Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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16 November 2015 |
Main ID: |
EUCTR2013-002352-32-DE |
Date of registration:
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30/09/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy and safety study of benralizumab added to medium dose inhaled corticosteroid plus LABA in patients with uncontrolled asthma
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Scientific title:
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A multicentre, randomised, double-blind, paralllel group, placebo-controlled, Phase 3 efficacy and safety study of benralizumab (MEDI-563) added to medium dose inhaled corticosteroid plus long acting Beta2 agonist in patients with uncontrolled asthma (PAMPERO) - PAMPERO |
Date of first enrolment:
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26/02/2014 |
Target sample size:
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846 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002352-32 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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: 3
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Phase:
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Countries of recruitment
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Argentina
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Brazil
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Bulgaria
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Germany
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Japan
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Mexico
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Peru
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Poland
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Russian Federation
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South Africa
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Sweden
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Turkey
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Ukraine
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United States
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Contacts
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Name:
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AZ Clinical Study Information
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Address:
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Vastra Malarehamnen 9
151 85
Sodertalje
Sweden |
Telephone:
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46855326000 |
Email:
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information.center@astrazeneca.com |
Affiliation:
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AstraZeneca AB |
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Name:
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AZ Clinical Study Information
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Address:
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Vastra Malarehamnen 9
151 85
Sodertalje
Sweden |
Telephone:
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46855326000 |
Email:
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information.center@astrazeneca.com |
Affiliation:
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AstraZeneca AB |
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Key inclusion & exclusion criteria
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Inclusion criteria: Provision of informed consent prior to any study specific procedure
Female and male aged 18-75 years, inclusively
History of physician diagnosed asthma requiring medium dose ICS (greater than 250 microgrammes fluticasone dry powder formulation equivalents total daily dose and a LABA for at least 12 months prior to Visit 1
Documented treatment with medium dose ICS (> 250 microgrammes and = 500 microgrammes fluticasone dry powder formulation equivalents total daily dose) and a LABA for at least 3 months prior to Visit 1
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria: Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alphs 1 anti trypsin deficiency and primary ciliarydyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophillic syndrome).
Any disorder including, but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric or major physical impairement that is not stable in the opinion of the investigator and could - affect the safety of the patient throughout the study-influence the findings of the studies or their interpretations-impede the patients ability to complete the entire duration of the study.
Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run in period.
Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry or urinalysis during screening/run in period, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patients ability to complete the entire duration of the study
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Asthma MedDRA version: 16.0
Level: PT
Classification code 10003553
Term: Asthma
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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Intervention(s)
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Product Name: benralizumab Product Code: MEDI-563 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: benralizumab CAS Number: 1044511-01-4 Current Sponsor code: MEDI-563 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Primary end point(s): Annual asthma exacerbation rate
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Secondary Objective: To assess the effect of benralizumab on pulmonary function To assess the effect of benralizumab on asthma symptoms and other asthma control metrics (as per the ePRO) To assess the effect of benralizumab on emergency room visits and hospitalisations due to asthma To evaluate the pharmacokinetics and immunogenicity of benralizumab To assess the safety and tolerability of benralizumab
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Main Objective: To evaluate the effect of benralizumab on asthma exacerbations in adult patients with uncontrolled asthma
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Timepoint(s) of evaluation of this end point: week 48
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Secondary Outcome(s)
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Secondary end point(s): Pre-dose/pre-bronchodilator FEV1 at the study centre
Asthma symptom score (total, daytime and night time), rescue medication use, home lung function (morning and evening PEF), nights with awakening due to asthma, ACQ-6
Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalisation
PK parameters, anti drug antibodies
AE/SAE, Laboratory variables, ECG, physical examination
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Timepoint(s) of evaluation of this end point: 48 weeks
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Secondary ID(s)
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D3250C00016
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Source(s) of Monetary Support
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AstraZeneca AB
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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