A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects

PHASE4CompletedINTERVENTIONAL
Enrollment

437

Participants

Timeline

Start Date

January 31, 2018

Primary Completion Date

January 24, 2019

Study Completion Date

January 24, 2019

Conditions
Asthma
Interventions
DRUG

RELVAR/BREO

RELVAR/BREO will be available at doses of 100/25 micrograms (µg) and 200/25 µg to be administered via ELLIPTA DPI. Subjects will be administered one inhalation of RELVAR/BREO once daily.

DRUG

Salbutamol

Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required.

DEVICE

Smart phone app

Subjects will be required to download an app associated with sensor on their smartphone. The sensors attached to the inhalers will be connected to the smartphone via Bluetooth.

DEVICE

HCP Dashboard

The information from sensors will be reviewed by the HCP via an online dashboard.

DEVICE

Sensors

Clip-on sensors will be fitted to electronically record the actuation data.

Trial Locations (66)

10119

GSK Investigational Site, Berlin

12203

GSK Investigational Site, Berlin

13156

GSK Investigational Site, Berlin

14059

GSK Investigational Site, Berlin

15011

GSK Investigational Site, A Coruña

15562

GSK Investigational Site, Rüdersdorf

17491

GSK Investigational Site, Peralada( Girona)

18300

GSK Investigational Site, Loja/ Granada

23230

GSK Investigational Site, Richmond

23552

GSK Investigational Site, Lübeck

28034

GSK Investigational Site, Madrid

28044

GSK Investigational Site, Madrid

28277

GSK Investigational Site, Charlotte

33170

GSK Investigational Site, Pordenone

33173

GSK Investigational Site, Miami

33180

GSK Investigational Site, Aventura

48231

GSK Investigational Site, Warendorf

53228

GSK Investigational Site, Greenfield

56124

GSK Investigational Site, Pisa

60026

GSK Investigational Site, Glenview

60422

GSK Investigational Site, Flossmoor

63042

GSK Investigational Site, Hazelwood

64283

GSK Investigational Site, Darmstadt

73120

GSK Investigational Site, Oklahoma City

78229

GSK Investigational Site, San Antonio

80131

GSK Investigational Site, Napoli

84131

GSK Investigational Site, Salerno

90146

GSK Investigational Site, Palermo

97504

GSK Investigational Site, Medford

V1W 1V3

GSK Investigational Site, Kelowna

V5Z 1M9

GSK Investigational Site, Vancouver

L1S 2J5

GSK Investigational Site, Ajax

L7N 3V2

GSK Investigational Site, Burlington

N5W 6A2

GSK Investigational Site, London

N7T 4X3

GSK Investigational Site, Sarnia

M5T 3A9

GSK Investigational Site, Toronto

M9V 4B4

GSK Investigational Site, Toronto

M9W 4L6

GSK Investigational Site, Toronto

N8X2G1

GSK Investigational Site, Windsor

H4J 1C5

GSK Investigational Site, Montreal

G1N 4V3

GSK Investigational Site, Québec

G1W 4R4

GSK Investigational Site, Québec

G3K 2P8

GSK Investigational Site, Québec

J1L 0H8

GSK Investigational Site, Sherbrooke

G6P 6P6

GSK Investigational Site, Victoriaville

04103

GSK Investigational Site, Leipzig

04357

GSK Investigational Site, Leipzig

4818 CK

GSK Investigational Site, Breda

9728 NT

GSK Investigational Site, Groningen

7555 DL

GSK Investigational Site, Hengelo

1624 NP

GSK Investigational Site, Hoorn

2526 HW

GSK Investigational Site, The Hague

7207 AE

GSK Investigational Site, Zutphen

08550

GSK Investigational Site, Balenyà (Barcelona)

08028

GSK Investigational Site, Barcelona

08036

GSK Investigational Site, Barcelona

08430

GSK Investigational Site, La Roca Del Valles (Barcelona)

HP21 8AL

GSK Investigational Site, Aylesbury

WN1 2NN

GSK Investigational Site, Wigan

NN8 4RW

GSK Investigational Site, Wellingborough

KT15 2BH

GSK Investigational Site, Addlestone

S65 1DA

GSK Investigational Site, Rotherham

BS37 4AX

GSK Investigational Site, Bristol

CM1 7ET

GSK Investigational Site, Chelmsford

KT16 0PZ

GSK Investigational Site, Chertsey, Surrey

HG2 7SX

GSK Investigational Site, Harrogate

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03380429 - A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects | Biotech Hunter | Biotech Hunter