Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma

NCT01912872 | Terminated Phase 4 Results DMC

• 1 other identifier: CIGE025AMX02
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 21

Brief Summary

Assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the use of inhaled corticosteroid (ICS) in pediatric and adult participants with severe Immunoglobulin E (IgE)-mediated asthma inadequately controlled with high doses of corticosteroids.

Conditions

Severe IgE-mediated Asthma

Outcome Measures

Primary Outcomes (1)

• The Mean Prescribed Budesonide Dose (μg) at Baseline

  prescribed budesonide dose (in μg) at Baseline in intention to treat population and in intention to treat population

  Baseline

Secondary Outcomes (8)

• Number of Hospital Admissions Due to Asthma Exacerbation

  12 month treatment duration

• Days Missed in School/Work Due to Asthma Exacerbation Episodes

  12 month treatment duration

• Control of Asthma Symptoms- Daytime Symptoms

  12 month treatment duration

• Control of Asthma Symptoms

  12 month treatment duration

• Control of Asthma Symptoms- Rescue Medication Use

  12 month treatment duration

Study Arms (2)

Omalizumab + budesonide and formoterol

EXPERIMENTAL

Participants will receive Omalizumab every 2 or 4 weeks depending on IgE level and body weight and will also receive budesonide and formoterol according to maximum daily dose.

Drug: Omalizumab; Drug: Budesonide; Drug: Formoterol

Budesonide and formoterol

ACTIVE COMPARATOR

Participants will receive budesonide and formoterol according to maximum daily dose.

Drug: Budesonide; Drug: Formoterol

Interventions

Omalizumab DRUG

Subcutaneous injection dose according to the IgE level and body weight.

Omalizumab + budesonide and formoterol

Budesonide DRUG

Budesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose.

Budesonide and formoterol; Omalizumab + budesonide and formoterol

Formoterol DRUG

Formoterol 12ug tablets taken orally according to maximum daily dose.

Budesonide and formoterol; Omalizumab + budesonide and formoterol

Eligibility Criteria

• Age: 6 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female between 6 and 55 years old. If female, participant of childbearing potential must use a safe and efficacious birth control method.
• Asthma is considered as not well-controlled if participant has 3 or more of the following conditions:
• Persistent day symptoms with current therapy twice at week or more, (siblings, dyspnea, cough, chest pain, thoracic oppression).
• One or more night-time awakenings over the last 4 weeks.
• Any limitation of age-appropriated habitual activities.
• Need of rescue medication (short acting β2 agonist) for two or more occasions per week during the last 4 weeks before screening and 2 consecutive weeks within the 4 weeks before selection.
• Peak expiratory flow (PEF) or VEF1 \<80% predicted or personal best (if known) this is not mandatory for pediatric participants (under 18 years old).
• Despite continuous treatment with high-dose inhaled corticosteroids (ICS) or oral corticosteroids (OCS) (CSO≥ 1 mg/kg/day) with or without controllers (As per GINA 2012 definition), the subject is receiving high doses of ICS (budesonide or its equivalent) and a long-acting β2-agonists(LABA) (formoterol) for the past 12 weeks at visit 0.
• At last one documented asthma exacerbation (defined as increase asthma symptoms requiring systemic corticosteroid rescue therapy) that requires visits to the emergency room or to be hospitalized in the past 12 months. It is also considered asthma exacerbation a non-planned visit that required rescue medication (β2-agonists and/or steroid nebulization every 20 minutes or β2-agonists inhaler shots every 20 minutes).
• Positive skin test or in vitro reactivity to a perennial aeroallergen, documented during the 12 months previous screening.
• IgE total concentration ranging from 30 to 1500 UI/ml.

You may not qualify if:

• Pregnant or lactating female or without safe and efficacious birth control method if of childbearing potential.
• Currently smokers or history of smoking 10 or more packs per year.
• Ex-smokers with a history of more than 10 years of smoking. As an exception, a participant with this criterion will be considered as eligible if the FEV1 reversibility of the first spirometry reaches 12%.
• Active lung disease other than asthma.
• Use of methotrexate, gold salts, troleandomycin, cyclosporine, immunosuppressants, gammaglobulin or any other type of monoclonal antibody used during the 6 months prior to the initial visit.
• Use of omalizumab during the 4 months prior to de screening visit.
• History of renal disease, cardiovascular disease, metabolic disease, hematologic disease, gastrointestinal disease, as well as immunodeficiency or cerebrovascular disease currently under treatment but not-controlled.
• History of hepatic, neurologic, oncologic or autoimmune disease.
• Participant under suspicion of having cancer.
• Participants with history of hypersensitivity to sucrose, histidine, polysorbate 20 as well as to monoclonal antibodies or gammaglobulin.
• Hypersensitivity to omalizumab or its excipients.
• Abnormal values of the blood chemistry laboratory tests, over 2 times the upper limit normal, that are considered clinically significant.
• Underage participant or any participant under vulnerable conditions who does not live with their parents or legal guardian.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (21)

Novartis Investigative Site

Tuxtla Gutiérrez, Chiapas, 29030, Mexico

Location

Novartis Investigative Site

México, Edo. de México, 53910, Mexico

Location

Novartis Investigative Site

Pachuca, Hidalgo, 42090, Mexico

Location

Novartis Investigative Site

Guadalajara, Jalisco, 44500, Mexico

Location

Novartis Investigative Site

Guadalajara, Jalisco, 44600, Mexico

Location

Novartis Investigative Site

Guadalajara, Jalisco, 44620, Mexico

Location

Novartis Investigative Site

Guadalajara, Jalisco, 44690, Mexico

Location

Novartis Investigative Site

Guadaljara, Jalisco, 44500, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 03020, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 03100, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 04700, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 04980, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 06090, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 06760, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 14000, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 14050, Mexico

Location

Novartis Investigative Site

Tepic, Nayarit, 63000, Mexico

Location

Novartis Investigative Site

Monterrey, Nuevo León, 64020, Mexico

Location

Novartis Investigative Site

Monterrey, Nuevo León, 64718, Mexico

Location

Novartis Investigative Site

Nezahualcóyotl, State of Mexico, 57730, Mexico

Location

Novartis Investigative Site

Mérida, Yucatán, 97070, Mexico

Location

MeSH Terms

Interventions

Omalizumab; Budesonide; Formoterol Fumarate

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: July 31, 2013
• Study Start: November 11, 2013
• Primary Completion: August 6, 2015
• Study Completion: January 8, 2016
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-06

Locations

ME (21)