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:
SkyePharma AG
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
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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:
MedlinePlus related topics:
Asthma
Drug Information available for:
Formoterol fumarate
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:
|
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
Show 39 Study LocationsSponsors 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 May 23, 2013