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

ClinicalTrials.gov processed this record on April 17, 2014