AsthmaPhase 3NCT00393952
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
A Phase 3 study testing Fluticasone propionate/Formoterol fumarate 250/10, Fluticasone propionate/Formoterol fumarate 100/10 and Fluticasone propionate 250 in people with Asthma, run by SkyePharma AG at 63 sites in 2 countries.
Trial summary
The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with moderate to severe asthma. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone propionate/Formoterol fumarate 250/10, Fluticasone propionate/Formoterol fumarate 100/10 and Fluticasone propionate 250
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 557 participants
- Where
- 63 sitesin 2 countries
- Study dates
- Jun 2006to Apr 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of asthma for at least 12 months.
- Documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit Demonstrate FEV-1 of 40-80% of predicted normal values at Screening and Baseline Visit.
- Documented reversibility of 15% within 12 months of Screening visit or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation or nebulized albuterol administration).
- Symptoms of Asthma during Run-in.
- Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline Visits. Females are eligible only if they are not pregnant or lactating, and are either sterile or using acceptable methods of contraception
- Must otherwise be healthy.
- Provide written informed consent. Wishes of minors must be respected.
Who cannot join
- Life-threatening asthma within past year or during Run-In Period.
- History of systemic corticosteroid medication within 3 months before Screening Visit.
- History of omalizumab use within past 6 months.
- History of leukotriene receptor antagonist use, e.g. montelukast, within past week.
- Current evidence or history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
- Upper or lower respiratory infection within 4 weeks prior to Screening visit or during Run-In Period
Show all 12Show fewer
- Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease [COPD], cystic fibrosis, bronchiectasis).
- Known Human Immunodeficiency Virus (HIV)-positive status.
- Smoking history equivalent to "10 pack years".
- Current smoking history within 12 months prior to Screening Visit.
- Current evidence or history of alcohol and/or substance abuse within 12 months prior to Screening visit.
- Patients who are confined in institution.
Trial locations and contacts
63 sites in 2 countries.
63 sites in 2 countries
United States62 sites
Research Center
Anderson, South Carolina, 29621
Research Site
Ashland, Oregon, 97520
Research Site
Austin, Texas, 78750
Research Site
Baltimore, Maryland, 21236
Research Site
Bozeman, Montana, 59718
Research Site
Brick, New Jersey, 08724
Research Site
Burbank, California, 91505
Research Center
Congers, Georgia, 30012
Research Site
Dallas, Texas, 75231
Research Site
El Paso, Texas, 79902
Research Center
Fort Worth, Texas, 76104
Research Site
Fresno, California, 93720
Research Center
Gainesville, Florida, 32605
Research Site
Glendale, Arizona, 85306
Research Site
Greenville, South Carolina, 29607
Research Site
Hialeah, Florida, 33013
Research Site
Jonesboro, Arkansas, 72401
Research Site
Las Vegas, Nevada, 89123
Research Site
Lincoln, Rhode Island, 02865
Research Site
Little Rock, Arkansas, 72205
Research Site
Long Beach, California, 90806
Research Site
Los Angeles, California, 90025
Research Center
Los Angeles, California, 90048
Research Site
Los Angeles, California, 90048
Research Site
Louisville, Kentucky, 40215
Research Site
Medford, Oregon, 97504
Research Site
Milwaukee, Wisconsin, 53209
Research Center
Minneapolis, Minnesota, 55402
Research Site
Minneapolis, Minnesota, 55402
Research Site
Mission Viejo, California, 92691
Research Site
Monterey Park, California, 91754
Research Site
Mount Laurel, New Jersey, 08054
Research Site
North Dartmouth, Massachusetts, 02747
Research Site
Oklahoma City, Oklahoma, 73139
Research Site
Omaha, Nebraska, 68130
Research Site
Ormond Beach, Florida, 32174
Research Site
Palmdale, California, 93551
Research Center
Panama City, Florida, 32405
Research Center
Pell City, Alabama, 35128
Research Site
Pensacola, Florida, 32503
Research Center
Phoenix, Arizona, 85050
Research Site
Phoenix, Arizona, 85050
Research Site
Plymouth, Minnesota, 55441
Research Center
Portland, Oregon, 97213
Research Site
Richmond, Virginia, 23225
Research Site
Rockville Centre, New York, 11570
Research Site
Round Lake Beach, Illinois, 60073
Research Site
Sacramento, California, 95819
Research Site
San Antonio, Texas, 72205
Research Site
San Antonio, Texas, 78229
Research Site
San Diego, California, 92120
Research Site
San Diego, California, 92123
Research Site
San Jose, California, 95128
Research Site
Savannah, Georgia, 31406
Research Site
Skillman, New Jersey, 08558
Research Site
St Louis, Missouri, 63141
Research Site
Tacoma, Washington, 98405
Research Site
Tampa, Florida, 33613
Research Site
Taunton, Massachusetts, 02780
Research Site
Tinton Falls, New Jersey, 07001
Research Site
Tucson, Arizona, 85712
Research Center
Upland, Pennsylvania, 19013
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Stratified, Multi-center, 12-Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm) 100/10 µg or 250/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Placebo or Fluticasone (250 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Moderate to Severe Asthma
The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with moderate to severe asthma.
- Conditions
- Asthma
- Being tested
- Fluticasone propionate/Formoterol fumarate 250/10, Placebo, Fluticasone propionate/Formoterol fumarate 100/10, Fluticasone propionate 250, Formoterol fumarate 10
- Keywords
- Asthma, Fluticasone Propionate, Formoterol Fumarate, Pressurized metered dose inhaler, Hydrofluoroalkane, Moderate-Severe Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone propionate/Formoterol fumarate 250/10Drug
Also called FlutiForm 250/10
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.
PlaceboDrug
Also called SKP Placebo
Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
Fluticasone propionate/Formoterol fumarate 100/10Drug
Also called FlutiForm 100/10
FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Fluticasone propionate 250Drug
Also called Fluticasone 250
Fluticasone 250 is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
Formoterol fumarate 10Drug
Also called SKP Formoterol 10
Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FlutiForm 250/10 Receives: Drug: Fluticasone propionate/Formoterol fumarate 250/10 |
| 2 | Active comparator | FlutiForm 100/10 Receives: Drug: Fluticasone propionate/Formoterol fumarate 100/10 |
| 3 | Active comparator | Fluticasone 250 Receives: Drug: Fluticasone propionate 250 |
| 4 | Active comparator | Formoterol 10 Receives: Drug: Formoterol fumarate 10 |
| 5 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Expiratory Volume in 1 s(FEV-1) from Baseline (Week 0) to Week 12.
Measured: Week 0 and 12 visits
Discontinuation due to lack of efficacy.
Measured: Whole duration of study
Secondary outcomes (4)
Other pulmonary function tests including forced vial capacity (FVC) and peak expiratory flow rate (PEFR).
Measured: Whole duration of study
Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR).
Measured: Whole duration of study
Serial 12-hour FEV-1 area under the curve (AUC).
Measured: Week 0, 2 and 12 visits
Safety variables including adverse events, ECGs clinical laboratory tests and vital signs.
Measured: Whole duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study startJun 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 557 participants (actual)
Sponsor and investigators
- Lead sponsor
- SkyePharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393952
- Sponsor's protocol ID
- SKY2028-3-004
- Status last verified
- Jun 2011
- First submitted
- 27 Oct 2006
- Last updated
- 23 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group, Stratified, Multi-center, 12-Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm) 100/10 µg or 250/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Placebo or Fluticasone (250 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Moderate to Severe Asthma
- ClinicalTrials.gov ID
- NCT00393952
- Acronym / sponsor ID
- SKY2028-3-004
- Conditions
- Asthma
- Keywords
- Asthma, Fluticasone Propionate, Formoterol Fumarate, Pressurized metered dose inhaler, Hydrofluoroalkane, Moderate-Severe Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 557 participants (actual)
- Lead sponsor
- SkyePharma AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 31 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with moderate to severe asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fluticasone propionate/Formoterol fumarate 250/10FlutiForm 250/10 |
| 2 | Active comparator | Drug: Fluticasone propionate/Formoterol fumarate 100/10FlutiForm 100/10 |
| 3 | Active comparator | Drug: Fluticasone propionate 250Fluticasone 250 |
| 4 | Active comparator | Drug: Formoterol fumarate 10Formoterol 10 |
| 5 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- History of asthma for at least 12 months.
- Documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit Demonstrate FEV-1 of 40-80% of predicted normal values at Screening and Baseline Visit.
- Documented reversibility of 15% within 12 months of Screening visit or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation or nebulized albuterol administration).
- Symptoms of Asthma during Run-in.
- Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline Visits. Females are eligible only if they are not pregnant or lactating, and are either sterile or using acceptable methods of contraception
Key exclusion criteria (12 listed)
- Life-threatening asthma within past year or during Run-In Period.
- History of systemic corticosteroid medication within 3 months before Screening Visit.
- History of omalizumab use within past 6 months.
- History of leukotriene receptor antagonist use, e.g. montelukast, within past week.
- Current evidence or history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone propionate/Formoterol fumarate 250/10Also: FlutiForm 250/10FlutiForm 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. | Drug | 1 |
| PlaceboAlso: SKP PlaceboPlacebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks. | Drug | 5 |
| Fluticasone propionate/Formoterol fumarate 100/10Also: FlutiForm 100/10FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks. | Drug | 2 |
| Fluticasone propionate 250Also: Fluticasone 250Fluticasone 250 is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks. | Drug | 3 |
| Formoterol fumarate 10Also: SKP Formoterol 10Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks. | Drug | 4 |
Primary outcome
Change in Forced Expiratory Volume in 1 s(FEV-1) from Baseline (Week 0) to Week 12.
Time frame: Week 0 and 12 visits
Discontinuation due to lack of efficacy.
Time frame: Whole duration of study
4 secondary outcomes
Other pulmonary function tests including forced vial capacity (FVC) and peak expiratory flow rate (PEFR).
Time frame: Whole duration of study
Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR).
Time frame: Whole duration of study
Serial 12-hour FEV-1 area under the curve (AUC).
Time frame: Week 0, 2 and 12 visits
Safety variables including adverse events, ECGs clinical laboratory tests and vital signs.
Time frame: Whole duration of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
63 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone propionate/Formoterol fumarate 250/10, Fluticasone propionate/Formoterol fumarate 100/10 and Fluticasone propionate 250 in people with Asthma, run by SkyePharma AG at 63 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forced Expiratory Volume in 1 s(FEV-1) from Baseline (Week 0) to Week 12. (time frame: Week 0 and 12 visits). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.