Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone Propionate; Fluticasone Propionate/Salmeterol; Placebo MDPI
Intervention description: Fluticasone propionate was administered via MDPI per the dose and schedule specified in the arm.; Fluticasone propionate/salmeterol was administered via MDPI per the dose and schedule specified in the arm.; Matching placebo was administered via MDPI per the schedule specified in the arm.
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 841.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No

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