A Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™) With Fluticasone or Flovent to Treat Moderate to Severe Asthma in Adolescents and Adults

NCT00649025 | Completed Phase 3 DMC

• 1 other identifier: SKY2028-3-005
• Study Type: interventional
• Target: 438
• Locations: 10 countries
• Sites: 103

Brief Summary

The medications being used in this study are individually approved by the Food and Drug Administration (FDA). The medication under investigation is a combination of two medications in one inhaler. The purpose of this study is to determine how well your asthma is controlled when taking one of the three treatment.

Conditions

Asthma

Keywords

Asthma; Asthma Moderate to Severe

Outcome Measures

Primary Outcomes (1)

• To demonstrate the efficacy in terms of the Formoterol fumarate component of SKP FlutiForm HFA pMDI (250/10ug) compared to SKP Fluticasone HFA pMDI (250ug), on the change in FEV1 from morning pre-dose at Baseline (Week 0) to 2 hours post-dose at Week 12.

  Week 0 and 12 visits

Secondary Outcomes (4)

• Demonstrate the efficacy of SKP FLUTIFORM HFA pMDI (250/10ug) compared to FLOVENT® Fluticasone pMDI (250ug) on the change in FEV1 from morning pre-dose at Baseline (Week 0) to 2 hours post-dose at Week 12.

  Week 0 and 12 visits

• Demonstrate the efficacy of SKP FLUTIFORM HFA pMDI (250/10ug) using other pulmonary function tests (PFTs), and clinical endpoints.

  Whole duration of study

• Assess the safety profile of SKP FLUTIFORM HFA pMDI (250/10ug twice daily) using incidence of adverse events, and changes in electrocardiograms, clinical laboratory tests and vital signs.

  Whole duration of study

• To assess the 12-hour serial FEV1 area under the curve (AUC) in a subset population (in a minimum of 66 patients).

  Week 0; 2 and 12 visits

Study Arms (3)

1

EXPERIMENTAL

FlutiForm 250/10ug

Drug: FlutiForm 250/10

2

ACTIVE COMPARATOR

SKP Fluticasone 250ug

Drug: SKP-Fluticasone

3

ACTIVE COMPARATOR

Flovent Fluticasone HFA

Drug: Flovent Fluticasone HFA

Interventions

FlutiForm 250/10 DRUG

SKP FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.

1

SKP-Fluticasone DRUG

SKP Fluticasone 250 ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.

2

Flovent Fluticasone HFA DRUG

Flovent 250 ug HFA is a pMDI that delivers after priming 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.

Also known as: Flovent

3

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ Age 12 years at the Screening Visit.
• History of asthma for 12 months prior to the Screening Visit.
• Documented use of an inhaled corticosteroid for at least 4 weeks prior to the Screening Visit.
• Steroid-requiring patient
• patients must demonstrate (1) an FEV1 of 40% to 80% (inclusive) of predicted normal values at both the Screening and Baseline Visits and (2) documented reversibility within 12 months of the Screening Visit, defined as a ≥ 15%

You may not qualify if:

• Life-threatening asthma within the past year or during the Run-In Period.
• History of systemic (oral or injectable) corticosteroid medication within 3 months before the Screening Visit.
• An upper or lower respiratory infection within 4 weeks prior to the Screening Visit or during the Run-In Period.
• Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease \[COPD\], cystic fibrosis, bronchiectasis).
• A smoking history equivalent to "10 pack years" (i.e., at least 1 pack of 20 cigarettes /day for 10 years or 10 packs/day for 1 year, etc.).
• Current smoking history within 12 months prior to the Screening Visit.
• Previous exposure to FlutiForm

Sponsors & Collaborators

• SkyePharma AG: lead
• Abbott: collaborator
• MDS Pharma Services: collaborator

Study Sites (103)

Investigational site

Scottsdale, Arizona, 85251, United States

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Tempe, Arizona, 85282, United States

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Encinitas, California, 92024, United States

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Long Beach, California, 90806, United States

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Orange, California, 92869, United States

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Oldsmar, Florida, 34677, United States

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Indianapolis, Indiana, 46208, United States

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Crestview Hills, Kentucky, 41017, United States

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Metarie, Louisiana, 70006, United States

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North Dartmouth, Massachusetts, 02747, United States

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Wellesley Hills, Massachusetts, 02481, United States

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Elizabeth City, North Carolina, 27909, United States

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Akron, Ohio, 44313, United States

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Cincinnati, Ohio, 45227, United States

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Portland, Oregon, 97213, United States

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East Providence, Rhode Island, 02914, United States

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Providence, Rhode Island, 02906, United States

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Austin, Texas, 78750, United States

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El Paso, Texas, 79925, United States

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Richmond, Virginia, 23229, United States

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West Allis, Wisconsin, 53227, United States

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Bahía Blanca, B8000JRB, Argentina

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Buenos Aires, B1704ESN, Argentina

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Buenos Aires, C1122AAK, Argentina

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Buenos Aires, C1426ABO, Argentina

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Caba, 1035, Argentina

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Caba, C1121ABE, Argentina

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Caba, C1122AAK, Argentina

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Caba, C1405BCH, Argentina

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Caba, C1425AUA, Argentina

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Caba, C1437HPA, Argentina

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Provincia de Buenos Aires, B6500BWQ, Argentina

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Salta, A4400ERH, Argentina

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San Miguel de Tucumán, 4000, Argentina

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Santa Fe, 2000, Argentina

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Santa Fe, S2000JKR, Argentina

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Concepción, Chile

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Rancagua, Chile

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Santiago, Chile

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Budapest, 1122, Hungary

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Budapest, 1525, Hungary

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Deszk, 6772, Hungary

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Miskolc, 3526, Hungary

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Miskolc, 3529, Hungary

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Pécs, 7621, Hungary

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Chihuahua City, 31238, Mexico

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Guerrero, 39670, Mexico

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Jalisco, 44100, Mexico

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Jalisco, 45200, Mexico

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Luis Encinas S/N, 83000, Mexico

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Mexico City, 06700, Mexico

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Mexico City, 14050, Mexico

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Michoacán, 58249, Mexico

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Nuevo León, 64460, Mexico

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Puebla City, 72190, Mexico

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San Bernardino, Mexico

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Tabasco, 86100, Mexico

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Cusco, Peru

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Jesus Maria, Peru

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Lima, 01, Peru

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Lima, 13, Peru

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Lima, 27, Peru

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Lima, 29, Peru

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Lima, 31, Peru

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Lima, 32, Peru

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Lima, 33, Peru

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Lima Cercado, Peru

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Gdansk, 80-847, Poland

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Krakow, 30-901, Poland

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Lodz, Poland

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Rzeszów, Poland

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Wroclaw, 50-434, Poland

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Brasov, 500326, Romania

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Bucharest, 010457, Romania

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Bucharest, 011172, Romania

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Bucharest, 021381, Romania

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Bucharest, 030303, Romania

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Bucharest, 050042, Romania

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Bucharest, 050554, Romania

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Craiova, 200515, Romania

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Palazu Mare, 9000002, Romania

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Timișoara, Romania

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Bloemfontein, 9301, South Africa

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Cape Town, 7530, South Africa

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Cape Town, 7700, South Africa

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Durban, 4126, South Africa

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Pretoria, 0157, South Africa

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Pretoria, 0181, South Africa

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Somerset West, 7130, South Africa

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Tygerberg, 7505, South Africa

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Dnipropetrovsk, 49017, Ukraine

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Dnipropetrovsk, 49026, Ukraine

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Dnipropetrovsk, 49101, Ukraine

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Donetsk, 83017, Ukraine

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Donetsk, 83099, Ukraine

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Kharkiv, 61035, Ukraine

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Kiev, 02125, Ukraine

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Kiev, 02232, Ukraine

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Kiev, 03680, Ukraine

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Lviv, 79010, Ukraine

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Vinnytsia, 21029, Ukraine

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Zaporizhzhya, 69063, Ukraine

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Zaporizhzhya, 69118, Ukraine

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Related Publications (1)

• Pertseva T, Dissanayake S, Kaiser K. Superiority of fluticasone propionate/formoterol fumarate versus fluticasone propionate alone in patients with moderate-to-severe asthma: a randomised controlled trial. Curr Med Res Opin. 2013 Oct;29(10):1357-69. doi: 10.1185/03007995.2013.825592. Epub 2013 Aug 20.

  PMID: 23865726 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: April 1, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 27, 2010

Record last verified: 2010-08

Locations

ME (12); UA (13); CL (3); US (21); HU (6); PE (10); PL (5); RO (10); AR (15); ZA (8)