Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects
Condition: Asthma
MeSH terms: Asthma
Intervention: Fp MDPI; FS MDPI; Advair Diskus; Albuterol
Intervention description: Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
Fp at 100 mcg was an active comparator (single dose). Further, participants were instructed to administer two inhalations of Fp MDPI 50 mcg twice daily (100 mcg total dose) during the Run-in (to replace the participant's current inhaled corticosteroid) and Washout Periods between treatments.; FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate and salmeterol xinafoate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened. The fluticasone propionate component was a fixed dose of 100 mcg. The salmeterol xinofoate dosage varied: 6.25, 12.5, 25 or 50 mcg.; ADVAIR DISKUS (100/50 mcg fluticasone propionate/salmeterol xinafoate) consists of a dry powder formulation of fluticasone propionate and salmeterol xinafoate in a lactose excipient. The dry powder is contained within individual blisters on a double foil strip within the device. Activation of the device opens a single blister of medication which is then dispersed into the air-stream by patient inhalation.; Albuterol (Pro-Air) hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
Intervention MeSH terms: Fluticasone; Xhance; Albuterol; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Adrenergic Agonists
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; dry powder inhaler; long-acting beta2-agonist; bronchodilation; bronchodilator; metered dose inhaler; inhaled corticosteroid

Summary:

      The primary objective of this study is to evaluate the dose response, efficacy, and safety of
      4 different doses of salmeterol Spiromax (6.25, 12.5, 25, and 50 mcg) each combined with a
      fixed dose of fluticasone propionate (100 mcg) delivered as Fluticasone/Salmeterol Spiromax®
      Inhalation Powder (FS Spiromax) when administered as a single dose in subjects 12 years of
      age and older with persistent asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent/assent

          -  General good health

          -  Diagnosis of asthma as defined by the National Institutes of Health (NIH)

          -  A best FEV1 of 40%-85% of the predicted normal value during the screening visit (SV)

          -  Subjects need to demonstrate a ≥ 15% reversibility of FEV1 within 30 minutes following
             4 inhalations of albuterol inhalation aerosol (if required, spacers are permitted for
             reversibility testing) at the SV.

          -  Other inclusion criteria apply

        Exclusion Criteria:

          -  History of life-threatening asthma that is defined for this protocol as an asthma
             episode that required intubation.

          -  Culture-documented or suspected bacterial or viral infection of the upper or lower
             respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to
             the SV.

          -  Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV. A
             subject must not have had any hospitalization for asthma within 6 months prior to the
             SV.

          -  Taking long-acting β-agonists within 2 weeks of the SV

          -  Other exclusion criteria apply.