ID

41527

Descrição

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

Palavras-chave

Clinical Trial

Concomitant Medication

D029424

Klinische Studie, Phase III [Dokumenttyp]

01/11/2020 01/11/2020 -

Titular dos direitos

GlaxoSmithKline

Transferido a

1 de novembro de 2020

DOI

Para um pedido faça login.

Licença

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

model
Detalhes

COPD and concomitant medication

1 Formulários

StudyEvent: ODM
1. COPD and concomitant medication

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Administrative Data

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])

COPD Prior concomitant medications

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])

Prior COPD Concomitant medication ongoing

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])

COPD concomitant medications

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])

COPD Concomitant medication Units

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)

COPD Concomitant medication frequency

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)

COPD Concomitant medication Route

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])

COPD Concomitant medication ongoing

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])

COPD concomitant medication administered for an exacerbation

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)

Concomitant medications

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])

Concomitant medication prior to study

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)

Concomitant medication ongoing

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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Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

COPD and concomitant medication

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