ID

23139

Description

Responsible Party: Teva Pharma GmbH ClinicalTrials.gov Identifier: NCT02384577 History of Changes Other Study ID Numbers: BFS-AS-40074 DRKS00006542 ( Registry Identifier: German Clinical Trials Register ) Study First Received: March 4, 2015 Last Updated: November 3, 2016 Study to Evaluate Satisfaction and Usability of DuoResp® SPIROMAX® in Asthma and COPD Treatment ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02384577

Link

https://clinicaltrials.gov/ct2/show/NCT02384577

Keywords

Versions (1)
  1. 6/25/17 6/25/17 -
Uploaded on

June 25, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma and COPD Treatment DRKS00006542 NCT02384577 DRKS00006542

English

Eligibility Asthma and COPD Treatment NCT02384577 DRKS00006542

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Male and female adult patients with clinical diagnosis of bronchial asthma or chronic obstructive pulmonary disease
Description

Asthma or COPD

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0024117
Patients on regular medication with inhaled corticosteroids and long-acting beta-2-agonists in fixed-dose combination
Description

Inhaled corticosteroids and long-acting beta-2-agonists

Data type

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2,1]
C0001644
UMLS CUI [2,2]
C0205166
Patients who recently changed medication to DuoResp® Spiromax or are about to do so
Description

Change of medication

Data type

boolean

Alias
UMLS CUI [1]
C0580105
Capacitated person with present declaration of consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Diseases contraindicated in accordance with the summary of product characteristic
Description

Contraindication

Data type

boolean

Alias
UMLS CUI [1]
C1301624
Patients who take part in interventional clinical trials parallel or during the last 4 weeks
Description

Study Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Patient shows conditions or diseases that might disturb the monitoring according to the physician
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Patients with substance misuse in their case history (drugs, alcohol) or with other factors (e.g. serious psychiatric conditions) that limit their ability to participate in the study
Description

Substance Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C2702800
Insufficient German language knowledge to understand the patient education and to complete the questionnaires in a correct manner
Description

Language Ability

Data type

boolean

Alias
UMLS CUI [1]
C1145677
Patients involved in the planning and construction of the study (Teva staff and employees of the centres)
Description

Study planning

Data type

boolean

Alias
UMLS CUI [1]
C0681871
Patient is incapable of giving consent
Description

Incapable of giving informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1550518
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Similar models

Eligibility Asthma and COPD Treatment NCT02384577 DRKS00006542

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Ages Eligible for Study: 18 Years and older (Adult, Senior)
boolean
C0001779 (UMLS CUI [1])
Asthma or COPD
Item
Male and female adult patients with clinical diagnosis of bronchial asthma or chronic obstructive pulmonary disease
boolean
C0004096 (UMLS CUI [1])
C0024117 (UMLS CUI [2])
Inhaled corticosteroids and long-acting beta-2-agonists
Item
Patients on regular medication with inhaled corticosteroids and long-acting beta-2-agonists in fixed-dose combination
boolean
C2065041 (UMLS CUI [1])
C0001644 (UMLS CUI [2,1])
C0205166 (UMLS CUI [2,2])
Change of medication
Item
Patients who recently changed medication to DuoResp® Spiromax or are about to do so
boolean
C0580105 (UMLS CUI [1])
Informed Consent
Item
Capacitated person with present declaration of consent
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Contraindication
Item
Diseases contraindicated in accordance with the summary of product characteristic
boolean
C1301624 (UMLS CUI [1])
Study Participation Status
Item
Patients who take part in interventional clinical trials parallel or during the last 4 weeks
boolean
C2348568 (UMLS CUI [1])
Comorbidity
Item
Patient shows conditions or diseases that might disturb the monitoring according to the physician
boolean
C0009488 (UMLS CUI [1])
Substance Use Disorder
Item
Patients with substance misuse in their case history (drugs, alcohol) or with other factors (e.g. serious psychiatric conditions) that limit their ability to participate in the study
boolean
C2702800 (UMLS CUI [1])
Language Ability
Item
Insufficient German language knowledge to understand the patient education and to complete the questionnaires in a correct manner
boolean
C1145677 (UMLS CUI [1])
Study planning
Item
Patients involved in the planning and construction of the study (Teva staff and employees of the centres)
boolean
C0681871 (UMLS CUI [1])
Incapable of giving informed consent
Item
Patient is incapable of giving consent
boolean
C0021430 (UMLS CUI [1,1])
C1550518 (UMLS CUI [1,2])
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