Study of ACT-129968 in Adult Patients With Partly Controlled Asthma. (CONTROL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01225315
First received: October 19, 2010
Last updated: June 13, 2013
Last verified: June 2013
  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: Placebo
Drug: Reliever Medication
Drug: ACT-129968
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
100 mg b.i.d.
Drug: Reliever Medication
Salbutamol/albuterol (100 Ug/puff, metered dose inhaler [MDI])
Other Name: Salbutamol/albuterol
Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
Other Name: setipiprant
Experimental: Investigational drug - Dose 2
500 mg b.i.d.
Drug: Reliever Medication
Salbutamol/albuterol (100 Ug/puff, metered dose inhaler [MDI])
Other Name: Salbutamol/albuterol
Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
Other Name: setipiprant
Experimental: Investigational drug - Dose 3
1,000 mg b.i.d
Drug: Reliever Medication
Salbutamol/albuterol (100 Ug/puff, metered dose inhaler [MDI])
Other Name: Salbutamol/albuterol
Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
Other Name: setipiprant
Placebo Comparator: Matching Placebo
Oral placebo
Drug: Placebo
matching placebo administered orally twice daily
Other Name: matching placebo
Drug: Reliever Medication
Salbutamol/albuterol (100 Ug/puff, metered dose inhaler [MDI])
Other Name: Salbutamol/albuterol

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225315

  Hide Study Locations
Locations
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: June 13, 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
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014