NCT00747318

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Sep 2008

Geographic Reach
5 countries

39 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

1.7 years

First QC Date

September 4, 2008

Last Update Submit

June 8, 2011

Conditions

Asthma

Keywords

Moderate to Severe

Outcome Measures

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

    week 60

Study Arms (1)

1

EXPERIMENTAL
Drug: SKP FlutiForm HFA pMDI

Interventions

SKP FlutiForm HFA pMDIDRUG

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.

Also known as: FlutiForm, fluticasone propionate/formoterol fumarate
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.
  • \. Females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test at the Day 1 Visit
  • \. Subject is judged to be in good general health as determined by the investigator.
  • \. Demonstrate satisfactory technique in the use of pMDI.

You may not qualify if:

  • \. Subjects who prematurely discontinued from the study SKY2028-3-005.
  • \. Life-threatening asthma within the past year.
  • \. History of systemic (oral or injectable) corticosteroid use within the past 12 weeks,
  • \. An upper or lower respiratory infection within 4 weeks prior to the Day 1 (Baseline) visit.
  • \. Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis).
  • \. Recent history of smoking, alcohol, substance abuse and/or psychiatric illness,
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

Investigational Site

Scottsdale, Arizona, 85251, United States

Location

Investigational Site

Orange County, California, 92868, United States

Location

Investigational Site

Colorado Springs, Colorado, 80907, United States

Location

Investigational Site

Valrico, Florida, 33596, United States

Location

Investigational Site

Elizabeth City, North Carolina, 27909, United States

Location

Investigational Site

Medford, Oregon, 97504, United States

Location

Investigational Site

Portland, Oregon, 97213, United States

Location

Investigational Site

East Providence, Rhode Island, 02914, United States

Location

Investigational Site

Providence, Rhode Island, 02906, United States

Location

Investigational Site

West Allis, Wisconsin, 53227, United States

Location

Investigational Site

Guadalajara, Jalisco, 44100, Mexico

Location

Investigational site

Mexico City, Mexico City, 14050, Mexico

Location

Investigational Site

Toluca, State of Mexico, 50080, Mexico

Location

Investigational Site

Villahermosa, Tabasco Mexico, 86100, Mexico

Location

Investigational Site

Zapopan, Zapopan Jalisco, 45200, Mexico

Location

Investigational site

Lima, Lima Province, Lima-01, Peru

Location

Investigational site

Lima, Lima Province, Lima-27, Peru

Location

Investigational site

Lima, Lima Province, Lima-29, Peru

Location

Investigational site

Lima, Lima Province, Lima-31, Peru

Location

Investigational site

Lima, Lima Province, Lima-32, Peru

Location

Investigational site

Lima, Lima Province, Lima-33, Peru

Location

Investigational site

Constanța, Jud. Constanta, 900002, Romania

Location

Investigational site

Craiova, Jud. Dolj, 200515, Romania

Location

Investigational site

Timișoara, Jud. Timis, 300359, Romania

Location

Investigational site

Bucharest, Sector 1, 010457, Romania

Location

Investigational site

Bucharest, Sector 3, 030303, Romania

Location

Investigational site

Bucharest, Sector 5, 050042, Romania

Location

Investigational site

Dnipropetrovsk, 49026, Ukraine

Location

Investigational site

Dnipropetrovsk, 49101, Ukraine

Location

Investigational site

Donetsk, 83017, Ukraine

Location

Investigational site

Donetsk, 83099, Ukraine

Location

Investigational site

Kharkiv, 61035, Ukraine

Location

Investigational site

Kiev, 3680, Ukraine

Location

Investigational site

Kyiv, 02125, Ukraine

Location

Investigational site

Kyiv, 02232, Ukraine

Location

Investigational site

Kyiv, 03680, Ukraine

Location

Investigational site

Lviv, 79010, Ukraine

Location

Investigational site

Vinnytsia, 21029, Ukraine

Location

Investigational site

Zaporizhzhya, 69118, Ukraine

Location

MeSH Terms

Conditions

Asthma

Interventions

fluticasone-formoterolFluticasoneFormoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Thao T Doan, MD

    Abbott Labs PPD R&D

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 4, 2008

First Posted

September 5, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

ME(5)RO(6)UA(12)US(10)PE(6)