ID

14548

Description

Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder; ODM derived from: https://clinicaltrials.gov/show/NCT01738087

Link

https://clinicaltrials.gov/show/NCT01738087

Keywords

Versions (1)
  1. 4/20/16 4/20/16 -
Uploaded on

April 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthmatic NCT01738087

English

Eligibility Asthmatic NCT01738087

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthmatic NCT01738087
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of asthma as defined by global initiative for asthma (gina) 2011
Description

Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
asthmatic patients already treated with low daily doses of inhaled corticosteroids (ics) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ics/long acting beta2 agonists (laba) fixed combinations.
Description

Therapeutic procedure Inhaled steroids | Budesonide | Adrenergic beta-2 Receptor Agonists

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2065041
UMLS CUI [2]
C0054201
UMLS CUI [3]
C2936789
patients with forced expiratory volume in 1 sec (fev1) >= 70 % of predicted values
Description

FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
non or ex-smokers
Description

Non-smoker | Former smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C0337671
body mass index (bmi) >= 18.5 and <= 32 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women unless using acceptable methods of contraception
Description

Pregnancy | Breast Feeding | Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
diagnosis of chronic obstructive pulmonary disease (copd)
Description

Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1]
C0024117
history of near fatal asthma
Description

Asthma Near Fatal

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1706276
UMLS CUI [1,3]
C1302234
patients with abnormal qtcf at screening visit
Description

QTcF Abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0205161
hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period.
Description

Exacerbation of asthma | Hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0019993
lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period.
Description

Lower respiratory tract infection

Data type

boolean

Alias
UMLS CUI [1]
C0149725
history of drug addiction or excessive use of alcohol ;
Description

Substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C0740858
diagnosis of restrictive lung disease.
Description

Restrictive lung disease

Data type

boolean

Alias
UMLS CUI [1]
C0085581
patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids)
Description

Oral steroid therapy | Parenteral steroid treatment | Parenteral Adrenal Cortex Hormones Depot Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0574135
UMLS CUI [2]
C3840673
UMLS CUI [3,1]
C1518896
UMLS CUI [3,2]
C0001617
UMLS CUI [3,3]
C0086129
significant medical history or any laboratory abnormality indicative of a significant underlying condition
Description

Significant Medical History | Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0750502
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C0438215
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Similar models

Eligibility Asthmatic NCT01738087

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthmatic NCT01738087
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Asthma
Item
diagnosis of asthma as defined by global initiative for asthma (gina) 2011
boolean
C0004096 (UMLS CUI [1])
Therapeutic procedure Inhaled steroids | Budesonide | Adrenergic beta-2 Receptor Agonists
Item
asthmatic patients already treated with low daily doses of inhaled corticosteroids (ics) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ics/long acting beta2 agonists (laba) fixed combinations.
boolean
C0087111 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C0054201 (UMLS CUI [2])
C2936789 (UMLS CUI [3])
FEV1
Item
patients with forced expiratory volume in 1 sec (fev1) >= 70 % of predicted values
boolean
C0748133 (UMLS CUI [1])
Non-smoker | Former smoker
Item
non or ex-smokers
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) >= 18.5 and <= 32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Contraceptive methods
Item
pregnant or lactating women unless using acceptable methods of contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Chronic Obstructive Airway Disease
Item
diagnosis of chronic obstructive pulmonary disease (copd)
boolean
C0024117 (UMLS CUI [1])
Asthma Near Fatal
Item
history of near fatal asthma
boolean
C0004096 (UMLS CUI [1,1])
C1706276 (UMLS CUI [1,2])
C1302234 (UMLS CUI [1,3])
QTcF Abnormal
Item
patients with abnormal qtcf at screening visit
boolean
C1882513 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Exacerbation of asthma | Hospitalization
Item
hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period.
boolean
C0349790 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
Lower respiratory tract infection
Item
lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period.
boolean
C0149725 (UMLS CUI [1])
Substance abuse
Item
history of drug addiction or excessive use of alcohol ;
boolean
C0740858 (UMLS CUI [1])
Restrictive lung disease
Item
diagnosis of restrictive lung disease.
boolean
C0085581 (UMLS CUI [1])
Oral steroid therapy | Parenteral steroid treatment | Parenteral Adrenal Cortex Hormones Depot Preparations
Item
patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids)
boolean
C0574135 (UMLS CUI [1])
C3840673 (UMLS CUI [2])
C1518896 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C0086129 (UMLS CUI [3,3])
Significant Medical History | Laboratory test result abnormal
Item
significant medical history or any laboratory abnormality indicative of a significant underlying condition
boolean
C0750502 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2])
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