ID

24131

Descrição

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

Palavras-chave

Versões (3)
  1. 25/07/2017 25/07/2017 -
  2. 27/07/2017 27/07/2017 -
  3. 08/08/2017 08/08/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

25 de julho de 2017

DOI

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Licença

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

Inglês

visit 1 (inclusion/exclusion criteria) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulários  
ELIGIBILITY QUESTION
Descrição

ELIGIBILITY QUESTION

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Descrição

criteria fulfilled

Tipo de dados

text

Alias
UMLS CUI [1]
C0013893
INCLUSION CRITERIA
Descrição

INCLUSION CRITERIA

Alias
UMLS CUI-1
C1512693
Male or female aged 40 - 80 years inclusive.
Descrição

age 40 years to 80 years

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Has an established clinical history of stage II COPD
Descrição

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 dados

boolean

Alias
UMLS CUI [1]
C0024117
Provided a signed and dated written informed consent form prior to participation.
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Demonstrated a post-bronchodilator FEV1 of <80% and ≥50% of predicted normal at Visit 1.
Descrição

post-bronchodilator FEV1

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599594
Demonstrated a post-bronchodilator FEV1/ FVC ratio < 70% at Visit 1.
Descrição

post bronchodilator FEV/FVC ratio

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C1287681
UMLS CUI [1,3]
C2599594
Has poor reversibility of airflow obstruction defined as ≤10% of the predicted normal FEV1 value recorded 30 minutes after inhalation of 400mcg VENTOLIN demonstrated at Visit 1.
Descrição

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 dados

boolean

Alias
UMLS CUI [1,1]
C3830088
UMLS CUI [1,2]
C2599594
A current or former smoker with a smoking history of ≥10 pack-year.
Descrição

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 dados

boolean

Alias
UMLS CUI [1,1]
C1277691
UMLS CUI [1,2]
C3241966
UMLS CUI [2,1]
C1277691
UMLS CUI [2,2]
C0337671
Achieved a minimum score of ≥ 2 on the Modified Medical Research Council Dyspnoea Scale at Visit 1.
Descrição

score of at least 2 on Modified Medical Research Council Dyspnoea Scale

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3826977
if female, non-childbearing potential
Descrição

i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3831118
if female, child-bearing potential but has a negative urinary pregnancy test at Visit 1 and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study
Descrição

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 dados

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0430056
UMLS CUI [3]
C0700589
EXCLUSION CRITERIA
Descrição

EXCLUSION CRITERIA

Alias
UMLS CUI-1
C0680251
Is experiencing an exacerbation of COPD requiring treatment with oral corticosteroids and/or antibiotics or hospitalisation, or has experienced such exacerbation in the 4 weeks prior to Visit 1.
Descrição

COPD exaceration requiring therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0087111
Has a current medical diagnosis of asthma, eczema, atopic dermatitis and/or allergic rhinitis.
Descrição

current medical diagnosis of asthma, eczema, atopic dermatitis and/or allergic rhinitis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0013595
UMLS CUI [3]
C0011615
UMLS CUI [4]
C2607914
Has a known respiratory disorder other than COPD.
Descrição

e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035204
Has undergone lung surgery.
Descrição

e.g., lung transplant and/or lung volume reduction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038903
Had a chest X-ray indicating diagnosis other than COPD that might interfere with the study.
Descrição

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 dados

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C2015792
Is a nursing mother.
Descrição

breastfeeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006147
Requires regular (daily) or long term oxygen therapy (LTOT).
Descrição

LTOT is defined as ≥ 12 hours oxygen use per day with resting pO2 below 7.3 kPa.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0184633
Is receiving β-blockers.
Descrição

except eye drops

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0304516
Has serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study.
Descrição

serious, uncontrolled disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
Had any changes in COPD medication in the 4 weeks prior to Visit 1.
Descrição

change in COPD medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0580105
Is undergoing pulmonary rehabilitation.
Descrição

pulmonary rehabilitation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0199529
Received antibiotic therapy and/or been hospitalised for a lower respiratory tract infection within the 4 weeks prior to Visit 1.
Descrição

respiratory tract infection requiring antibiotics and/or hospitalization

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0003232
UMLS CUI [1,3]
C0019993
Has received tiotropium bromide, inhaled corticosteroids or anti-leukotrienes within 14 days prior to Visit 1.
Descrição

receiving tiotropium bromide, inhaled corticosteroids or anti-leukotrienes

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1306772
UMLS CUI [2]
C4050091
UMLS CUI [3,1]
C0206517
UMLS CUI [3,2]
C0332206
Has received oral/parenteral corticosteroids within the 4 weeks prior to Visit 1.
Descrição

oral/parenteral corticosteroids

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4053960
Has received any other investigational drugs within the 4 weeks prior to Visit 1.
Descrição

other investigational drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
Has used any medications that significantly inhibit cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole.
Descrição

medications inhibiting cytochrome P450 CYP3A4

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0059563
Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
Descrição

substance abuse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
Has a known or suspected hypersensitivity to ß2 -agonists, inhaled steroids or any components of the formulations (e.g. lactose or milk protein).
Descrição

hypersensitivity to ß2 -agonists, inhaled steroids or lactose

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1373132
UMLS CUI [1,3]
C3536709
UMLS CUI [1,4]
C0022949
Is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or an immediate family member of the aforementioned.
Descrição

belongs to reasearch personnel

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035173
Has previously been enrolled to this study.
Descrição

previously enrolled to this study

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347180
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Similar models

visit 1 (inclusion/exclusion criteria) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
ELIGIBILITY QUESTION
C0013893 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C0013893 (UMLS CUI [1])
criteria fulfilled
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
INCLUSION CRITERIA
C1512693 (UMLS CUI-1)
age 40 years to 80 years
Item
Male or female aged 40 - 80 years inclusive.
boolean
C0001779 (UMLS CUI [1])
clinical history of COPD
Item
Has an established clinical history of stage II COPD
boolean
C0024117 (UMLS CUI [1])
informed consent
Item
Provided a signed and dated written informed consent form prior to participation.
boolean
C0021430 (UMLS CUI [1])
post-bronchodilator FEV1
Item
Demonstrated a post-bronchodilator FEV1 of <80% and ≥50% of predicted normal at Visit 1.
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
post bronchodilator FEV/FVC ratio
Item
Demonstrated a post-bronchodilator FEV1/ FVC ratio < 70% at Visit 1.
boolean
C0748133 (UMLS CUI [1,1])
C1287681 (UMLS CUI [1,2])
C2599594 (UMLS CUI [1,3])
reversibility of FEV1 post-bronchodilator
Item
Has poor reversibility of airflow obstruction defined as ≤10% of the predicted normal FEV1 value recorded 30 minutes after inhalation of 400mcg VENTOLIN demonstrated at Visit 1.
boolean
C3830088 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
current or former smoker with at least 10 pack years
Item
A current or former smoker with a smoking history of ≥10 pack-year.
boolean
C1277691 (UMLS CUI [1,1])
C3241966 (UMLS CUI [1,2])
C1277691 (UMLS CUI [2,1])
C0337671 (UMLS CUI [2,2])
score of at least 2 on Modified Medical Research Council Dyspnoea Scale
Item
Achieved a minimum score of ≥ 2 on the Modified Medical Research Council Dyspnoea Scale at Visit 1.
boolean
C3826977 (UMLS CUI [1])
childbearing potential
Item
if female, non-childbearing potential
boolean
C3831118 (UMLS CUI [1])
childbearing potential, but negative urinary pregnancy test und willing to take contraceptive precautions
Item
if female, child-bearing potential but has a negative urinary pregnancy test at Visit 1 and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study
boolean
C3831118 (UMLS CUI [1])
C0430056 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Item Group
EXCLUSION CRITERIA
C0680251 (UMLS CUI-1)
COPD exaceration requiring therapy
Item
Is experiencing an exacerbation of COPD requiring treatment with oral corticosteroids and/or antibiotics or hospitalisation, or has experienced such exacerbation in the 4 weeks prior to Visit 1.
boolean
C0740304 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
current medical diagnosis of asthma, eczema, atopic dermatitis and/or allergic rhinitis
Item
Has a current medical diagnosis of asthma, eczema, atopic dermatitis and/or allergic rhinitis.
boolean
C0004096 (UMLS CUI [1])
C0013595 (UMLS CUI [2])
C0011615 (UMLS CUI [3])
C2607914 (UMLS CUI [4])
respiratory disorder except from COPD
Item
Has a known respiratory disorder other than COPD.
boolean
C0035204 (UMLS CUI [1])
lung surgery
Item
Has undergone lung surgery.
boolean
C0038903 (UMLS CUI [1])
chest x-ray for other diagnosis
Item
Had a chest X-ray indicating diagnosis other than COPD that might interfere with the study.
boolean
C0039985 (UMLS CUI [1,1])
C2015792 (UMLS CUI [1,2])
breastfeeding
Item
Is a nursing mother.
boolean
C0006147 (UMLS CUI [1])
oxygen therapy
Item
Requires regular (daily) or long term oxygen therapy (LTOT).
boolean
C0184633 (UMLS CUI [1])
beta blockers
Item
Is receiving β-blockers.
boolean
C0304516 (UMLS CUI [1])
serious, uncontrolled disease
Item
Has serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study.
boolean
C0009488 (UMLS CUI [1])
change in COPD medication
Item
Had any changes in COPD medication in the 4 weeks prior to Visit 1.
boolean
C0024117 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])
pulmonary rehabilitation
Item
Is undergoing pulmonary rehabilitation.
boolean
C0199529 (UMLS CUI [1])
respiratory tract infection requiring antibiotics and/or hospitalization
Item
Received antibiotic therapy and/or been hospitalised for a lower respiratory tract infection within the 4 weeks prior to Visit 1.
boolean
C0035243 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
receiving tiotropium bromide, inhaled corticosteroids or anti-leukotrienes
Item
Has received tiotropium bromide, inhaled corticosteroids or anti-leukotrienes within 14 days prior to Visit 1.
boolean
C1306772 (UMLS CUI [1])
C4050091 (UMLS CUI [2])
C0206517 (UMLS CUI [3,1])
C0332206 (UMLS CUI [3,2])
oral/parenteral corticosteroids
Item
Has received oral/parenteral corticosteroids within the 4 weeks prior to Visit 1.
boolean
C4053960 (UMLS CUI [1])
other investigational drugs
Item
Has received any other investigational drugs within the 4 weeks prior to Visit 1.
boolean
C0013230 (UMLS CUI [1])
medications inhibiting cytochrome P450 CYP3A4
Item
Has used any medications that significantly inhibit cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole.
boolean
C0059563 (UMLS CUI [1])
substance abuse
Item
Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
boolean
C0038586 (UMLS CUI [1])
hypersensitivity to ß2 -agonists, inhaled steroids or lactose
Item
Has a known or suspected hypersensitivity to ß2 -agonists, inhaled steroids or any components of the formulations (e.g. lactose or milk protein).
boolean
C0020517 (UMLS CUI [1,1])
C1373132 (UMLS CUI [1,2])
C3536709 (UMLS CUI [1,3])
C0022949 (UMLS CUI [1,4])
belongs to reasearch personnel
Item
Is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or an immediate family member of the aforementioned.
boolean
C0035173 (UMLS CUI [1])
previously enrolled to this study
Item
Has previously been enrolled to this study.
boolean
C2347180 (UMLS CUI [1])
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