AsthmaPhase 3NCT00649025
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
A Phase 3 study testing FlutiForm 250/10, SKP-Fluticasone and Flovent Fluticasone HFA in people with Asthma, run by SkyePharma AG at 103 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- FlutiForm 250/10, SKP-Fluticasone and Flovent Fluticasone HFA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 103 sitesin 10 countries
- Study dates
- Mar 2008to Oct 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
Main 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%
Main 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
Trial locations and contacts
103 sites in 10 countries.
103 sites in 10 countries
United States21 sites
Investigational Site
Akron, Ohio, 44313
Investigational Site
Austin, Texas, 78750
Investigational site
Cincinnati, Ohio, 45227
Investigational site
Crestview Hills, Kentucky, 41017
Investigational Site
East Providence, Rhode Island, 02914
Investigational site
El Paso, Texas, 79925
Investigational site
Elizabeth City, North Carolina, 27909
Investigational Site
Encinitas, California, 92024
Investigational Site
Indianapolis, Indiana, 46208
Investigational site
Long Beach, California, 90806
Investigational Site
Metarie, Louisiana, 70006
Investigational site
North Dartmouth, Massachusetts, 02747
Investigational Site
Oldsmar, Florida, 34677
Investigational site
Orange, California, 92869
Investigational Site
Portland, Oregon, 97213
Investigational site
Providence, Rhode Island, 02906
Investigational site
Richmond, Virginia, 23229
Investigational site
Scottsdale, Arizona, 85251
Investigational Site
Tempe, Arizona, 85282
Investigational Site
Wellesley Hills, Massachusetts, 02481
Investigational Site
West Allis, Wisconsin, 53227
Argentina15 sites
Investigational Site
Bahía Blanca, B8000JRB
Investigational Site
Buenos Aires, B1704ESN
Investigational Site
Buenos Aires, C1122AAK
Investigational Site
Buenos Aires, C1426ABO
Investigational Site
Caba, 1035
Investigational Site
Caba, C1121ABE
Investigational Site
Caba, C1122AAK
Investigational Site
Caba, C1405BCH
Investigational Site
Caba, C1425AUA
Investigational Site
Caba, C1437HPA
Investigational Site
Provincia de Buenos Aires, B6500BWQ
Investigational Site
Salta, A4400ERH
Investigational Site
San Miguel de Tucumán, 4000
Investigational Site
Santa Fe, 2000
Investigational Site
Santa Fe, S2000JKR
Ukraine13 sites
Investigational Site
Dnipropetrovsk, 49017
Investigational Site
Dnipropetrovsk, 49026
Investigational Site
Dnipropetrovsk, 49101
Investigational Site
Donetsk, 83017
Investigational Site
Donetsk, 83099
Investigational Site
Kharkiv, 61035
Investigational Site
Kiev, 02125
Investigational Site
Kiev, 02232
Investigational Site
Kiev, 03680
Investigational Site
Lviv, 79010
Investigational Site
Vinnytsia, 21029
Investigational Site
Zaporizhzhya, 69063
Investigational Site
Zaporizhzhya, 69118
Mexico12 sites
Investigational Site
Chihuahua City, 31238
Investigational Site
Guerrero, 39670
Investigational Site
Jalisco, 44100
Investigational Site
Jalisco, 45200
Investigational Site
Luis Encinas S/N, 83000
Investigational Site
Mexico City, 06700
Investigational Site
Mexico City, 14050
Investigational Site
Michoacán, 58249
Investigational Site
Nuevo León, 64460
Investigational Site
Puebla City, 72190
Investigational Site
San Bernardino
Investigational Site
Tabasco, 86100
Peru10 sites
Investigational Site
Cusco
Investigational Site
Jesus Maria
Investigational Site
Lima, 01
Investigational Site
Lima, 13
Investigational Site
Lima, 27
Investigational Site
Lima, 29
Investigational Site
Lima, 31
Investigational Site
Lima, 32
Investigational Site
Lima, 33
Investigational Site
Lima Cercado
Romania10 sites
Investigational Site
Brasov, 500326
Investigational Site
Bucharest, 010457
Investigational Site
Bucharest, 011172
Investigational Site
Bucharest, 021381
Investigational Site
Bucharest, 030303
Investigational Site
Bucharest, 050042
Investigational Site
Bucharest, 050554
Investigational Site
Craiova, 200515
Investigational Site
Palazu Mare, 9000002
Investigational Site
Timișoara
South Africa8 sites
Investigational Site
Bloemfontein, 9301
Investigational Site
Cape Town, 7530
Investigational Site
Cape Town, 7700
Investigational Site
Durban, 4126
Investigational Site
Pretoria, 0157
Investigational Site
Pretoria, 0181
Investigational Site
Somerset West, 7130
Investigational Site
Tygerberg, 7505
Hungary6 sites
Investigational Site
Budapest, 1122
Investigational Site
Budapest, 1525
Investigational Site
Deszk, 6772
Investigational Site
Miskolc, 3526
Investigational Site
Miskolc, 3529
Investigational Site
Pécs, 7621
Poland5 sites
Investigational Site
Gdansk, 80-847
Investigational Site
Krakow, 30-901
Investigational Site
Lodz
Investigational Site
Rzeszów
Investigational Site
Wroclaw, 50-434
Chile3 sites
Investigational Site
Concepción
Investigational Site
Rancagua
Investigational Site
Santiago
About this study
Official title: A Randomized, Double-blind, Active-controlled, Parallel Group, Stratified, Multi-center, 12-Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™ 250/10ug Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Fluticasone (250ug Twice Daily) Alone in SkyePharma HFA pMDI and Flovent® HFA pMDI in Adolescent and Adult Patients With Moderate to Severe Asthma
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.
Read the detailed description
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
- Asthma
- Being tested
- FlutiForm 250/10, SKP-Fluticasone, Flovent Fluticasone HFA
- Keywords
- Asthma, Asthma Moderate to Severe
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlutiForm 250/10Drug
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.
SKP-FluticasoneDrug
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.
Flovent Fluticasone HFADrug
Also called Flovent
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FlutiForm 250/10ug Receives: Drug: FlutiForm 250/10 |
| 2 | Active comparator | SKP Fluticasone 250ug Receives: Drug: SKP-Fluticasone |
| 3 | Active comparator | Flovent Fluticasone HFA Receives: Drug: Flovent Fluticasone HFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 0 and 12 visits
Demonstrate the efficacy of SKP FLUTIFORM HFA pMDI (250/10ug) using other pulmonary function tests (PFTs), and clinical endpoints.
Measured: 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.
Measured: 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).
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 posted1 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2008
- Study completionOct 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
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- SkyePharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott, MDS Pharma Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00649025
- Sponsor's protocol ID
- SKY2028-3-005
- Status last verified
- Aug 2010
- First submitted
- 28 Mar 2008
- Last updated
- 27 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23865726
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. 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 and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™ 250/10ug Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Fluticasone (250ug Twice Daily) Alone in SkyePharma HFA pMDI and Flovent® HFA pMDI in Adolescent and Adult Patients With Moderate to Severe Asthma
- ClinicalTrials.gov ID
- NCT00649025
- Acronym / sponsor ID
- SKY2028-3-005
- Conditions
- Asthma
- Keywords
- Asthma, Asthma Moderate to Severe
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- SkyePharma AGIndustry (pharma, biotech, devices)
- Collaborators
- Abbott, MDS Pharma Services
- Study start
- Mar 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 1 Apr 2008 (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 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.
Detailed description
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.
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: FlutiForm 250/10FlutiForm 250/10ug |
| 2 | Active comparator | Drug: SKP-FluticasoneSKP Fluticasone 250ug |
| 3 | Active comparator | Drug: Flovent Fluticasone HFAFlovent Fluticasone HFA |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| FlutiForm 250/10SKP 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. | Drug | 1 |
| SKP-FluticasoneSKP Fluticasone 250 ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks. | Drug | 2 |
| Flovent Fluticasone HFAAlso: FloventFlovent 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. | Drug | 3 |
Primary outcome
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.
Time frame: Week 0 and 12 visits
4 secondary outcomes
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.
Time frame: Week 0 and 12 visits
Demonstrate the efficacy of SKP FLUTIFORM HFA pMDI (250/10ug) using other pulmonary function tests (PFTs), and clinical endpoints.
Time frame: 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.
Time frame: 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).
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 27 Aug 2010.
- Derived from this study: PubMed 23865726Pertseva 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.
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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.
103 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FlutiForm 250/10, SKP-Fluticasone and Flovent Fluticasone HFA in people with Asthma, run by SkyePharma AG at 103 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 103 sites in United States, Argentina, Ukraine, Mexico, Peru and 5 more countries. 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?
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. (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 NCT00649025, 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 27 Aug 2010.