ID
24131
Descripción
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
Palabras clave
Versiones (3)
- 25/7/17 25/7/17 -
- 27/7/17 27/7/17 -
- 8/8/17 8/8/17 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
25 de julio de 2017
DOI
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Licencia
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
Descripción
INCLUSION CRITERIA
Alias
- UMLS CUI-1
- C1512693
Descripción
age 40 years to 80 years
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0001779
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0024117
Descripción
informed consent
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0021430
Descripción
post-bronchodilator FEV1
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C2599594
Descripción
post bronchodilator FEV/FVC ratio
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C1287681
- UMLS CUI [1,3]
- C2599594
Descripción
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%.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3830088
- UMLS CUI [1,2]
- C2599594
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1277691
- UMLS CUI [1,2]
- C3241966
- UMLS CUI [2,1]
- C1277691
- UMLS CUI [2,2]
- C0337671
Descripción
score of at least 2 on Modified Medical Research Council Dyspnoea Scale
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3826977
Descripción
i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3831118
Descripción
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
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0430056
- UMLS CUI [3]
- C0700589
Descripción
EXCLUSION CRITERIA
Alias
- UMLS CUI-1
- C0680251
Descripción
COPD exaceration requiring therapy
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0740304
- UMLS CUI [1,2]
- C0087111
Descripción
current medical diagnosis of asthma, eczema, atopic dermatitis and/or allergic rhinitis
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0004096
- UMLS CUI [2]
- C0013595
- UMLS CUI [3]
- C0011615
- UMLS CUI [4]
- C2607914
Descripción
e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0035204
Descripción
e.g., lung transplant and/or lung volume reduction
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0038903
Descripción
chest Xray to be taken at entry to the run-in period, if subject has not had one taken within the last 3 months
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C2015792
Descripción
breastfeeding
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0006147
Descripción
LTOT is defined as ≥ 12 hours oxygen use per day with resting pO2 below 7.3 kPa.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0184633
Descripción
except eye drops
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0304516
Descripción
serious, uncontrolled disease
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0009488
Descripción
change in COPD medication
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C0580105
Descripción
pulmonary rehabilitation
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0199529
Descripción
respiratory tract infection requiring antibiotics and/or hospitalization
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0035243
- UMLS CUI [1,2]
- C0003232
- UMLS CUI [1,3]
- C0019993
Descripción
receiving tiotropium bromide, inhaled corticosteroids or anti-leukotrienes
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1306772
- UMLS CUI [2]
- C4050091
- UMLS CUI [3,1]
- C0206517
- UMLS CUI [3,2]
- C0332206
Descripción
oral/parenteral corticosteroids
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C4053960
Descripción
other investigational drugs
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0013230
Descripción
medications inhibiting cytochrome P450 CYP3A4
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0059563
Descripción
substance abuse
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0038586
Descripción
hypersensitivity to ß2 -agonists, inhaled steroids or lactose
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C1373132
- UMLS CUI [1,3]
- C3536709
- UMLS CUI [1,4]
- C0022949
Descripción
belongs to reasearch personnel
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0035173
Descripción
previously enrolled to this study
Tipo de datos
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])