ID

24607

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)
  1. 8/6/17 8/6/17 -
  2. 8/8/17 8/8/17 -
  3. 8/8/17 8/8/17 -
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August 8, 2017

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concomitant medication salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

English

concomitant medication salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

subject identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
COPD CONCOMITANT MEDICATIONS
Description

COPD CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0024117
Were any COPD concomitant medications taken by the subject prior to screening and/or during the study?
Description

COPD concomitant medication

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0024117
If "yes" to COPD concomitant medication, record each medication separately by fulfilling the following items.
Description

If "yes" to COPD concomitant medication, record each medication separately by fulfilling the following items.

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0024117
Drug Name
Description

Trade name preferred.

Data type

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Description

unit dose

Data type

integer

Alias
UMLS CUI [1]
C0869039
Unit
Description

units of medication

Data type

text

Alias
UMLS CUI [1]
C1519795
Frequency
Description

frequency of medication

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

medication routes

Data type

text

Alias
UMLS CUI [1]
C0013153
Start Date
Description

start date of medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Taken prior to study?
Description

medication taken prior to study

Data type

text

Alias
UMLS CUI [1]
C2826667
Stop Date
Description

stop date of medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Ongoing medication?
Description

concomitant medication ongoing

Data type

text

Alias
UMLS CUI [1]
C2826666
Was drug administered for an exacerbation?
Description

drug adminstered for a COPD exacerbation

Data type

text

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0740304
NON-COPD CONCOMITANT MEDICATIONS
Description

NON-COPD CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject prior to screening and/or during the study?
Description

medication that is not COPD-related

Data type

text

Alias
UMLS CUI [1]
C2347852
If "yes" to non-COPD concomitant medication, record each medication separately by fulfilling the following items.
Description

If "yes" to non-COPD concomitant medication, record each medication separately by fulfilling the following items.

Alias
UMLS CUI-1
C2347852
Drug name
Description

Trade name preferred.

Data type

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Description

unit dose

Data type

integer

Alias
UMLS CUI [1]
C0869039
Unit
Description

units of medication

Data type

text

Alias
UMLS CUI [1]
C1519795
Frequency
Description

frequency of medication

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

medication routes

Data type

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Description

reason for medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Start Date
Description

start date of medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Taken prior to study?
Description

medication taken prior to study

Data type

text

Alias
UMLS CUI [1]
C2826667
Stop Date
Description

stop date of medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Ongoing medication?
Description

concomitant medication ongoing

Data type

text

Alias
UMLS CUI [1]
C2826666
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Similar models

concomitant medication salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
COPD CONCOMITANT MEDICATIONS
C2347852 (UMLS CUI-1)
C0024117 (UMLS CUI-2)
Item
Were any COPD concomitant medications taken by the subject prior to screening and/or during the study?
text
C2347852 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
COPD concomitant medication
Code List
Were any COPD concomitant medications taken by the subject prior to screening and/or during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
If "yes" to COPD concomitant medication, record each medication separately by fulfilling the following items.
C2347852 (UMLS CUI-1)
C0024117 (UMLS CUI-2)
medication name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
unit dose
Item
Unit Dose
integer
C0869039 (UMLS CUI [1])
Item
Unit
text
C1519795 (UMLS CUI [1])
units of medication
Code List
Unit
CL Item
Actuation (ACTU)
CL Item
Ampoule  (AMP)
CL Item
Application  (APP)
CL Item
Bottle  (BOT)
CL Item
Cubic centimeter (CC)
CL Item
Capsule (CAP)
CL Item
Gram (G)
CL Item
Drops  (GTT)
CL Item
International Units (IU)
CL Item
Litre (L)
CL Item
Litres per minute (L/MIN)
CL Item
Lozenge (LOZ)
CL Item
Microgram (MCG)
CL Item
Microgram per kilogram per minute (MCG/KG/MIN)
CL Item
Microlitre (MCL)
CL Item
Millimole (MMOL)
CL Item
Nebule (NEB)
CL Item
Puff (PUFF)
CL Item
Spray (SPR)
CL Item
Tablet (TAB)
CL Item
Tablespoon (TBLSP)
CL Item
Teaspoon (TSP)
CL Item
Percent (%)
CL Item
Unknown (UNK)
Item
Frequency
text
C3476109 (UMLS CUI [1])
frequency of medication
Code List
Frequency
CL Item
1 X daily (OD/QD)
CL Item
2 X daily (BID)
CL Item
3 X daily (TID)
CL Item
4 X daily  (QID)
CL Item
Continuous (CONT)
CL Item
Cumulative dose (CUM)
CL Item
Daily (D)
CL Item
Intermittent (INT)
CL Item
Not available (NA)
CL Item
At night (NOCT)
CL Item
Other (OTH)
CL Item
As required (PRN)
CL Item
Every hour (quaque hora) (QH)
CL Item
Every other day (QOD)
CL Item
Every night (quaque nocte) (QN)
CL Item
Single dose (SD)
CL Item
Immediately (STAT)
CL Item
Taper (TAP)
CL Item
Unknown (UNK)
Item
Route
text
C0013153 (UMLS CUI [1])
medication routes
Code List
Route
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intranasal (IN)
CL Item
Injection (INJ)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Other (OTH)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Topical (TP)
CL Item
Unknown (UNK)
start date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Taken prior to study?
text
C2826667 (UMLS CUI [1])
medication taken prior to study
Code List
Taken prior to study?
CL Item
Yes (Y)
CL Item
No (N)
stop date of medication
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Ongoing medication?
text
C2826666 (UMLS CUI [1])
concomitant medication ongoing
Code List
Ongoing medication?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was drug administered for an exacerbation?
text
C3469597 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
drug adminstered for a COPD exacerbation
Code List
Was drug administered for an exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
NON-COPD CONCOMITANT MEDICATIONS
C2347852 (UMLS CUI-1)
Item
Were any concomitant medications taken by the subject prior to screening and/or during the study?
text
C2347852 (UMLS CUI [1])
concomitant medication
Code List
Were any concomitant medications taken by the subject prior to screening and/or during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
If "yes" to non-COPD concomitant medication, record each medication separately by fulfilling the following items.
C2347852 (UMLS CUI-1)
medication name
Item
Drug name
text
C2360065 (UMLS CUI [1])
unit dose
Item
Unit Dose
integer
C0869039 (UMLS CUI [1])
Item
Unit
text
C1519795 (UMLS CUI [1])
units of medication
Code List
Unit
CL Item
Actuation (ACTU)
CL Item
Ampoule  (AMP)
CL Item
Application  (APP)
CL Item
Bottle  (BOT)
CL Item
Cubic centimeter (CC)
CL Item
Capsule (CAP)
CL Item
Gram (G)
CL Item
Drops  (GTT)
CL Item
International Units (IU)
CL Item
Litre (L)
CL Item
Litres per minute (L/MIN)
CL Item
Lozenge (LOZ)
CL Item
Microgram (MCG)
CL Item
Microgram per kilogram per minute (MCG/KG/MIN)
CL Item
Microlitre (MCL)
CL Item
Millimole (MMOL)
CL Item
Nebule (NEB)
CL Item
Puff (PUFF)
CL Item
Spray (SPR)
CL Item
Tablet (TAB)
CL Item
Tablespoon (TBLSP)
CL Item
Teaspoon (TSP)
CL Item
Percent (%)
CL Item
Unknown (UNK)
Item
Frequency
text
C3476109 (UMLS CUI [1])
frequency of medication
Code List
Frequency
CL Item
1 X daily (OD/QD)
CL Item
2 X daily (BID)
CL Item
3 X daily (TID)
CL Item
4 X daily  (QID)
CL Item
Continuous (CONT)
CL Item
Cumulative dose (CUM)
CL Item
Daily (D)
CL Item
Intermittent (INT)
CL Item
Not available (NA)
CL Item
At night (NOCT)
CL Item
Other (OTH)
CL Item
As required (PRN)
CL Item
Every hour (quaque hora) (QH)
CL Item
Every other day (QOD)
CL Item
Every night (quaque nocte) (QN)
CL Item
Single dose (SD)
CL Item
Immediately (STAT)
CL Item
Taper (TAP)
CL Item
Unknown (UNK)
Item
Route
text
C0013153 (UMLS CUI [1])
medication routes
Code List
Route
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intranasal (IN)
CL Item
Injection (INJ)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Other (OTH)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Topical (TP)
CL Item
Unknown (UNK)
reason for medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
start date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Taken prior to study?
text
C2826667 (UMLS CUI [1])
medication taken prior to study
Code List
Taken prior to study?
CL Item
Yes (Y)
CL Item
No (N)
stop date of medication
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Ongoing medication?
text
C2826666 (UMLS CUI [1])
concomitant medication ongoing
Code List
Ongoing medication?
CL Item
Yes (Y)
CL Item
No (N)
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