ID

14400

Beschreibung

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

Stichworte

Versionen (1)
  1. 13.04.16 13.04.16 -
Rechteinhaber

CC BY-NC 3.0

Hochgeladen am

13. April 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Asthma NCT00545272

Englisch

Eligibility Asthma NCT00545272

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00545272
Inclusion Criteria
Beschreibung

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.
Beschreibung

age informed consent

Datentyp

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:
Beschreibung

asthma

Datentyp

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.
Beschreibung

inhaled corticosteroid

Datentyp

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.
Beschreibung

fev1

Datentyp

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
Beschreibung

fev1 post-bronchodilator

Datentyp

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.
Beschreibung

salbutamol fev1 reversibility

Datentyp

boolean

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

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.
Beschreibung

pregnancy lactation childbearing potential contraception

Datentyp

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.
Beschreibung

copd and smoking history

Datentyp

boolean

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

patients

Datentyp

boolean

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

asthma worsening

Datentyp

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,
Beschreibung

hospitalization for asthma exacerbation

Datentyp

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
Beschreibung

emergency room admission for asthma exacerbation

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

inhaled beta-2 agonists

Datentyp

boolean

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

criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0242801
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Asthma NCT00545272

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00545272
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video