Asthma Clinical Trial
— CONTROLOfficial title:
A Multi-center, Double-blind, Placebo-controlled, Parallel-group Study to Establish Proof-of-concept and Explore the Efficacy of Different Doses of ACT-129968 in Adult Patients With Partly Controlled Asthma
| Verified date | July 2018 |
| Source | Idorsia Pharmaceuticals Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will assess the efficacy and safety of ACT-129968 in subjects with partly controlled asthma on reliever therapy only.
| Status | Completed |
| Enrollment | 438 |
| Est. completion date | February 1, 2012 |
| Est. primary completion date | January 1, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Clinical Investigative Site 5002 | Glebe | |
| Australia | Clinical Investigative Site 5003 | Nedlands | |
| Australia | Clinical Investigative Site 5001 | Sherwood | |
| Bulgaria | Clinical Investigative Site # 5103 | Ruse | |
| Bulgaria | Clinical Investigative Site # 5101 | Sofia | |
| Bulgaria | Clinical Investigative Site # 5104 | Sofia | |
| Bulgaria | Clinical Investigative Site # 5102 | Stara Zagora | |
| Germany | 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 | |
| Hungary | Clinical Investigative Site 5310 | Budapest | |
| Hungary | Clinical Investigative Site 5307 | Csorna | |
| Hungary | Clinical Investigative Site 5304 | Miskolc | |
| Hungary | Clinical Investigative Site # 5303 | Nyiregyhaza | |
| Hungary | Clinical Investigative Site 5309 | Sátoraljaújhely | |
| Hungary | Clinical Investigative Site 5301 | Siofok | |
| Hungary | Clinical Investigative Site # 5308 | Sopron | |
| Hungary | Clinical Investigative Site # 5305 | Szombathely | |
| Hungary | Clinical Investigative Site 5302 | Tatabanya | |
| Israel | 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 | |
| Poland | 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 | Tarnow | |
| Russian Federation | Clinical Investigative Site 5606 | Barnaul | |
| Russian Federation | Clinical Investigative Site 5610 | Barnaul | |
| Russian Federation | Clinical Investigative Site 5603 | Kazan | |
| Russian Federation | Clinical Investigative Site 5602 | Moscow | |
| Russian Federation | Clinical Investigative Site 5607 | Moscow | |
| Russian Federation | Clinical Investigative Site 5654 | Moscow | |
| Russian Federation | Clinical Investigative Site 5609 | Novosibirsk | |
| Russian Federation | Clinical Investigative Site 5604 | St. Petersburg | |
| Russian Federation | Clinical Investigative Site 5605 | St. Petersburg | |
| Russian Federation | Clinical Investigative Site 5608 | Tomsk | |
| Serbia | Clinical Investigative Site 5701 | Belgrade | |
| Serbia | Clinical Investigative Site 5702 | Belgrade | |
| Singapore | Clinical Investigative Site 5802 | Singapore | |
| South Africa | 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 | |
| Sweden | Clinical Investigative Site 6001 | Goteborg | |
| Sweden | Clinical Investigative Site # 6006 | Harnosand | |
| Sweden | Clinical Investigative Site 6003 | Linköping | |
| Sweden | Clinical Investigative Site # 6002 | Lulea | |
| Sweden | Clinical Investigative Site 6052 | Lund | |
| Sweden | Clinical Investigative Site 6007 | Stockholm | |
| Sweden | Clinical Investigative Site 6004 | Varberg | |
| Ukraine | Clinical Investigative Site # 6104 | Donetsk | |
| Ukraine | Clinical Investigative Site # 6101 | Kharkiv | |
| Ukraine | Clinical Investigative Site 6110 | 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 # 6106 | Zaporizhia | |
| Ukraine | Clinical Investigative Site 6105 | Zaporizhia | |
| United States | Clinical Investigative Site 6205 | Bronx | New York |
| United States | Clinical Investigative Site # 6220 | El Paso | Texas |
| United States | Clinical Investigative Site # 6225 | Fort Worth | Texas |
| United States | Clinical Investigative Site # 6228 | Greenville | South Carolina |
| United States | Clinical Investigative Site 6202 | Knoxville | Tennessee |
| United States | Clinical Inverstigative Site #6201 | Lake Oswego | Oregon |
| United States | Clinical Investigative Site # 6204 | Los Angeles | California |
| United States | Clinical Investigative Site 6208 | Los Angeles | California |
| United States | Clinical Investigative Site # 6217 | Madison | Wisconsin |
| United States | Clinical Investigative Site # 6207 | Medford | Oregon |
| United States | Clinical Investigative Site 6226 | Nashville | Tennessee |
| United States | Clinical Investigative Site # 6215 | New Orleans | Louisiana |
| United States | Clinical Investigative Site 6213 | Normal | Illinois |
| United States | Clinical Investigative Site # 6211 | North Dartmouth | Massachusetts |
| United States | Clinical Investigative Site 6203 | Philadelphia | Pennsylvania |
| United States | Clinical Investigative Site # 6214 | Portland | Oregon |
| United States | Clinical Investigative Site # 6209 | Saint Louis | Missouri |
| United States | Clinical Investigative Site # 6222 | San Antonio | Texas |
| United States | Clinical Investigative Site 6229 | San Antonio | Texas |
| United States | Clinical Investigative Site 6230 | Spartanburg | South Carolina |
| United States | Clinical Investigative Site # 6219 | Tallahassee | Florida |
| United States | Clinical Investigative Site # 6223 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Idorsia Pharmaceuticals Ltd. |
United States, Australia, Bulgaria, Germany, Hungary, Israel, Poland, Russian Federation, Serbia, Singapore, South Africa, Sweden, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo | Baseline to week 12 | ||
| Secondary | Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control | Baseline to 12 weeks |
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