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

Completed · Phase 2

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01772368

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

72

Starts

2013-01-01

Expected to finish

2013-06-01

Last updated by the study team

2017-06-12

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Teva Investigational Site 10453 — Denver, Colorado, United States
• Teva Investigational Site 10452 — North Dartmouth, Massachusetts, United States
• Teva Investigational Site 10455 — St Louis, Missouri, United States
• Teva Investigational Site 10454 — Skillman, New Jersey, United States
• Teva Investigational Site 10448 — Raleigh, North Carolina, United States
• Teva Investigational Site 10451 — Medford, Oregon, United States
• Teva Investigational Site 10449 — Portland, Oregon, United States
• Teva Investigational Site 10457 — El Paso, Texas, United States
• Teva Investigational Site 10450 — New Braunfels, Texas, United States
• Teva Investigational Site 10456 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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