ID

41527

Description

Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (COPD and concomitant medication) is to be filled out continuously during the study whenever applicable.

Link

https://clinicaltrials.gov/ct2/show/NCT00784550

Keywords

Versions (1)
  1. 11/1/20 11/1/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 1, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

English

COPD and concomitant medication

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identification number
Description

Subject identification number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Description

Date of visit/assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
COPD Prior concomitant medications
Description

COPD Prior concomitant medications

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
UMLS CUI-3
C0024117
Sequence number
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826257
UMLS CUI [1,4]
C0024117
Drug name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826257
UMLS CUI [1,4]
C0024117
Modified reported term
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C2826819
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0024117
GSK Drug synonym
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C2826819
UMLS CUI [1,2]
C0871468
UMLS CUI [1,3]
C2826257
UMLS CUI [1,4]
C0024117
GSK Drug Collection code
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0024117
UMLS CUI [1,4]
C1516698
UMLS CUI [1,5]
C0805701
Failed coding
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0024117
UMLS CUI [1,4]
C0805701
UMLS CUI [1,5]
C0231175
Start Date concomitant medication
Description

Time is optional.

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C2826734
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0024117
Stop Date concomitant medication
Description

Time is optional

Data type

date

Alias
UMLS CUI [1,1]
C2826744
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0024117
Ongoing?
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C0024117
Medication type
Description

This item will be calculated by InForm. [hidden]

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C2826257
UMLS CUI [1,4]
C0024117
COPD concomitant medications
Description

COPD concomitant medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0024117
Sequence number
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0024117
Drug name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0024117
Modified reported term
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C2826819
UMLS CUI [1,2]
C0024117
GSK Drug synonym
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C2826819
UMLS CUI [1,3]
C0871468
GSK Drug Collection code
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C2826819
UMLS CUI [1,3]
C1516698
UMLS CUI [1,4]
C0805701
Failed coding
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0805701
UMLS CUI [1,4]
C0231175
Unit Dose
Description

This item is conditional

Data type

text

Alias
UMLS CUI [1,1]
C2826646
UMLS CUI [1,2]
C0024117
Units
Description

This item is conditional

Data type

text

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439148
Frequency
Description

This item is conditional

Data type

text

Alias
UMLS CUI [1,1]
C2826654
UMLS CUI [1,2]
C0024117
Route
Description

This item is optional

Data type

text

Alias
UMLS CUI [1,1]
C2826730
UMLS CUI [1,2]
C0024117
Start Date
Description

Time is optional

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C2826734
UMLS CUI [1,2]
C0024117
Ongoing?
Description

COPD Concomitant medication ongoing

Data type

text

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0024117
If not ongoing specify End Date
Description

Time is optional

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C2826744
UMLS CUI [1,2]
C0024117
Was drug administered for an exacerbation?
Description

This item is optional

Data type

text

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C3469597
UMLS CUI [1,4]
C0740304
Concomitant medications
Description

Concomitant medications

Alias
UMLS CUI-1
C2347852
Sequence number
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1]
C2348184
Drug name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Modified reported term
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C2826819
UMLS CUI [1,2]
C0871468
GSK Drug Collection code
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C2826819
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Failed coding
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Reason for medication
Description

This item is optional

Data type

text

Alias
UMLS CUI [1]
C2826696
Start Date
Description

Time is optional

Data type

partialDatetime

Alias
UMLS CUI [1]
C2826734
Taken prior to study?
Description

This item is optional

Data type

text

Alias
UMLS CUI [1,1]
C2826667
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
Ongoing?
Description

Concomitant medication ongoing

Data type

text

Alias
UMLS CUI [1]
C2826666
If not ongoing specify End Date
Description

Time is optional

Data type

partialDatetime

Alias
UMLS CUI [1]
C2826744
Medication type
Description

This item will be calculated by InForm. [hidden]

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332307
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Similar models

COPD and concomitant medication

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject identification number
Item
Subject identification number
text
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
COPD Prior concomitant medications
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0024117 (UMLS CUI-3)
Sequence number of prior COPD concomitant agent
Item
Sequence number
integer
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826257 (UMLS CUI [1,3])
C0024117 (UMLS CUI [1,4])
Drug name of prior COPD concomitant agent
Item
Drug name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826257 (UMLS CUI [1,3])
C0024117 (UMLS CUI [1,4])
Modified reported term of prior COPD concomitant medication
Item
Modified reported term
text
C2826819 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
GSK Drug synonym (COPD, prior to study)
Item
GSK Drug synonym
text
C2826819 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C2826257 (UMLS CUI [1,3])
C0024117 (UMLS CUI [1,4])
GSK prior COPD concomitant medication Collection code
Item
GSK Drug Collection code
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
C1516698 (UMLS CUI [1,4])
C0805701 (UMLS CUI [1,5])
Prior COPD concomitant medication Failed coding
Item
Failed coding
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
C0231175 (UMLS CUI [1,5])
Start Date prior COPD concomitant medication
Item
Start Date concomitant medication
partialDatetime
C2826734 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
Stop Date prior COPD concomitant medication
Item
Stop Date concomitant medication
date
C2826744 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
Item
Ongoing?
text
C2826666 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
Concomitant medication ongoing
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No (N)
Prior COPD concomitant medication type
Item
Medication type
text
C2347852 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C2826257 (UMLS CUI [1,3])
C0024117 (UMLS CUI [1,4])
Item Group
COPD concomitant medications
C2347852 (UMLS CUI-1)
C0024117 (UMLS CUI-2)
Sequence number of COPD concomitant medication
Item
Sequence number
integer
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
COPD concomitant medication Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
Modified reported term for COPD concomitant medication
Item
Modified reported term
text
C2826819 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
GSK Drug synonym for COPD concomitant medication
Item
GSK Drug synonym
text
C0024117 (UMLS CUI [1,1])
C2826819 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
GSK COPD concomitant medication Collection code
Item
GSK Drug Collection code
text
C0024117 (UMLS CUI [1,1])
C2826819 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
COPD concomitant medication Failed coding
Item
Failed coding
text
C0024117 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
COPD Concomitant medication Unit Dose
Item
Unit Dose
text
C2826646 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
Item
Units
text
C0024117 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
Concomitant medication Units
Code List
Units
CL Item
Actuation (ACTU)
CL Item
Ampoule (AMP)
CL Item
Bottle (BT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter (CC)
CL Item
Lozenge (LOZ)
CL Item
Microgram/kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Nebel (NEB)
CL Item
Patch (PAT)
CL Item
Puff (PUFF)
CL Item
Spray (SPR)
CL Item
Tablet (TAB)
CL Item
Teaspoon (TSP)
CL Item
Units (U)
CL Item
Application (APP)
CL Item
Area under curve (AUC)
CL Item
Cup (CUP)
CL Item
Drops (GTT)
CL Item
Finger tip unit (FTU)
CL Item
Gamma per kilogram per minute (GA/KG/MIN)
CL Item
Gram (G)
CL Item
Grams per kilogram (G/GK)
CL Item
Grams per litre (G/L)
CL Item
grams per metre squared (G/M2)
CL Item
Grams per millilitre (G/ML)
CL Item
Inhalation (INH)
CL Item
100 International units/ml (100IU/ML)
CL Item
International units (IU)
CL Item
International units per kilogram (IU/KG)
CL Item
International units per kilogram per hour (IU/KG/HR)
CL Item
International units per millilitre (IU/ML)
CL Item
Litre (L)
CL Item
Litre per minute (L/MIN)
CL Item
Mega becquerels (MBq) (MBQ)
CL Item
Megaunits (million units) (MU)
CL Item
Microgram (MCG) (MCG)
CL Item
Microgram (UG) (UG)
CL Item
Microgram/gram (MCG/G)
CL Item
Micrograms per hour (MCG/HR)
CL Item
Microgram/kilogram (MCG/KG)
CL Item
Micrograms per millilitre (MCG/ML)
CL Item
Microlitre (MCL)
CL Item
Micromoles (UMOL)
CL Item
Micromoles per 24 hours (UMOL/24HR)
CL Item
Millicurie (MCI)
CL Item
Milliequivalent (MEQ)
CL Item
Milliequivalent per 24 hours (MEQ/24HR)
CL Item
Milligram (MG)
CL Item
Milligram per day (MG/DAY)
CL Item
Milligram per hour (MG/HR)
CL Item
Milligram/kilogram (MG/KG)
CL Item
Milligram/kilogram per hour (MG/KG/HR)
CL Item
Milligram/kilogram per minute (MG/KG/MIN)
CL Item
Milligram/metre squared (MG/M2)
CL Item
Milligram/millilitre (MG/ML)
CL Item
Milligrams percent (MG%)
CL Item
Millilitre (ML)
CL Item
Millilitre per hour (ML/HR)
CL Item
Millilitre per minute (ML/MIN)
CL Item
Millimole (MMOL)
CL Item
Millimoles per kilogram (MMOL/KG)
CL Item
Millimoles per millilitre (MMOL/ML)
CL Item
Million international units (MIU)
CL Item
Ounce (OZ)
CL Item
Pack (PACK)
CL Item
Percent (%)
CL Item
Ring (RING)
CL Item
Sachet (SACH)
CL Item
Suppository (SUPP)
CL Item
Tablespoon (TBLSP)
CL Item
Units per gram (Units per gram)
CL Item
Units per hour (U/HR)
CL Item
Units per kilogram per minute (U/KG/MIN)
CL Item
Units per minute  (U/MIN)
CL Item
Unknown (UNK)
CL Item
Vial (VIAL)
Item
Frequency
text
C2826654 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
Concomitant medication frequency
Code List
Frequency
CL Item
AC (AC)
CL Item
Every 3 months (Q3M)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q3D (Q3D)
CL Item
Q4D (Q4D)
CL Item
2 times per week (2XWK)
CL Item
3 times per week (3XWK)
CL Item
4 times per week (4XWK)
CL Item
5 times per day (5XD)
CL Item
5 times per week (5XWK)
CL Item
BID (BID)
CL Item
Continuous infection (CINF)
CL Item
HS (HS)
CL Item
Once daily (OD)
CL Item
Once only (ONE)
CL Item
Q12H (Q12H)
CL Item
Q2H (Q2H)
CL Item
Every 2 weeks (Q2WK)
CL Item
Every 3 weeks (Q3WK)
CL Item
Q4H (Q4H)
CL Item
Q6H (Q6H)
CL Item
Q8H (Q8H)
CL Item
QAM (QAM)
CL Item
QH (QH)
CL Item
QID (QID)
CL Item
Every other day (QOD)
CL Item
Once a month (QM)
CL Item
QPM (QPM)
CL Item
Once a week (QWK)
CL Item
TID (TID)
CL Item
Unknown (UNK)
Item
Route
text
C2826730 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
Concomitant medication Route
Code List
Route
CL Item
Epidural (EP)
CL Item
Gatrostomy tube (GTT)
CL Item
Intra-arterial (IA)
CL Item
Intra-articular (IART)
CL Item
Intra-bursa (IB)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intralesional (ILES)
CL Item
Intramuscular (IM)
CL Item
Intranasal (IN)
CL Item
Injection (INJ)
CL Item
Intraocular (IO)
CL Item
intraosteal (IOS)
CL Item
Intraperitoneal (IP)
CL Item
Intrathecal (IT)
CL Item
Intrauterine (IU)
CL Item
Intravenous (IV)
CL Item
Jejunostomy feeding tube (JEJ or PEJ) (JEJ)
CL Item
Nasogastric (NG)
CL Item
Nasal (NS)
CL Item
Right eye (OD)
CL Item
Ophthalmic (OP)
CL Item
Left eye (OS)
CL Item
Otic (OT)
CL Item
Other (OTH)
CL Item
Both eyes (OU)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
transdermal (TD)
CL Item
Transmucosal (TM)
CL Item
Topical (TP)
CL Item
Unknown (UNK)
CL Item
Vaginal (VG)
COPD Concomitant medication Start Date
Item
Start Date
partialDatetime
C2826734 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
Item
Ongoing?
text
C2826666 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
Concomitant medication ongoing
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No, specify End Date (N)
COPD Concomitant medication End Date
Item
If not ongoing specify End Date
partialDatetime
C2826744 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
Item
Was drug administered for an exacerbation?
text
C0024117 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0740304 (UMLS CUI [1,4])
Concomitant medication ongoing
Code List
Was drug administered for an exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Concomitant medications
C2347852 (UMLS CUI-1)
Sequence number
Item
Sequence number
integer
C2348184 (UMLS CUI [1])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
GSK Drug synonym
Item
GSK Drug synonym
text
C2826819 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
GSK Drug Collection code
Item
GSK Drug Collection code
text
C2826819 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
CM: Failed coding
Item
Failed coding
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Reason for concomitant medication
Item
Reason for medication
text
C2826696 (UMLS CUI [1])
Concomitant medication Start Date
Item
Start Date
partialDatetime
C2826734 (UMLS CUI [1])
Item
Taken prior to study?
text
C2826667 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Concomitant medication ongoing
Code List
Taken prior to study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Ongoing?
text
C2826666 (UMLS CUI [1])
Concomitant medication ongoing
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No, specify End Date (N)
Concomitant medication End Date
Item
If not ongoing specify End Date
partialDatetime
C2826744 (UMLS CUI [1])
Medication type
Item
Medication type
text
C2347852 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
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