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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

NCT ID: NCT00747318

Last Updated: 2011-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

SKP FlutiForm HFA pMDI

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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FlutiForm fluticasone propionate/formoterol fumarate

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

SkyePharma AG

INDUSTRY

Sponsor Role lead

Responsible Party

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SkyePharma AG

Principal Investigators

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Thao T Doan, MD

Role: STUDY_DIRECTOR

Abbott Labs PPD R&D

Locations

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Investigational Site

Scottsdale, Arizona, United States

Site Status

Investigational Site

Orange County, California, United States

Site Status

Investigational Site

Colorado Springs, Colorado, United States

Site Status

Investigational Site

Valrico, Florida, United States

Site Status

Investigational Site

Elizabeth City, North Carolina, United States

Site Status

Investigational Site

Medford, Oregon, United States

Site Status

Investigational Site

Portland, Oregon, United States

Site Status

Investigational Site

East Providence, Rhode Island, United States

Site Status

Investigational Site

Providence, Rhode Island, United States

Site Status

Investigational Site

West Allis, Wisconsin, United States

Site Status

Investigational Site

Guadalajara, Jalisco, Mexico

Site Status

Investigational site

Mexico City, Mexico City, Mexico

Site Status

Investigational Site

Toluca, State of Mexico, Mexico

Site Status

Investigational Site

Villahermosa, Tabasco Mexico, Mexico

Site Status

Investigational Site

Zapopan, Zapopan Jalisco, Mexico

Site Status

Investigational site

Lima, Lima Province, Peru

Site Status

Investigational site

Lima, Lima Province, Peru

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Lima, Lima Province, Peru

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Lima, Lima Province, Peru

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Lima, Lima Province, Peru

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Lima, Lima Province, Peru

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Investigational site

Constanța, Jud. Constanta, Romania

Site Status

Investigational site

Craiova, Jud. Dolj, Romania

Site Status

Investigational site

Timișoara, Jud. Timis, Romania

Site Status

Investigational site

Bucharest, Sector 1, Romania

Site Status

Investigational site

Bucharest, Sector 3, Romania

Site Status

Investigational site

Bucharest, Sector 5, Romania

Site Status

Investigational site

Dnipropetrovsk, , Ukraine

Site Status

Investigational site

Dnipropetrovsk, , Ukraine

Site Status

Investigational site

Donetsk, , Ukraine

Site Status

Investigational site

Donetsk, , Ukraine

Site Status

Investigational site

Kharkiv, , Ukraine

Site Status

Investigational site

Kiev, , Ukraine

Site Status

Investigational site

Kyiv, , Ukraine

Site Status

Investigational site

Kyiv, , Ukraine

Site Status

Investigational site

Kyiv, , Ukraine

Site Status

Investigational site

Lviv, , Ukraine

Site Status

Investigational site

Vinnytsia, , Ukraine

Site Status

Investigational site

Zaporizhzhya, , Ukraine

Site Status

Countries

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United States Mexico Peru Romania Ukraine

Other Identifiers

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SKY2028-3-006

Identifier Type: -

Identifier Source: org_study_id

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