Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma

Asthma Clinical Trial

— NATAIR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007149
• Other study ID #: CIGE025AFR05
• Secondary ID: 2009-010937-38
• Status: Completed
• Phase: Phase 3
• First received: October 30, 2009
• Last updated: July 18, 2012
• Start date: September 2009
• Est. completion date: February 2011

Study information

• Verified date: July 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 ß2 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• omalizumab
Omalizumab was supplied in 5mL vials with solution for subcutaneous injection.
• Placebo
Placebo was supplied in vials with solution for subcutaneous injection.

Locations

Country	Name	City	State
France	Novartis Investigative Site	Arnaud de Villeneuve
France	Novartis Investigative Site	Bethune
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Clamart
France	Novartis Investigative Site	Lyon
France	Novartis Investigative Site	Nantes
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Strasbourg
France	Novartis Investigative Site	Suresnes
France	Novartis Investigative Site	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Expression of FceRI Receptors of Blood Basophils	Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FceRI 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	No
Primary	Change From Baseline in the Expression of FceRI Receptors of Dendritic Cells	Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FceRI 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	No
Secondary	Change in Fractional Exhaled Nitric Oxide (FeNO)	FeNO was measured at baseline, and after 4, 8, 12 and 16 weeks of treatment. Absolute change in FeNO was expressed at each time point versus baseline value.	Baseline and 4, 8, 12 and 16 weeks	No
Secondary	Change From Baseline in Induced Sputum Eosinophil Count	The induced sputum eosinophil count was measured in a subset of patients in selected centers. Sputum samples were collected at screening and Week 16. Sputum eosinophil count was expressed as a percentage of total nonsquamous cells. Absolute change in sputum eosinophil count was expressed versus baseline value.	Baseline and 16 weeks	No
Secondary	Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting ß2-agonist)	The shortened version of the asthma control questionnaire (symptoms plus ß2-agonist) consists of 6 subscores (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheeze and rescue short-acting ß2-agonist use) between 0 and 6 (0 = no impairment; 6 = maximum impairment) and a total score between 0 and 6 (subscores mean value). Absolute change in total score and subscores count was expressed versus baseline value. A decrease in score indicates improvement.	Baseline and 16 weeks	No
Secondary	Change From Baseline in Nasal Symptom Global Score and Individual Components	Nasal symptom score calculated from six scales assessing the nasal symptom severity (sneezing, runny nose, congestion, itchy nose, postnasal drip and nasal symptoms overall). These six scores were rated on a scale from 1 to 7, with 7 being the worst rating. Absolute changes in these six scores were expressed versus baseline values. A negative change indicates improvement. The range of the global score was from 1 to 7, since this is the mean value of all the subscores.	Baseline and 16 weeks	No
Secondary	Physician and Patient Global Evaluation of Treatment Effectiveness	The GETE is an assessment of asthma symptoms controlled in response to asthma treatment. The evaluation was performed independently by both investigator and patient using the same 5 point scale. The scale points are: excellent, good, moderate, poor and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.	16 weeks	No
Secondary	Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks	Spirometry was conducted according to internationally accepted standards. At least three maneuvers were performed at each sampling timepoint. The FEV1 recorded was taken from the maneuver obtained from the single best test curve. The best test curve was defined as the spirogram that gave the largest FEV1.	Baseline and 16 weeks	No
Secondary	Number of Patients With at Least One Asthma-related Event Over 16 Weeks	Asthma-related events were: unscheduled medical visits, emergency room visits and hospitalizations. Details of exacerbations requiring oral or IV corticosteroids were recorded at each visit.	16 weeks	No