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Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids (MESOS)

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ClinicalTrials.gov Identifier: NCT02449473
Recruitment Status : Completed
First Posted : May 20, 2015
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma Inadequately Controlled on Inhaled Corticosteroid.

Condition or disease Intervention/treatment Phase
Asthma Biological: Tralokinumab Other: Placebo Phase 2

Detailed Description:
This is a multicentre, randomized, double-blind, parallel group, placebo-controlled, phase 2 study to designed evaluate the effect of a 300 mg dose of tralokinumab administered subcutaneously every 2 weeks on airway inflammation in adults with asthma inadequately controlled on inhaled corticosteroids (ICS) with or without other controllers. Approximately 80 subjects will be randomized. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 12 week treatment period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Ph 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults With Asthma Inadequately Controlled on Inhaled Corticosteroid (MESOS)
Actual Study Start Date : September 29, 2015
Actual Primary Completion Date : June 21, 2017
Actual Study Completion Date : June 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
Experimental: Tralokinumab Dose Regimen
Tralokinumab Subcutaneous Injection
Biological: Tralokinumab
Subcutaneous Injection

Placebo Comparator: Placebo Dose Regimen
Placebo Subcutaneous Injection
Other: Placebo
Subcutaneous Injection




Primary Outcome Measures :
  1. Change From Baseline to Week 12, Expressed as a Ratio, in Number of Airway Submucosal Eosinophils [ Time Frame: Baseline (Week 0) and Week 12 ]
    The number of airway submucosal eosinophils per millimetre squared (mm^2) was determined by microscopic evaluation of bronchoscopic biopsies. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of airway submucosal eosinophils is presented as geometric mean ± standard deviation (SD) of log values.


Secondary Outcome Measures :
  1. Change From Baseline to Week 12, Expressed as a Ratio, in Number of Blood Eosinophils [ Time Frame: Baseline (Week 0) and Week 12 ]
    The blood eosinophil count was obtained from the total and differential white blood cell counts. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of blood eosinophils is presented as geometric mean ± SD of log values.

  2. Change From Baseline to Week 12, Expressed as a Ratio, in Number of Differential Sputum Eosinophils [ Time Frame: Baseline (Week 0) and Week 12 ]
    Sputum induction was performed to obtain satisfactory samples of sputum originating from the airways. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of eosinophils in induced sputum is presented as geometric mean ± SD of log values.

  3. Change From Baseline to Week 12, Expressed as a Ratio, in Blood Free Eosinophil Cationic Protein (ECP) Concentrations [ Time Frame: Baseline (Week 0) and Week 12 ]
    ECP concentrations were determined to assess evidence of activation of eosinophils in blood. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in blood free ECP concentrations is presented as geometric mean ± SD of log values.

  4. Change From Baseline to Week 12, Expressed as a Ratio, in Sputum Free ECP Concentrations [ Time Frame: Baseline (Week 0) and Week 12 ]
    ECP concentrations were determined to assess evidence of activation of eosinophils in sputum. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in sputum free ECP concentrations is presented as geometric mean ± SD of log values.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 to 75 years
  2. Documented physician-diagnosed asthma for at least 12 months prior to enrolment (v1)
  3. Documented treatment with an asthma controller regimen requiring treatment with ICS (minimum dose of ≥ 250 ug fluticasone propionate via dry powder inhaler equivalents total daily dose) alone or in combination ≥ 6 months and that has been taken at a stable dose for at least 1 month prior to enrolment (v1)
  4. Additional maintenance asthma controller medications must be given at a stable dose for at least 1 month prior to v1.
  5. At enrolment (v1) the subject must have a predicted normal value (PNV) for the pre-bronchodilator (BD) FEV1>50% and more than 1L.
  6. Post-BD reversibility in FEV1 of ≥12% and ≥200 mL at enrolment (v1).

Exclusion Criteria:

  1. History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma.
  2. History of anaphylaxis following any biologic therapy.
  3. Hepatitis B, C or HIV
  4. Pregnant or breastfeeding
  5. History of cancer
  6. Current tobacco smoking or a history of tobacco smoking for >10 pack-years.
  7. Previous receipt of tralokinumab

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449473


Locations
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Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H4A 3J1
Canada
Research Site
Quebec, Canada, G1V 4G5
Denmark
Research Site
Hvidovre, Denmark, 2650
Research Site
København NV, Denmark, 2400
Research Site
Odense C, Denmark, 5000
Research Site
Ålborg, Denmark, 9000
Research Site
Århus C, Denmark, 8000
United Kingdom
Research Site
Belfast, United Kingdom, BT12 6BA
Research Site
Glasgow, United Kingdom, G12 OYN
Research Site
Leicester, United Kingdom, LE3 9QP
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom, M23 9QZ
Research Site
Nottingham, United Kingdom, NG5 1PB
Research Site
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Christopher Brightling, MD Institute for Lung Health, United Kingdom
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] January 15, 2016
Statistical Analysis Plan  [PDF] July 28, 2017

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02449473    
Other Study ID Numbers: D2210C00014
First Posted: May 20, 2015    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019
Last Verified: January 2019
Keywords provided by AstraZeneca:
Asthma
Reactive Airways
Respiratory Tract Disease
Obstructive Tract Disease
Lung Diseases
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases