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AsthmaPhase 3NCT00079937

Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma

A Phase 3 study testing Omalizumab and Fluticasone in people with Asthma, run by Novartis Pharmaceuticals at 56 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. Read more about this study

Who is it for?
Ages 6 to 11 years
Conditions the study is for
Asthma
What is being tested?
Omalizumab and Fluticasone
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
628 participants
Where
56 sitesUnited States
Study dates
Apr 2004to Mar 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Parent or legal guardian was informed of the study procedures and medications and gave written informed consent.
  • Outpatient males and females aged 6 - < 12 years on study entry, with body weight between 20 and 150 kg.
  • Total serum IgE level ≥ 30 to ≤ 1300 IU.
  • Diagnosis of allergic asthma ≥ 1 year duration, according to American Thoracic Society (ATS) criteria, and a screening history consistent with clinical features of moderate or severe persistent asthma according to National Heart Lung and Blood Institute (NHLBI) guidelines.
  • Positive prick skin test to at least one perennial allergen, documented within the past 2 years or taken at Screening. A radioallergosorbent test (RAST) could have been performed for patients with a borderline skin prick test result after consultation with Novartis clinical personnel.
  • Patients with ≥ 12% increase in forced expiratory volume in 1 second (FEV1) over starting value within 30 minutes of taking up to 4 puffs (4x100 µg) salbutamol (albuterol) or nebulized salbutamol up to 5 mg (or equivalent of alternative B2-agonist) documented within the past year, at screening, during the run-in period, or prior to randomization. Patients were not to take their long acting B2-agonist (LABA) medication within 12 hours of reversibility testing.
  • Clinical features of moderate or severe persistent asthma (at least step 3) despite therapy at step 3 or 4 (at least medium dose inhaled corticosteroid (ICS) - fluticasone dry-powder inhaler (DPI) ≥ 200 mg/day or equivalent with or without other controller medications).
  • Documented history of experiencing asthma exacerbations and demonstrated inadequate symptom control during the last 4 weeks of run-in despite receiving an equivalent dose of fluticasone DPI ≥ 200 mg/day total daily ex-valve dose.

Who cannot join

  • Patients who received systemic corticosteroids for reasons other than asthma, beta-adrenergic antagonists by any route, anticholinergics within 24 hours of Screening, methotrexate, gold salts, cyclosporin or troleandomycin, or had received desensitization therapy with less than 3 months of stable maintenance doses prior to Screening.
  • Patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction, a history of allergy to antibiotics, with aspirin or other non-steroidal anti-inflammatory drugs (NSAID)-related asthma (unless the NSAID could be avoided), with active lung disease or acute sinusitis/chest infection, elevated serum IgE levels for other reasons, presence/history of a clinically significant uncontrolled systemic disease, cancer, abnormal, electrocardiogram (ECG) in the previous month, or platelets ≤ 100 x 109/L or clinically significant laboratory abnormalities at Screening.

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

United States56 sites

  • Georgia Pollens

    Albany, Georgia, 31707

  • 501 Howard Av

    Altoona, Pennsylvania, 16601

  • Family Allergy and Asthma Center, PC

    Atlanta, Georgia, 30342

  • Alabama Allergy and Asthma Center

    Birmingham, Alabama, 35209

  • Ocean Allergy & Respiratory Research Center

    Brick, New Jersey, 08724

  • Womes And childrens Hospital of Buffalo

    Buffalo, New York, 14222

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Bernstein Clinical Research Center

    Cincinnati, Ohio, 45231

  • Pediatric Allergy/Immunology Associates, PA

    Dallas, Texas, 75230

  • Pediatric Pulmonary Association of North Texas

    Dallas, Texas, 75230

  • National Jewish Medical and Research Center

    Denver, Colorado, 80206

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Asthma & Allergy Center

    Elliott, Maryland, 21042

  • North Texas Institute for Clinical Trials

    Fort Worth, Texas, 76132

  • Allergy & Asthma Center of North carolina

    High Point, North Carolina, 27262

  • Baylor College of Medicine

    Houston, Texas, 77030

  • 7707 Fannin/Ste. 195

    Houston, Texas, 77054

  • Allergy and Asthma Specialists Medical Group

    Huntington Beach, California, 92647

  • Pediatric Care and Medical Group

    Huntington Beach, California, 92647

  • Asthma & Allergy Associates

    Ithaca, New York, 14850

  • Allergy Assoc., The ASthma, Allergy & Sinus Ctr

    Knoxville, Tennessee, 37922

  • AAPRI Clinical Research Institute

    Lincoln, Rhode Island, 02865

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72202

  • Clinical Research Center

    Little Rock, Arkansas, 72205

  • Allergy and Asthma Diagnostic Office

    Liverpool, New York, 13088

  • West Coast Clinical Trials

    Long Beach, California, 90806

  • Clinical Research Institute of Southern Oregon

    Medford, Oregon, 97504

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Southern California Research Center

    Mission Viejo, California, 92691

  • Vanderbilt University

    Nashville, Tennessee, 37203

  • UMDNJ

    Newark, New Jersey, 07101

  • Childrens Hospital of the Kings Daughters

    Norfolk, Virginia, 23507

  • Northeast Med Research Associates

    North Dartmouth, Massachusetts, 02747

  • Resp Dis of Children and Adolescents

    Oklahoma City, Oklahoma, 73112

  • Midwest Allergy & Asthma Clinic

    Omaha, Nebraska, 68114

  • Children's Hosptial of Orange County, Div Asthma, Allergy & Immunology

    Orange, California, 92868

  • CA Allergy & Asthma Med Group

    Palmdale, California, 93551

  • Dr. Joann Blessing-Moore

    Palo Alto, California, 94304

  • West Penn Allegheny General Health System

    Pittsburgh, Pennsylvania, 15212

  • Virgina Commonwealth

    Richmond, Virginia, 23219

  • Integrated Research Group

    Riverside, California, 92506

  • Island Medical Research (Allergy and Asthma Center)

    Rockville Centre, New York, 11570

  • Sylvanna Research

    San Antonio, Texas, 78229

  • Allergy Associates Medical Group

    San Diego, California, 92120

  • Allergy and Asthma Medical Group & Research Center

    San Diego, California, 92123

  • Allergy and Asthma Associates of Santa Clara Valley RC

    San Jose, California, 95117

  • 1304 15th St

    Santa Monica, California, 90404

  • Aeroallergy Research Labs of Savannah, Inc

    Savannah, Georgia, 31406

  • A.S.T.H.M.A., Inc.

    Seattle, Washington, 98105

  • Copperview Medical Center

    South Jordan, Utah, 84095

  • 508 W 6th Av

    Spokane, Washington, 99204

  • St. Louis University School of Medicine

    St Louis, Missouri, 63104

  • Bensch Research Associates

    Stockton, California, 95207

  • Asthma and Allergy Associates

    Upland, Pennsylvania, 19013

  • Allergy & Asthma Med Group of Diablo Valley CR

    Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A 1 Year, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Evaluation of Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Persistent, Inadequately Controlled Allergic Asthma

A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.

Read the detailed description

This study was designed to provide one year efficacy and safety data for subcutaneous (SC) omalizumab, compared to placebo in children (6 to < 12 years) with moderate to severe persistent asthma who have inadequate asthma control despite treatment according to National Heart, Lung and Blood Institute (NHLBI) step 3 or 4 (at least medium dose inhaled corticosteroids with or without other controller asthma medications).

Conditions
Asthma
Being tested
Omalizumab, Placebo, Fluticasone
Keywords
allergic, asthma, atopic, omalizumab, immunoglobulin E, IgE, anti-IgE
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmalizumabDrug

    The omalizumab dose administered, based on the patient's body weight and total serum IgE level at Screening, and the number of injections and injection volume was determined from the dosing tables in the protocol. Omalizumab 75 to 375 mg was administered subcutaneous (SC) every 2 or 4 weeks depending on the dose.

  • PlaceboDrug

    Placebo was administered subcutaneous (SC) every 2 or 4 weeks depending on the dosing schedule in the protocol.

  • FluticasoneDrug

    Patients entered the study using their current formulation of any inhaled steroid (proprietary drug and device) ≥ 200 μg/day equivalent of fluticasone administered with a dry-powder inhaler.

Study groups in NCT00079937
Study groupRoleWhat they receive
OmalizumabExperimentalParticipants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
Receives: Drug: Omalizumab; Drug: Fluticasone
PlaceboPlacebo comparatorPlacebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
Receives: Drug: Placebo; Drug: Fluticasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period

    A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 24-week fixed-dose steroid treatment period.

    Measured: Baseline to end of the fixed-dose steroid treatment period (Week 24)

  2. Percentage of Participants With at Least 1 Adverse Event

    See Adverse Events module for details.

    Measured: Baseline to end of the study (Week 68)

Secondary outcomes (4)

  1. Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period

    Nocturnal asthma symptom was measured daily on a scale of 0 to 4 in response to the question "How did you sleep last night?", with 0 as the best response and 4 as the worst response. The mean of the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean score indicated improvement.

    Measured: Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period

  2. Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period

    A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 52-week treatment period.

    Measured: Baseline to end of the treatment period (Week 52)

  3. Change in Mean Daily Number of Puffs of Asthma Rescue Medication From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period

    Patients were instructed to record the number of puffs of rescue medication they took twice daily in a diary. The mean daily number of puffs during the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean daily number of puffs indicated reduced use of rescue medication.

    Measured: Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period

  4. Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24)

    PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Patients responded to each question on a 7-point Likert scale. Overall PAQLQ score is mean of 23 questions; each domain score is mean of questions in that domain. Minimum possible value is 1 (maximum impairment); maximum possible value is 7 (no impairment). Positive change indicated improvement. The analysis included country, baseline PAQLQ value, and dosing schedule (2-weekly/4-weekly) as factors and covariates.

    Measured: Baseline to the end of the 24-week fixed-dose steroid treatment period (Week 24)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
628 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00079937
Sponsor's protocol ID
CIGE025AIA05
Status last verified
Apr 2012
First submitted
18 Mar 2004
Last updated
11 Apr 2012

Publications

  • Fiocchi A, Chinthrajah RS, Ansotegui IJ, Sriaroon P, Mustafa SS, Raut P, Cameron B, Gupta S, Fleischer DM. Does Comorbid Food Allergy Affect Response to Omalizumab in Patients with Asthma? J Asthma Allergy. 2024 Sep 17;17:889-900. doi: 10.2147/JAA.S475517. eCollection 2024.

    PubMed 39309477

  • Witonsky J, Elhawary JR, Millette LA, Holweg CTJ, Ko J, Raut P, Borrell LN. Similar response to omalizumab in children with allergic asthma from different racial backgrounds. J Allergy Clin Immunol Pract. 2023 Sep;11(9):2911-2913. doi: 10.1016/j.jaip.2023.03.055. Epub 2023 Apr 23. No abstract available.

    PubMed 37088376

  • Busse WW, Szefler SJ, Haselkorn T, Iqbal A, Ortiz B, Lanier BQ, Chipps BE. Possible Protective Effect of Omalizumab on Lung Function Decline in Patients Experiencing Asthma Exacerbations. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1201-1211. doi: 10.1016/j.jaip.2020.10.027. Epub 2020 Oct 24.

    PubMed 33223095

  • Szefler SJ, Casale TB, Haselkorn T, Yoo B, Ortiz B, Kattan M, Busse WW. Treatment Benefit with Omalizumab in Children by Indicators of Asthma Severity. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2673-2680.e3. doi: 10.1016/j.jaip.2020.03.033. Epub 2020 Apr 13.

    PubMed 32298853

  • Lanier B, Bridges T, Kulus M, Taylor AF, Berhane I, Vidaurre CF. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009 Dec;124(6):1210-6. doi: 10.1016/j.jaci.2009.09.021.

    PubMed 19910033

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omalizumab and Fluticasone in people with Asthma, run by Novartis Pharmaceuticals at 56 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period (time frame: Baseline to end of the fixed-dose steroid treatment period (Week 24)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00079937, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2012.

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