Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 5/27/2013 |
Start Date: | January 2013 |
End Date: | July 2013 |
Contact: | Teva US Medical Information |
Phone: | 1-800-896-5855 |
A Six-Period Crossover, Dose-Ranging Study to Evaluate the Efficacy and Safety of Four Doses of FS Spiromax (Fluticasone Propionate/Salmeterol Xinafoate Inhalation Powder) Administered as Single Doses Compared With Single Doses of Fluticasone Propionate Spiromax and Open Label Advair Diskus in Adult and Adolescent Subjects With Persistent Asthma
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.
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.
We found this trial at
17
sites
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