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A Phase 3 Study to Compare Efficacy and Safety of Masitinib to Placebo in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids

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: NCT01449162
Recruitment Status : Unknown
Verified September 2012 by AB Science.
Recruitment status was:  Recruiting
First Posted : October 10, 2011
Last Update Posted : September 26, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.

Condition or disease Intervention/treatment Phase
Asthma Drug: masitinib 6 mg/kg/day Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and the Safety of Masitinib at 6 mg/kg/Day Versus Placebo in the Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids
Study Start Date : June 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: masitinib
masitinib 6 mg/kg/day
Drug: masitinib 6 mg/kg/day
6 mg/kg/day
Placebo Comparator: placebo
placebo matching masitinib 6 mg/kg/day
Drug: placebo
placebo matching masitinib 6 mg/kg/day


Outcome Measures

Primary Outcome Measures :
  1. asthma exacerbation rate [ Time Frame: week 36 ]

Secondary Outcome Measures :
  1. asthma control questionnaire score [ Time Frame: week 36 ]
  2. moderate and severe asthma exacerbation rate [ Time Frame: week 36 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient with severe persistent asthma already treated
  2. Patient with history of asthma > 1 year prior to screening visit
  3. Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit
  4. Non-smoker patient for at least one year and with a prior tobacco consumption < 10 packs a year

Exclusion Criteria:

  1. Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
  2. Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening
  3. Patient presenting with cardiac disorders
  4. Patient with active lung disease other than asthma
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): NCT01449162


Contacts
Contact: Christophe LEROYER, MD, PhD christophe.leroyer@chu-brest.fr

Locations
Hungary
University of Debrecen Medical and Health Science Center Recruiting
Debrecen, Hungary, 4032
Sponsors and Collaborators
AB Science
More Information

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01449162     History of Changes
Other Study ID Numbers: AB07015
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012

Keywords provided by AB Science:
severe persistent asthma
patients treated with oral corticosteroids

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases