AsthmaPhase 3NCT00394199
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone 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 41 sites in 2 countries.
Trial summary
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, 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?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 41 sitesin 2 countries
- Study dates
- Jun 2006to Feb 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 steriod-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
- Patients will not be eligible for the study if they meet any of the following criteria:
- Life-threatening asthma within the past year or during the Run-In Period.
- History of systemic corticosteroid medication within 3 months before the 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.
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- Upper or lower respiratory infection within 4 weeks prior to Screening Visit or during Run-In Period.
- 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
41 sites in 2 countries.
41 sites in 2 countries
United States29 sites
Research Site
Asheville, North Carolina, 28801
Research Site
Bethesda, Maryland, 20814
Research Site
Birmingham, Alabama, 35242
Research Site
Chattanooga, Tennessee, 37421
Research Site
Cincinnati, Ohio, 45242
Research Site
Denver, Colorado, 80230
Research Site
Easton, Pennsylvania, 18045
Research Site
El Paso, Texas, 79902
Research Site
Elizabeth, New Jersey, 07202
Research Site
Greenfield, Wisconsin, 53228
Research Site
Greenville, South Carolina, 29605
Research Site
Houston, Texas, 77054
Research Site
Katy, Texas, 77450
Research Site
Lilburn, Georgia, 30047
Research Site
Lincoln, Rhode Island, 02906
Research Site
Mission Viejo, California, 92691
Research Site
New Braunfels, Texas, 78130
Research Site
North Dartmouth, Massachusetts, 02747
Research Site
Orange, California, 92868
Research Site
Park City, Kansas, 67219
Research Site
Raleigh, North Carolina, 27607
Research Center
Rochester, New York, 14618
Research Site
San Jose, California, 95117
Research Site
Savannah, Georgia, 31406
Research Site
South Burlington, Vermont, 05403
Research Center
Stevensville, Michigan, 49127
Research Site
Sylvania, Ohio, 43560
Research Site
Vista, California, 92083
Research Site
Waco, Texas, 76712
Canada12 sites
Research Site
Hamilton, Ontario, L8N 1Y2
Research Site
Kelowna, British Columbia, V1Y 9L8
Research Center
London, Ontario, N5X 4E7
Research Site
London, Ontario, N6A 1V2
Research Site
Longueuil, Quebec, J4N 1E1
Research Site
Mississauga, Ontario, L4W 1N2
Research Site
Montreal, Quebec, H2L 2W5
Research Site
Oshawa, Ontario, L1H 1B9
Research Site
Saint Foy, Quebec, G1V 4M6
Research Site
Toronto, Ontario, M4P 1P2
Research Site
Trois-Rivières, Quebec, G8T 7A1
Research Site
Vancouver, British Columbia, V5Z 3J5
About this study
Official title: A Randomized, Double-blind, Active-controlled, Parallel Group, 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 Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent & Adult Patients With Mild to Moderate Asthma
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, 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
- 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 Fluticasone 100
Fluticasone 100 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FlutiForm 100/10ug Receives: Drug: Fluticasone propionate/Formoterol Fumarate 100/10 |
| 2 | Experimental | Fluticasone 100 Receives: Drug: Fluticasone propionate 100 |
| 3 | Active comparator | Formoterol 10 Receives: Drug: Formoterol fumarate 10 |
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 morning predose at Baseline (Week 0) to predose at Week 12
Measured: Week 0 and 12
Secondary outcomes (3)
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 include 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 completionFeb 2008
- Study completionFeb 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
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- SkyePharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394199
- Sponsor's protocol ID
- SKY2028-3-002
- Status last verified
- Jun 2011
- First submitted
- 27 Oct 2006
- Last updated
- 23 Jun 2011
- Results posted
- No
Publications
Pearlman DS, LaForce CF, Kaiser K. Fluticasone/Formoterol combination therapy compared with monotherapy in adolescent and adult patients with mild to moderate asthma. Clin Ther. 2013 Jul;35(7):950-66. doi: 10.1016/j.clinthera.2013.05.012.
PubMed 23870606
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, Active-controlled, Parallel Group, 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 Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent & Adult Patients With Mild to Moderate Asthma
- ClinicalTrials.gov ID
- NCT00394199
- Acronym / sponsor ID
- SKY2028-3-002
- 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
- 357 participants (actual)
- Lead sponsor
- SkyePharma AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 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.
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, 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
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fluticasone propionate/Formoterol Fumarate 100/10FlutiForm 100/10ug |
| 2 | Experimental | Drug: Fluticasone propionate 100Fluticasone 100 |
| 3 | Active comparator | Drug: Formoterol fumarate 10Formoterol 10 |
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 steriod-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 (13 listed)
- Life-threatening asthma within the past year or during the Run-In Period.
- History of systemic corticosteroid medication within 3 months before the 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: Fluticasone 100Fluticasone 100 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 |
Primary outcome
Change in Forced Expiratory volume in 1 s (FEV-1) from morning predose at Baseline (Week 0) to predose at Week 12
Time frame: Week 0 and 12
3 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 include 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.
- Derived from this study: PubMed 23870606Pearlman DS, LaForce CF, Kaiser K. Fluticasone/Formoterol combination therapy compared with monotherapy in adolescent and adult patients with mild to moderate asthma. Clin Ther. 2013 Jul;35(7):950-66. doi: 10.1016/j.clinthera.2013.05.012.
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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.
41 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 41 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 13 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 41 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. 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 morning predose at Baseline (Week 0) to predose at Week 12 (time frame: Week 0 and 12). 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 NCT00394199, 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.