Clinical trial NCT02980133: Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-02
Enrollment: 841
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety and efficacy of fluticasone propionate and fluticasone propionate salmeterol in pediatric participants with a documented history of persistent asthma.


Eligibility criteria: Inclusion Criteria:

* The participant has a diagnosis of asthma as defined by the National Institutes of Health (NIH).
* The participant 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 participant's persistent asthma is stable and is currently being treated with stable asthma therapy for at least 30 days before the SV. Participants currently on a short-acting β2-agonist (SABA) only, regimen or as needed (PRN), are not eligible.
* The participant has demonstrated ≥10% response to a bronchodilator from screening FEV1 within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol.
* The participant (with assistance from parents/legal guardians/caregivers, as needed) is able to perform technically acceptable lung function assessments by handheld device.
* All participants must be able to replace their current SABA with albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (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 participant 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 participant is pregnant or lactating or plans to become pregnant during the study period or within 30 days after the participant's last study-related visit.
* The participant has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the investigational medicinal product (IMP) or rescue medication formulation (that is, lactose).
* The participant has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (for example, ketoconazole, ritonavir, clarithromycin) within 30 days before the SV or plans to be treated with any strong CYP3A4 inhibitor during the study.
* The participant currently smokes or has a smoking history. The participant must not have used tobacco products within the past year (for example, cigarettes, cigars, chewing tobacco, or pipe tobacco).
* The participant 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 participant has used immunosuppressive medications within 30 days before the SV.
* The participant has untreated oral candidiasis at the SV. Participants 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 participant has a history of a positive test for human immunodeficiency virus, active hepatitis B virus, or hepatitis C infection.
* The participant is an immediate relative of an employee of the clinical investigational center.
* A member of the participant's household is participating in the study at the same time.
* Vulnerable participants (that is, people kept in detention) are excluded from participation.

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

Primary outcomes:
measure: For FS MDPI Versus Fp MDPI: Change From Baseline in 1-Hour Postdose Percent Predicted Morning Forced Expiratory Volume in 1 Second (FEV1) at Week 12
timeFrame: Baseline, Week 12
measure: For Fp MDPI Versus Placebo: Change From Baseline in Weekly Average of the Percent Predicted Trough Morning FEV1 at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in the Weekly Average of Daily Trough Morning (Predose and Pre-Rescue Bronchodilator) Peak Expiratory Flow (PEF) Over the 12 Week Treatment Period
timeFrame: Baseline, Week 1 to 12
measure: 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
timeFrame: Baseline, Week 1 to 12
measure: Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1 Through 12
timeFrame: Baseline, Week 1 to 12
measure: Change From Baseline in Asthma Control (Measured by Childhood Asthma Control Test [C-ACT] Score) Over the 12 Week Treatment Period
timeFrame: Baseline, Week 1 to 12
measure: Time to First Onset of Effect
timeFrame: Baseline up to Week 12
measure: Percentage of Participants Who Discontinued From Investigational Medicinal Product (IMP) for Asthma Exacerbation During the 12 Week Treatment Period
timeFrame: Baseline up to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 13881
state: Alabama
city: Little Rock
country: United States
facility: Teva Investigational Site 13883
state: Arkansas
city: Bakersfield
country: United States
facility: Teva Investigational Site 13906
state: California
city: Corona
country: United States
facility: Teva Investigational Site 14615
state: California
city: Downey
country: United States
facility: Teva Investigational Site 13892
state: California
city: Fountain Valley
country: United States
facility: Teva Investigational Site 13875
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 13904
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 13877
state: California
city: Long Beach
country: United States
facility: Teva Investigational Site 14668
state: California
city: Napa
country: United States
facility: Teva Investigational Site 13914
state: California
city: Paramount
country: United States
facility: Teva Investigational Site 13918
state: California
city: Rolling Hills Estates
country: United States
facility: Teva Investigational Site 14618
state: California
city: Roseville
country: United States
facility: Teva Investigational Site 13912
state: California
city: Stockton
country: United States
facility: Teva Investigational Site 13847
state: California
city: Thousand Oaks
country: United States
facility: Teva Investigational Site 13848
state: California
city: Centennial
country: United States
facility: Teva Investigational Site 13856
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Investigational Site 13910
state: Colorado
city: Longmont
country: United States
facility: Teva Investigational Site 13868
state: Colorado
city: Chiefland
country: United States
facility: Teva Investigational Site 13913
state: Florida
city: DeLand
country: United States
facility: Teva Investigational Site 14616
state: Florida
city: Homestead
country: United States
facility: Teva Investigational Site 13909
state: Florida
city: Loxahatchee Groves
country: United States
facility: Teva Investigational Site 13857
state: Florida
city: Miami Lakes
country: United States
facility: Teva Investigational Site 13870
state: Florida
city: Miami Lakes
country: United States
facility: Teva Investigational Site 14617
state: Florida
city: Miami Springs
country: United States
facility: Teva Investigational Site 13916
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13872
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13907
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13893
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13886
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13899
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13864
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13880
state: Florida
city: Ocala
country: United States
facility: Teva Investigational Site 13911
state: Florida
city: Palmetto Bay
country: United States
facility: Teva Investigational Site 13876
state: Florida
city: Winter Park
country: United States
facility: Teva Investigational Site 13844
state: Florida
city: Gainesville
country: United States
facility: Teva Investigational Site 13866
state: Georgia
city: Savannah
country: United States
facility: Teva Investigational Site 13858
state: Georgia
city: Eagle
country: United States
facility: Teva Investigational Site 13896
state: Idaho
city: Idaho Falls
country: United States
facility: Teva Investigational Site 13903
state: Idaho
city: Springfield
country: United States
facility: Teva Investigational Site 13882
state: Illinois
city: Overland Park
country: United States
facility: Teva Investigational Site 13887
state: Kansas
city: Owensboro
country: United States
facility: Teva Investigational Site 13851
state: Kentucky
city: Rockville
country: United States
facility: Teva Investigational Site 13849
state: Maryland
city: Columbia
country: United States
facility: Teva Investigational Site 13865
state: Missouri
city: Columbia
country: United States
facility: Teva Investigational Site 13885
state: Missouri
city: Missoula
country: United States
facility: Teva Investigational Site 13891
state: Montana
city: Ocean City
country: United States
facility: Teva Investigational Site 13897
state: New Jersey
city: Verona
country: United States
facility: Teva Investigational Site 13854
state: New Jersey
city: Watertown
country: United States
facility: Teva Investigational Site 13908
state: New York
city: Charlotte
country: United States
facility: Teva Investigational Site 13890
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 13863
state: North Carolina
city: Canton
country: United States
facility: Teva Investigational Site 13855
state: Ohio
city: Milford
country: United States
facility: Teva Investigational Site 13905
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 13852
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 13879
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 13884
state: Oklahoma
city: Tulsa
country: United States
facility: Teva Investigational Site 13860
state: Oklahoma
city: Tulsa
country: United States
facility: Teva Investigational Site 13894
state: Oklahoma
city: Medford
country: United States
facility: Teva Investigational Site 13861
state: Oregon
city: Pittsburgh
country: United States
facility: Teva Investigational Site 13874
state: Pennsylvania
city: Scottdale
country: United States
facility: Teva Investigational Site 13895
state: Pennsylvania
city: Providence
country: United States
facility: Teva Investigational Site 13888
state: Rhode Island
city: Charleston
country: United States
facility: Teva Investigational Site 13871
state: South Carolina
city: Charleston
country: United States
facility: Teva Investigational Site 13889
state: South Carolina
city: Spartanburg
country: United States
facility: Teva Investigational Site 13853
state: South Carolina
city: Summerville
country: United States
facility: Teva Investigational Site 14671
state: South Carolina
city: Baytown
country: United States
facility: Teva Investigational Site 13898
state: Texas
city: Boerne
country: United States
facility: Teva Investigational Site 14673
state: Texas
city: El Paso
country: United States
facility: Teva Investigational Site 13867
state: Texas
city: Killeen
country: United States
facility: Teva Investigational Site 13902
state: Texas
city: Live Oak
country: United States
facility: Teva Investigational Site 13846
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 13878
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 14672
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 13917
state: Texas
city: Waco
country: United States
facility: Teva Investigational Site 13845
state: Texas
city: Richmond
country: United States
facility: Teva Investigational Site 13850
state: Virginia
city: Bellingham
country: United States
facility: Teva Investigational Site 13915
state: Washington
city: Kutaisi
country: Georgia
facility: Teva Investigational Site 81041
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81047
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81046
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81044
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81040
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81045
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81042
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81043
city: Budapest
country: Hungary
facility: Teva Investigational Site 51277
city: Budapest
country: Hungary
facility: Teva Investigational Site 51278
city: Budapest
country: Hungary
facility: Teva Investigational Site 51272
city: Debrecen
country: Hungary
facility: Teva Investigational Site 51279
city: Dombovar
country: Hungary
facility: Teva Investigational Site 51271
city: Gyor
country: Hungary
facility: Teva Investigational Site 51269
city: Kaposvar
country: Hungary
facility: Teva Investigational Site 51274
city: Miskolc
country: Hungary
facility: Teva Investigational Site 51270
city: Szeged
country: Hungary
facility: Teva Investigational Site 51276
city: Szigetvar
country: Hungary
facility: Teva Investigational Site 51273
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50444
city: Perm
country: Russian Federation
facility: Teva Investigational Site 50446
city: Saint Petersburg
country: Russian Federation
facility: Teva Investigational Site 50445
city: Saint Petersburg
country: Russian Federation
facility: Teva Investigational Site 50443
city: Saint-Petersburg
country: Russian Federation
facility: Teva Investigational Site 50442
city: Saint-Petersburg
country: Russian Federation
facility: Teva Investigational Site 50447
city: Saint-Petersburg
country: Russian Federation
facility: Teva Investigational Site 50441
city: Saint-Petersburg
country: Russian Federation
facility: Teva Investigational Site 50448
city: Tomsk
country: Russian Federation
facility: Teva Investigational Site 50440
city: Chernivtsi
country: Ukraine
facility: Teva Investigational Site 58261
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 58262
city: Ivano-Frankivsk
country: Ukraine
facility: Teva Investigational Site 58269
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58270
city: Kryvyi Rih
country: Ukraine
facility: Teva Investigational Site 58265
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58271
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58268
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58264
city: Lviv
country: Ukraine
facility: Teva Investigational Site 58260
city: Odesa
country: Ukraine
facility: Teva Investigational Site 58259
city: Odessa
country: Ukraine
facility: Teva Investigational Site 58272
city: Vinnytsya
country: Ukraine
facility: Teva Investigational Site 58263
city: Zaporizhzhia
country: Ukraine
facility: Teva Investigational Site 58267
city: Zaporizhzhya
country: Ukraine
facility: Teva Investigational Site 58266
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: