Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:4 - 11
Updated:2/17/2019
Start Date:December 28, 2016
End Date:March 31, 2019
Contact:Teva U.S. Medical Information
Email:USMedInfo@tevapharm.com
Phone:1-888-483-8279

Use our guide to learn which trials are right for you!

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients Aged 4 Through 11 Years With Persistent Asthma

This study is to evaluate the safety and efficacy of Fluticasone Propionate and Fluticasone
propionate Salmeterol in pediatric patients with a documented history of persistent asthma.


Inclusion Criteria:

- The patient has a diagnosis of asthma as defined by the NIH

- The patient has persistent asthma with a FEV1 ≥50% and ≤90% of the value predicted for
age, height, sex, and race at the screening visit (SV).

- The patient's persistent asthma is stable and is currently being treated with stable
asthma therapy for at least 30 days before the SV.

- The patient (with assistance from parents/legal guardians/caregivers, as needed) is
able to perform technically acceptable lung function assessments by handheld device

- The patient (with assistance from parents/legal guardians/caregivers, as needed) is
able to use an MDI device and an MDPI device.

- All patients must be able to replace their current SABA with albuterol/salbutamol HFA
MDI inhalation aerosol at the SV for use as needed for the duration of the study

- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

- The patient has a history of life-threatening asthma exacerbation that is defined for
this protocol as an asthma episode that required intubation and/or was associated with
hypercapnia, respiratory arrest, or hypoxic seizures.

- The patient is pregnant or lactating or plans to become pregnant during the study
period or within 30 days after the patient's last study-related visit.

- The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of
the excipients in the IMP or rescue medication formulation (ie, lactose).

- The patient has been treated with any known strong cytochrome P450 (CYP) 3A4
inhibitors (eg, ketoconazole, ritonavir, clarithromycin) within 30 days before the SV
or plans to be treated with any strong CYP3A4 inhibitor during the study.

- The patient currently smokes or has a smoking history. The patient must not have used
tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or
pipe tobacco).

- The patient has had an asthma exacerbation requiring systemic corticosteroids within
30 days before the SV or has had any hospitalization for asthma within 2 months before
the SV.

- The patient has used immunosuppressive medications within 30 days before the screening
visit.

- The patient has untreated oral candidiasis at the SV. Patients with clinical visual
evidence of oral candidiasis who agree to receive treatment and comply with
appropriate medical monitoring may enter the run-in period.

- The patient has a history of a positive test for human immunodeficiency virus, active
hepatitis B virus, or hepatitis C infection.

- The patient is an immediate relative of an employee of the clinical investigational
center.

- A member of the patient's household is participating in the study at the same time

- Vulnerable patients (ie, people kept in detention) are excluded from participation.

- Additional criteria apply, please contact the investigator for more information
We found this trial at
63
sites
1166
mi
from 91732
Boerne, TX
Click here to add this to my saved trials
Bakersfield, California
Phone: 661-864-7710
106
mi
from 91732
Bakersfield, CA
Click here to add this to my saved trials
Baytown, Texas
Phone: 832-606-2053
1380
mi
from 91732
Baytown, TX
Click here to add this to my saved trials
Bellingham, Washington
Phone: 360-733-5733
?
mi
from 91732
Bellingham, WA
Click here to add this to my saved trials
Birmingham, Alabama
Phone: 205-871-9661
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
2047
mi
from 91732
Canton, OH
Click here to add this to my saved trials
Centennial, Colorado
Phone: 720-858-7510
818
mi
from 91732
Centennial, CO
Click here to add this to my saved trials
Charleston, South Carolina
Phone: 843-576-2538
2184
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina
Phone: 980-999-2050
2102
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
Chiefland, Florida
2078
mi
from 91732
Chiefland, FL
Click here to add this to my saved trials
Colorado Springs, Colorado
Phone: 719-473-8330
802
mi
from 91732
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, Missouri
Phone: 573-442-3070
1459
mi
from 91732
Columbia, MO
Click here to add this to my saved trials
Corona, California
Phone: 951-314-7818
29
mi
from 91732
Corona, CA
Click here to add this to my saved trials
?
mi
from 91732
DeLand, FL
Click here to add this to my saved trials
Downey, California
Phone: 562-904-2123
?
mi
from 91732
Downey, CA
Click here to add this to my saved trials
670
mi
from 91732
Eagle, ID
Click here to add this to my saved trials
El Paso, Texas
Phone: 915-544-2557
686
mi
from 91732
El Paso, TX
Click here to add this to my saved trials
Fountain Valley, California
25
mi
from 91732
Fountain Valley, CA
Click here to add this to my saved trials
Gainesville, Georgia
Phone: 678-971-5005
1944
mi
from 91732
Gainesville, GA
Click here to add this to my saved trials
Homestead, Florida
Phone: 786-600-0012
2314
mi
from 91732
Homestead, FL
Click here to add this to my saved trials
Huntington Beach, California
Phone: 714-477-8001
27
mi
from 91732
Huntington Beach, CA
Click here to add this to my saved trials
Idaho Falls, Idaho
Phone: 410-933-9407
725
mi
from 91732
Idaho Falls, ID
Click here to add this to my saved trials
Killeen, Texas
Phone: 254-690-2800
1196
mi
from 91732
Killeen, TX
Click here to add this to my saved trials
Kutaisi,
Phone: +995 431 224 211
?
mi
from 91732
Kutaisi,
Click here to add this to my saved trials
Little Rock, Arkansas 72205
Phone: 501-224-1156
1460
mi
from 91732
Little Rock, AR
Click here to add this to my saved trials
Live Oak, Texas
Phone: 210-646-6978
1238
mi
from 91732
Live Oak, TX
Click here to add this to my saved trials
Long Beach, California
Phone: 714-656-8909
23
mi
from 91732
Long Beach, CA
Click here to add this to my saved trials
Longmont, Colorado
Phone: 720-929-8300
825
mi
from 91732
Longmont, CO
Click here to add this to my saved trials
Loxahatchee Groves, Florida 33470
2292
mi
from 91732
Loxahatchee Groves, FL
Click here to add this to my saved trials
Medford, Oregon 97504
Phone: 541-858-1018
627
mi
from 91732
Medford, OR
Click here to add this to my saved trials
Miami, Florida
Phone: 305-273-2988
2320
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Miami Lakes, Florida
2311
mi
from 91732
Miami Lakes, FL
Click here to add this to my saved trials
Miami Springs, Florida
2315
mi
from 91732
Miami Springs, FL
Click here to add this to my saved trials
1891
mi
from 91732
Milford, OH
Click here to add this to my saved trials
Missoula, Montana
Phone: 406-549-1124
908
mi
from 91732
Missoula, MT
Click here to add this to my saved trials
Napa, California
Phone: 707-258-8147
376
mi
from 91732
Napa, CA
Click here to add this to my saved trials
2126
mi
from 91732
Ocala, FL
Click here to add this to my saved trials
Ocean City, New Jersey 07712
Phone: +1-732-695-2555 (111)
2410
mi
from 91732
Ocean City, NJ
Click here to add this to my saved trials
Oklahoma City, Oklahoma
Phone: 405-752-0393
1164
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
Overland Park, Kansas
Phone: 913-345-2383
1335
mi
from 91732
Overland Park, KS
Click here to add this to my saved trials
Owensboro, Kentucky
Phone: 270-684-6144
1739
mi
from 91732
Owensboro, KY
Click here to add this to my saved trials
Palmetto Bay, Florida
Phone: 786-339-8454
2318
mi
from 91732
Palmetto Bay, FL
Click here to add this to my saved trials
Paramount, California
Phone: 562-633-5101
15
mi
from 91732
Paramount, CA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania
Phone: 412-833-4051
2119
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials
Providence, Rhode Island
Phone: +1-401-681-4960 (202)
2562
mi
from 91732
Providence, RI
Click here to add this to my saved trials
Raleigh, North Carolina
Phone: 919-881-0309
2218
mi
from 91732
Raleigh, NC
Click here to add this to my saved trials
Richmond, Virginia
Phone: 804-285-7420
2268
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
Rockville, Maryland
Phone: 402-592-2055
2274
mi
from 91732
Rockville, MD
Click here to add this to my saved trials
Rolling Hills Estates, California
Phone: +1-310-265-1623 (307)
28
mi
from 91732
Rolling Hills Estates, CA
Click here to add this to my saved trials
Roseville, California
370
mi
from 91732
Roseville, CA
Click here to add this to my saved trials
San Antonio, Texas
Phone: 210-451-9911
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
Savannah, Georgia 31406
Phone: 912-356-3619
2131
mi
from 91732
Savannah, GA
Click here to add this to my saved trials
Scottdale, Pennsylvania
Phone: 724-220-5281
2141
mi
from 91732
Scottdale, PA
Click here to add this to my saved trials
Spartanburg, South Carolina
Phone: 864-583-1556
2043
mi
from 91732
Spartanburg, SC
Click here to add this to my saved trials
Springfield, Illinois
Phone: 309-452-0995
1608
mi
from 91732
Springfield, IL
Click here to add this to my saved trials
Stockton, California
Phone: 209-951-6741
324
mi
from 91732
Stockton, CA
Click here to add this to my saved trials
Summerville, South Carolina
2167
mi
from 91732
Summerville, SC
Click here to add this to my saved trials
Thousand Oaks, California
Phone: +1-949-347-8700 (113)
47
mi
from 91732
Thousand Oaks, CA
Click here to add this to my saved trials
Tulsa, Oklahoma 74105
Phone: 918-392-4550
1251
mi
from 91732
Tulsa, OK
Click here to add this to my saved trials
Verona, New Jersey
Phone: 973-857-1604
2420
mi
from 91732
Verona, NJ
Click here to add this to my saved trials
Waco, Texas
Phone: 254-751-1144
1221
mi
from 91732
Waco, TX
Click here to add this to my saved trials
Watertown, New York
Phone: 315-681-4192
2333
mi
from 91732
Watertown, NY
Click here to add this to my saved trials
Winter Park, Florida
Phone: 407-898-2767
2185
mi
from 91732
Winter Park, FL
Click here to add this to my saved trials