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

October 19, 2010
June 13, 2013
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • 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
  • 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: Reliever Medication
    • Drug: ACT-129968
  • Experimental: Investigational drug - Dose 2
    500 mg b.i.d.
    Interventions:
    • Drug: Reliever Medication
    • Drug: ACT-129968
  • Experimental: Investigational drug - Dose 3
    1,000 mg b.i.d
    Interventions:
    • Drug: Reliever Medication
    • Drug: ACT-129968
  • Placebo Comparator: Matching Placebo
    Oral placebo
    Interventions:
    • Drug: Placebo
    • Drug: Reliever Medication
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Bulgaria,   Germany,   Hungary,   Israel,   Poland,   Russian Federation,   Serbia,   Singapore,   South Africa,   Sweden,   Ukraine
 
NCT01225315
AC-060A202
Yes
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