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

NCT ID: NCT02980133

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 841 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-28
• Study Completion Date: 2019-04-13

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo MDPI

Participants received matching placebo via multidose dry powder inhaler (MDPI) for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo MDPI

Intervention Type: DRUG

Matching placebo was administered via MDPI per the schedule specified in the arm.

Fp MDPI 25 mcg BID

Participants received 1 inhalation of 25 mcg fluticasone propionate (Fp) via MDPI twice daily (BID) (total daily dose: 50 mcg) for 12 weeks.

Group Type: EXPERIMENTAL

Fluticasone Propionate

Intervention Type: DRUG

Fluticasone propionate was administered via MDPI per the dose and schedule specified in the arm.

Fp MDPI 50 mcg BID

Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.

Group Type: EXPERIMENTAL

Fluticasone Propionate

Intervention Type: DRUG

Fluticasone propionate was administered via MDPI per the dose and schedule specified in the arm.

FS MDPI 50/12.5 mcg BID

Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol (FS) via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.

Group Type: EXPERIMENTAL

Fluticasone Propionate/Salmeterol

Intervention Type: DRUG

Fluticasone propionate/salmeterol was administered via MDPI per the dose and schedule specified in the arm.

Interventions

Fluticasone Propionate

Fluticasone propionate was administered via MDPI per the dose and schedule specified in the arm.

Intervention Type: DRUG

Fluticasone Propionate/Salmeterol

Fluticasone propionate/salmeterol was administered via MDPI per the dose and schedule specified in the arm.

Intervention Type: DRUG

Placebo MDPI

Matching placebo was administered via MDPI per the schedule specified in the arm.

Intervention Type: DRUG

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 13881

Birmingham, Alabama, United States

Teva Investigational Site 13883

Little Rock, Arkansas, United States

Teva Investigational Site 13906

Bakersfield, California, United States

Teva Investigational Site 14615

Corona, California, United States

Teva Investigational Site 13892

Downey, California, United States

Teva Investigational Site 13875

Fountain Valley, California, United States

Teva Investigational Site 13904

Huntington Beach, California, United States

Teva Investigational Site 13877

Huntington Beach, California, United States

Teva Investigational Site 14668

Long Beach, California, United States

Teva Investigational Site 13914

Napa, California, United States

Teva Investigational Site 13918

Paramount, California, United States

Teva Investigational Site 14618

Rolling Hills Estates, California, United States

Teva Investigational Site 13912

Roseville, California, United States

Teva Investigational Site 13847

Stockton, California, United States

Teva Investigational Site 13848

Thousand Oaks, California, United States

Teva Investigational Site 13856

Centennial, Colorado, United States

Teva Investigational Site 13910

Colorado Springs, Colorado, United States

Teva Investigational Site 13868

Longmont, Colorado, United States

Teva Investigational Site 13913

Chiefland, Florida, United States

Teva Investigational Site 14616

DeLand, Florida, United States

Teva Investigational Site 13909

Homestead, Florida, United States

Teva Investigational Site 13857

Loxahatchee Groves, Florida, United States

Teva Investigational Site 13872

Miami, Florida, United States

Teva Investigational Site 13907

Miami, Florida, United States

Teva Investigational Site 13893

Miami, Florida, United States

Teva Investigational Site 13886

Miami, Florida, United States

Teva Investigational Site 13899

Miami, Florida, United States

Teva Investigational Site 13864

Miami, Florida, United States

Teva Investigational Site 13880

Miami, Florida, United States

Teva Investigational Site 13870

Miami Lakes, Florida, United States

Teva Investigational Site 14617

Miami Lakes, Florida, United States

Teva Investigational Site 13916

Miami Springs, Florida, United States

Teva Investigational Site 13911

Ocala, Florida, United States

Teva Investigational Site 13876

Palmetto Bay, Florida, United States

Teva Investigational Site 13844

Winter Park, Florida, United States

Teva Investigational Site 13866

Gainesville, Georgia, United States

Teva Investigational Site 13858

Savannah, Georgia, United States

Teva Investigational Site 13896

Eagle, Idaho, United States

Teva Investigational Site 13903

Idaho Falls, Idaho, United States

Teva Investigational Site 13882

Springfield, Illinois, United States

Teva Investigational Site 13887

Overland Park, Kansas, United States

Teva Investigational Site 13851

Owensboro, Kentucky, United States

Teva Investigational Site 13849

Rockville, Maryland, United States

Teva Investigational Site 13865

Columbia, Missouri, United States

Teva Investigational Site 13885

Columbia, Missouri, United States

Teva Investigational Site 13891

Missoula, Montana, United States

Teva Investigational Site 13897

Ocean City, New Jersey, United States

Teva Investigational Site 13854

Verona, New Jersey, United States

Teva Investigational Site 13908

Watertown, New York, United States

Teva Investigational Site 13890

Charlotte, North Carolina, United States

Teva Investigational Site 13863

Raleigh, North Carolina, United States

Teva Investigational Site 13855

Canton, Ohio, United States

Teva Investigational Site 13905

Milford, Ohio, United States

Teva Investigational Site 13852

Oklahoma City, Oklahoma, United States

Teva Investigational Site 13879

Oklahoma City, Oklahoma, United States

Teva Investigational Site 13884

Oklahoma City, Oklahoma, United States

Teva Investigational Site 13860

Tulsa, Oklahoma, United States

Teva Investigational Site 13894

Tulsa, Oklahoma, United States

Teva Investigational Site 13861

Medford, Oregon, United States

Teva Investigational Site 13874

Pittsburgh, Pennsylvania, United States

Teva Investigational Site 13895

Scottdale, Pennsylvania, United States

Teva Investigational Site 13888

Providence, Rhode Island, United States

Teva Investigational Site 13871

Charleston, South Carolina, United States

Teva Investigational Site 13889

Charleston, South Carolina, United States

Teva Investigational Site 13853

Spartanburg, South Carolina, United States

Teva Investigational Site 14671

Summerville, South Carolina, United States

Teva Investigational Site 13898

Baytown, Texas, United States

Teva Investigational Site 14673

Boerne, Texas, United States

Teva Investigational Site 13867

El Paso, Texas, United States

Teva Investigational Site 13902

Killeen, Texas, United States

Teva Investigational Site 13846

Live Oak, Texas, United States

Teva Investigational Site 13878

San Antonio, Texas, United States

Teva Investigational Site 14672

San Antonio, Texas, United States

Teva Investigational Site 13917

San Antonio, Texas, United States

Teva Investigational Site 13845

Waco, Texas, United States

Teva Investigational Site 13850

Richmond, Virginia, United States

Teva Investigational Site 13915

Bellingham, Washington, United States

Teva Investigational Site 81041

Kutaisi, , Georgia

Teva Investigational Site 81047

Tbilisi, , Georgia

Teva Investigational Site 81046

Tbilisi, , Georgia

Teva Investigational Site 81044

Tbilisi, , Georgia

Teva Investigational Site 81040

Tbilisi, , Georgia

Teva Investigational Site 81045

Tbilisi, , Georgia

Teva Investigational Site 81042

Tbilisi, , Georgia

Teva Investigational Site 81043

Tbilisi, , Georgia

Teva Investigational Site 51277

Budapest, , Hungary

Teva Investigational Site 51278

Budapest, , Hungary

Teva Investigational Site 51272

Budapest, , Hungary

Teva Investigational Site 51279

Debrecen, , Hungary

Teva Investigational Site 51271

Dombóvár, , Hungary

Teva Investigational Site 51269

Győr, , Hungary

Teva Investigational Site 51274

Kaposvár, , Hungary

Teva Investigational Site 51270

Miskolc, , Hungary

Teva Investigational Site 51276

Szeged, , Hungary

Teva Investigational Site 51273

Szigetvár, , Hungary

Teva Investigational Site 50444

Moscow, , Russia

Teva Investigational Site 50446

Perm, , Russia

Teva Investigational Site 50442

Saint Petersburg, , Russia

Teva Investigational Site 50447

Saint Petersburg, , Russia

Teva Investigational Site 50441

Saint Petersburg, , Russia

Teva Investigational Site 50448

Saint Petersburg, , Russia

Teva Investigational Site 50445

Saint Petersburg, , Russia

Teva Investigational Site 50443

Saint Petersburg, , Russia

Teva Investigational Site 50440

Tomsk, , Russia

Teva Investigational Site 58261

Chernivtsi, , Ukraine

Teva Investigational Site 58262

Dnipropetrovsk, , Ukraine

Teva Investigational Site 58269

Ivano-Frankivsk, , Ukraine

Teva Investigational Site 58270

Kharkiv, , Ukraine

Teva Investigational Site 58265

Kryvyi Rih, , Ukraine

Teva Investigational Site 58271

Kyiv, , Ukraine

Teva Investigational Site 58268

Kyiv, , Ukraine

Teva Investigational Site 58264

Kyiv, , Ukraine

Teva Investigational Site 58260

Lviv, , Ukraine

Teva Investigational Site 58259

Odesa, , Ukraine

Teva Investigational Site 58272

Odesa, , Ukraine

Teva Investigational Site 58263

Vinnytsia, , Ukraine

Teva Investigational Site 58267

Zaporizhzhia, , Ukraine

Teva Investigational Site 58266

Zaporizhzhya, , Ukraine

Countries

Poland; United States; Georgia; Hungary; Russia; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-003835-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FSS-AS-30003

Identifier Type: -

Identifier Source: org_study_id