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

24. juni 2019 opdateret af: Novartis Pharmaceuticals

Multicentric, Open-label, Randomized, Parallel--group Study to Evaluate the Efficacy and Safety of Omalizumab in a 12- Month Period, in Patients With Severe IgE-mediated Asthma Inadequately Controlled With High Doses of Corticosteroids.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This was a multicentric, open label, randomized, parallel-group study with a 12-month treatment period. Participants were assigned to one of the 2 treatment groups, omalizumab plus budesonide/formoterol or budesonide/formoterol alone.

The study comprised 4 phases:

During the 4-week run-in phase adult participants received budesonide 800 mg and formoterol 24 mg. If a participant complied with all inclusion and exclusion criteria and had received the according-to-age run-in proposed doses during the last month, the participant continued to the stable-steroid phase.

During the 16-week stable-steroid phase, adult and pediatric eligible participants were randomized to one of the two treatment groups.

During the 8-week steroid-reduction phase, adult and pediatric participants reduced 25% of the budesonide baseline dose every 2 weeks, depending of the asthma control, until they reached a 100% reduction of the baseline dose. The clinical control of asthma was defined according to criteria (GINA 2012).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

112

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Mexico
    • Chiapas
      • Tuxtla Gutierrez, Chiapas, Mexico, 29030
        • Novartis Investigative Site
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 14050
        • Novartis Investigative Site
      • Mexico, Distrito Federal, Mexico, 06760
        • Novartis Investigative Site
      • Mexico, Distrito Federal, Mexico, 03100
        • Novartis Investigative Site
      • Mexico, Distrito Federal, Mexico, 03020
        • Novartis Investigative Site
      • Mexico, Distrito Federal, Mexico, 06090
        • Novartis Investigative Site
      • Mexico, Distrito Federal, Mexico, 04700
        • Novartis Investigative Site
      • Mexico, Distrito Federal, Mexico, 04980
        • Novartis Investigative Site
      • Mexico City, Distrito Federal, Mexico, 14000
        • Novartis Investigative Site
    • Edo. De México
      • Mexico, Edo. De México, Mexico, 53910
        • Novartis Investigative Site
    • Estado De Mexico
      • Nezahualcoyotl, Estado De Mexico, Mexico, 57730
        • Novartis Investigative Site
    • Hidalgo
      • Pachuca de Soto, Hidalgo, Mexico, 42090
        • Novartis Investigative Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Novartis Investigative Site
      • Guadalajara, Jalisco, Mexico, 44500
        • Novartis Investigative Site
      • Guadalajara, Jalisco, Mexico, 44620
        • Novartis Investigative Site
      • Guadalajara, Jalisco, Mexico, 44690
        • Novartis Investigative Site
      • Guadaljara, Jalisco, Mexico, 44500
        • Novartis Investigative Site
    • Nayarit
      • Tepic, Nayarit, Mexico, 63000
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64020
        • Novartis Investigative Site
      • Monterrey, Nuevo León, Mexico, 64718
        • Novartis Investigative Site
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Novartis Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 55 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

  • 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:

    1. Persistent day symptoms with current therapy twice at week or more, (siblings, dyspnea, cough, chest pain, thoracic oppression).
    2. One or more night-time awakenings over the last 4 weeks.
    3. Any limitation of age-appropriated habitual activities.
    4. 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.
    5. 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.
  • Body weight between 20 to 150 kg Exclusion Criteria
  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Omalizumab + budesonide and formoterol
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.
Medicin: Omalizumab
Subcutaneous injection dose according to the IgE level and body weight.
Medicin: Budesonide
Budesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose.
Medicin: Formoterol
Formoterol 12ug tablets taken orally according to maximum daily dose.
Medicin: Budesonide
Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.
Medicin: Formoterol
Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.
Aktiv komparator: Budesonide and formoterol
Participants will receive budesonide and formoterol according to maximum daily dose.
Medicin: Budesonide
Budesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose.
Medicin: Formoterol
Formoterol 12ug tablets taken orally according to maximum daily dose.
Medicin: Budesonide
Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.
Medicin: Formoterol
Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Mean Prescribed Budesonide Dose (μg) at Baseline
Tidsramme: Baseline
prescribed budesonide dose (in μg) at Baseline in intention to treat population and in intention to treat population
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Hospital Admissions Due to Asthma Exacerbation
Tidsramme: 12 month treatment duration
A hospital admission is defined as admissions to hospital involving a stay of at least 24 hours.
12 month treatment duration
Days Missed in School/Work Due to Asthma Exacerbation Episodes
Tidsramme: 12 month treatment duration
Participants /parent/legal guarding reported number of missed days of school or work at each study visit via diaries.
12 month treatment duration
Control of Asthma Symptoms- Daytime Symptoms
Tidsramme: 12 month treatment duration
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
12 month treatment duration
Control of Asthma Symptoms
Tidsramme: 12 month treatment duration
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
12 month treatment duration
Control of Asthma Symptoms- Rescue Medication Use
Tidsramme: 12 month treatment duration
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
12 month treatment duration
Participants Requiring Oral Systemic Corticosteroids During the 12 Month Study Duration
Tidsramme: 12 month treatment duration
Number of days of concomitant medications use reported by participants at all visits via diaries.
12 month treatment duration
Asthma Control Questionnaire (ACQ) at Baseline
Tidsramme: Baseline
The Asthma Control Questionnaire (ACQ) has six questions to be answered by the participants, each with a 7 point scale (0-good control, 6-poor control), and one question where the actual pre-bronchodilator Forced expiratory volume in 1 second (FEV1) value expressed in % of predicted FEV1 was classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma.
Baseline
Asthma Quality of Life Questionnaire (AQLQ) at Baseline
Tidsramme: Baseline
The quality of life will be measured by the standardized version of the Asthma Quality of Life Questionnaire (AQLQ[S]) score for adults and the pediatric version of the AQLQ(S) for pediatric participants (PAQLQ[S]) . The AQLQ(S) and PAQLQ(S0 contain 4 domains (activity limitations, symptoms, emotional function, and environmental stimuli), with a total of 32 items; each item is measured in a 7-point Likert scale of 1 to 7 (1 = severe impairment, 7 = no impairment). All items are weighted equally. Mean score is calculated across all items within each domain and the overall score is the mean score of the 32 items.
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. november 2013

Primær færdiggørelse (Faktiske)

6. august 2015

Studieafslutning (Faktiske)

8. januar 2016

Datoer for studieregistrering

Først indsendt

29. juli 2013

Først indsendt, der opfyldte QC-kriterier

30. juli 2013

Først opslået (Skøn)

31. juli 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2019

Sidst verificeret

1. juni 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CIGE025AMX02

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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