ID

14400

Description

A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00545272

Link

https://clinicaltrials.gov/show/NCT00545272

Keywords

Versions (1)
  1. 4/13/16 4/13/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 13, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00545272

English

Eligibility Asthma NCT00545272

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00545272
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female adult and adolescent patients aged 12-75 years inclusive (or ≥18-75 years depending upon regulatory and/or institutional review board (irb)/independent ethics committee (iec)/research ethics board (reb) approval), who have signed an informed consent form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to visit 1. patients below the legal age of consent are required to have the informed consent form signed by the patient's parent / guardian.
Description

age informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
2. patients with asthma, diagnosed according to global initiative for asthma (gina) guidelines (national institute of health, national heart, lung and blood institute, 2006) and who additionally meet the following criteria:
Description

asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
1. patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to visit 1.
Description

inhaled corticosteroid

Data type

boolean

Alias
UMLS CUI [1,1]
C0586793
UMLS CUI [1,2]
C0332173
2. patients with a forced expiratory volume in one second (fev1) at visit 1 of ≥50% of the predicted normal value for the patient. this criterion for fev1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting β2-agonist has been inhaled, and a minimum of 48 hours for a long acting β2-agonist.
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C1373132
3. patients who demonstrate an increase of ≥12% and ≥200 ml in fev1 over their pre-bronchodilator value within 30 minutes after inhaling a total of 200 µg/180
Description

fev1 post-bronchodilator

Data type

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599594
µg of salbutamol/albuterol metered dose inhaler (mdi) (or equivalent dose of dry powder inhaler [dpi]) (the reversibility test). reversibility will have to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a short-acting β2-agonist. the administration of salbutamol/albuterol for the reversibility test is to be within 30 minutes after pre bronchodilator spirometry. reversibility has to be demonstrated at visit 1 or between visits 1 and 2, in order for patients to be included in the trial.
Description

salbutamol fev1 reversibility

Data type

boolean

Alias
UMLS CUI [1]
C0001927
UMLS CUI [2,1]
C0748133
UMLS CUI [2,2]
C0449261
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception.
Description

pregnancy lactation childbearing potential contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C3831118
patients with chronic obstructive pulmonary disease (copd), or current smokers, or patients who have used tobacco products within the 6 month period prior to visit 1, or who have a smoking history of greater than 10 pack years.
Description

copd and smoking history

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C1519384
UMLS CUI [3]
C1277691
patients:
Description

patients

Data type

boolean

Alias
UMLS CUI [1]
C0030705
1. who's asthma is likely to deteriorate during the study (including seasonal allergy),
Description

asthma worsening

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1457868
2. hospitalized for an acute asthma attack/asthma exacerbation within 6 months prior to visit 1,
Description

hospitalization for asthma exacerbation

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0019993
3. who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to visit 1
Description

emergency room admission for asthma exacerbation

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0583237
4. who have had a respiratory tract infection or emergency room treatment for an asthma attack/asthma exacerbation within 4 weeks prior to visit 1
Description

respiratory tract infection or emergency room treatment for an asthma attack/asthma exacerbation

Data type

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C0349790
UMLS CUI [2,2]
C0583237
5. patients who require the use of ≥8 inhalations per day of short acting b2-agonist (100 µg/ 90 µg salbutamol/albuterol mdi or equivalent dose of dpi) on any 2 consecutive days from screening to randomization.
Description

inhaled beta-2 agonists

Data type

boolean

Alias
UMLS CUI [1,1]
C1373132
UMLS CUI [1,2]
C0001559
other protocol-defined inclusion/exclusion criteria may apply
Description

criteria

Data type

boolean

Alias
UMLS CUI [1]
C0242801
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Similar models

Eligibility Asthma NCT00545272

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00545272
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age informed consent
Item
1. male and female adult and adolescent patients aged 12-75 years inclusive (or ≥18-75 years depending upon regulatory and/or institutional review board (irb)/independent ethics committee (iec)/research ethics board (reb) approval), who have signed an informed consent form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to visit 1. patients below the legal age of consent are required to have the informed consent form signed by the patient's parent / guardian.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
asthma
Item
2. patients with asthma, diagnosed according to global initiative for asthma (gina) guidelines (national institute of health, national heart, lung and blood institute, 2006) and who additionally meet the following criteria:
boolean
C0004096 (UMLS CUI [1])
inhaled corticosteroid
Item
1. patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to visit 1.
boolean
C0586793 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
fev1
Item
2. patients with a forced expiratory volume in one second (fev1) at visit 1 of ≥50% of the predicted normal value for the patient. this criterion for fev1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting β2-agonist has been inhaled, and a minimum of 48 hours for a long acting β2-agonist.
boolean
C0748133 (UMLS CUI [1])
C1373132 (UMLS CUI [2])
fev1 post-bronchodilator
Item
3. patients who demonstrate an increase of ≥12% and ≥200 ml in fev1 over their pre-bronchodilator value within 30 minutes after inhaling a total of 200 µg/180
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
salbutamol fev1 reversibility
Item
µg of salbutamol/albuterol metered dose inhaler (mdi) (or equivalent dose of dry powder inhaler [dpi]) (the reversibility test). reversibility will have to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a short-acting β2-agonist. the administration of salbutamol/albuterol for the reversibility test is to be within 30 minutes after pre bronchodilator spirometry. reversibility has to be demonstrated at visit 1 or between visits 1 and 2, in order for patients to be included in the trial.
boolean
C0001927 (UMLS CUI [1])
C0748133 (UMLS CUI [2,1])
C0449261 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
pregnancy lactation childbearing potential contraception
Item
pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5])
copd and smoking history
Item
patients with chronic obstructive pulmonary disease (copd), or current smokers, or patients who have used tobacco products within the 6 month period prior to visit 1, or who have a smoking history of greater than 10 pack years.
boolean
C0024117 (UMLS CUI [1])
C1519384 (UMLS CUI [2])
C1277691 (UMLS CUI [3])
patients
Item
patients:
boolean
C0030705 (UMLS CUI [1])
asthma worsening
Item
1. who's asthma is likely to deteriorate during the study (including seasonal allergy),
boolean
C0004096 (UMLS CUI [1,1])
C1457868 (UMLS CUI [1,2])
hospitalization for asthma exacerbation
Item
2. hospitalized for an acute asthma attack/asthma exacerbation within 6 months prior to visit 1,
boolean
C0349790 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
emergency room admission for asthma exacerbation
Item
3. who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to visit 1
boolean
C0349790 (UMLS CUI [1,1])
C0583237 (UMLS CUI [1,2])
respiratory tract infection or emergency room treatment for an asthma attack/asthma exacerbation
Item
4. who have had a respiratory tract infection or emergency room treatment for an asthma attack/asthma exacerbation within 4 weeks prior to visit 1
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0349790 (UMLS CUI [2,1])
C0583237 (UMLS CUI [2,2])
inhaled beta-2 agonists
Item
5. patients who require the use of ≥8 inhalations per day of short acting b2-agonist (100 µg/ 90 µg salbutamol/albuterol mdi or equivalent dose of dpi) on any 2 consecutive days from screening to randomization.
boolean
C1373132 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
criteria
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C0242801 (UMLS CUI [1])
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