A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005

June 8, 2011 updated by: SkyePharma AG

A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005, Incorporating Amendment 1 and 2

The objective of this study is to assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 14050
        • Investigational Site
    • Estado de Mexico
      • Toluca, Estado de Mexico, Mexico, 50080
        • Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44100
        • Investigational Site
    • Tabasco Mexico
      • Villahermosa, Tabasco Mexico, Mexico, 86100
        • Investigational Site
    • Zapopan Jalisco
      • Zapopan, Zapopan Jalisco, Mexico, 45200
        • Investigational Site
  • Peru
      • Lima, Peru, Lima-01
        • Investigational Site
      • Lima, Peru, Lima-27
        • Investigational Site
      • Lima, Peru, Lima-29
        • Investigational Site
      • Lima, Peru, Lima-31
        • Investigational Site
      • Lima, Peru, Lima-32
        • Investigational Site
      • Lima, Peru, Lima-33
        • Investigational Site
  • Romania
    • Jud. Constanta
      • Constanta, Jud. Constanta, Romania, 900002
        • Investigational Site
    • Jud. Dolj
      • Craiova, Jud. Dolj, Romania, 200515
        • Investigational Site
    • Jud. Timis
      • Timisoara, Jud. Timis, Romania, 300359
        • Investigational Site
    • Sector 1
      • Bucharest, Sector 1, Romania, 010457
        • Investigational Site
    • Sector 3
      • Bucharest, Sector 3, Romania, 030303
        • Investigational Site
    • Sector 5
      • Bucharest, Sector 5, Romania, 050042
        • Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49026
        • Investigational Site
      • Dnipropetrovsk, Ukraine, 49101
        • Investigational Site
      • Donetsk, Ukraine, 83099
        • Investigational Site
      • Donetsk, Ukraine, 83017
        • Investigational Site
      • Kharkiv, Ukraine, 61035
        • Investigational Site
      • Kiev, Ukraine, 3680
        • Investigational Site
      • Kyiv, Ukraine, 03680
        • Investigational Site
      • Kyiv, Ukraine, 02125
        • Investigational Site
      • Kyiv, Ukraine, 02232
        • Investigational Site
      • Lviv, Ukraine, 79010
        • Investigational Site
      • Vinnytsya, Ukraine, 21029
        • Investigational Site
      • Zaporizhzhya, Ukraine, 69118
        • Investigational Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Investigational Site
    • California
      • Orange County, California, United States, 92868
        • Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Investigational Site
    • Florida
      • Valrico, Florida, United States, 33596
        • Investigational Site
    • North Carolina
      • Elizabeth City, North Carolina, United States, 27909
        • Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Investigational Site
      • Portland, Oregon, United States, 97213
        • Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Investigational Site
      • Providence, Rhode Island, United States, 02906
        • Investigational Site
    • Wisconsin
      • West Allis, Wisconsin, United States, 53227
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Documented use of an inhaled corticosteroid for at least 4 weeks prior to the Day 1 (Baseline) visit and at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids). Subjects who enroll in this study SKY2028-3-006 immediately upon completion of study SKY2028-3-005 have automatically satisfied this criterion. Subjects who enroll in this study SKY2028-3-006 after completion of study SKY2028-3-005 within 24 weeks must use inhaled corticosteroid therapy at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids) for at least 4 weeks prior to the Day 1 (Baseline) visit.
  • 2. Females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test at the Day 1 Visit
  • 3. Subject is judged to be in good general health as determined by the investigator.
  • 4. Demonstrate satisfactory technique in the use of pMDI.

Exclusion Criteria:

  • 1. Subjects who prematurely discontinued from the study SKY2028-3-005.
  • 2. Life-threatening asthma within the past year.
  • 3. History of systemic (oral or injectable) corticosteroid use within the past 12 weeks,
  • 4. An upper or lower respiratory infection within 4 weeks prior to the Day 1 (Baseline) visit.
  • 5. Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis).
  • 6. Recent history of smoking, alcohol, substance abuse and/or psychiatric illness,
  • 7. Subjects who have taken beta-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past 1 week.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: SKP FlutiForm HFA pMDI
Each subject will receive SKP FlutiForm HFA pMDI 250/10 microgram twice daily for 60 weeks (two actuations of SKP FlutiForm HFA pMDI 125/5 microgram/actuation) for a total daily dose of 500 microgram fluticasone propionate and 20 microgram formoterol fumarate.
Other Names:
  • FlutiForm
  • fluticasone propionate/formoterol fumarate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005
Time Frame: week 60
week 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SkyePharma AG

Collaborators

Abbott

Investigators

  • Study Director: Thao T Doan, MD, Abbott Labs PPD R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

September 4, 2008

First Submitted That Met QC Criteria

September 4, 2008

First Posted (ESTIMATE)

September 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKY2028-3-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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