Study of ACT-129968 in Adult Patients With Partly Controlled Asthma. (CONTROL)
This study has been completed.
Sponsor:
Actelion
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01225315
First received: October 19, 2010
Last updated: March 27, 2013
Last verified: March 2013
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Purpose
This study will assess the efficacy and safety of ACT-129968 in subjects with partly controlled asthma on reliever therapy only.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: ACT-129968 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Actelion:
Primary Outcome Measures:
- To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 438 |
| Study Start Date: | October 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Investigational drug - Dose 1 |
Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
|
| Experimental: Investigational drug - Dose 2 |
Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
|
| Experimental: Investigational drug - Dose 3 |
Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
|
| Placebo Comparator: Matching Placebo |
Drug: Placebo
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and females age 18 to 65 years
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225315
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| United States, California | |
| Clinical Investigative Site # 6204 | |
| Los Angeles, California, United States, 90025 | |
| Clinical Investigative Site 6208 | |
| Los Angeles, California, United States, 90095 | |
| United States, Florida | |
| Clinical Investigative Site # 6219 | |
| Tallahassee, Florida, United States, 32308 | |
| United States, Illinois | |
| Clinical Investigative Site 6213 | |
| Normal, Illinois, United States, 61761 | |
| United States, Louisiana | |
| Clinical Investigative Site # 6215 | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Clinical Investigative Site # 6211 | |
| North Dartmouth, Massachusetts, United States, 02747 | |
| United States, Missouri | |
| Clinical Investigative Site # 6209 | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New York | |
| Clinical Investigative Site 6205 | |
| Bronx, New York, United States, 10461 | |
| United States, North Carolina | |
| Clinical Investigative Site # 6223 | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Oregon | |
| Clinical Inverstigative Site #6201 | |
| Lake Oswego, Oregon, United States, 97035 | |
| Clinical Investigative Site # 6207 | |
| Medford, Oregon, United States, 97504 | |
| Clinical Investigative Site # 6214 | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Clinical Investigative Site 6203 | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Clinical Investigative Site # 6228 | |
| Greenville, South Carolina, United States, 29615 | |
| Clinical Investigative Site 6230 | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| Clinical Investigative Site 6202 | |
| Knoxville, Tennessee, United States, 37909 | |
| Clinical Investigative Site 6226 | |
| Nashville, Tennessee, United States, 37208 | |
| United States, Texas | |
| Clinical Investigative Site # 6220 | |
| El Paso, Texas, United States, 79903 | |
| Clinical Investigative Site # 6225 | |
| Fort Worth, Texas, United States, 76132 | |
| Clinical Investigative Site # 6222 | |
| San Antonio, Texas, United States, 78229 | |
| Clinical Investigative Site 6229 | |
| San Antonio, Texas, United States, 78229 | |
| United States, Wisconsin | |
| Clinical Investigative Site # 6217 | |
| Madison, Wisconsin, United States, 53792 | |
| Australia | |
| Clinical Investigative Site 5002 | |
| Glebe, Australia, 2037 | |
| Clinical Investigative Site 5003 | |
| Nedlands, Australia, 6009 | |
| Clinical Investigative Site 5001 | |
| Sherwood, Australia, 4075 | |
| Bulgaria | |
| Clinical Investigative Site # 5103 | |
| Ruse, Bulgaria, 7002 | |
| Clinical Investigative Site # 5104 | |
| Sofia, Bulgaria, 1431 | |
| Clinical Investigative Site # 5101 | |
| Sofia, Bulgaria, 1431 | |
| Clinical Investigative Site # 5102 | |
| Stara Zagora, Bulgaria, 6003 | |
| Germany | |
| Clinical Investigative Site 5212 | |
| Berlin, Germany, 12165 | |
| Clinical Investigative Site 5208 | |
| Berlin, Germany, 10969 | |
| Clinical Investigative Site 5205 | |
| Dortmund, Germany, 44263 | |
| Clinical Investigative Site 5207 | |
| Gelnhausen, Germany, 63571 | |
| Clinical Investigative Site 5211 | |
| Hamburg, Germany, 20357 | |
| Clinical Investigative 5209 | |
| Lübeck, Germany, 23552 | |
| Clinical Investigative Site 5204 | |
| Mainz, Germany, 55116 | |
| Clinical Investigative Site 5202 | |
| Rüdersdorf, Germany, 15562 | |
| Hungary | |
| Clinical Investigative Site 5310 | |
| Budapest, Hungary, 1036 | |
| Clinical Investigative Site 5307 | |
| Csorna, Hungary, 9300 | |
| Clinical Investigative Site 5304 | |
| Miskolc, Hungary, 3529 | |
| Clinical Investigative Site # 5303 | |
| Nyiregyhaza, Hungary, 4400 | |
| Clinical Investigative Site 5301 | |
| Siofok, Hungary, 8600 | |
| Clinical Investigative Site # 5308 | |
| Sopron, Hungary, 9400 | |
| Clinical Investigative Site # 5305 | |
| Szombathely, Hungary, H-9700 | |
| Clinical Investigative Site 5309 | |
| Sátoraljaújhely, Hungary, 3980 | |
| Clinical Investigative Site 5302 | |
| Tatabanya, Hungary, H-2800 | |
| Israel | |
| Clinical Investigative Site # 5407 | |
| Ashkelon, Israel, 78278 | |
| Clinical Investigative Site 5401 | |
| Haifa, Israel, 34362 | |
| Clinical Investigative Site # 5402 | |
| Jerusalem, Israel, 91120 | |
| Clinical Investigative Site 5405 | |
| Petach Tikvah, Israel, 49100 | |
| Clinical Investigative Site # 5403 | |
| Rehovot, Israel, 76100 | |
| Clinical Investigative Site # 5406 | |
| Tel-Aviv, Israel, 64239 | |
| Clinical Investigative Site # 5404 | |
| Tel-Aviv, Israel, 64239 | |
| Poland | |
| Clinical Investigative Site # 5507 | |
| Bialystok, Poland, 15-010 | |
| Clinical Investigative Site # 5505 | |
| Krakow, Poland, 31-023 | |
| Clinical Investigative Site # 5501 | |
| Lodz, Poland, 90-553 | |
| Clinical Investigative Site # 5502 | |
| Lublin, Poland, 20-095 | |
| Clinical Investigative Site # 5503 | |
| Tarnow, Poland, 33-100 | |
| Russian Federation | |
| Clinical Investigative Site 5606 | |
| Barnaul, Russian Federation, 656045 | |
| Clinical Investigative Site 5610 | |
| Barnaul, Russian Federation, 656024 | |
| Clinical Investigative Site 5603 | |
| Kazan, Russian Federation, 420015 | |
| Clinical Investigative Site 5607 | |
| Moscow, Russian Federation, 115280 | |
| Clinical Investigative Site 5654 | |
| Moscow, Russian Federation, 105229 | |
| Clinical Investigative Site 5602 | |
| Moscow, Russian Federation, 105077 | |
| Clinical Investigative Site 5609 | |
| Novosibirsk, Russian Federation, 630037 | |
| Clinical Investigative Site 5605 | |
| St. Petersburg, Russian Federation, 194044 | |
| Clinical Investigative Site 5604 | |
| St. Petersburg, Russian Federation, 197022 | |
| Clinical Investigative Site 5608 | |
| Tomsk, Russian Federation, 634034 | |
| Serbia | |
| Clinical Investigative Site 5701 | |
| Belgrade, Serbia, 11080 | |
| Clinical Investigative Site 5702 | |
| Belgrade, Serbia, 11080 | |
| Singapore | |
| Clinical Investigative Site 5802 | |
| Singapore, Singapore, 529889 | |
| South Africa | |
| Clinical Investigative Site 5908 | |
| Bloemfontein, South Africa, 9300 | |
| Clinical Ivestigative Site 5902 | |
| Cape Town, South Africa, 7700 | |
| Clinical Investigative Site 5905 | |
| Cape Town, South Africa, 7530 | |
| Clinical Investigative Site 5901 | |
| Durban, South Africa, 4001 | |
| Clinical Investigative Site 5909 | |
| George, South Africa, 6529 | |
| Clinical Investigative Site 5906 | |
| Johannesburg, South Africa, 1829 | |
| Clinical Investigative Site 5910 | |
| Port Elizabeth, South Africa, 6045 | |
| Clinical Investigative Site 5903 | |
| Pretoria, South Africa, 0157 | |
| Clinical Investigative Site 5907 | |
| Pretoria, South Africa, 0181 | |
| Sweden | |
| Clinical Investigative Site 6001 | |
| Goteborg, Sweden, 413 42 | |
| Clinical Investigative Site # 6006 | |
| Harnosand, Sweden, 87182 | |
| Clinical Investigative Site 6003 | |
| Linköping, Sweden, 58185 | |
| Clinical Investigative Site # 6002 | |
| Lulea, Sweden, 97231 | |
| Clinical Investigative Site 6052 | |
| Lund, Sweden, 22185 | |
| Clinical Investigative Site 6007 | |
| Stockholm, Sweden, 111 57 | |
| Clinical Investigative Site 6004 | |
| Varberg, Sweden, 432 44 | |
| Ukraine | |
| Clinical Investigative Site # 6104 | |
| Donetsk, Ukraine, 83099 | |
| Clinical Investigative Site 6110 | |
| Kharkiv, Ukraine, 61018 | |
| Clinical Investigative Site # 6101 | |
| Kharkiv, Ukraine, 61035 | |
| Clinical Investigative Site # 6103 | |
| Kyiv, Ukraine, 03680 | |
| Clinical Investigative Site # 6102 | |
| Kyiv, Ukraine, 03680 | |
| Clinical Ivestigative Site 6111 | |
| Odesa, Ukraine, 65025 | |
| Clinical Investigative Site 6108 | |
| Poltava, Ukraine, 36028 | |
| Clinical Investigative Site # 6107 | |
| Uzhhorod, Ukraine, 88009 | |
| Clinical Investigative Site 6105 | |
| Zaporizhia, Ukraine, 69035 | |
| Clinical Investigative Site # 6106 | |
| Zaporizhia, Ukraine, 69118 | |
Sponsors and Collaborators
Actelion
Investigators
| Study Director: | Sara Mangialaio, MD | Actelion |
More Information
No publications provided
| Responsible Party: | Actelion |
| ClinicalTrials.gov Identifier: | NCT01225315 History of Changes |
| Other Study ID Numbers: | AC-060A202 |
| Study First Received: | October 19, 2010 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Human Research Ethics Committee Bulgaria: Bulgarian Drug Agency Bulgaria: Ethics committee Germany: Federal Institute for Drugs and Medical Devices Germany: Ethics Commission Hungary: National Institute of Pharmacy Hungary: Research Ethics Medical Committee Israel: Ministry of Health Israel: Ethics Commission Poland: Ministry of Health Poland: Ethics Committee Russia: Ministry of Health of the Russian Federation Russia: Ethics Committee Serbia and Montenegro: Agency for Drugs and Medicinal Devices Serbia: Ethics Committee Singapore: Health Sciences Authority South Africa: Medicines Control Council South Africa: Human Research Ethics Committee Sweden: Medical Products Agency Sweden: Regional Ethical Review Board Ukraine: State Pharmacological Center - Ministry of Health Ukraine: Ethics Committee |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013