ID
24131
Beschreibung
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
Stichworte
Versionen (3)
- 25.07.17 25.07.17 -
- 27.07.17 27.07.17 -
- 08.08.17 08.08.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
25. Juli 2017
DOI
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Lizenz
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
Beschreibung
INCLUSION CRITERIA
Alias
- UMLS CUI-1
- C1512693
Beschreibung
age 40 years to 80 years
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0024117
Beschreibung
informed consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
post-bronchodilator FEV1
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C2599594
Beschreibung
post bronchodilator FEV/FVC ratio
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0748133
- UMLS CUI [1,2]
- C1287681
- UMLS CUI [1,3]
- C2599594
Beschreibung
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%.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3830088
- UMLS CUI [1,2]
- C2599594
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1277691
- UMLS CUI [1,2]
- C3241966
- UMLS CUI [2,1]
- C1277691
- UMLS CUI [2,2]
- C0337671
Beschreibung
score of at least 2 on Modified Medical Research Council Dyspnoea Scale
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3826977
Beschreibung
i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3831118
Beschreibung
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
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0430056
- UMLS CUI [3]
- C0700589
Beschreibung
EXCLUSION CRITERIA
Alias
- UMLS CUI-1
- C0680251
Beschreibung
COPD exaceration requiring therapy
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0740304
- UMLS CUI [1,2]
- C0087111
Beschreibung
current medical diagnosis of asthma, eczema, atopic dermatitis and/or allergic rhinitis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004096
- UMLS CUI [2]
- C0013595
- UMLS CUI [3]
- C0011615
- UMLS CUI [4]
- C2607914
Beschreibung
e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0035204
Beschreibung
e.g., lung transplant and/or lung volume reduction
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038903
Beschreibung
chest Xray to be taken at entry to the run-in period, if subject has not had one taken within the last 3 months
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C2015792
Beschreibung
breastfeeding
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0006147
Beschreibung
LTOT is defined as ≥ 12 hours oxygen use per day with resting pO2 below 7.3 kPa.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0184633
Beschreibung
except eye drops
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0304516
Beschreibung
serious, uncontrolled disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
change in COPD medication
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C0580105
Beschreibung
pulmonary rehabilitation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0199529
Beschreibung
respiratory tract infection requiring antibiotics and/or hospitalization
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0035243
- UMLS CUI [1,2]
- C0003232
- UMLS CUI [1,3]
- C0019993
Beschreibung
receiving tiotropium bromide, inhaled corticosteroids or anti-leukotrienes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1306772
- UMLS CUI [2]
- C4050091
- UMLS CUI [3,1]
- C0206517
- UMLS CUI [3,2]
- C0332206
Beschreibung
oral/parenteral corticosteroids
Datentyp
boolean
Alias
- UMLS CUI [1]
- C4053960
Beschreibung
other investigational drugs
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013230
Beschreibung
medications inhibiting cytochrome P450 CYP3A4
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0059563
Beschreibung
substance abuse
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038586
Beschreibung
hypersensitivity to ß2 -agonists, inhaled steroids or lactose
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C1373132
- UMLS CUI [1,3]
- C3536709
- UMLS CUI [1,4]
- C0022949
Beschreibung
belongs to reasearch personnel
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0035173
Beschreibung
previously enrolled to this study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347180
Ähnliche Modelle
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])