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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by AB Science
Sponsor:
Information provided by (Responsible Party):
AB Science
ClinicalTrials.gov Identifier:
NCT01449162
First received: October 6, 2011
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Asthma
Drug: masitinib 6 mg/kg/day
Drug: placebo
Phase 3

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 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

Resource links provided by NLM:


Further study details as provided by AB Science:

Primary Outcome Measures:
  • asthma exacerbation rate [ Time Frame: week 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • asthma control questionnaire score [ Time Frame: week 36 ] [ Designated as safety issue: No ]
  • moderate and severe asthma exacerbation rate [ Time Frame: week 36 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01449162     History of Changes
Other Study ID Numbers: AB07015
Study First Received: October 6, 2011
Last Updated: September 25, 2012
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: State Institute for Drug Control
Bulgaria: Bulgarian Drug Agency
Thailand: Food and Drug Administration
Hungary: Ministry of Health, Social and Family Affairs
Poland: Ministry of Health

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

ClinicalTrials.gov processed this record on September 18, 2014