A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma

PHASE3CompletedINTERVENTIONAL
Enrollment

273

Participants

Timeline

Start Date

December 26, 2013

Primary Completion Date

December 24, 2014

Study Completion Date

December 24, 2014

Conditions
Persistent Asthma
Interventions
DRUG

Beclomethasone dipropionate breath-actuated inhaler

Beclomethasone dipropionate (BDP) breath-actuated inhaler (BAI) given in dosages of either 40 mcg/inhalation or 80 mcg/inhalation. Study drug was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.

DRUG

Placebo breath-actuated inhaler

Placebo was provided in matching breath-actuated inhaler (BAI) devices. The placebo devices were identical to the devices used to deliver active drug. Placebo was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.

DRUG

albuterol/salbutamol

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

Trial Locations (47)

Unknown

Teva Investigational Site 12813, Huntington Beach

Teva Investigational Site 10944, Mission Viejo

Teva Investigational Site 10946, Orange

Teva Investigational Site 10963, Rolling Hills Estates

Teva Investigational Site 10960, San Diego

Teva Investigational Site 10973, San Diego

Teva Investigational Site 10975, San Jose

Teva Investigational Site 10948, Centennial

Teva Investigational Site 10958, Centennial

Teva Investigational Site 10957, Colorado Springs

Teva Investigational Site 12814, Sarasota

Teva Investigational Site 10962, Tallahassee

Teva Investigational Site 12809, Savannah

Teva Investigational Site 10947, Indianapolis

Teva Investigational Site 10943, Iowa City

Teva Investigational Site 10954, Baltimore

Teva Investigational Site 12940, Bethesda

Teva Investigational Site 10955, North Dartmouth

Teva Investigational Site 10941, Minneapolis

Teva Investigational Site 10970, Columbia

Teva Investigational Site 10968, Rolla

Teva Investigational Site 10972, Bozeman

Teva Investigational Site 12941, Missoula

Teva Investigational Site 10942, Bellevue

Teva Investigational Site 10959, Skillman

Teva Investigational Site 10945, Raleigh

Teva Investigational Site 12810, Cincinnati

Teva Investigational Site 10974, Sylvania

Teva Investigational Site 12805, Oklahoma City

Teva Investigational Site 12942, Oklahoma City

Teva Investigational Site 10951, Tulsa

Teva Investigational Site 10940, Lake Oswego

Teva Investigational Site 10952, Medford

Teva Investigational Site 10956, Portland

Teva Investigational Site 12939, Pittsburgh

Teva Investigational Site 12806, Orangeburg

Teva Investigational Site 12811, Knoxville

Teva Investigational Site 10969, Austin

Teva Investigational Site 12812, Boerne

Teva Investigational Site 10949, Dallas

Teva Investigational Site 10953, El Paso

Teva Investigational Site 12807, Houston

Teva Investigational Site 10950, New Braunfels

Teva Investigational Site 10961, San Antonio

Teva Investigational Site 12808, Waco

Teva Investigational Site 10967, Seattle

Teva Investigational Site 10964, Greenfield

All Listed Sponsors
lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT02040779 - A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma | Biotech Hunter | Biotech Hunter