Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma

PHASE3CompletedINTERVENTIONAL
Enrollment

713

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions
Persistent Asthma
Interventions
DRUG

Beclomethasone Dipropionate 640

Beclomethasone Dipropionate 640 mcg BAI

DRUG

Placebo

"Placebo, taken in the morning and evening each day, was provided in matching BAI and MDI devices.~The placebo devices were identical to the devices used to deliver active drug."

DRUG

Beclomethasone dipropionate via 320 mcg BAI

Beclomethasone dipropionate treatment administered via breath-actuated inhaler (BAI) (320 mcg/day).

DRUG

albuterol/salbutamol

Each patient's current rescue medication was replaced with study-supplied albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent during the run-in and double-blind study periods.

DRUG

Beclomethasone dipropionate via 320 mcg MDI

Beclomethasone dipropionate treatment administered via metered-dose inhaler (MDI) (320 mcg/day).

Trial Locations (75)

Unknown

Teva Investigational Site 13415, Peoria

Teva Investigational Site 13389, Downey

Teva Investigational Site 13421, Huntington Beach

Teva Investigational Site 13434, Huntington Beach

Teva Investigational Site 13427, Los Angeles

Teva Investigational Site 13386, Mission Viejo

Teva Investigational Site 13394, Orange

Teva Investigational Site 13417, Riverside

Teva Investigational Site 13445, Rolling Hills Estates

Teva Investigational Site 13420, San Diego

Teva Investigational Site 13443, San Diego

Teva Investigational Site 13438, San Jose

Teva Investigational Site 13397, Centennial

Teva Investigational Site 13454, Denver

Teva Investigational Site 13404, Aventura

Teva Investigational Site 13458, Hialeah

Teva Investigational Site 13416, Miami

Teva Investigational Site 13440, Miami

Teva Investigational Site 13455, Miami

Teva Investigational Site 13431, Ormond Beach

Teva Investigational Site 13437, Sarasota

Teva Investigational Site 13425, Tallahassee

Teva Investigational Site 13450, Normal

Teva Investigational Site 13448, River Forest

Teva Investigational Site 13408, Lenexa

Teva Investigational Site 13410, Baltimore

Teva Investigational Site 13422, Bethesda

Teva Investigational Site 13435, Wheaton

Teva Investigational Site 13411, North Dartmouth

Teva Investigational Site 13398, Plymouth

Teva Investigational Site 13429, Plymouth

Teva Investigational Site 13433, Columbia

Teva Investigational Site 13432, Rolla

Teva Investigational Site 13414, St Louis

Teva Investigational Site 13430, St Louis

Teva Investigational Site 13384, Bellevue

Teva Investigational Site 13392, Brick

Teva Investigational Site 13426, Ocean City

Teva Investigational Site 13419, Skillman

Teva Investigational Site 13388, Rochester

Teva Investigational Site 13441, Hickory

Teva Investigational Site 13403, Raleigh

Teva Investigational Site 13405, Wilmington

Teva Investigational Site 13395, Canton

Teva Investigational Site 13396, Cincinnati

Teva Investigational Site 13436, Sylvania

Teva Investigational Site 13423, Toledo

Teva Investigational Site 13387, Oklahoma City

Teva Investigational Site 13453, Eugene

Teva Investigational Site 13439, Lake Oswego

Teva Investigational Site 13402, Medford

Teva Investigational Site 13412, Portland

Teva Investigational Site 13391, Pittsburgh

Teva Investigational Site 13449, East Providence

Teva Investigational Site 13456, Warwick

Teva Investigational Site 13413, North Charleston

Teva Investigational Site 13390, Knoxville

Teva Investigational Site 13442, Knoxville

Teva Investigational Site 13400, Austin

Teva Investigational Site 13452, Boerne

Teva Investigational Site 13407, Dallas

Teva Investigational Site 13424, Dallas

Teva Investigational Site 13409, El Paso

Teva Investigational Site 13451, Houston

Teva Investigational Site 13399, New Braunfels

Teva Investigational Site 13393, San Antonio

Teva Investigational Site 13444, San Antonio

Teva Investigational Site 13446, San Antonio

Teva Investigational Site 13457, San Antonio

Teva Investigational Site 13459, San Antonio

Teva Investigational Site 13383, Waco

Teva Investigational Site 13401, South Burlington

Teva Investigational Site 13385, Richmond

Teva Investigational Site 13447, Richmond

Teva Investigational Site 13428, Greenfield

All Listed Sponsors
lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT02513160 - Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma | Biotech Hunter | Biotech Hunter