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

Sponsor:	SkyePharma AG
Collaborator:	Abbott
Information provided by:	SkyePharma AG
ClinicalTrials.gov Identifier:	NCT00747318

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 III

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:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Arformoterol Formoterol Fluticasone propionate Fluticasone Arformoterol Tartrate

U.S. FDA Resources

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 February 09, 2012