A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma

PHASE3CompletedINTERVENTIONAL
Enrollment

1,001

Participants

Timeline

Start Date

March 20, 2019

Primary Completion Date

July 20, 2021

Study Completion Date

July 20, 2021

Conditions
Asthma
Interventions
COMBINATION_PRODUCT

Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose)

Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)

COMBINATION_PRODUCT

Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose)

Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)

DRUG

Budesonide metered dose inhaler / BD MDI 160 µg

Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)

DRUG

Albuterol sulfate metered dose inhaler / AS MDI 180 μg

Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)

OTHER

Placebo metered-dose inhaler / Placebo MDI

Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)

Trial Locations (129)

1128

Research Site, Buenos Aires

1414

Research Site, Buenos Aires

1425

Research Site, Buenos Aires

1824

Research Site, Buenos Aires

1878

Research Site, Buenos Aires

2000

Research Site, Santa Fe

4000

Research Site, San Miguel de Tucumán

10036

Research Site, New York

10119

Research Site, Berlin

10461

Research Site, The Bronx

10787

Research Site, Berlin

11000

Research Site, Belgrade

11040

Research Site, New Hyde Park

12157

Research Site, Berlin

12159

Research Site, Berlin

12203

Research Site, Berlin

13187

Research Site, Berlin

16508

Research Site, Erie

21162

Research Site, White Marsh

26505

Research Site, Morgantown

27607

Research Site, Raleigh

28112

Research Site, Monroe

29303

Research Site, Spartanburg

29341

Research Site, Gaffney

32653

Research Site, Gainesville

32765

Research Site, Oviedo

32819

Research Site, Orlando

33024

Research Site, Pembroke Pines

33026

Research Site, Pembroke Pines

33126

Research Site, Miami

33157

Research Site, Palmetto Bay

33173

Research Site, Miami

33174

Research Site, Miami

33180

Research Site, Aventura

33186

Research Site, Miami

33467

Research Site, Greenacres City

33765

Research Site, Clearwater

36608

Research Site, Mobile

37909

Research Site, Knoxville

48307

Research Site, Rochester Hills

48336

Research Site, Farmington Hills

48507

Research Site, Flint

53228

Research Site, Greenfield

55125

Research Site, Woodbury

59808

Research Site, Missoula

60602

Research Site, Chicago

60644

Research Site, Chicago

61002

Research Site, Kharkiv

61039

Research Site, Kharkiv

61124

Research Site, Kharkiv

63141

Research Site, St Louis

64093

Research Site, Warrensburg

65203

Research Site, Columbia

65401

Research Site, Rolla

68005

Research Site, Bellevue

68123

Research Site, Bellevue

69035

Research Site, Zaporizhzhya

69600

Research Site, Zaporizhzhya

73106

Research Site, Oklahoma City

73112

Research Site, Oklahoma City

74136

Research Site, Tulsa

75092

Research Site, Sherman

75110

Research Site, Corsicana

75225

Research Site, Dallas

78006

Research Site, Boerne

78207

Research Site, San Antonio

78229

Research Site, San Antonio

78759

Research Site, Austin

79903

Research Site, El Paso

83646

Research Site, Meridian

89106

Research Site, Las Vegas

89119

Research Site, Las Vegas

90017

Research Site, Los Angeles

90048

Research Site, Los Angeles

92024

Research Site, Encinitas

92123

Research Site, San Diego

92627

Research Site, Costa Mesa

92647

Research Site, Huntington Beach

92663

Research Site, Newport Beach

93301

Research Site, Bakersfield

93534

Research Site, Lancaster

95117

Research Site, San Jose

95661

Research Site, Roseville

95823

Research Site, Sacramento

97202

Research Site, Portland

97504

Research Site, Medford

06708

Research Site, Waterbury

02115

Research Site, Boston

02747

Research Site, North Dartmouth

08558

Research Site, Skillman

08755

Research Site, Toms River

02886

Research Site, Warwick

Unknown

Research Site, Brandýs nad Labem

Research Site, Kralupy nad Vltavou

Research Site, Lovosice

Research Site, Neratovice

Research Site, Prague

Research Site, Rokycany

Research Site, Varnsdorf

Research Site, Darmstadt

Research Site, Dortmund

Research Site, Frankfurt

Research Site, Halle

Research Site, Hamburg

Research Site, Hessen

Research Site, Leipzig

Research Site, Lübeck

Research Site, Marburg

Research Site, Munich

Research Site, Neu-Isenburg

Research Site, Sachsen

Research Site, Schleswig

Research Site, Wiesbaden

Research Site, Witten

Research Site, Kamenitz

Research Site, Kragujevac

Research Site, Valjevo

Research Site, Košice

Research Site, Žilina

Research Site, Cherkasy

Research Site, Dnipro

Research Site, Ivano-Frankivsk

Research Site, Kherson

Research Site, Lutsk

Research Site, Vinnytsia

02002

Research Site, Kyiv

02232

Research Site, Kyiv

03680

Research Site, Kyiv

04201

Research Site, Kyiv

All Listed Sponsors
lead

Bond Avillion 2 Development LP

INDUSTRY

NCT03847896 - A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma | Biotech Hunter | Biotech Hunter