Study of the Prednisone Sparing Effect of Xolair (Omalizumab) in Patients With Prednisone-dependent Asthma With Eosinophilic Bronchitis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by McMaster University
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Parameswaran Nair, McMaster University
ClinicalTrials.gov Identifier:
NCT02049294
First received: January 28, 2014
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to investigate whether addition of Omalizumab enables a reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis.

This will be a double-blind placebo-controlled, 3-centre, randomized parallel group trial divided into two sequential study periods.

Period 1: After establishing the minimum dose of prednisone to maintain asthma control and maintain sputum eosinophils <3%, subjects will be randomized to either placebo or Omalizumab for 16 weeks (either once monthly for 4 months or every 2 weeks for 4 months).

Period 2: standardised prednisone reduction at intervals of 4-weeks until there is a clinical and eosinophilic exacerbation or bothersome steroid withdrawal effects. If patients have an exacerbation, they will be treated with prednisone. This patient will continue on Omalizumab or placebo during the entire duration of the study but not continue the phase of steroid reduction.


Condition Intervention Phase
Prednisone Dependent Asthma
Eosinophilic Bronchitis
Biological: Omalizumab (Xolair)
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Placebo Controlled Trial of the Prednisone Sparing Effect of Xolair (Omalizumab) in Patients With Prednisone-dependent Asthma With Eosinophilic Bronchitis

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • proportion of patients with exacerbations in each study group from week 0 to week 32. [ Time Frame: Week 0 to Week 32 ] [ Designated as safety issue: No ]
  • the magnitude of the reduction in the dose of prednisone from week 12 to week 32. [ Time Frame: week 12 to week 32 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in % sputum eosinophil [ Time Frame: Week 0 to Week 32 ] [ Designated as safety issue: No ]
  • Blood eosinophils [ Time Frame: Week 0 to week 32 ] [ Designated as safety issue: No ]
  • Forced Expired Volume in 1 second (FEV1) [ Time Frame: Week 0 to Week 32 ] [ Designated as safety issue: No ]
  • Ratio of Forced Expired Volume in 1 second to Forced Vital Capacity (FEV1/VC) [ Time Frame: Week 0 to Week 32 ] [ Designated as safety issue: No ]
  • Provocative concentration causing a 20% drop in FEV1 (PC20) [ Time Frame: Week 0 to Week 32 ] [ Designated as safety issue: No ]
  • Asthma Control Questionnaire [ Time Frame: Week 0 to Week 32 ] [ Designated as safety issue: No ]
  • Fraction of exhaled nitric oxide (FeNO) [ Time Frame: Week 0 to Week 32 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omalizumab (Xolair)
Dosage/frequency is dependent on body weight (kg) and baseline blood IgE level.
Drug: Placebo
Other Name: 0.9% normal saline
Placebo Comparator: Placebo (Normal Saline)
0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab
Biological: Omalizumab (Xolair)
Other Name: Anti IgE

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed asthma within the past 2 years (12% bronchodilator reversibility or PC20 methacholine less than 8 mg/ml)
  • Sputum eosinophils greater than 3% on at least 2 occasions
  • Asthma Control Questionnaire (ACQ) <1.5 and sputum eos <3% at the time of randomization (ie. optimal steroid dose)
  • On Inhaled corticosteroids (ICS) and Long acting beta agonist (LABA) (irrespective of dose)
  • Total serum IgE >120 IU/L
  • Age between 18 and 75 years

Exclusion Criteria:

  • Current smoker or ex-smokers with greater than 20 pack years
  • Co-morbid diseases which in the investigator's opinion would make the patient unsuitable to participate in the study
  • Currently on Omalizumab or has previously been treated with Omalizumab
  • Currently on other biologic therapies
  • Pregnancy or lactation
  • Post bronchodilator FEV1 less than 50% predicted
  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: NCT02049294

Contacts
Contact: Melanie Kjarsgaard 905-522-1155 ext 33024 mkjarsga@stjoes.ca

Locations
Canada, Ontario
McMaster University Not yet recruiting
Hamilton, Ontario, Canada
Principal Investigator: Parameswaran Nair, MD, PhD         
Canada, Quebec
University of Laval
Laval, Quebec, Canada
University of Montreal
Montreal, Quebec, Canada
Sponsors and Collaborators
Parameswaran Nair
Novartis
Investigators
Principal Investigator: Parameswaran Nair, MD, PhD McMaster University
Principal Investigator: Louis-Philippe Boulet, MD University of Laval
Principal Investigator: Catherine Lemiere, MD Université de Montréal
Principal Investigator: James Martin, MD McGill University
  More Information

No publications provided

Responsible Party: Parameswaran Nair, Associate Professor of Medicine, McMaster University
ClinicalTrials.gov Identifier: NCT02049294     History of Changes
Other Study ID Numbers: RP 14-008
Study First Received: January 28, 2014
Last Updated: January 29, 2014
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Prednisone
Eosinophils
Immunoglobin E (IgE)
Asthma
Bronchitis
Inflammation
Allergy

Additional relevant MeSH terms:
Bronchitis
Asthma
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Prednisone
Omalizumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 16, 2014