NCT01007149

Brief Summary

This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 8, 2012

Completed
Last Updated

July 20, 2012

Status Verified

July 1, 2012

Enrollment Period

1.4 years

First QC Date

October 30, 2009

Results QC Date

February 20, 2012

Last Update Submit

July 18, 2012

Conditions

Asthma

Keywords

Severe asthma,non-atopic,omalizumab

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils

    Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of blood basophils (mean fluorescence intensity(MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.

    Baseline and 16 weeks

  • Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells

    Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of dendritic cells (mean fluorescence intensity (MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.

    Baseline and 16 weeks

Secondary Outcomes (7)

  • Change in Fractional Exhaled Nitric Oxide (FeNO)

    Baseline and 4, 8, 12 and 16 weeks

  • Change From Baseline in Induced Sputum Eosinophil Count

    Baseline and 16 weeks

  • Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)

    Baseline and 16 weeks

  • Change From Baseline in Nasal Symptom Global Score and Individual Components

    Baseline and 16 weeks

  • Physician and Patient Global Evaluation of Treatment Effectiveness

    16 weeks

  • +2 more secondary outcomes

Study Arms (2)

Omalizumab

EXPERIMENTAL

Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.

Drug: omalizumab

Placebo

PLACEBO COMPARATOR

Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.

Drug: Placebo

Interventions

omalizumabDRUG

Omalizumab was supplied in 5mL vials with solution for subcutaneous injection.

Omalizumab
PlaceboDRUG

Placebo was supplied in vials with solution for subcutaneous injection.

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe persistent asthma with the following characteristics:
  • Uncontrolled according to Global Initiative for Asthma (GINA) 2007 guidelines and at least 2 exacerbations having required systemic corticosteroid and/or at least 1 hospitalization or emergency room visit in the past year.
  • Treated with high-dose inhaled corticosteroid (i.e. \> 1,000 µg beclometasone dipropionate equivalent per day) plus inhaled long-acting β2 agonist (with or without maintenance oral corticosteroid).
  • Non-atopic, i.e. negative blood multiallergic testing and negative Aspergillus-specific IgE-radio allergosorbent blood test and negative skin prick tests to a battery of common aeroallergens

You may not qualify if:

  • Current smokers or smoking history stopped for less than 3 years or \> 10 pack years.
  • Asthma exacerbation during the 4 weeks prior to randomization.
  • Active lung disease other than non-atopic asthma.
  • Patients with an active cancer, a suspicion of cancer or any history of cancer with less than 5 disease free years.
  • Pregnant or nursing (lactating) women.
  • Treatment with omalizumab.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Novartis Investigative Site

Arnaud de Villeneuve, France

Location

Novartis Investigative Site

Béthune, France

Location

Novartis Investigative Site

Bordeaux, France

Location

Novartis Investigative Site

Clamart, France

Location

Novartis Investigative Site

Lyon, France

Location

Novartis Investigative Site

Nantes, France

Location

Novartis Investigative Site

Paris, France

Location

Novartis Investigative Site

Strasbourg, France

Location

Novartis Investigative Site

Suresnes, France

Location

Novartis Investigative Site

Toulouse, France

Location

Related Publications (1)

  • Garcia G, Magnan A, Chiron R, Contin-Bordes C, Berger P, Taille C, Devouassoux G, de Blay F, Couderc LJ, Didier A, O'Callaghan DS, Girodet PO, Bourdeix I, Le Gros V, Humbert M. A proof-of-concept, randomized, controlled trial of omalizumab in patients with severe, difficult-to-control, nonatopic asthma. Chest. 2013 Aug;144(2):411-419. doi: 10.1378/chest.12-1961.

    PMID: 23579324DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 3, 2009

Study Start

September 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

July 20, 2012

Results First Posted

June 8, 2012

Record last verified: 2012-07

Locations

FR(10)