AsthmaPhase 3NCT00393991
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma
A Phase 3 study testing Fluticasone propionate/formoterol fumarate 100/10, Fluticasone propionate 100 and Formoterol fumarate 10 in people with Asthma, run by SkyePharma AG at 57 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 HFA MDI with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with mild to moderate 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 100/10, Fluticasone propionate 100 and Formoterol fumarate 10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 475 participants
- Where
- 57 sitesin 2 countries
- Study dates
- Jul 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.
- For steroid-requiring patients, documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit
- For steroid-free patients, no history of inhaled steroid asthma medication for at least 12 weeks prior to Screening Visit.
- Demonstrate FEV-1 of 60-85% of predicted normal values at Screening and Baseline Visit.
- Documented reversibility of 15% within 12 months of Screening or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation or nebulized albuterol administration).
- Symptoms of Asthma during Run-in
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- 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.
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- 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
57 sites in 2 countries.
57 sites in 2 countries
United States47 sites
Research Site
Asheville, North Carolina, 28801
Research Site
Austin, Texas, 78750
Research Site
Aventura, Florida, 33180
Research Site
Bellingham, Washington, 98225
Research Site
Bethesda, Maryland, 20814
Research Site
Brockton, Massachusetts, 02301
Research Site
Centennial, Colorado, 80112
Research Site
Cherry Hill, New Jersey, 08003
Research Site
Colorado Springs, Colorado, 80907
Research Site
Columbus, Ohio, 43235
Research Site
Conyers, Georgia, 30012
Research Site
Cypress, California, 90630
Research Site
Dallas, Texas, 75246
Research Site
El Paso, Texas, 79925
Research Center
Elizabeth City, North Carolina, 27909
Research Site
Elizabeth City, North Carolina, 27909
Research Site
Encinitas, California, 92024
Research Site
Englewood, Colorado, 80112
Research Site
Eugene, Oregon, 97401
Research Site
Forked River, New Jersey, 08732
Research Site
Fountain Valley, California, 92708
Research Site
Gainesville, Florida, 32610
Research Site
Houston, Texas, 77024
Research Site
Indianapolis, Indiana, 46208
Research Site
Lake Oswego, Oregon, 97035
Research Center
Largo, Florida, 33770
Research Site
Lawrenceville, Georgia, 32308
Research Center
Los Angeles, California, 90048
Research Site
McKinney, Texas, 75069
Research Site
Medford, Oregon, 97504
Research Site
Miami, Florida, 33176
Research Site
Mission Hills, California, 91345
Research Site
Ocala, Florida, 34471
Research Site
Okalahoma City, Oklahoma, 73139
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Oklahoma City, Oklahoma, 73112
Research Site
Pell City, Alabama, 35128
Research Site
Philadelphia, Pennsylvania, 19115
Research Site
Pittsburgh, Pennsylvania, 15241
Research Site
Round Lake Beach, Illinois, 60073
Research Site
Round Rock, Texas, 78681
Research Site
San Antonio, Texas, 78229
Research Site
Scottsdale, Arizona, 85251
Research Site
Scranton, Pennsylvania, 18509
Research Site
Tallahassee, Florida, 32308
Research Site
Toledo, Ohio, 43617
Research Site
Waterbury, Connecticut, 06708
Canada10 sites
Research Site
Ajax, Ontario, L1S 2J5
Research Site
Greater Sudbury, Ontario, P3A 1Y8
Research Site
Greater Sudbury, Ontario, P3A1Y8
Research Site
Mississauga, Ontario, L5B 1N1
Research Site
Ottawa, Ontario, K1Y 4G2
Research Site
Point Edward, Ontario, N7V 1X4
Research Site
Saint Romuald, Quebec, G6W 5M6
Research Site
St. John's, A1B 4S8
Research Site
Toronto, Ontario, M5S 2A5
Research Site
Toronto, Ontario, M6H 3M2
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel, Stratified, Multi-center, 12-Week Study Comparing the Safety & Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm)100/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI)With the Administration of Placebo or Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Mild to Moderate Asthma
The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm HFA MDI with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with mild to moderate asthma.
- Conditions
- Asthma
- Being tested
- Fluticasone propionate/formoterol fumarate 100/10, Fluticasone propionate 100, Formoterol fumarate 10, Placebo
- Keywords
- Asthma, Fluticasone Propionate, Formoterol Fumarate, Pressurized metered dose inhaler, Hydrofluoroalkane, Mild to Moderate 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 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 100Drug
Also called SKP Fluticasone 100
Fluticasone 100ug is a HFA pMDI that delivers 50ug 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.
PlaceboDrug
Also called SKP Placebo
Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FlutiForm 100/10 μg Receives: Drug: Fluticasone propionate/formoterol fumarate 100/10 |
| 2 | Active comparator | Fluticasone 100 μg Receives: Drug: Fluticasone propionate 100 |
| 3 | Active comparator | Formoterol 10 μg Receives: Drug: Formoterol fumarate 10 |
| 4 | 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) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy
Measured: Week 0 and 12 visits
Secondary outcomes (4)
Other pulmonary function tests including forced vital 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
Safety variables including adverse events, ECGs, clinical laboratory tests and vital signs.
Measured: Whole duration of study
Serial 12-hour FEV-1 area under the curve (AUC).
Measured: Week 0, 2 and 12 visits
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 startJul 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- SkyePharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393991
- Sponsor's protocol ID
- SKY2028-3-001
- Status last verified
- Jun 2011
- First submitted
- 27 Oct 2006
- Last updated
- 23 Jun 2011
- Results posted
- No
Publications
Nathan RA, D'Urzo A, Blazhko V, Kaiser K. Safety and efficacy of fluticasone/formoterol combination therapy in adolescent and adult patients with mild-to-moderate asthma: a randomised controlled trial. BMC Pulm Med. 2012 Oct 18;12:67. doi: 10.1186/1471-2466-12-67.
PubMed 23078148
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, Stratified, Multi-center, 12-Week Study Comparing the Safety & Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm)100/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI)With the Administration of Placebo or Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Mild to Moderate Asthma
- ClinicalTrials.gov ID
- NCT00393991
- Acronym / sponsor ID
- SKY2028-3-001
- Conditions
- Asthma
- Keywords
- Asthma, Fluticasone Propionate, Formoterol Fumarate, Pressurized metered dose inhaler, Hydrofluoroalkane, Mild to Moderate Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- SkyePharma AGIndustry (pharma, biotech, devices)
- Study start
- Jul 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 HFA MDI with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with mild to moderate asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fluticasone propionate/formoterol fumarate 100/10FlutiForm 100/10 μg |
| 2 | Active comparator | Drug: Fluticasone propionate 100Fluticasone 100 μg |
| 3 | Active comparator | Drug: Formoterol fumarate 10Formoterol 10 μg |
| 4 | 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 (9 listed)
- History of asthma for at least 12 months.
- For steroid-requiring patients, documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit
- For steroid-free patients, no history of inhaled steroid asthma medication for at least 12 weeks prior to Screening Visit.
- Demonstrate FEV-1 of 60-85% of predicted normal values at Screening and Baseline Visit.
- Documented reversibility of 15% within 12 months of Screening or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation or nebulized albuterol administration).
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 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 | 1 |
| Fluticasone propionate 100Also: SKP Fluticasone 100Fluticasone 100ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks. | Drug | 2 |
| 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 | 3 |
| PlaceboAlso: SKP PlaceboPlacebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks. | Drug | 4 |
Primary outcome
Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy
Time frame: Week 0 and 12 visits
4 secondary outcomes
Other pulmonary function tests including forced vital 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
Safety variables including adverse events, ECGs, clinical laboratory tests and vital signs.
Time frame: Whole duration of study
Serial 12-hour FEV-1 area under the curve (AUC).
Time frame: Week 0, 2 and 12 visits
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.
- Derived from this study: PubMed 23078148Nathan RA, D'Urzo A, Blazhko V, Kaiser K. Safety and efficacy of fluticasone/formoterol combination therapy in adolescent and adult patients with mild-to-moderate asthma: a randomised controlled trial. BMC Pulm Med. 2012 Oct 18;12:67. doi: 10.1186/1471-2466-12-67.
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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.
57 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 100/10, Fluticasone propionate 100 and Formoterol fumarate 10 in people with Asthma, run by SkyePharma AG at 57 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 9 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 57 sites in United States, Canada. 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) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy (time frame: Week 0 and 12 visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00393991, which also lists 1 linked publication.
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.