ID
24131
Beschrijving
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
Trefwoorden
Versies (3)
- 25-07-17 25-07-17 -
- 27-07-17 27-07-17 -
- 08-08-17 08-08-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
25 juli 2017
DOI
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Licentie
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
Beschrijving
INCLUSION CRITERIA
Alias
- UMLS CUI-1
- C1512693
Beschrijving
age 40 years to 80 years
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0024117
Beschrijving
informed consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
post-bronchodilator FEV1
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C2599594
Beschrijving
post bronchodilator FEV/FVC ratio
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C1287681
- UMLS CUI [1,3]
- C2599594
Beschrijving
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%.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3830088
- UMLS CUI [1,2]
- C2599594
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1277691
- UMLS CUI [1,2]
- C3241966
- UMLS CUI [2,1]
- C1277691
- UMLS CUI [2,2]
- C0337671
Beschrijving
score of at least 2 on Modified Medical Research Council Dyspnoea Scale
Datatype
boolean
Alias
- UMLS CUI [1]
- C3826977
Beschrijving
i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal
Datatype
boolean
Alias
- UMLS CUI [1]
- C3831118
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0430056
- UMLS CUI [3]
- C0700589
Beschrijving
EXCLUSION CRITERIA
Alias
- UMLS CUI-1
- C0680251
Beschrijving
COPD exaceration requiring therapy
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0740304
- UMLS CUI [1,2]
- C0087111
Beschrijving
current medical diagnosis of asthma, eczema, atopic dermatitis and/or allergic rhinitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004096
- UMLS CUI [2]
- C0013595
- UMLS CUI [3]
- C0011615
- UMLS CUI [4]
- C2607914
Beschrijving
e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0035204
Beschrijving
e.g., lung transplant and/or lung volume reduction
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038903
Beschrijving
chest Xray to be taken at entry to the run-in period, if subject has not had one taken within the last 3 months
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C2015792
Beschrijving
breastfeeding
Datatype
boolean
Alias
- UMLS CUI [1]
- C0006147
Beschrijving
LTOT is defined as ≥ 12 hours oxygen use per day with resting pO2 below 7.3 kPa.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0184633
Beschrijving
except eye drops
Datatype
boolean
Alias
- UMLS CUI [1]
- C0304516
Beschrijving
serious, uncontrolled disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschrijving
change in COPD medication
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C0580105
Beschrijving
pulmonary rehabilitation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0199529
Beschrijving
respiratory tract infection requiring antibiotics and/or hospitalization
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0035243
- UMLS CUI [1,2]
- C0003232
- UMLS CUI [1,3]
- C0019993
Beschrijving
receiving tiotropium bromide, inhaled corticosteroids or anti-leukotrienes
Datatype
boolean
Alias
- UMLS CUI [1]
- C1306772
- UMLS CUI [2]
- C4050091
- UMLS CUI [3,1]
- C0206517
- UMLS CUI [3,2]
- C0332206
Beschrijving
oral/parenteral corticosteroids
Datatype
boolean
Alias
- UMLS CUI [1]
- C4053960
Beschrijving
other investigational drugs
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013230
Beschrijving
medications inhibiting cytochrome P450 CYP3A4
Datatype
boolean
Alias
- UMLS CUI [1]
- C0059563
Beschrijving
substance abuse
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038586
Beschrijving
hypersensitivity to ß2 -agonists, inhaled steroids or lactose
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C1373132
- UMLS CUI [1,3]
- C3536709
- UMLS CUI [1,4]
- C0022949
Beschrijving
belongs to reasearch personnel
Datatype
boolean
Alias
- UMLS CUI [1]
- C0035173
Beschrijving
previously enrolled to this study
Datatype
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])