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Completed

NCT Number: NCT00747318

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site, Guadalajara, Jalisco, Mexico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SKP FlutiForm HFA pMDI

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.

Other names: FlutiForm, fluticasone propionate/formoterol fumarate

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

SkyePharma AG

Industry

Collaborators

  • Abbott

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 5, 2008
Registry last updated
Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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