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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: FS Spiromax (Drug); Fluticasone propionate Spiromax (Drug); Advair Diskus (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Teva Branded Pharmaceutical Products, R&D Inc.

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Area under curve (AUC) for forced expiratory volume at one second (FEV1) over 12 hours post-dose

Secondary outcome: Change from baseline in FEV1 at 12 hours

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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

Additional Information

Starting date: January 2013
Last updated: March 19, 2015

Page last updated: August 23, 2015

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