Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Adrenergic Agonists; Albuterol; Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Salmeterol Xinafoate; Xhance

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.