The effect of Omalizumab on asthma control

The effect of a humanised monoclonal anti-IgE antibody (omalizumab) on disease control and bronchial mucosal inflammation in non-atopic (“intrinsic”) asthma - Omalizumab

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-009154-25-GB

Enrollment

Registered

2009-05-15

Start date

2009-07-07

Completion date

Unknown

Last updated

2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 16.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Xolair Product Name: Omalizumab (Xolair) Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Omalizumab CAS Number: 242138-07-4 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Males and females aged 18 to 75 years inclusive. Moderate/severe non-atopic asthma treated with inhaled corticosteroid, with or without oral corticosteroids(oral, up to 20mg/day prednisolone or equivalent) for at least 3 months prior to screening. Written, informed consent provided. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Smoking within the last 3 months or total smoking history 10 pack years. Pregnant or lactating females or those at risk of pregnancy. Patients taking >20mg of prednisolone daily. Hospitalisation for asthma or exacerbation requiring systemic corticosteroid therapy within 3 months of the screening visit. History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest and/or hypoxic seizures within the 6 months prior to screening. Pre bronchodilator FEV1 < 40% of the predicted. Patients in whom, in the opinion of the study investigators, omalizumab therapy might normally require precaution (current or suspected malignancy, current or suspected autoimmune disease, renal or hepatic impairment, hyperimmunoglobulin E syndrome, allergic bronchopulmonary aspergillosis , diabetes mellitus, current immunosuppressive therapy and known Churg-Strauss or hypereosinophilic syndrome).

Design outcomes

Primary

Measure	Time frame
Primary end point(s): (a) prior to reduction of existing anti-asthma therapy (first 12 weeks of study): Differences in changes in pre-bronchodilator FEV1 after 12 weeks of treatment with omalizumab or placebo (b) during anti-asthma therapy reduction phase (subsequent 8 weeks of study): The primary outcome measure will be disease exacerbation, defined as a need for rescue oral corticosteroid medication for worsening of symptoms and/or deterioration in lung function, as agreed between the patient and the study physician The primary outcome measure will be disease exacerbation, defined as a need for rescue oral corticosteroid medication for worsening of symptoms and/or deterioration in lung function, as agreed between the patient and the study physician ;Main Objective: To obtain proof of principle that omalizumab is of therapeutic benefit to non-atopic asthmatics. Primary Efficacy Parameters Change in pre-bronchodilator FEV1 after 12 weeks of treatment with omalizumab (b) during anti-asthma therapy reduction phase (subsequent 8 weeks of study): The primary outcome measure will be disease exacerbation, defined as a need for rescue oral corticosteroid medication for worsening of symptoms and/or deterioration in lung function, ;Secondary Objective: -Morning and evening peakflow readings -Exhaled nitric oxide to assess airway inflammation -Day time and night time symptom scores -Total dosages of rescue beta-2-agonists(Terbutaline turbohaler) -Mild exacerbations -Total symptom free days -Asthma quality of life measured using validated questionnaires LABORATORY OUTCOME MEASURES(from airway biopsy samples) -Lay down of collagen types I,III,IV &V and tenascin -vascular structres and angiogenic stimuli(type IV collagen,CD31 and human VEGF) -Inflammatory cells( eosinophils,T cells,plasma cells, macrophages, neutrophils,mast cells) -Goblet cells -Immunoglobulin E and its receptors -Cytokine and chemokine concentrations -PCR analysis for expression of IgE synthesis in	—

Measure

Time frame

Primary end point(s): (a) prior to reduction of existing anti-asthma therapy (first 12 weeks of study): Differences in changes in pre-bronchodilator FEV1 after 12 weeks of treatment with omalizumab or placebo (b) during anti-asthma therapy reduction phase (subsequent 8 weeks of study): The primary outcome measure will be disease exacerbation, defined as a need for rescue oral corticosteroid medication for worsening of symptoms and/or deterioration in lung function, as agreed between the patient and the study physician The primary outcome measure will be disease exacerbation, defined as a need for rescue oral corticosteroid medication for worsening of symptoms and/or deterioration in lung function, as agreed between the patient and the study physician ;Main Objective: To obtain proof of principle that omalizumab is of therapeutic benefit to non-atopic asthmatics. Primary Efficacy Parameters Change in pre-bronchodilator FEV1 after 12 weeks of treatment with omalizumab (b) during anti-asthma therapy reduction phase (subsequent 8 weeks of study): The primary outcome measure will be disease exacerbation, defined as a need for rescue oral corticosteroid medication for worsening of symptoms and/or deterioration in lung function, ;Secondary Objective: -Morning and evening peakflow readings -Exhaled nitric oxide to assess airway inflammation -Day time and night time symptom scores -Total dosages of rescue beta-2-agonists(Terbutaline turbohaler) -Mild exacerbations -Total symptom free days -Asthma quality of life measured using validated questionnaires LABORATORY OUTCOME MEASURES(from airway biopsy samples) -Lay down of collagen types I,III,IV &V and tenascin -vascular structres and angiogenic stimuli(type IV collagen,CD31 and human VEGF) -Inflammatory cells( eosinophils,T cells,plasma cells, macrophages, neutrophils,mast cells) -Goblet cells -Immunoglobulin E and its receptors -Cytokine and chemokine concentrations -PCR analysis for expression of IgE synthesis in

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary outcome measures will include all those measurements listed in section above, unless they cannot be measured because of disease exacerbation (the primary outcome measure);Timepoint(s) of evaluation of this end point: Throughout 2nd half of study	—

Countries

United Kingdom

Contacts

Public ContactDr. Prathap Pillai

Kings College London

prathap.pillai@kcl.ac.uk+4402071880606

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026