Clinical trial NCT01007149: Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma
Official title: A 16-week Treatment, Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study to Assess the Effect of Omalizumab on the Expression of FcεRI Receptors of Blood Basophils and Dendritic Cells in Patients With Severe Persistent Non-atopic Asthma, Uncontrolled Despite Optimal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Severe asthma,
non-atopic,
omalizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-11-03
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils
timeFrame: Baseline and 16 weeks
measure: Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Change in Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: Baseline and 4, 8, 12 and 16 weeks
measure: Change From Baseline in Induced Sputum Eosinophil Count
timeFrame: Baseline and 16 weeks
measure: Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)
timeFrame: Baseline and 16 weeks
measure: Change From Baseline in Nasal Symptom Global Score and Individual Components
timeFrame: Baseline and 16 weeks
measure: Physician and Patient Global Evaluation of Treatment Effectiveness
timeFrame: 16 weeks
measure: Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks
timeFrame: Baseline and 16 weeks
measure: Number of Patients With at Least One Asthma-related Event Over 16 Weeks
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Arnaud de Villeneuve
country: France
facility: Novartis Investigative Site
city: Bethune
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Clamart
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Suresnes
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.