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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
SkyePharma AG
ClinicalTrials.gov Identifier:
NCT00747318
First received: September 4, 2008
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: SKP FlutiForm HFA pMDI
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by SkyePharma AG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: September 2008
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00747318

  Show 39 Study Locations
Sponsors and Collaborators
SkyePharma AG
Abbott
Investigators
Study Director: Thao T Doan, MD Abbott Labs PPD R&D
  More Information

No publications provided

Responsible Party: Kirsten Kaiser, MD, SkyePharma AG
ClinicalTrials.gov Identifier: NCT00747318     History of Changes
Other Study ID Numbers: SKY2028-3-006
Study First Received: September 4, 2008
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by SkyePharma AG:
Moderate to Severe

Additional relevant MeSH terms:
Fluticasone
Formoterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014