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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
| MDS Pharma Services | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | FlutiForm 250/10ug |
|
| 2 | Active Comparator | SKP Fluticasone 250ug |
|
| 3 | Active Comparator | Flovent Fluticasone HFA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FlutiForm 250/10 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0 and 12 visits |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0 and 12 visits | |
| Demonstrate the efficacy of SKP FLUTIFORM HFA pMDI (250/10ug) using other pulmonary function tests (PFTs), and clinical endpoints. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Scottsdale | Arizona | 85251 | United States | ||
| Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23865726 | Derived | 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. |
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| SKP-Fluticasone | 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. |
|
| Flovent Fluticasone HFA | 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. |
|
|
| 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. | 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). | Week 0; 2 and 12 visits |
| Tempe |
| Arizona |
| 85282 |
| United States |
| Investigational Site | Encinitas | California | 92024 | United States |
| Investigational site | Long Beach | California | 90806 | United States |
| Investigational site | Orange | California | 92869 | United States |
| Investigational Site | Oldsmar | Florida | 34677 | United States |
| Investigational Site | Indianapolis | Indiana | 46208 | United States |
| Investigational site | Crestview Hills | Kentucky | 41017 | United States |
| Investigational Site | Metarie | Louisiana | 70006 | United States |
| Investigational site | North Dartmouth | Massachusetts | 02747 | United States |
| Investigational Site | Wellesley Hills | Massachusetts | 02481 | United States |
| Investigational site | Elizabeth City | North Carolina | 27909 | United States |
| Investigational Site | Akron | Ohio | 44313 | United States |
| Investigational site | Cincinnati | Ohio | 45227 | United States |
| Investigational Site | Portland | Oregon | 97213 | United States |
| Investigational Site | East Providence | Rhode Island | 02914 | United States |
| Investigational site | Providence | Rhode Island | 02906 | United States |
| Investigational Site | Austin | Texas | 78750 | United States |
| Investigational site | El Paso | Texas | 79925 | United States |
| Investigational site | Richmond | Virginia | 23229 | United States |
| Investigational Site | West Allis | Wisconsin | 53227 | United States |
| Investigational Site | Bahía Blanca | B8000JRB | Argentina |
| Investigational Site | Buenos Aires | B1704ESN | Argentina |
| Investigational Site | Buenos Aires | C1122AAK | Argentina |
| Investigational Site | Buenos Aires | C1426ABO | Argentina |
| Investigational Site | Caba | 1035 | Argentina |
| Investigational Site | Caba | C1121ABE | Argentina |
| Investigational Site | Caba | C1122AAK | Argentina |
| Investigational Site | Caba | C1405BCH | Argentina |
| Investigational Site | Caba | C1425AUA | Argentina |
| Investigational Site | Caba | C1437HPA | Argentina |
| Investigational Site | Provincia de Buenos Aires | B6500BWQ | Argentina |
| Investigational Site | Salta | A4400ERH | Argentina |
| Investigational Site | San Miguel de Tucumán | 4000 | Argentina |
| Investigational Site | Santa Fe | 2000 | Argentina |
| Investigational Site | Santa Fe | S2000JKR | Argentina |
| Investigational Site | Concepción | Chile |
| Investigational Site | Rancagua | Chile |
| Investigational Site | Santiago | Chile |
| Investigational Site | Budapest | 1122 | Hungary |
| Investigational Site | Budapest | 1525 | Hungary |
| Investigational Site | Deszk | 6772 | Hungary |
| Investigational Site | Miskolc | 3526 | Hungary |
| Investigational Site | Miskolc | 3529 | Hungary |
| Investigational Site | Pécs | 7621 | Hungary |
| Investigational Site | Chihuahua City | 31238 | Mexico |
| Investigational Site | Guerrero | 39670 | Mexico |
| Investigational Site | Jalisco | 44100 | Mexico |
| Investigational Site | Jalisco | 45200 | Mexico |
| Investigational Site | Luis Encinas S/N | 83000 | Mexico |
| Investigational Site | Mexico City | 06700 | Mexico |
| Investigational Site | Mexico City | 14050 | Mexico |
| Investigational Site | Michoacán | 58249 | Mexico |
| Investigational Site | Nuevo León | 64460 | Mexico |
| Investigational Site | Puebla City | 72190 | Mexico |
| Investigational Site | San Bernardino | Mexico |
| Investigational Site | Tabasco | 86100 | Mexico |
| Investigational Site | Cusco | Peru |
| Investigational Site | Jesus Maria | Peru |
| Investigational Site | Lima | 01 | Peru |
| Investigational Site | Lima | 13 | Peru |
| Investigational Site | Lima | 27 | Peru |
| Investigational Site | Lima | 29 | Peru |
| Investigational Site | Lima | 31 | Peru |
| Investigational Site | Lima | 32 | Peru |
| Investigational Site | Lima | 33 | Peru |
| Investigational Site | Lima Cercado | Peru |
| Investigational Site | Gdansk | 80-847 | Poland |
| Investigational Site | Krakow | 30-901 | Poland |
| Investigational Site | Lodz | Poland |
| Investigational Site | Rzeszów | Poland |
| Investigational Site | Wroclaw | 50-434 | Poland |
| Investigational Site | Brasov | 500326 | Romania |
| Investigational Site | Bucharest | 010457 | Romania |
| Investigational Site | Bucharest | 011172 | Romania |
| Investigational Site | Bucharest | 021381 | Romania |
| Investigational Site | Bucharest | 030303 | Romania |
| Investigational Site | Bucharest | 050042 | Romania |
| Investigational Site | Bucharest | 050554 | Romania |
| Investigational Site | Craiova | 200515 | Romania |
| Investigational Site | Palazu Mare | 9000002 | Romania |
| Investigational Site | Timișoara | Romania |
| Investigational Site | Bloemfontein | 9301 | South Africa |
| Investigational Site | Cape Town | 7530 | South Africa |
| Investigational Site | Cape Town | 7700 | South Africa |
| Investigational Site | Durban | 4126 | South Africa |
| Investigational Site | Pretoria | 0157 | South Africa |
| Investigational Site | Pretoria | 0181 | South Africa |
| Investigational Site | Somerset West | 7130 | South Africa |
| Investigational Site | Tygerberg | 7505 | South Africa |
| Investigational Site | Dnipropetrovsk | 49017 | Ukraine |
| Investigational Site | Dnipropetrovsk | 49026 | Ukraine |
| Investigational Site | Dnipropetrovsk | 49101 | Ukraine |
| Investigational Site | Donetsk | 83017 | Ukraine |
| Investigational Site | Donetsk | 83099 | Ukraine |
| Investigational Site | Kharkiv | 61035 | Ukraine |
| Investigational Site | Kiev | 02125 | Ukraine |
| Investigational Site | Kiev | 02232 | Ukraine |
| Investigational Site | Kiev | 03680 | Ukraine |
| Investigational Site | Lviv | 79010 | Ukraine |
| Investigational Site | Vinnytsia | 21029 | Ukraine |
| Investigational Site | Zaporizhzhya | 69063 | Ukraine |
| Investigational Site | Zaporizhzhya | 69118 | Ukraine |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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