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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01772368
First received: January 17, 2013
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: FS Spiromax
Drug: Fluticasone propionate Spiromax
Drug: Advair Diskus
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Area under curve (AUC) for forced expiratory volume at one second (FEV1) over 12 hours post-dose [ Time Frame: Treatment Visits 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from baseline in FEV1 at 12 hours [ Time Frame: Baseline and Treatment Visits 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
    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.


Enrollment: 72
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FS Spiromax 100/6.25 mcg
Subjects will inhale 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate per dose.
Drug: FS Spiromax
Fluticasone/Salmeterol Spiromax is an inhalation driven, multi-dose dry powder inhaler (DPI) containing salmeterol xinafoate with a fixed dose (100 mcg) of fluticasone propionate dispersed in a lactose monohydrate excipient and contained within a reservoir. The inhaler contains 60 actuations, with a target per-inhalation dose of 6.25, 12.5, 25, or 50 mcg of salmeterol xinafoate, each with 100 mcg of fluticasone propionate.
Experimental: FS Spiromax 100/12.5mcg
Subjects will inhale 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate per dose.
Drug: FS Spiromax
Fluticasone/Salmeterol Spiromax is an inhalation driven, multi-dose dry powder inhaler (DPI) containing salmeterol xinafoate with a fixed dose (100 mcg) of fluticasone propionate dispersed in a lactose monohydrate excipient and contained within a reservoir. The inhaler contains 60 actuations, with a target per-inhalation dose of 6.25, 12.5, 25, or 50 mcg of salmeterol xinafoate, each with 100 mcg of fluticasone propionate.
Experimental: FS Spiromax 100/25
Subjects will inhale 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate per dose.
Drug: FS Spiromax
Fluticasone/Salmeterol Spiromax is an inhalation driven, multi-dose dry powder inhaler (DPI) containing salmeterol xinafoate with a fixed dose (100 mcg) of fluticasone propionate dispersed in a lactose monohydrate excipient and contained within a reservoir. The inhaler contains 60 actuations, with a target per-inhalation dose of 6.25, 12.5, 25, or 50 mcg of salmeterol xinafoate, each with 100 mcg of fluticasone propionate.
Experimental: FS Spiromax 100/50
Subjects will inhale 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate per dose.
Drug: FS Spiromax
Fluticasone/Salmeterol Spiromax is an inhalation driven, multi-dose dry powder inhaler (DPI) containing salmeterol xinafoate with a fixed dose (100 mcg) of fluticasone propionate dispersed in a lactose monohydrate excipient and contained within a reservoir. The inhaler contains 60 actuations, with a target per-inhalation dose of 6.25, 12.5, 25, or 50 mcg of salmeterol xinafoate, each with 100 mcg of fluticasone propionate.
Experimental: Fluticasone propionate 100 mcg
Subjects will inhale 100 mcg fluticasone propionate per dose.
Drug: 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.
Active Comparator: Advair Diskus 100/50 mcg
Subjects will inhale 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate per dose. This arm is the only arm which is open-label.
Drug: Advair Diskus
Each inhalation consists of a dry powder formulation of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate in a lactose excipient.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772368

Locations
United States, Colorado
Teva Investigational Site 10453
Denver, Colorado, United States
United States, Massachusetts
Teva Investigational Site 10452
North Dartmouth, Massachusetts, United States
United States, Missouri
Teva Investigational Site 10455
St. Louis, Missouri, United States
United States, New Jersey
Teva Investigational Site 10454
Skillman, New Jersey, United States
United States, North Carolina
Teva Investigational Site 10448
Raleigh, North Carolina, United States
United States, Oregon
Teva Investigational Site 10451
Medford, Oregon, United States
Teva Investigational Site 10449
Portland, Oregon, United States
United States, Texas
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
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01772368     History of Changes
Other Study ID Numbers: FSS-AS-201
Study First Received: January 17, 2013
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Asthma
dry powder inhaler
long-acting beta2-agonist
bronchodilation
bronchodilator
metered dose inhaler
inhaled corticosteroid

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Salmeterol
Albuterol
Fluticasone, salmeterol drug combination
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014