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
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Placebo
Drug: Reliever Medication
Drug: ACT-129968
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 438
Study Start Date: October 2010
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational drug - Dose 1
100 mg b.i.d.
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 2
500 mg b.i.d.
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 3
1,000 mg b.i.d
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
Placebo Comparator: Matching Placebo
Oral placebo
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225315

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

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01225315     History of Changes
Other Study ID Numbers: AC-060A202
Study First Received: October 19, 2010
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ethics committee
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Hungary: National Institute of Pharmacy
Hungary: Research Ethics Medical Committee
Israel: Ministry of Health
Israel: Ethics Commission
Poland: Ministry of Health
Poland: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Serbia: Ethics Committee
Singapore: Health Sciences Authority
South Africa: Medicines Control Council
South Africa: Human Research Ethics Committee
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Ukraine: State Pharmacological Center - Ministry of Health
Ukraine: Ethics Committee

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 24, 2014