MedDataX Logo

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

NCT ID: NCT00649025

Last Updated: 2010-08-27

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

438 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma

NCT00393952

Asthma
COMPLETED PHASE3

Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma

NCT00394199

Asthma
COMPLETED PHASE3

Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma

NCT00393991

Asthma
COMPLETED PHASE3

New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma

NCT00394121

Asthma
COMPLETED PHASE3

An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma

NCT02301975

Asthma
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This Phase 3 randomized, double-blind, active-controlled, parallel group, stratified, multi-center study will evaluate the safety and efficacy of FlutiForm (250/10ug) after twice daily dosing over 12 weeks delivered by SKP HFA pMDI compared with Fluticasone propionate (250ug of twice daily) delivered by SKP HFA pMDI and Flovent® Fluticasone 250ug HFA pMDI in adolescent and adult patients with moderate to severe asthma. Only steroid-requiring patients (inhaled steroid regimen stable for at least 4 weeks prior to the Screening Visit at a dose not greater than 500ug/day Fluticasone propionate or equivalent) will be eligible. All patients will undergo a Run-In Period of 14 ± 3 days during which they will receive asthma maintenance therapy using Fluticasone HFA pMDI (Flovent® HFA 50 ug/actuation: 100µg/day (one inhalation twice daily) if they were using less than or equal to 250mg/day Fluticasone propionate or equivalent inhaled steroid, or 200ug/day (two inhalations twice daily) if they were using greater than 250ug/day Fluticasone propionate or equivalent inhaled steroid prior to the Screening Visit.). The use of rescue Salbutamol (Albuterol) pMDI will be permitted for all patients as needed for the control of worsening asthma symptoms during the Run-In Period. At the Baseline Visit (Week 0) following the Run-In period, eligible patients will be randomized to the treatment groups. Treatment assignment will be stratified according to their Baseline FEV1 % predicted (40-60% or \>60-80%).Study drug will be administered twice daily over a 12-week period. Patient visits will occur at Weeks 2, 4, 8, and 12 during which assessments (including serial PFTs up to 4 hours) will be made. In a subset of at least 66 patients (22 patients per treatment group) from selected centers, post-dose 12-hour serial PFTs will be performed at Baseline, Weeks 2 and 12. During the Treatment Period, patients may only take their blinded study medication; all other asthma medications will be withheld for the duration of the Treatment Period. However, the use of rescue Salbutamol (Albuterol) pMDI will be permitted in all patients as needed during the Treatment Period for the control of worsening asthma symptoms.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

FlutiForm 250/10ug

Group Type EXPERIMENTAL

FlutiForm 250/10

Intervention Type 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.

2

SKP Fluticasone 250ug

Group Type ACTIVE_COMPARATOR

SKP-Fluticasone

Intervention Type 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.

3

Flovent Fluticasone HFA

Group Type ACTIVE_COMPARATOR

Flovent Fluticasone HFA

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FlutiForm 250/10

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.

Intervention Type DRUG

SKP-Fluticasone

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.

Intervention Type DRUG

Flovent Fluticasone HFA

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Flovent

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ≥ 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%

Exclusion Criteria

* 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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott

INDUSTRY

Sponsor Role collaborator

MDS Pharma Services

INDUSTRY

Sponsor Role collaborator

SkyePharma AG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

SkyePharma AG

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Investigational site

Scottsdale, Arizona, United States

Site Status

Investigational Site

Tempe, Arizona, United States

Site Status

Investigational Site

Encinitas, California, United States

Site Status

Investigational site

Long Beach, California, United States

Site Status

Investigational site

Orange, California, United States

Site Status

Investigational Site

Oldsmar, Florida, United States

Site Status

Investigational Site

Indianapolis, Indiana, United States

Site Status

Investigational site

Crestview Hills, Kentucky, United States

Site Status

Investigational Site

Metarie, Louisiana, United States

Site Status

Investigational site

North Dartmouth, Massachusetts, United States

Site Status

Investigational Site

Wellesley Hills, Massachusetts, United States

Site Status

Investigational site

Elizabeth City, North Carolina, United States

Site Status

Investigational Site

Akron, Ohio, United States

Site Status

Investigational site

Cincinnati, Ohio, 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

Austin, Texas, United States

Site Status

Investigational site

El Paso, Texas, United States

Site Status

Investigational site

Richmond, Virginia, United States

Site Status

Investigational Site

West Allis, Wisconsin, United States

Site Status

Investigational Site

Bahía Blanca, , Argentina

Site Status

Investigational Site

Buenos Aires, , Argentina

Site Status

Investigational Site

Buenos Aires, , Argentina

Site Status

Investigational Site

Buenos Aires, , Argentina

Site Status

Investigational Site

Caba, , Argentina

Site Status

Investigational Site

Caba, , Argentina

Site Status

Investigational Site

Caba, , Argentina

Site Status

Investigational Site

Caba, , Argentina

Site Status

Investigational Site

Caba, , Argentina

Site Status

Investigational Site

Caba, , Argentina

Site Status

Investigational Site

Provincia de Buenos Aires, , Argentina

Site Status

Investigational Site

Salta, , Argentina

Site Status

Investigational Site

San Miguel de Tucumán, , Argentina

Site Status

Investigational Site

Santa Fe, , Argentina

Site Status

Investigational Site

Santa Fe, , Argentina

Site Status

Investigational Site

Concepción, , Chile

Site Status

Investigational Site

Rancagua, , Chile

Site Status

Investigational Site

Santiago, , Chile

Site Status

Investigational Site

Budapest, , Hungary

Site Status

Investigational Site

Budapest, , Hungary

Site Status

Investigational Site

Deszk, , Hungary

Site Status

Investigational Site

Miskolc, , Hungary

Site Status

Investigational Site

Miskolc, , Hungary

Site Status

Investigational Site

Pécs, , Hungary

Site Status

Investigational Site

Chihuahua City, , Mexico

Site Status

Investigational Site

Guerrero, , Mexico

Site Status

Investigational Site

Jalisco, , Mexico

Site Status

Investigational Site

Jalisco, , Mexico

Site Status

Investigational Site

Luis Encinas S/N, , Mexico

Site Status

Investigational Site

Mexico City, , Mexico

Site Status

Investigational Site

Mexico City, , Mexico

Site Status

Investigational Site

Michoacán, , Mexico

Site Status

Investigational Site

Nuevo León, , Mexico

Site Status

Investigational Site

Puebla City, , Mexico

Site Status

Investigational Site

San Bernardino, , Mexico

Site Status

Investigational Site

Tabasco, , Mexico

Site Status

Investigational Site

Cusco, , Peru

Site Status

Investigational Site

Jesus Maria, , Peru

Site Status

Investigational Site

Lima, , Peru

Site Status

Investigational Site

Lima, , Peru

Site Status

Investigational Site

Lima, , Peru

Site Status

Investigational Site

Lima, , Peru

Site Status

Investigational Site

Lima, , Peru

Site Status

Investigational Site

Lima, , Peru

Site Status

Investigational Site

Lima, , Peru

Site Status

Investigational Site

Lima Cercado, , Peru

Site Status

Investigational Site

Gdansk, , Poland

Site Status

Investigational Site

Krakow, , Poland

Site Status

Investigational Site

Lodz, , Poland

Site Status

Investigational Site

Rzeszów, , Poland

Site Status

Investigational Site

Wroclaw, , Poland

Site Status

Investigational Site

Brasov, , Romania

Site Status

Investigational Site

Bucharest, , Romania

Site Status

Investigational Site

Bucharest, , Romania

Site Status

Investigational Site

Bucharest, , Romania

Site Status

Investigational Site

Bucharest, , Romania

Site Status

Investigational Site

Bucharest, , Romania

Site Status

Investigational Site

Bucharest, , Romania

Site Status

Investigational Site

Craiova, , Romania

Site Status

Investigational Site

Palazu Mare, , Romania

Site Status

Investigational Site

Timișoara, , Romania

Site Status

Investigational Site

Bloemfontein, , South Africa

Site Status

Investigational Site

Cape Town, , South Africa

Site Status

Investigational Site

Cape Town, , South Africa

Site Status

Investigational Site

Durban, , South Africa

Site Status

Investigational Site

Pretoria, , South Africa

Site Status

Investigational Site

Pretoria, , South Africa

Site Status

Investigational Site

Somerset West, , South Africa

Site Status

Investigational Site

Tygerberg, , South Africa

Site Status

Investigational Site

Dnipropetrovsk, , Ukraine

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

Kiev, , Ukraine

Site Status

Investigational Site

Kiev, , Ukraine

Site Status

Investigational Site

Lviv, , Ukraine

Site Status

Investigational Site

Vinnytsia, , Ukraine

Site Status

Investigational Site

Zaporizhzhya, , Ukraine

Site Status

Investigational Site

Zaporizhzhya, , Ukraine

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Chile Hungary Mexico Peru Poland Romania South Africa Ukraine

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23865726 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SKY2028-3-005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005
NCT00747318 COMPLETED PHASE3
6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old
NCT01462344 COMPLETED PHASE4
Long-Term Safety Study of Fluticasone Propionate (Fp) Multidose Dry Powder Inhaler (MDPI) and Fluticasone Propionate/Salmeterol (FS) MDPI in Patients With Persistent Asthma
NCT02175771 COMPLETED PHASE3
Study of Safety of Foradil in Patients With Persistent Asthma
NCT01845025 TERMINATED PHASE4
To Investigate the Pharmacokinetics and Safety of Fluticasone Furoate (FF)/ Umeclidinium (UMEC) Combination Compared With FF and UMEC Monotherapies in Adult Healthy Volunteers Using a Dry Powder Inhaler (DPI)
NCT01725685 COMPLETED PHASE1
A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma
NCT06664619 RECRUITING PHASE3
Study of FlutiForm® Versus Fluticasone Plus Formoterol in Adult Subjects With Severe Asthma
NCT00734318 COMPLETED PHASE3
Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma
NCT02139644 COMPLETED PHASE3
SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.
NCT01475721 COMPLETED PHASE4
An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol (FF/VI) 200/25 Microgram (mcg) , FF/VI 100/25 mcg, and FF 100 mcg in Adults and Adolescents With Persistent Asthma.
NCT01686633 COMPLETED PHASE3
A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2)
NCT01258803 COMPLETED PHASE2
HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents
NCT01147848 COMPLETED PHASE3
Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old
NCT06290102 COMPLETED PHASE1
A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg Twice Daily In Symptomatic Patients With Asthma
NCT00452348 COMPLETED PHASE4
A Double Blind Open Label Comparator Study to Compare Treatments in 4 to 11 Year Old Patients With Asthma
NCT02680561 COMPLETED PHASE1
Fluticasone/Salmeterol (FP/SM) Versus Double the Dose Fluticasone (FP) in Patients With Mild to Moderate Asthma
NCT00830505 COMPLETED PHASE4
A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens With Exercise
NCT01435902 WITHDRAWN PHASE3
Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler
NCT02980133 COMPLETED PHASE3
A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma
NCT00441441 COMPLETED PHASE3
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
NCT06052267 RECRUITING PHASE3
Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)
NCT00379288 COMPLETED PHASE3
Efficacy and Safety Study of FP MDPI Compared With FS MDPI in Adolescent and Adult Patients With Persistent Asthma
NCT02141854 COMPLETED PHASE3
Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations
NCT00272753 COMPLETED PHASE4
Pediatric Study to Evaluate Treatment of Persistent Moderate or Severe Asthma With the Association Fluticasone 250 mcg/Dose and Salmeterol 50 mcg/Dose - ADERE PROJECT
NCT01476059 COMPLETED PHASE4
Randomized, Placebo-controlled Study Comparing Efficacy of Fluticasone/Salmeterol Combination to Advair in Asthmatics
NCT02496715 WITHDRAWN PHASE3