ID
24131
Description
Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive
Keywords
Versions (3)
- 7/25/17 7/25/17 -
- 7/27/17 7/27/17 -
- 8/8/17 8/8/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
July 25, 2017
DOI
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License
Creative Commons BY-NC 3.0
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visit 1 (inclusion/exclusion criteria) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470
visit 1 (inclusion/exclusion criteria) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470
Description
INCLUSION CRITERIA
Alias
- UMLS CUI-1
- C1512693
Description
age 40 years to 80 years
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
As per the GOLD definition [GOLD, 2003] which defines COPD as characterised by airflow limitation that is not fully reversible. The airflow limitation is usually both progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases.
Data type
boolean
Alias
- UMLS CUI [1]
- C0024117
Description
informed consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
post-bronchodilator FEV1
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C2599594
Description
post bronchodilator FEV/FVC ratio
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C1287681
- UMLS CUI [1,3]
- C2599594
Description
Values of 10.1 to 10.4% will be rounded down to 10%; values of 10.5 to 10.9% will be rounded up to 11%.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3830088
- UMLS CUI [1,2]
- C2599594
Description
10 pack years is defined as 20 cigarettes (or equivalent if subject smoked cigars or a pipe) per day for 10 years, or 10 cigarettes per day for 20 years). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Smokers who have stopped smoking less than 6 months before Visit 1 will be defined as current smokers.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1277691
- UMLS CUI [1,2]
- C3241966
- UMLS CUI [2,1]
- C1277691
- UMLS CUI [2,2]
- C0337671
Description
score of at least 2 on Modified Medical Research Council Dyspnoea Scale
Data type
boolean
Alias
- UMLS CUI [1]
- C3826977
Description
i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal
Data type
boolean
Alias
- UMLS CUI [1]
- C3831118
Description
Acceptable methods of contraception are: • complete abstinence from intercourse for the duration of the study • male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject • implants of levo-norgestrol • injectable progestogen • oral contraceptive (either combined or progestogen only) • any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year • any other methods with published data showing that the lowest expected failure rate for that method is less than 1% per year • barrier method only if used in combination with any of the above acceptable methods
Data type
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0430056
- UMLS CUI [3]
- C0700589
Description
EXCLUSION CRITERIA
Alias
- UMLS CUI-1
- C0680251
Description
COPD exaceration requiring therapy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0740304
- UMLS CUI [1,2]
- C0087111
Description
current medical diagnosis of asthma, eczema, atopic dermatitis and/or allergic rhinitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0004096
- UMLS CUI [2]
- C0013595
- UMLS CUI [3]
- C0011615
- UMLS CUI [4]
- C2607914
Description
e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0035204
Description
e.g., lung transplant and/or lung volume reduction
Data type
boolean
Alias
- UMLS CUI [1]
- C0038903
Description
chest Xray to be taken at entry to the run-in period, if subject has not had one taken within the last 3 months
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C2015792
Description
breastfeeding
Data type
boolean
Alias
- UMLS CUI [1]
- C0006147
Description
LTOT is defined as ≥ 12 hours oxygen use per day with resting pO2 below 7.3 kPa.
Data type
boolean
Alias
- UMLS CUI [1]
- C0184633
Description
except eye drops
Data type
boolean
Alias
- UMLS CUI [1]
- C0304516
Description
serious, uncontrolled disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
change in COPD medication
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C0580105
Description
pulmonary rehabilitation
Data type
boolean
Alias
- UMLS CUI [1]
- C0199529
Description
respiratory tract infection requiring antibiotics and/or hospitalization
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0035243
- UMLS CUI [1,2]
- C0003232
- UMLS CUI [1,3]
- C0019993
Description
receiving tiotropium bromide, inhaled corticosteroids or anti-leukotrienes
Data type
boolean
Alias
- UMLS CUI [1]
- C1306772
- UMLS CUI [2]
- C4050091
- UMLS CUI [3,1]
- C0206517
- UMLS CUI [3,2]
- C0332206
Description
oral/parenteral corticosteroids
Data type
boolean
Alias
- UMLS CUI [1]
- C4053960
Description
other investigational drugs
Data type
boolean
Alias
- UMLS CUI [1]
- C0013230
Description
medications inhibiting cytochrome P450 CYP3A4
Data type
boolean
Alias
- UMLS CUI [1]
- C0059563
Description
substance abuse
Data type
boolean
Alias
- UMLS CUI [1]
- C0038586
Description
hypersensitivity to ß2 -agonists, inhaled steroids or lactose
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C1373132
- UMLS CUI [1,3]
- C3536709
- UMLS CUI [1,4]
- C0022949
Description
belongs to reasearch personnel
Data type
boolean
Alias
- UMLS CUI [1]
- C0035173
Description
previously enrolled to this study
Data type
boolean
Alias
- UMLS CUI [1]
- C2347180
Similar models
visit 1 (inclusion/exclusion criteria) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470
C2599594 (UMLS CUI [1,2])
C1287681 (UMLS CUI [1,2])
C2599594 (UMLS CUI [1,3])
C2599594 (UMLS CUI [1,2])
C3241966 (UMLS CUI [1,2])
C1277691 (UMLS CUI [2,1])
C0337671 (UMLS CUI [2,2])
C0430056 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0087111 (UMLS CUI [1,2])
C0013595 (UMLS CUI [2])
C0011615 (UMLS CUI [3])
C2607914 (UMLS CUI [4])
C2015792 (UMLS CUI [1,2])
C0580105 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
C4050091 (UMLS CUI [2])
C0206517 (UMLS CUI [3,1])
C0332206 (UMLS CUI [3,2])
C1373132 (UMLS CUI [1,2])
C3536709 (UMLS CUI [1,3])
C0022949 (UMLS CUI [1,4])