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

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ClinicalTrials.gov Identifier: NCT02980133
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Fp MDPI Drug: FS MDPI Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 824 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 28, 2016
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Treatment group A
Fp MDPI- Dose Regimen 1
Drug: Fp MDPI
Experimental: Treatment Group B
Fp MDPI- Dose Regimen 2
Drug: Fp MDPI
Experimental: Treatment Group C
FS MDPI
Drug: FS MDPI
Placebo Comparator: Treatment Group D
Matching placebo
Drug: Placebo



Primary Outcome Measures :
  1. For Fp MDPI versus placebo: the change from baseline in weekly average of the percent predicted trough morning forced expiratory volume in 1 second (FEV1) at week 12 [ Time Frame: Baseline - Week 12 ]
  2. For FS MDPI versus Fp MDPI: the change from baseline in 1-hour postdose percent predicted morning FEV1 at week 12 [ Time Frame: Baseline - Week 12 ]

Secondary Outcome Measures :
  1. Change from baseline in the weekly average of daily trough morning (predose and pre-rescue bronchodilator) PEF over the 12-week treatment period [ Time Frame: Baseline - Week 12 ]
  2. Change from baseline in the weekly average of total daily (24-hour) use of albuterol/salbutamol inhalation aerosol (number of inhalations) over weeks 1 through 12 [ Time Frame: Week 1 - Week 12 ]
  3. Change from baseline in the weekly average of the total daily asthma symptom score (defined as the average of the daytime and nighttime scores) over weeks 1 through 12 [ Time Frame: Week 1 - Week 12 ]
  4. Change from baseline in asthma control (measured by Childhood Asthma Control Test [C-ACT]) over the 12-week treatment period [ Time Frame: Week 1 - Week 12 ]
  5. Time to first onset of effect defined as the first decrease from baseline in daily rescue medication use [ Time Frame: Baseline - Week 12 ]
  6. Proportion of patients discontinued from IMP for asthma exacerbation during the 12-week treatment period [ Time Frame: Week 1 - Week 12 ]


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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980133


Contacts
Contact: Teva U.S. Medical Information 1-888-483-8279 USMedInfo@tevapharm.com

  Hide Study Locations
Locations
United States, Alabama
Teva Investigational Site 13881 Recruiting
Birmingham, Alabama, United States, 35209
United States, Arkansas
Teva Investigational Site 13883 Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Teva Investigational Site 13906 Recruiting
Bakersfield, California, United States, 93301
Teva Investigational Site 14615 Recruiting
Corona, California, United States, 92883
Teva Investigational Site 13892 Recruiting
Downey, California, United States, 90241
Teva Investigational Site 13875 Terminated
Fountain Valley, California, United States, 92708
Teva Investigational Site 13904 Terminated
Huntington Beach, California, United States, 92647 6818
Teva Investigational Site 13877 Recruiting
Huntington Beach, California, United States, 92648
Teva Investigational Site 14668 Recruiting
Long Beach, California, United States, 90806
Teva Investigational Site 13914 Recruiting
Napa, California, United States, 94558
Teva Investigational Site 13918 Recruiting
Paramount, California, United States, 90723
Teva Investigational Site 14618 Recruiting
Rolling Hills Estates, California, United States, 90274
Teva Investigational Site 13912 Completed
Roseville, California, United States, 95661
Teva Investigational Site 13847 Recruiting
Stockton, California, United States, 95207
Teva Investigational Site 13848 Recruiting
Thousand Oaks, California, United States, 91360
United States, Colorado
Teva Investigational Site 13856 Recruiting
Centennial, Colorado, United States, 80112
Teva Investigational Site 13910 Recruiting
Colorado Springs, Colorado, United States, 80907
Teva Investigational Site 13868 Recruiting
Longmont, Colorado, United States, 80501
United States, Florida
Teva Investigational Site 13913 Terminated
Chiefland, Florida, United States, 32626
Teva Investigational Site 14616 Terminated
DeLand, Florida, United States, 32720
Teva Investigational Site 13909 Recruiting
Homestead, Florida, United States, 33030
Teva Investigational Site 13857 Terminated
Loxahatchee Groves, Florida, United States, 33470
Teva Investigational Site 13870 Recruiting
Miami Lakes, Florida, United States, 33014
Teva Investigational Site 14617 Terminated
Miami Lakes, Florida, United States, 33015
Teva Investigational Site 13916 Terminated
Miami Springs, Florida, United States, 33166
Teva Investigational Site 13872 Recruiting
Miami, Florida, United States, 33134
Teva Investigational Site 13907 Recruiting
Miami, Florida, United States, 33134
Teva Investigational Site 13893 Recruiting
Miami, Florida, United States, 33142
Teva Investigational Site 13886 Recruiting
Miami, Florida, United States, 33155
Teva Investigational Site 13899 Recruiting
Miami, Florida, United States, 33175
Teva Investigational Site 13864 Recruiting
Miami, Florida, United States, 33176
Teva Investigational Site 13880 Recruiting
Miami, Florida, United States, 33176
Teva Investigational Site 13911 Terminated
Ocala, Florida, United States, 34471
Teva Investigational Site 13876 Recruiting
Palmetto Bay, Florida, United States, 33157
Teva Investigational Site 13844 Recruiting
Winter Park, Florida, United States, 32789
United States, Georgia
Teva Investigational Site 13866 Recruiting
Gainesville, Georgia, United States, 30501
Teva Investigational Site 13858 Recruiting
Savannah, Georgia, United States, 31406
United States, Idaho
Teva Investigational Site 13896 Terminated
Eagle, Idaho, United States, 83616
Teva Investigational Site 13903 Recruiting
Idaho Falls, Idaho, United States, 83402
United States, Illinois
Teva Investigational Site 13882 Terminated
Springfield, Illinois, United States, 62704
United States, Kansas
Teva Investigational Site 13887 Recruiting
Overland Park, Kansas, United States, 66210
United States, Kentucky
Teva Investigational Site 13851 Recruiting
Owensboro, Kentucky, United States, 42301
United States, Maryland
Teva Investigational Site 13849 Recruiting
Rockville, Maryland, United States, 20850
United States, Missouri
Teva Investigational Site 13865 Recruiting
Columbia, Missouri, United States, 65203
Teva Investigational Site 13885 Recruiting
Columbia, Missouri, United States, 65203
United States, Montana
Teva Investigational Site 13891 Recruiting
Missoula, Montana, United States, 59808
United States, New Jersey
Teva Investigational Site 13897 Recruiting
Ocean City, New Jersey, United States, 07712
Teva Investigational Site 13854 Recruiting
Verona, New Jersey, United States, 07044
United States, New York
Teva Investigational Site 13908 Recruiting
Watertown, New York, United States, 13601
United States, North Carolina
Teva Investigational Site 13890 Recruiting
Charlotte, North Carolina, United States, 28277
Teva Investigational Site 13863 Recruiting
Raleigh, North Carolina, United States, 27607
United States, Ohio
Teva Investigational Site 13855 Terminated
Canton, Ohio, United States, 44718
Teva Investigational Site 13905 Terminated
Milford, Ohio, United States, 45150
United States, Oklahoma
Teva Investigational Site 13852 Recruiting
Oklahoma City, Oklahoma, United States, 73112
Teva Investigational Site 13879 Recruiting
Oklahoma City, Oklahoma, United States, 73112
Teva Investigational Site 13884 Recruiting
Oklahoma City, Oklahoma, United States, 73120
Teva Investigational Site 13860 Recruiting
Tulsa, Oklahoma, United States, 74136
Teva Investigational Site 13894 Terminated
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Teva Investigational Site 13861 Recruiting
Medford, Oregon, United States, 97504
United States, Pennsylvania
Teva Investigational Site 13874 Recruiting
Pittsburgh, Pennsylvania, United States, 15241
Teva Investigational Site 13895 Active, not recruiting
Scottdale, Pennsylvania, United States, 15683
United States, Rhode Island
Teva Investigational Site 13888 Recruiting
Providence, Rhode Island, United States, 02909
United States, South Carolina
Teva Investigational Site 13871 Recruiting
Charleston, South Carolina, United States, 29407
Teva Investigational Site 13889 Recruiting
Charleston, South Carolina, United States, 29414
Teva Investigational Site 13853 Recruiting
Spartanburg, South Carolina, United States, 29303
Teva Investigational Site 14671 Terminated
Summerville, South Carolina, United States, 29483
United States, Texas
Teva Investigational Site 13898 Recruiting
Baytown, Texas, United States, 77521
Teva Investigational Site 13867 Recruiting
El Paso, Texas, United States, 79903
Teva Investigational Site 13902 Recruiting
Killeen, Texas, United States, 76542-0969
Teva Investigational Site 13846 Recruiting
Live Oak, Texas, United States, 78233
Teva Investigational Site 13878 Active, not recruiting
San Antonio, Texas, United States, 78229
Teva Investigational Site 13917 Recruiting
San Antonio, Texas, United States, 78251
Teva Investigational Site 13845 Recruiting
Waco, Texas, United States, 76712
United States, Virginia
Teva Investigational Site 13850 Recruiting
Richmond, Virginia, United States, 23223
United States, Washington
Teva Investigational Site 13915 Recruiting
Bellingham, Washington, United States, 98225
Georgia
Teva Investigational Site 81041 Recruiting
Kutaisi, Georgia, 4600
Teva Investigational Site 81047 Recruiting
Tbilisi, Georgia, 0119
Teva Investigational Site 81046 Recruiting
Tbilisi, Georgia, 0141
Teva Investigational Site 81044 Recruiting
Tbilisi, Georgia, 0159
Teva Investigational Site 81040 Recruiting
Tbilisi, Georgia, 0160
Teva Investigational Site 81045 Recruiting
Tbilisi, Georgia, 0171
Teva Investigational Site 81042 Recruiting
Tbilisi, Georgia, 0179
Teva Investigational Site 81043 Recruiting
Tbilisi, Georgia, 0186
Hungary
Teva Investigational Site 51277 Recruiting
Budapest, Hungary, 1083
Teva Investigational Site 51278 Recruiting
Budapest, Hungary, 1094
Teva Investigational Site 51272 Recruiting
Budapest, Hungary, H-1021
Teva Investigational Site 51279 Recruiting
Debrecen, Hungary, 4032
Teva Investigational Site 51271 Recruiting
Dombovar, Hungary, 7200
Teva Investigational Site 51269 Recruiting
Gyor, Hungary, 9023
Teva Investigational Site 51274 Recruiting
Kaposvar, Hungary, 7400
Teva Investigational Site 51270 Terminated
Miskolc, Hungary, 3526
Teva Investigational Site 51276 Recruiting
Szeged, Hungary, 6720
Teva Investigational Site 51273 Recruiting
Szigetvar, Hungary, 7900
Russian Federation
Teva Investigational Site 50444 Recruiting
Moscow, Russian Federation, 125412
Teva Investigational Site 50446 Recruiting
Perm, Russian Federation, 614066
Teva Investigational Site 50445 Recruiting
Saint Petersburg, Russian Federation, 196240
Teva Investigational Site 50443 Recruiting
Saint Petersburg, Russian Federation, 196657
Teva Investigational Site 50442 Recruiting
Saint-Petersburg, Russian Federation, 191144
Teva Investigational Site 50447 Recruiting
Saint-Petersburg, Russian Federation, 192071
Teva Investigational Site 50441 Recruiting
Saint-Petersburg, Russian Federation, 192148
Teva Investigational Site 50448 Recruiting
Saint-Petersburg, Russian Federation, 196191
Teva Investigational Site 50440 Recruiting
Tomsk, Russian Federation, 634050
Ukraine
Teva Investigational Site 58261 Recruiting
Chernivtsi, Ukraine, 58023
Teva Investigational Site 58262 Recruiting
Dnipropetrovsk, Ukraine, 49101
Teva Investigational Site 58269 Recruiting
Ivano-Frankivsk, Ukraine, 76014
Teva Investigational Site 58270 Recruiting
Kharkiv, Ukraine, 61093
Teva Investigational Site 58265 Recruiting
Kryvyi Rih, Ukraine, 50082
Teva Investigational Site 58271 Recruiting
Kyiv, Ukraine, 03115
Teva Investigational Site 58264 Recruiting
Kyiv, Ukraine, 04050
Teva Investigational Site 58268 Recruiting
Kyiv, Ukraine, 3680
Teva Investigational Site 58260 Recruiting
Lviv, Ukraine, 79059
Teva Investigational Site 58259 Recruiting
Odesa, Ukraine, 65000
Teva Investigational Site 58272 Recruiting
Odessa, Ukraine, 65000
Teva Investigational Site 58263 Recruiting
Vinnytsya, Ukraine, 21021
Teva Investigational Site 58267 Recruiting
Zaporizhzhia, Ukraine, 69000
Teva Investigational Site 58266 Recruiting
Zaporizhzhya, Ukraine, 69038
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT02980133     History of Changes
Other Study ID Numbers: FSS-AS-30003
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Lung Diseases
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists