Clinical Study to Explore the Efficacy of ACT-129968 in Patients With Partly Controlled Asthma (CONTROL)

July 6, 2018 updated by: Idorsia Pharmaceuticals Ltd.

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

This study will assess the efficacy and safety of ACT-129968 in subjects with partly controlled asthma on reliever therapy only.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

438

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Glebe, Australia, 2037
        • Clinical Investigative Site 5002
      • Nedlands, Australia, 6009
        • Clinical Investigative Site 5003
      • Sherwood, Australia, 4075
        • Clinical Investigative Site 5001
  • Bulgaria
      • Ruse, Bulgaria, 7002
        • Clinical Investigative Site # 5103
      • Sofia, Bulgaria, 1431
        • Clinical Investigative Site # 5101
      • Sofia, Bulgaria, 1431
        • Clinical Investigative Site # 5104
      • Stara Zagora, Bulgaria, 6003
        • Clinical Investigative Site # 5102
  • Germany
      • Berlin, Germany, 10969
        • Clinical Investigative Site 5208
      • Berlin, Germany, 12165
        • Clinical Investigative Site 5212
      • Dortmund, Germany, 44263
        • Clinical Investigative Site 5205
      • Gelnhausen, Germany, 63571
        • Clinical Investigative Site 5207
      • Hamburg, Germany, 20357
        • Clinical Investigative Site 5211
      • Lübeck, Germany, 23552
        • Clinical Investigative 5209
      • Mainz, Germany, 55116
        • Clinical Investigative Site 5204
      • Rüdersdorf, Germany, 15562
        • Clinical Investigative Site 5202
  • Hungary
      • Budapest, Hungary, 1036
        • Clinical Investigative Site 5310
      • Csorna, Hungary, 9300
        • Clinical Investigative Site 5307
      • Miskolc, Hungary, 3529
        • Clinical Investigative Site 5304
      • Nyiregyhaza, Hungary, 4400
        • Clinical Investigative Site # 5303
      • Siofok, Hungary, 8600
        • Clinical Investigative Site 5301
      • Sopron, Hungary, 9400
        • Clinical Investigative Site # 5308
      • Szombathely, Hungary, H-9700
        • Clinical Investigative Site # 5305
      • Sátoraljaújhely, Hungary, 3980
        • Clinical Investigative Site 5309
      • Tatabanya, Hungary, H-2800
        • Clinical Investigative Site 5302
  • Israel
      • Ashkelon, Israel, 78278
        • Clinical Investigative Site # 5407
      • Haifa, Israel, 34362
        • Clinical Investigative Site 5401
      • Jerusalem, Israel, 91120
        • Clinical Investigative Site # 5402
      • Petach Tikvah, Israel, 49100
        • Clinical Investigative Site 5405
      • Rehovot, Israel, 76100
        • Clinical Investigative Site # 5403
      • Tel-Aviv, Israel, 64239
        • Clinical Investigative Site # 5404
      • Tel-Aviv, Israel, 64239
        • Clinical Investigative Site # 5406
  • Poland
      • Bialystok, Poland, 15-010
        • Clinical Investigative Site # 5507
      • Krakow, Poland, 31-023
        • Clinical Investigative Site # 5505
      • Lodz, Poland, 90-553
        • Clinical Investigative Site # 5501
      • Lublin, Poland, 20-095
        • Clinical Investigative Site # 5502
      • Tarnow, Poland, 33-100
        • Clinical Investigative Site # 5503
  • Russian Federation
      • Barnaul, Russian Federation, 656024
        • Clinical Investigative Site 5610
      • Barnaul, Russian Federation, 656045
        • Clinical Investigative Site 5606
      • Kazan, Russian Federation, 420015
        • Clinical Investigative Site 5603
      • Moscow, Russian Federation, 105077
        • Clinical Investigative Site 5602
      • Moscow, Russian Federation, 105229
        • Clinical Investigative Site 5654
      • Moscow, Russian Federation, 115280
        • Clinical Investigative Site 5607
      • Novosibirsk, Russian Federation, 630037
        • Clinical Investigative Site 5609
      • St. Petersburg, Russian Federation, 194044
        • Clinical Investigative Site 5605
      • St. Petersburg, Russian Federation, 197022
        • Clinical Investigative Site 5604
      • Tomsk, Russian Federation, 634034
        • Clinical Investigative Site 5608
  • Serbia
      • Belgrade, Serbia, 11080
        • Clinical Investigative Site 5701
      • Belgrade, Serbia, 11080
        • Clinical Investigative Site 5702
  • Singapore
      • Singapore, Singapore, 529889
        • Clinical Investigative Site 5802
  • South Africa
      • Bloemfontein, South Africa, 9300
        • Clinical Investigative Site 5908
      • Cape Town, South Africa, 7530
        • Clinical Investigative Site 5905
      • Cape Town, South Africa, 7700
        • Clinical Ivestigative Site 5902
      • Durban, South Africa, 4001
        • Clinical Investigative Site 5901
      • George, South Africa, 6529
        • Clinical Investigative Site 5909
      • Johannesburg, South Africa, 1829
        • Clinical Investigative Site 5906
      • Port Elizabeth, South Africa, 6045
        • Clinical Investigative Site 5910
      • Pretoria, South Africa, 0157
        • Clinical Investigative Site 5903
      • Pretoria, South Africa, 0181
        • Clinical Investigative Site 5907
  • Sweden
      • Goteborg, Sweden, 413 42
        • Clinical Investigative Site 6001
      • Harnosand, Sweden, 87182
        • Clinical Investigative Site # 6006
      • Linköping, Sweden, 58185
        • Clinical Investigative Site 6003
      • Lulea, Sweden, 97231
        • Clinical Investigative Site # 6002
      • Lund, Sweden, 22185
        • Clinical Investigative Site 6052
      • Stockholm, Sweden, 111 57
        • Clinical Investigative Site 6007
      • Varberg, Sweden, 432 44
        • Clinical Investigative Site 6004
  • Ukraine
      • Donetsk, Ukraine, 83099
        • Clinical Investigative Site # 6104
      • Kharkiv, Ukraine, 61018
        • Clinical Investigative Site 6110
      • Kharkiv, Ukraine, 61035
        • Clinical Investigative Site # 6101
      • Kyiv, Ukraine, 03680
        • Clinical Investigative Site # 6102
      • Kyiv, Ukraine, 03680
        • Clinical Investigative Site # 6103
      • Odesa, Ukraine, 65025
        • Clinical Ivestigative Site 6111
      • Poltava, Ukraine, 36028
        • Clinical Investigative Site 6108
      • Uzhhorod, Ukraine, 88009
        • Clinical Investigative Site # 6107
      • Zaporizhia, Ukraine, 69035
        • Clinical Investigative Site 6105
      • Zaporizhia, Ukraine, 69118
        • Clinical Investigative Site # 6106
  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Clinical Investigative Site # 6204
      • Los Angeles, California, United States, 90095
        • Clinical Investigative Site 6208
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Clinical Investigative Site # 6219
    • Illinois
      • Normal, Illinois, United States, 61761
        • Clinical Investigative Site 6213
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Clinical Investigative Site # 6215
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Clinical Investigative Site # 6211
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Clinical Investigative Site # 6209
    • New York
      • Bronx, New York, United States, 10461
        • Clinical Investigative Site 6205
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Clinical Investigative Site # 6223
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Clinical Inverstigative Site #6201
      • Medford, Oregon, United States, 97504
        • Clinical Investigative Site # 6207
      • Portland, Oregon, United States, 97213
        • Clinical Investigative Site # 6214
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Clinical Investigative Site 6203
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Clinical Investigative Site # 6228
      • Spartanburg, South Carolina, United States, 29303
        • Clinical Investigative Site 6230
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Clinical Investigative Site 6202
      • Nashville, Tennessee, United States, 37208
        • Clinical Investigative Site 6226
    • Texas
      • El Paso, Texas, United States, 79903
        • Clinical Investigative Site # 6220
      • Fort Worth, Texas, United States, 76132
        • Clinical Investigative Site # 6225
      • San Antonio, Texas, United States, 78229
        • Clinical Investigative Site # 6222
      • San Antonio, Texas, United States, 78229
        • Clinical Investigative Site 6229
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Clinical Investigative Site # 6217

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Setipiprant - Dose 1
100 mg b.i.d.
Drug: Setipiprant
ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
Other Names:
  • ACT-129968
Experimental: Setipiprant - Dose 2
500 mg b.i.d.
Drug: Setipiprant
ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
Other Names:
  • ACT-129968
Experimental: Setipiprant - Dose 3
1,000 mg b.i.d
Drug: Setipiprant
ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
Other Names:
  • ACT-129968
Placebo Comparator: Matching Placebo
Oral placebo
Drug: Placebo
Matching placebo administered orally twice daily
Other Names:
  • matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo
Time Frame: Baseline to week 12
Baseline to week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Idorsia Pharmaceuticals Ltd.

Investigators

  • Study Director: Sara Mangialaio, MD, Actelion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

October 19, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (Estimate)

October 21, 2010

Study Record Updates

Last Update Posted (Actual)

July 9, 2018

Last Update Submitted That Met QC Criteria

July 6, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-060A202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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