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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01225315
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

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

Condition or disease Intervention/treatment Phase
Asthma Drug: Placebo Drug: Setipiprant Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 1, 2010
Actual Primary Completion Date : January 1, 2012
Actual Study Completion Date : February 1, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: 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 Name: 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 Name: ACT-129968

Placebo Comparator: Matching Placebo
Oral placebo
Drug: Placebo
Matching placebo administered orally twice daily
Other Name: matching placebo




Primary Outcome Measures :
  1. To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo [ Time Frame: Baseline to week 12 ]

Secondary Outcome Measures :
  1. Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control [ Time Frame: Baseline to 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225315


Locations
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Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Sara Mangialaio, MD Actelion
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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01225315    
Other Study ID Numbers: AC-060A202
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases