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Completed

NCT Number: NCT01007149

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Arnaud de Villeneuve, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omalizumab

Drug

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

Placebo

Drug

Placebo was supplied in vials with solution for subcutaneous injection.

Primary outcomes

  1. Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils

    Time frame: Baseline and 16 weeks

    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.

  2. Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells

    Time frame: Baseline and 16 weeks

    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.

Secondary outcomes

  1. Change in Fractional Exhaled Nitric Oxide (FeNO)

    Time frame: Baseline and 4, 8, 12 and 16 weeks

    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.

  2. Change From Baseline in Induced Sputum Eosinophil Count

    Time frame: Baseline and 16 weeks

    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.

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

    Time frame: Baseline and 16 weeks

    The shortened version of the asthma control questionnaire (symptoms plus β2-agonist) consists of 6 subscores (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheeze and rescue short-acting β2-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.

  4. Change From Baseline in Nasal Symptom Global Score and Individual Components

    Time frame: Baseline and 16 weeks

    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.

  5. Physician and Patient Global Evaluation of Treatment Effectiveness

    Time frame: 16 weeks

    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.

  6. Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks

    Time frame: Baseline and 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.

  7. Number of Patients With at Least One Asthma-related Event Over 16 Weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: NATAIR

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 3, 2009
Registry last updated
Jul 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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