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Omalizumab in Non-atopic Asthma

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ClinicalTrials.gov Identifier: NCT01113437
Recruitment Status : Unknown
Verified April 2010 by King's College London.
Recruitment status was:  Recruiting
First Posted : April 29, 2010
Last Update Posted : January 21, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:

Hypothesis- Omalizumab(humanized monoclonal anti-IgE antibody)improves disease control and reduces bronchial mucosal inflammation in non-atopic asthma.

In order to test the above hypothesis, the investigators propose a placebo controlled, double blind, parallel group study to obtain proof of principle that omalizumab exerts beneficial effects on disease control in non-atopic severe adult asthmatics aged 18-60 years . Forty patients will be randomized in a 1:1 ratio to receive omalizumab or matching placebo. Following 12 weeks of treatment with omalizumab/placebo, and as this treatment is continued for a further 8 weeks, anti-asthma treatment will be reduced. Dosages will be administered at 4 or 2 weekly intervals over a 16 week period (5 or 10 doses in total), which corresponds with the time stated as necessary to judge efficacy of therapy according to omalizumab's licensed indications in atopic asthma. Efficacy will be judged by clinical monitoring and by bronchial biopsy to assess effects on bronchial inflammation and local IgE production.


Condition or disease Intervention/treatment Phase
Bronchial Asthma Drug: Omalizumab Drug: Placebo Phase 2 Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of a Humanised Monoclonal Anti-IgE Antibody,Omalizumab, on Disease Control and Bronchial Mucosal Inflammation in Non-atpic Asthma
Study Start Date : April 2010
Estimated Primary Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Omalizumab
There are 2 arms of the study; patients in one arm receiving omalizumab and in the other arm receiving placebo.
Drug: Omalizumab

Omalizumab or placebo by subcutaneous injections, at 4 weekly or 2 weekly intervals.

Dosage is according to manufacturer's guidance and calculated based on body weight and total serum IgE.

Other Name: Xolair
Placebo Comparator: Placebo
There are 2 arms of the study; patients in one arm receiving omalizumab and in the other arm receiving placebo.
Drug: Placebo

Omalizumab or placebo by subcutaneous injections, at 4 weekly or 2 weekly intervals.

Dosage is according to manufacturer's guidance and calculated based on body weight and total serum IgE.



Outcome Measures

Primary Outcome Measures :
  1. Pre-bronchodilator FEV1 [ Time Frame: before and after treatment with omalizumab for 16 weeks ]

    Prior to reduction of existing anti-asthma therapy (first 12 weeks of study):

    • Pre-bronchodilator FEV1 (primary outcome measure)


  2. Disease exacerbation [ Time Frame: From week 12 to week 20 of the study ]

    During anti-asthma therapy reduction phase (subsequent 8 weeks of study):

    The primary outcome measure during asthma therapy reduction phase 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



Secondary Outcome Measures :
  1. Day and night time symptom scores [ Time Frame: before and after treatment with omalizumab for 16 weeks ]
    These will be measured using standard Asthma Control Questionnaires(ACQ)

  2. Morning and evening peakflows [ Time Frame: before and after treatment with omalizumab for 16 weeks ]
  3. Exhaled nitric oxide [ Time Frame: before and after treatment with omalizumab for 16 weeks(from week 0 to week 16) ]
  4. Total dosage of rescue beta-2-agonists [ Time Frame: before and after treatment with omalizumab for 16 weeks(from week 0 to week 16) ]
  5. Total symptom free days [ Time Frame: before and after treatment with omalizumab for 16 weeks(from week 0 to week 16) ]
  6. Quality of life scores [ Time Frame: before and after treatment with omalizumab for 16 weeks(from week 0 to week 16) ]
  7. Markers of airway remodelling and inflammation [ Time Frame: before and after treatment with omalizumab for 16 weeks(from week 0 to week 16) ]
    These include- Collagen,tenascin,VEGF,CD31,inflammatory cells,goblet cells etc.

  8. Local IgE synthesis in the bronchial mucosa and its expression [ Time Frame: before and after treatment with omalizumab for 16 weeks(from week 0 to week 16) ]
    The measurement will include- IgE, its low and high affinity receptors, expression of free kappa and lambda light chains on B-cells and plasma cells


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria-

  • Males and females aged 18 to 60 years inclusive.
  • Moderate or severe non-atopic asthma as defined below treated with inhaled corticosteroids for at least 6 months.
  • Daytime and nighttime symptoms at least 3 days per week in the last 3 months prior to screening visit(despite taking inhaled corticosteroids with or without beta-2-agonists or leukotriene blockers.
  • Pre-bronchodilator FEV1 40-80% of the predicted; reversibility equal to or more than 12% in response to inhaled beta-2-agonists documented at any time within the past 2 years.
  • Negative skin prick and/or in vitro IgE tests to a range of 12 common aeroallergens(pollens:grass, hazel, alder, birch; danders: cat, dog; dust mite: D.pteronyssinus, D.farinae; moulds: Cladosporium, Aspergillus, Alternaria).

Exclusion Criteria

  • Smoking within the past year or total smoking history more than 0.5 pack years.
  • Pregnant or lactating females or those at risk of pregnancy.
  • Treatment with more than 2000 mcg/day beclometasone, 1600 mcg/day budesonide or 1000 mcg/day fluticasone by inhalation or regular systemic corticosteroid at screening.
  • Hospitalization 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 intubations and/or was associated with hypercapnia, respiratory arrest and/or hypoxic seizures.
  • Patients in whom, in the opinion of the study investigators, omalizumab therapy might normally require precaution (history of autoimmune disease, renal or hepatic impairment, hyperimmunoglobulin E syndrome, allergic bronchopulmonary aspergillosis and diabetes mellitus)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113437


Contacts
Contact: Christopher Corrigan, MD,PhD 00-44-2071880610 chris.corrigan@kcl.ac.uk
Contact: Prathap Pillai, MD 00-44-2071880606 prathap.pillai@kcl.ac.uk

Locations
United Kingdom
London Chest Hospital Not yet recruiting
London, United Kingdom, E2 9JX
Contact: Neil Barnes, MD    02089832433    neil.barnes@bartsandthelondon.nhs.uk   
Principal Investigator: Neil Barnes, MD         
Guy's Hospital, London, UK Recruiting
London, United Kingdom, SE1 9RT
Contact: Christopher Corrigan, MD,PhD    00-44-2071880610    chris.corrigan@kcl.ac.uk   
Contact: Prathap Pillai, MD    00-44-2071880606    prathap.pillai@kcl.ac.uk   
Principal Investigator: Chris Corrigan, MD,PhD         
Sub-Investigator: Prathap Pillai, MD         
Sponsors and Collaborators
King's College London
Investigators
Principal Investigator: Christopher Corrigan, MD, PhD King's College, London, UK
Principal Investigator: Neil Barnes, MD London Chest Hospital, UK
Principal Investigator: Prathap Pillai, MD King's College London
More Information

Responsible Party: Prof. Christopher Corrigan, King's College, London, United Kingdom
ClinicalTrials.gov Identifier: NCT01113437     History of Changes
Other Study ID Numbers: 09/H0804/43
2009-009154-25 ( EudraCT Number )
First Posted: April 29, 2010    Key Record Dates
Last Update Posted: January 21, 2011
Last Verified: April 2010

Keywords provided by King's College London:
Bronchial Asthma
Allergy

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents