CUI [1]
C0023976
UMLS CUI [2]
C0151878
8. certain medications for asthma and allied conditions such as long-acting bronchodilators must not be used prior to screening and for a pre-specified minimum washout period.
Beskrivning

asthma medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0040223
other protocol-defined inclusion/exclusion criteria applied to the study.
Beskrivning

criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0242801
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Similar models

Eligibility Asthma NCT00529529

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00529529
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
age and informed consent
Item
1. male and female patients aged ≥ 12 years (or ≥ 18 years depending upon regulatory and/or institutional review board/independent ethics committee/research ethics board [irb/iec/reb] approval) who have signed an informed consent form.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
moderate to severe persistent asthma
Item
2. patients with moderate to severe persistent asthma, diagnosed according to the global initiative for asthma (gina) guidelines (updated 2006) and who additionally meet the following criteria:
boolean
C1960047 (UMLS CUI [1])
C1960048 (UMLS CUI [2])
bronchodilator and beclomethasone dipropionate
Item
patients who have used treatment with a bronchodilator, either regularly or on-demand, and who had used a daily dose of at least 100 μg beclomethasone dipropionate (or equivalent) for at least 1 month prior to screening.
boolean
C0006280 (UMLS CUI [1])
C0004906 (UMLS CUI [2,1])
C2348070 (UMLS CUI [2,2])
C0040223 (UMLS CUI [3])
fev1
Item
patients whose forced expiratory volume in 1 second (fev1) is ≥ 50% of the predicted normal value.
boolean
C0748133 (UMLS CUI [1])
fev1 post-bronchodilator
Item
patients with documented (in the previous 6 months) or who demonstrate (prior to randomization) a ≥ 12% and at least 200 ml increase in fev1, after inhaling 200
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
salbutamol
Item
μg salbutamol.
boolean
C0001927 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnant or nursing (lactating) women and women of child-bearing potential unless they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception
Item
1. pregnant or nursing (lactating) women and women of child-bearing potential unless they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0232970 (UMLS CUI [5])
smoking history
Item
2. patients who have used tobacco products within the 12 month period prior to screening, or who have a smoking history of greater than 10 pack years.
boolean
C1519384 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
copd
Item
3. patients who suffer from chronic obstructive pulmonary disease (copd) as diagnosed by the global initiative for chronic obstructive lung disease (gold) guidelines (2006).
boolean
C0024117 (UMLS CUI [1])
emergency room or hospitalization for asthma
Item
4. patients who have had emergency room treatment for an acute asthma attack in the 6 weeks prior to screening or who have been hospitalized for an acute asthma attack in the 6 months prior to screening, or at any time between screening and week 1.
boolean
C0583237 (UMLS CUI [1,1])
C0347950 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0347950 (UMLS CUI [2,2])
diabetes mellitus
Item
5. patients with diabetes type i or those with uncontrolled diabetes type ii including patients with a history of blood glucose levels consistently outside the normal range or glycosylated hemoglobin (hba1c) > 8.0% measured at screening.
boolean
C0011849 (UMLS CUI [1])
C0202042 (UMLS CUI [2])
C0019018 (UMLS CUI [3])
comorbidity limiting study protocol
Item
6. patients who, in the judgment of the investigator or the responsible novartis personnel, have a clinically significant condition or a clinically relevant laboratory abnormality that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
long qt syndrome or whose qtc interval (bazett's formula) is prolonged
Item
7. patients with a history of long qt syndrome, or whose qtc interval (bazett's formula) is prolonged to > 450 ms (males) or > 470 ms (females).
boolean
C0023976 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
asthma medication
Item
8. certain medications for asthma and allied conditions such as long-acting bronchodilators must not be used prior to screening and for a pre-specified minimum washout period.
boolean
C0013227 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
criteria
Item
other protocol-defined inclusion/exclusion criteria applied to the study.
boolean
C0242801 (UMLS CUI [1])
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