Clinical Study to Explore the Efficacy of ACT-129968 in Patients With Partly Controlled Asthma
NCT ID: NCT01225315
Last Updated: 2018-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
438 participants
INTERVENTIONAL
2010-11-01
2012-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Setipiprant - Dose 1
100 mg b.i.d.
Setipiprant
ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
Setipiprant - Dose 2
500 mg b.i.d.
Setipiprant
ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
Setipiprant - Dose 3
1,000 mg b.i.d
Setipiprant
ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
Matching Placebo
Oral placebo
Placebo
Matching placebo administered orally twice daily
Interventions
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Placebo
Matching placebo administered orally twice daily
Setipiprant
ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Sara Mangialaio, MD
Role: STUDY_DIRECTOR
Actelion
Locations
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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 6213
Normal, Illinois, United States
Clinical Investigative Site # 6215
New Orleans, Louisiana, United States
Clinical Investigative Site # 6211
North Dartmouth, Massachusetts, United States
Clinical Investigative Site # 6209
St Louis, Missouri, United States
Clinical Investigative Site 6205
The Bronx, New York, United States
Clinical Investigative Site # 6223
Winston-Salem, North Carolina, United States
Clinical Inverstigative Site #6201
Lake Oswego, Oregon, United States
Clinical Investigative Site # 6207
Medford, Oregon, United States
Clinical Investigative Site # 6214
Portland, Oregon, United States
Clinical Investigative Site 6203
Philadelphia, Pennsylvania, United States
Clinical Investigative Site # 6228
Greenville, South Carolina, United States
Clinical Investigative Site 6230
Spartanburg, South Carolina, United States
Clinical Investigative Site 6202
Knoxville, Tennessee, United States
Clinical Investigative Site 6226
Nashville, Tennessee, United States
Clinical Investigative Site # 6220
El Paso, Texas, United States
Clinical Investigative Site # 6225
Fort Worth, Texas, United States
Clinical Investigative Site # 6222
San Antonio, Texas, United States
Clinical Investigative Site 6229
San Antonio, Texas, United States
Clinical Investigative Site # 6217
Madison, Wisconsin, United States
Clinical Investigative Site 5002
Glebe, , Australia
Clinical Investigative Site 5003
Nedlands, , Australia
Clinical Investigative Site 5001
Sherwood, , Australia
Clinical Investigative Site # 5103
Rousse, , Bulgaria
Clinical Investigative Site # 5101
Sofia, , Bulgaria
Clinical Investigative Site # 5104
Sofia, , Bulgaria
Clinical Investigative Site # 5102
Stara Zagora, , Bulgaria
Clinical Investigative Site 5208
Berlin, , Germany
Clinical Investigative Site 5212
Berlin, , Germany
Clinical Investigative Site 5205
Dortmund, , Germany
Clinical Investigative Site 5207
Gelnhausen, , Germany
Clinical Investigative Site 5211
Hamburg, , Germany
Clinical Investigative 5209
Lübeck, , Germany
Clinical Investigative Site 5204
Mainz, , Germany
Clinical Investigative Site 5202
Rüdersdorf, , Germany
Clinical Investigative Site 5310
Budapest, , Hungary
Clinical Investigative Site 5307
Csorna, , Hungary
Clinical Investigative Site 5304
Miskolc, , Hungary
Clinical Investigative Site # 5303
Nyíregyháza, , Hungary
Clinical Investigative Site 5309
Sátoraljaújhely, , Hungary
Clinical Investigative Site 5301
Siófok, , Hungary
Clinical Investigative Site # 5308
Sopron, , Hungary
Clinical Investigative Site # 5305
Szombathely, , Hungary
Clinical Investigative Site 5302
Tatabánya, , Hungary
Clinical Investigative Site # 5407
Ashkelon, , Israel
Clinical Investigative Site 5401
Haifa, , Israel
Clinical Investigative Site # 5402
Jerusalem, , Israel
Clinical Investigative Site 5405
Petach Tikvah, , Israel
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 # 5505
Krakow, , Poland
Clinical Investigative Site # 5501
Lodz, , Poland
Clinical Investigative Site # 5502
Lublin, , Poland
Clinical Investigative Site # 5503
Tarnów, , Poland
Clinical Investigative Site 5610
Barnaul, , Russia
Clinical Investigative Site 5606
Barnaul, , Russia
Clinical Investigative Site 5603
Kazan', , Russia
Clinical Investigative Site 5602
Moscow, , Russia
Clinical Investigative Site 5654
Moscow, , Russia
Clinical Investigative Site 5607
Moscow, , Russia
Clinical Investigative Site 5609
Novosibirsk, , Russia
Clinical Investigative Site 5605
Saint Petersburg, , Russia
Clinical Investigative Site 5604
Saint Petersburg, , Russia
Clinical Investigative Site 5608
Tomsk, , Russia
Clinical Investigative Site 5701
Belgrade, , Serbia
Clinical Investigative Site 5702
Belgrade, , Serbia
Clinical Investigative Site 5802
Singapore, , Singapore
Clinical Investigative Site 5908
Bloemfontein, , South Africa
Clinical Investigative Site 5905
Cape Town, , South Africa
Clinical Ivestigative Site 5902
Cape Town, , South Africa
Clinical Investigative Site 5901
Durban, , South Africa
Clinical Investigative Site 5909
George, , 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 5907
Pretoria, , South Africa
Clinical Investigative Site 6001
Gothenburg, , Sweden
Clinical Investigative Site # 6006
Härnösand, , Sweden
Clinical Investigative Site 6003
Linköping, , Sweden
Clinical Investigative Site # 6002
Luleå, , Sweden
Clinical Investigative Site 6052
Lund, , Sweden
Clinical Investigative Site 6007
Stockholm, , Sweden
Clinical Investigative Site 6004
Varberg, , Sweden
Clinical Investigative Site # 6104
Donetsk, , Ukraine
Clinical Investigative Site 6110
Kharkiv, , Ukraine
Clinical Investigative Site # 6101
Kharkiv, , Ukraine
Clinical Investigative Site # 6102
Kyiv, , Ukraine
Clinical Investigative Site # 6103
Kyiv, , Ukraine
Clinical Ivestigative Site 6111
Odesa, , Ukraine
Clinical Investigative Site 6108
Poltava, , Ukraine
Clinical Investigative Site # 6107
Uzhhorod, , Ukraine
Clinical Investigative Site 6105
Zaporizhia, , Ukraine
Clinical Investigative Site # 6106
Zaporizhia, , Ukraine
Countries
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Other Identifiers
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AC-060A202
Identifier Type: -
Identifier Source: org_study_id
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