A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS)

PHASE3CompletedINTERVENTIONAL
Enrollment

373

Participants

Timeline

Start Date

February 27, 2023

Primary Completion Date

November 19, 2024

Study Completion Date

November 19, 2024

Conditions
Asthma
Interventions
DRUG

BFF MDI 160/9.6 μg BID (320/19.2μg/day)

Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg BID (320/19.2μg/day)

DRUG

BD MDI 160 μg BID (320 μg/day)

Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day)

Trial Locations (104)

1000

Research Site, Manila

1014

Research Site, Manila

2113

Research Site, Newton

3019

Research Site, Marilao

4001

Research Site, Durban

4450

Research Site, Durban

5000

Research Site, Iloilo City

5460

Research Site, Alor Star

7530

Research Site, Tygervalley

10450

Research Site, George Town

11923

Research Site, Guri-si

12308

Research Site, Schenectady

12553

Research Site, New Windsor

15236

Research Site, Pittsburgh

15586

Research Site, Kota Bharu

19040

Research Site, Hatboro

20400

Research Site, Kuala Terengganu

21162

Research Site, White Marsh

21401

Research Site, Annapolis

27607

Research Site, Raleigh

28314

Research Site, Fayetteville

30361

Research Site, Atlanta

30990

Research Site, Ipoh

32713

Research Site, DeBary

32720

Research Site, DeLand

33155

Research Site, Miami

33173

Research Site, Miami

33175

Research Site, Miami

33180

Research Site, Miami

33189

Research Site, Cutler Bay

33324

Research Site, Plantation

33607

Research Site, Tampa

40509

Research Site, Lexington

42415

Research Site, Daegu

43000

Research Site, Kajang

43215

Research Site, Columbus

44033

Research Site, Ulsan

46617

Research Site, South Bend

48336

Research Site, Farmington Hills

53228

Research Site, Milwaukee

54907

Research Site, Jeonju

59100

Research Site, Kuala Lumpur

59808

Research Site, Missoula

59901

Research Site, Kalispell

63141

Research Site, St Louis

65401

Research Site, Rolla

68123

Research Site, Bellevue

70300

Research Site, Seremban

73034

Research Site, Edmond

73120

Research Site, Oklahoma City

75126

Research Site, Forney

76712

Research Site, Waco

77701

Research Site, Beaumont

77901

Research Site, Victoria

78006

Research Site, Boerne

78229

Research Site, San Antonio

78258

Research Site, San Antonio

78704

Research Site, Austin

79912

Research Site, El Paso

84003

Research Site, American Fork

84010

Research Site, Bountiful

85213

Research Site, Mesa

85224

Research Site, Chandler

85745

Research Site, Tucson

89030

Research Site, North Las Vegas

89052

Research Site, Henderson

89102

Research Site, Las Vegas

90017

Research Site, Los Angeles

90025

Research Site, Los Angeles

90048

Research Site, Los Angeles

91324

Research Site, Northridge

92024

Research Site, Encinitas

92123

Research Site, San Diego

92647

Research Site, Huntington Beach

92663

Research Site, Newport Beach

93003

Research Site, Ventura

93301

Research Site, Bakersfield

93720

Research Site, Fresno

94598

Research Site, Walnut Creek

95117

Research Site, San Jose

95823

Research Site, Sacramento

98000

Research Site, Sarawak Miri

02747

Research Site, North Dartmouth

03801

Research Site, Portsmouth

V2C 5T1

Research Site, Kamloops

V1Y 4N7

Research Site, Kelowna

V2A 5L5

Research Site, Penticton

L1S 2J5

Research Site, Ajax

M9V 4B4

Research Site, Toronto

K0C 2K0

Research Site, Winchester

N8X 2G1

Research Site, Windsor

H3M 1L3

Research Site, Montreal

G1G 3Y8

Research Site, Québec

G1V 4W2

Research Site, Québec

377 01

Research Site, Jindřichův Hradec

44 001

Research Site, Louny

410 02

Research Site, Lovosice

671 72

Research Site, Miroslav

148 00

Research Site, Prague

190 00

Research Site, Prague

415 01

Research Site, Teplice

407 47

Research Site, Varnsdorf

0186

Research Site, Pretoria

03312

Research Site, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY

NCT05755906 - A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS) | Biotech Hunter | Biotech Hunter