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

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ClinicalTrials.gov Identifier: NCT01225315
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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: Salbutamol/albuterol Drug: ACT-129968 Phase 2

Study Design

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 : October 2010
Primary Completion Date : January 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Albuterol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Investigational drug - Dose 1
100 mg b.i.d.
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 2
500 mg b.i.d.
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 3
1,000 mg b.i.d
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
Placebo Comparator: Matching Placebo
Oral placebo
Drug: Placebo
matching placebo administered orally twice daily
Other Name: matching placebo
Drug: Salbutamol/albuterol
Salbutamol/albuterol (100 Ug/puff, metered dose inhaler [MDI])


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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


  Show 97 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Director: Sara Mangialaio, MD Actelion
More Information

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01225315     History of Changes
Other Study ID Numbers: AC-060A202
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: June 2013

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
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action