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

• Register: EUCTR
• Last refreshed on: 14 March 2016
• Main ID: EUCTR2015-003538-28-Outside-EU/EEA
• Date of registration: 16/02/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma
• Scientific 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
• Target sample size: 570
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003538-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Argentina, Brazil, Canada, Colombia, South Africa, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

Inclusion criteria:
•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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 628
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Moderate-severe inadequately controlled Allergic Asthma

Intervention(s)

Trade Name: Xolair
Product Code: IGE025
Pharmaceutical Form: Powder and solvent for solution for injection
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: • Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid
• Percentage of Participants With at Least 1 Adverse Event

Secondary Objective: The secondary objectives were to assess in the studied population the effect of omalizumab compared to placebo on:
a) Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period.

b)Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period

c) Change in Mean Daily Number of Puffs of Asthma Rescue Medication (ß2-agonist rescue medication) From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid

d) 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)

Timepoint(s) of evaluation of this end point: a) Baseline to end of the fixed-dose steroid treatment period (Week 24)

b) Baseline to end of the study (Week 68) ]

Primary end point(s): a) 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.

b) Percentage of Participants With at Least 1 Adverse Event

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: a) Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period ]

b) Baseline to end of the treatment period (Week 52)

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

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

Secondary end point(s): a) Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period.

b)Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period

c) Change in Mean Daily Number of Puffs of Asthma Rescue Medication (ß2-agonist rescue medication) From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid

d) 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)

Secondary ID(s)

CIGE025AIA05

Source(s) of Monetary Support

Novartis Pharmaceuticals