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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01225315
First Posted: October 21, 2010
Last Update Posted: October 13, 2016
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.
Information provided by (Responsible Party):
Actelion
October 19, 2010
October 21, 2010
October 13, 2016
October 2010
January 2012   (Final data collection date for primary outcome measure)
To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo [ Time Frame: Baseline to week 12 ]
Same as current
Complete list of historical versions of study NCT01225315 on ClinicalTrials.gov Archive Site
Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control [ Time Frame: Baseline to 12 weeks ]
Same as current
Not Provided
Not Provided
 
Study of ACT-129968 in Adult Patients With Partly Controlled Asthma.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: Placebo
    matching placebo administered orally twice daily
    Other Name: matching placebo
  • Drug: Salbutamol/albuterol
    Salbutamol/albuterol (100 Ug/puff, metered dose inhaler [MDI])
  • Drug: ACT-129968
    ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
    Other Name: setipiprant
  • Experimental: Investigational drug - Dose 1
    100 mg b.i.d.
    Interventions:
    • Drug: Salbutamol/albuterol
    • Drug: ACT-129968
  • Experimental: Investigational drug - Dose 2
    500 mg b.i.d.
    Interventions:
    • Drug: Salbutamol/albuterol
    • Drug: ACT-129968
  • Experimental: Investigational drug - Dose 3
    1,000 mg b.i.d
    Interventions:
    • Drug: Salbutamol/albuterol
    • Drug: ACT-129968
  • Placebo Comparator: Matching Placebo
    Oral placebo
    Interventions:
    • Drug: Placebo
    • Drug: Salbutamol/albuterol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
438
February 2012
January 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Bulgaria,   Germany,   Hungary,   Israel,   Poland,   Russian Federation,   Serbia,   Singapore,   South Africa,   Sweden,   Ukraine,   United States
 
 
NCT01225315
AC-060A202
Yes
Not Provided
Not Provided
Actelion
Actelion
Not Provided
Study Director: Sara Mangialaio, MD Actelion
Actelion
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP