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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772368
• Other study ID #: FSS-AS-201
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2013
• Last updated: July 20, 2016
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: July 2016
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 ß-agonists within 2 weeks of the SV

• Other exclusion criteria apply.

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• FS Spiromax 6.25
Fluticasone/Salmeterol Spiromax fixed dose of 100 mcg is an inhalation driven, multi-dose dry powder inhaler (DPI) containing salmeterol xinafoate (6.25 mcg)
• Fluticasone propionate Spiromax
This inhaler will be provided in a device identical in appearance to FS Spiromax. It is an inhalation driven, multiple-dose, dry powder inhaler (MDPI) containing 100 or 50 mcg of fluticasone propionate per inhalation dispersed in a lactose monohydrate excipient and contained within a reservoir.
• Advair Diskus
Each inhalation consists of a dry powder formulation of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate in a lactose excipient.
• FS Spiromax 12.5
Fluticasone/Salmeterol Spiromax fixed dose of 100 mcg is an inhalation driven, multi-dose dry powder inhaler (DPI) containing salmeterol xinafoate (12.5 mcg)
• FS Spiromax 25
Fluticasone/Salmeterol Spiromax fixed dose of 100 mcg is an inhalation driven, multi-dose dry powder inhaler (DPI) containing salmeterol xinafoate (25 mcg)
• FS Spiromax 50
Fluticasone/Salmeterol Spiromax fixed dose of 100 mcg is an inhalation driven, multi-dose dry powder inhaler (DPI) containing salmeterol xinafoate (50 mcg)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products, R&D Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under curve (AUC) for forced expiratory volume at one second (FEV1) over 12 hours post-dose	This is the baseline-adjusted area under curve for Forced Expiratory Volume (in liters) in 1 second from zero to 12 hours post inhaler dose. For each pulmonary function test, the subject will be allowed up to five efforts and can stop once three acceptable and two repeatable efforts have been achieved. If repeatability criteria are not met, the highest FEV1 from the best acceptable effort will be chosen. If acceptability criteria are not met, the highest FEV1 from the best effort will be chosen. All baseline FEV1 values during the treatment period will be obtained between 05:30 and 11:00 AM and must be within ± 1 hour of the time of the screening FEV1 time. The primary analysis will be performed using an analysis of covariance.	Treatment Visits 1, 2, 3, 4, 5, 6	No
Secondary	Change from baseline in FEV1 at 12 hours	During all treatment visits (TV1, TV2, TV3, TV4, TV5, and TV6), the highest FEV1 value from three acceptable and two repeatable maneuvers will be obtained at each serial time point. This FEV1 will be compared to the FEV1 from the Screening Visit.	Baseline and Treatment Visits 1, 2, 3, 4, 5, 6	No