Long-Term Safety Study of Fluticasone Propionate (Fp) Multidose Dry Powder Inhaler (MDPI) and Fluticasone Propionate/Salmeterol (FS) MDPI in Patients With Persistent Asthma

PHASE3CompletedINTERVENTIONAL
Enrollment

758

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
Persistent Asthma
Interventions
DRUG

Fp MDPI

"Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient.~During the treatment period, participants were randomized to either 100 mcg or 200 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 400 mcg. Study drug was administered in the morning and in the evening."

DRUG

FS MDPI

"FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) and salmeterol xinafoate (Sx) dispersed in a lactose monohydrate excipient.~During the treatment period, participants were randomized to either Fp/Sx MDPI 100/12.5 mcg or Fp/Sx MDPI 100/12.5 mcg twice a day for a total daily dose of 200/25 mcg or 400/25 mcg Fp/Sx. Study drug was administered in the morning and in the evening."

DRUG

FLOVENT HFA

"FLOVENT HFA is a hydrofluoroalkane (HFA) inhaler containing fluticasone propionate.~During the treatment period, participants were randomized to either 110 mcg or 220 mcg of FLOVENT two puffs, twice a day for a total daily dose of 440 mcg or 880 mcg. Study drug was administered in the morning and in the evening."

DRUG

ADVAIR DISKUS

"ADVAIR DISKUS contains a dry powder formulation of fluticasone propionate (Fp) and salmeterol xinafoate (Sx) in a lactose excipient.~During the treatment period, participants were randomized to Fp 250 mcg/Sx 50 mcg or Fp 500 mcg/Sx 50 mcg one inhalation, twice a day for a total daily dose of 500/100 mcg or 1000/100 mcg. Study drug was administered in the morning and in the evening."

DRUG

albuterol/salbutamol HFA

A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).

Trial Locations (101)

Unknown

Teva Investigational Site 12068, Birmingham

Teva Investigational Site 12112, Mobile

Teva Investigational Site 12130, Pell City

Teva Investigational Site 12119, Little Rock

Teva Investigational Site 12076, Phoenix

Teva Investigational Site 12135, Scottsdale

Teva Investigational Site 12132, Tucson

Teva Investigational Site 12102, Fountain Valley

Teva Investigational Site 12104, Fresno

Teva Investigational Site 12123, Fullerton

Teva Investigational Site 12103, Huntington Beach

Teva Investigational Site 12073, Long Beach

Teva Investigational Site 12077, Mission Viejo

Teva Investigational Site 12098, Napa

Teva Investigational Site 12149, Northridge

Teva Investigational Site 12081, Orange

Teva Investigational Site 12100, Rancho Mirage

Teva Investigational Site 12133, Riverside

Teva Investigational Site 12146, Riverside

Teva Investigational Site 12075, Rolling Hills Estates

Teva Investigational Site 12074, San Diego

Teva Investigational Site 12150, San Diego

Teva Investigational Site 12064, San Jose

Teva Investigational Site 12061, Stockton

Teva Investigational Site 12141, Walnut Creek

Teva Investigational Site 12043, Denver

Teva Investigational Site 12051, Denver

Teva Investigational Site 12091, Waterbury

Teva Investigational Site 12078, Fort Lauderdale

Teva Investigational Site 12140, Hialeah

Teva Investigational Site 12066, Kissimmee

Teva Investigational Site 12120, Miami

Teva Investigational Site 12127, Miami

Teva Investigational Site 12148, Miami

Teva Investigational Site 12114, Ocala

Teva Investigational Site 12055, Sarasota

Teva Investigational Site 12048, Tallahassee

Teva Investigational Site 12122, Tamarac

Teva Investigational Site 12086, Winter Park

Teva Investigational Site 12111, Gainesville

Teva Investigational Site 12070, Lawrenceville

Teva Investigational Site 12072, Marietta

Teva Investigational Site 12106, Coeur d'Alene

Teva Investigational Site 12117, Eagle

Teva Investigational Site 12065, River Forest

Teva Investigational Site 12059, Shiloh

Teva Investigational Site 12056, Overland Park

Teva Investigational Site 12138, Fort Mitchell

Teva Investigational Site 12092, Owensboro

Teva Investigational Site 12087, Covington

Teva Investigational Site 12095, Bangor

Teva Investigational Site 12042, Baltimore

Teva Investigational Site 12124, Baltimore

Teva Investigational Site 12052, North Dartmouth

Teva Investigational Site 12139, Minneapolis

Teva Investigational Site 12137, Plymouth

Teva Investigational Site 12079, Columbia

Teva Investigational Site 12067, Rolla

Teva Investigational Site 12057, St Louis

Teva Investigational Site 12060, St Louis

Teva Investigational Site 12108, St Louis

Teva Investigational Site 12128, Warrensburg

Teva Investigational Site 12136, Bellevue

Teva Investigational Site 12115, Las Vegas

Teva Investigational Site 12131, Las Vegas

Teva Investigational Site 12126, Ocean City

Teva Investigational Site 12129, Verona

Teva Investigational Site 12058, Rochester

Teva Investigational Site 12113, Rockville Centre

Teva Investigational Site 12047, Charlotte

Teva Investigational Site 12085, Charlotte

Teva Investigational Site 12144, Winston-Salem

Teva Investigational Site 12053, Canton

Teva Investigational Site 12094, Cincinnati

Teva Investigational Site 12105, Cincinnati

Teva Investigational Site 12107, Sylvania

Teva Investigational Site 12069, Tiffin

Teva Investigational Site 12045, Oklahoma City

Teva Investigational Site 12080, Oklahoma City

Teva Investigational Site 12083, Oklahoma City

Teva Investigational Site 12062, Eugene

Teva Investigational Site 12097, Medford

Teva Investigational Site 12049, Portland

Teva Investigational Site 12134, Bryn Mawr

Teva Investigational Site 12090, Philadelphia

Teva Investigational Site 12089, Providence

Teva Investigational Site 12088, Warwick

Teva Investigational Site 12096, Charleston

Teva Investigational Site 12147, Spartanburg

Teva Investigational Site 12121, Dallas

Teva Investigational Site 12099, El Paso

Teva Investigational Site 12071, Live Oak

Teva Investigational Site 12054, San Antonio

Teva Investigational Site 12145, Waco

Teva Investigational Site 12046, Murray

Teva Investigational Site 12041, South Burlington

Teva Investigational Site 12125, Richmond

Teva Investigational Site 12101, Seattle

Teva Investigational Site 12109, Spokane

Teva Investigational Site 12044, Tacoma

Teva Investigational Site 12082, Greenfield

All Listed Sponsors
lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT02175771 - Long-Term Safety Study of Fluticasone Propionate (Fp) Multidose Dry Powder Inhaler (MDPI) and Fluticasone Propionate/Salmeterol (FS) MDPI in Patients With Persistent Asthma | Biotech Hunter | Biotech Hunter