A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma

PHASE3CompletedINTERVENTIONAL
Enrollment

628

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

February 29, 2016

Study Completion Date

March 31, 2016

Conditions
Asthma
Interventions
DRUG

Beclomethasone dipropionate BAI

Beclomethasone dipropionate (BDP), was delivered by a single inhalation using a breath-actuated inhaler (BAI) at levels of 40 mcg or 80 mcg per inhalation, twice each day.

DRUG

Placebo BAI

Placebo was delivered by a single inhalation using a breath-actuated inhaler (BAI) twice each day.

DRUG

albuterol/salbutamol 90 mcg

Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.

DRUG

Beclomethasone dipropionate MDI

Beclomethasone dipropionate (BDP), was delivered by a single inhalation using a metered-dose inhaler (MDI) at levels of 40 mcg or 80 mcg per inhalation, twice each day.

DRUG

Placebo MDI

Placebo was delivered by a single inhalation using a metered-dose inhaler (MDI) twice each day.

Trial Locations (102)

Unknown

Teva Investigational Site 12346, Hoover

Teva Investigational Site 12294, Montgomery

Teva Investigational Site 10925, Phoenix

Teva Investigational Site 12349, Little Rock

Teva Investigational Site 10903, Costa Mesa

Teva Investigational Site 10911, Downey

Teva Investigational Site 10901, Huntington Beach

Teva Investigational Site 12297, Huntington Beach

Teva Investigational Site 10880, Mission Viejo

Teva Investigational Site 10895, Orange

Teva Investigational Site 10924, Paramount

Teva Investigational Site 10910, Rolling Hills Estates

Teva Investigational Site 12343, Roseville

Teva Investigational Site 12298, San Diego

Teva Investigational Site 12300, San Diego

Teva Investigational Site 12295, San Jose

Teva Investigational Site 12312, West Covina

Teva Investigational Site 10937, Centennial

Teva Investigational Site 10899, Colorado Springs

Teva Investigational Site 10894, Aventura

Teva Investigational Site 12335, Gainesville

Teva Investigational Site 12336, Homestead

Teva Investigational Site 12345, Homestead

Teva Investigational Site 12315, Miami

Teva Investigational Site 12341, Miami

Teva Investigational Site 12342, Miami

Teva Investigational Site 10919, Orlando

Teva Investigational Site 12281, Sarasota

Teva Investigational Site 12332, Winter Park

Teva Investigational Site 10935, Gainesville

Teva Investigational Site 10912, Lawrenceville

Teva Investigational Site 10927, Savannah

Teva Investigational Site 10885, Owensboro

Teva Investigational Site 12317, Covington

Teva Investigational Site 12296, Baltimore

Teva Investigational Site 12323, White Marsh

Teva Investigational Site 10897, North Dartmouth

Teva Investigational Site 10932, Ypsilanti

Teva Investigational Site 10914, Plymouth

Teva Investigational Site 10917, Columbia

Teva Investigational Site 10916, Rolla

Teva Investigational Site 12331, Missoula

Teva Investigational Site 10922, Brick

Teva Investigational Site 10909, Ocean City

Teva Investigational Site 12289, Verona

Teva Investigational Site 10939, Asheville

Teva Investigational Site 12348, Charlotte

Teva Investigational Site 10893, Raleigh

Teva Investigational Site 10888, Canton

Teva Investigational Site 12302, Fairfield

Teva Investigational Site 10921, Toledo

Teva Investigational Site 12285, Toledo

Teva Investigational Site 10906, Oklahoma City

Teva Investigational Site 10915, Oklahoma City

Teva Investigational Site 12314, Oklahoma City

Teva Investigational Site 10891, Tulsa

Teva Investigational Site 10892, Medford

Teva Investigational Site 10898, Portland

Teva Investigational Site 12273, Pittsburgh

Teva Investigational Site 12282, Warwick

Teva Investigational Site 10902, North Charleston

Teva Investigational Site 10938, Orangeburg

Teva Investigational Site 12347, Beaumont

Teva Investigational Site 10926, Boerne

Teva Investigational Site 10908, Dallas

Teva Investigational Site 10918, Dallas

Teva Investigational Site 12291, El Paso

Teva Investigational Site 12329, Live Oak

Teva Investigational Site 10890, New Braunfels

Teva Investigational Site 10904, San Antonio

Teva Investigational Site 10929, San Antonio

Teva Investigational Site 10879, Waco

Teva Investigational Site 10883, Richmond

Teva Investigational Site 10886, Bellingham

Teva Investigational Site 10913, Greenfield

Teva Investigational Site 60017, Čakovec

Teva Investigational Site 60018, Zagreb

Teva Investigational Site 60019, Zagreb

Teva Investigational Site 21037, Guadalajara

Teva Investigational Site 21042, Guadalajara

Teva Investigational Site 21039, Mexico City

Teva Investigational Site 21045, Mexico City

Teva Investigational Site 21035, Monterrey

Teva Investigational Site 21043, San Lucas Tepetlacalco

Teva Investigational Site 21047, San Lucas Tepetlacalco

Teva Investigational Site 21051, Zapopan

Teva Investigational Site 53276, Bialystok

Teva Investigational Site 53267, Krakow

Teva Investigational Site 53269, Lodz

Teva Investigational Site 53272, Lodz

Teva Investigational Site 53271, Lublin

Teva Investigational Site 53274, Lublin

Teva Investigational Site 53273, Tarnów

Teva Investigational Site 53275, Wroclaw

Teva Investigational Site 53270, Zawadzkie

Teva Investigational Site 58165, Dnipropetrovsk

Teva Investigational Site 58171, Kharkiv

Teva Investigational Site 58168, Kryvyi Rih

Teva Investigational Site 58167, Kyiv

Teva Investigational Site 58172, Kyiv

Teva Investigational Site 58169, Zaporizhzhia

Teva Investigational Site 58170, Zaporizhzhya

All Listed Sponsors
lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT02040766 - A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma | Biotech Hunter | Biotech Hunter