Clinical Study to Explore the Efficacy of ACT-129968 in Patients With Partly Controlled Asthma
- Registration Number
- NCT01225315
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Brief Summary
This study will assess the efficacy and safety of ACT-129968 in subjects with partly controlled asthma on reliever therapy only.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 438
- Signed informed consent prior to any study-mandated procedure
- Males and females age 18 to 65 years
- Women of childbearing potential must use adequate contraception
- Presenting with a diagnosis of asthma according to GINA Guidelines
- Pre-bronchodilator forced expiratory volume in one second (FEV1) < / = 85% of patient's predicted normal value
- Reversibility of airway obstruction of > / = 12% and > / = 200mL from pre-bronchodilator FEV1
- ACQ score > / = 1.5
- History of life-threatening asthma
- Any asthma exacerbation requiring treatment with systemic corticosteroids within the last 3 months
- Ongoing or recent treatment with medication for allergic airway disease
- Smoking within the last year, or life-time consumption > / = 10 pack-years (e.g., 20 cigarettes/day for 10 years)
- History of chronic pulmonary disease (other than asthma), such as chronic obstructive pulmonary disease (COPD), fibrosis, tuberculosis or sarcoidosis
- Pregnant or lactating women
- Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced asthma
- Any hospital admission for asthma within the last 6 months
- Anti-IgE therapy at any time check/update interventions by explicitely writing the experimental drug dosage in the interventions description
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Setipiprant - Dose 1 Setipiprant 100 mg b.i.d. Setipiprant - Dose 3 Setipiprant 1,000 mg b.i.d Setipiprant - Dose 2 Setipiprant 500 mg b.i.d. Matching Placebo Placebo Oral placebo
- Primary Outcome Measures
Name Time Method To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo Baseline to week 12
- Secondary Outcome Measures
Name Time Method Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control Baseline to 12 weeks
Trial Locations
- Locations (97)
Clinical Investigative Site # 5501
🇵🇱Lodz, Poland
Clinical Investigative Site # 6215
🇺🇸New Orleans, Louisiana, United States
Clinical Investigative Site 6202
🇺🇸Knoxville, Tennessee, United States
Clinical Investigative Site # 5104
🇧🇬Sofia, Bulgaria
Clinical Investigative Site 5302
🇭🇺Tatabanya, Hungary
Clinical Investigative Site 6226
🇺🇸Nashville, Tennessee, United States
Clinical Investigative Site 6230
🇺🇸Spartanburg, South Carolina, United States
Clinical Investigative Site # 5101
🇧🇬Sofia, Bulgaria
Clinical Investigative Site # 5308
🇭🇺Sopron, Hungary
Clinical Investigative Site 5304
🇭🇺Miskolc, Hungary
Clinical Investigative Site # 5303
🇭🇺Nyiregyhaza, Hungary
Clinical Investigative Site 5310
🇭🇺Budapest, Hungary
Clinical Investigative Site # 5403
🇮🇱Rehovot, Israel
Clinical Investigative Site # 5404
🇮🇱Tel-Aviv, Israel
Clinical Investigative Site # 5406
🇮🇱Tel-Aviv, Israel
Clinical Investigative Site # 5507
🇵🇱Bialystok, Poland
Clinical Investigative Site # 5503
🇵🇱Tarnow, Poland
Clinical Investigative Site 5604
🇷🇺St. Petersburg, Russian Federation
Clinical Investigative Site # 5502
🇵🇱Lublin, Poland
Clinical Investigative Site 5610
🇷🇺Barnaul, Russian Federation
Clinical Investigative Site 5609
🇷🇺Novosibirsk, Russian Federation
Clinical Investigative Site 5603
🇷🇺Kazan, Russian Federation
Clinical Investigative Site 5605
🇷🇺St. Petersburg, Russian Federation
Clinical Investigative Site 5654
🇷🇺Moscow, Russian Federation
Clinical Investigative Site 5701
🇷🇸Belgrade, Serbia
Clinical Investigative Site 5607
🇷🇺Moscow, Russian Federation
Clinical Investigative Site # 6102
🇺🇦Kyiv, Ukraine
Clinical Investigative Site # 6204
🇺🇸Los Angeles, California, United States
Clinical Investigative Site 6208
🇺🇸Los Angeles, California, United States
Clinical Investigative Site # 6219
🇺🇸Tallahassee, Florida, United States
Clinical Investigative Site 6205
🇺🇸Bronx, New York, United States
Clinical Inverstigative Site #6201
🇺🇸Lake Oswego, Oregon, United States
Clinical Investigative Site # 6214
🇺🇸Portland, Oregon, United States
Clinical Investigative Site 6229
🇺🇸San Antonio, Texas, United States
Clinical Investigative Site 5212
🇩🇪Berlin, Germany
Clinical Investigative Site 5309
🇭🇺Sátoraljaújhely, Hungary
Clinical Investigative Site # 5402
🇮🇱Jerusalem, Israel
Clinical Investigative Site 5401
🇮🇱Haifa, Israel
Clinical Investigative Site 5606
🇷🇺Barnaul, Russian Federation
Clinical Investigative Site 5608
🇷🇺Tomsk, Russian Federation
Clinical Investigative Site 5908
🇿🇦Bloemfontein, South Africa
Clinical Investigative Site 5909
🇿🇦George, South Africa
Clinical Investigative Site 5901
🇿🇦Durban, South Africa
Clinical Ivestigative Site 5902
🇿🇦Cape Town, South Africa
Clinical Investigative Site 5906
🇿🇦Johannesburg, South Africa
Clinical Investigative Site 5910
🇿🇦Port Elizabeth, South Africa
Clinical Investigative Site 5903
🇿🇦Pretoria, South Africa
Clinical Investigative Site # 6104
🇺🇦Donetsk, Ukraine
Clinical Investigative Site 6110
🇺🇦Kharkiv, Ukraine
Clinical Investigative Site 5003
🇦🇺Nedlands, Australia
Clinical Investigative Site 5001
🇦🇺Sherwood, Australia
Clinical Investigative Site 5204
🇩🇪Mainz, Germany
Clinical Investigative Site # 5305
🇭🇺Szombathely, Hungary
Clinical Investigative Site # 6223
🇺🇸Winston-Salem, North Carolina, United States
Clinical Investigative Site # 6209
🇺🇸Saint Louis, Missouri, United States
Clinical Investigative Site 6213
🇺🇸Normal, Illinois, United States
Clinical Investigative Site 5307
🇭🇺Csorna, Hungary
Clinical Investigative Site # 6220
🇺🇸El Paso, Texas, United States
Clinical Investigative Site 5905
🇿🇦Cape Town, South Africa
Clinical Investigative Site # 5103
🇧🇬Ruse, Bulgaria
Clinical Investigative Site # 6006
🇸🇪Harnosand, Sweden
Clinical Investigative Site 6003
🇸🇪Linköping, Sweden
Clinical Investigative Site # 6228
🇺🇸Greenville, South Carolina, United States
Clinical Investigative Site 6007
🇸🇪Stockholm, Sweden
Clinical Investigative Site # 6207
🇺🇸Medford, Oregon, United States
Clinical Investigative Site 5202
🇩🇪Rüdersdorf, Germany
Clinical Investigative Site 5002
🇦🇺Glebe, Australia
Clinical Investigative Site 6203
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Investigative Site # 5102
🇧🇬Stara Zagora, Bulgaria
Clinical Investigative Site # 6217
🇺🇸Madison, Wisconsin, United States
Clinical Investigative Site 5208
🇩🇪Berlin, Germany
Clinical Investigative Site # 6225
🇺🇸Fort Worth, Texas, United States
Clinical Investigative Site # 5407
🇮🇱Ashkelon, Israel
Clinical Investigative Site # 5505
🇵🇱Krakow, Poland
Clinical Investigative Site 5211
🇩🇪Hamburg, Germany
Clinical Investigative Site 5602
🇷🇺Moscow, Russian Federation
Clinical Investigative Site 5205
🇩🇪Dortmund, Germany
Clinical Investigative Site 5207
🇩🇪Gelnhausen, Germany
Clinical Investigative 5209
🇩🇪Lübeck, Germany
Clinical Investigative Site 5301
🇭🇺Siofok, Hungary
Clinical Investigative Site 5405
🇮🇱Petach Tikvah, Israel
Clinical Investigative Site 5702
🇷🇸Belgrade, Serbia
Clinical Investigative Site 5802
🇸🇬Singapore, Singapore
Clinical Investigative Site 6001
🇸🇪Goteborg, Sweden
Clinical Investigative Site # 6002
🇸🇪Lulea, Sweden
Clinical Investigative Site 6052
🇸🇪Lund, Sweden
Clinical Investigative Site 6004
🇸🇪Varberg, Sweden
Clinical Investigative Site 5907
🇿🇦Pretoria, South Africa
Clinical Ivestigative Site 6111
🇺🇦Odesa, Ukraine
Clinical Investigative Site # 6107
🇺🇦Uzhhorod, Ukraine
Clinical Investigative Site # 6101
🇺🇦Kharkiv, Ukraine
Clinical Investigative Site # 6103
🇺🇦Kyiv, Ukraine
Clinical Investigative Site 6108
🇺🇦Poltava, Ukraine
Clinical Investigative Site 6105
🇺🇦Zaporizhia, Ukraine
Clinical Investigative Site # 6106
🇺🇦Zaporizhia, Ukraine
Clinical Investigative Site # 6211
🇺🇸North Dartmouth, Massachusetts, United States
Clinical Investigative Site # 6222
🇺🇸San Antonio, Texas, United States