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. 2017 Sep 21;2017(9):CD010834. doi: 10.1002/14651858.CD010834.pub3

NCT02594332

Trial name or title A randomised, double‐blind, placebo‐controlled, mono‐center study to evaluate the effects of mepolizumab on airway physiology in patients with eosinophilic asthma: the MEMORY Study
Methods Randomised, double‐blind, placebo‐controlled, mono‐centre study
Participants 29 participants with severe eosinophilic asthma
Inclusion criteria

  • Men or women at least 18 years

  • Physician‐diagnosis of asthma and evidence of asthma as documented by either reversibility of airflow obstruction (FEV1 ≥ 12% or 200 mL) demonstrated at visit 1 or visit 2

  • ICS dose must be ≥ 1000 μg/d BDP or equivalent daily with or without maintenance oral corticosteroids

  • Treatment in the past 12 months with an additional controller medication for at least 3 successive months, e.g. long‐acting beta2‐agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline

  • Persistent airflow obstruction as indicated by a pre‐bronchodilator FEV1 < 80% predicted recorded at visit 1 or < 90% for participants on oral corticosteroids

  • An elevated peripheral blood eosinophil level of ≥ 300/µL that is related to asthma or ≥ 150/µL in participants treated with oral corticosteroids as maintenance therapy demonstrated at visit 1 or in the previous 12 months

  • Confirmed history of ≥ 2 exacerbations requiring treatment with systemic corticosteroids (intramuscular, intravenous, or oral), in the 12 months prior to visit 1, despite the use of high‐dose inhaled corticosteroids. For participants receiving maintenance corticosteroids, the corticosteroid treatment for the exacerbations must have been a two‐fold increase or greater in the dose.
Interventions Mepolizumab 100 mg SC every 4 weeks for 13 injections and placebo
Outcomes Primary outcome measures

  1. Mean change from baseline in pre‐ and post‐bronchodilator FVC at visit 10 (week 24) and at time of response

  2. Mean change from baseline in pre‐ and post‐bronchodilator FEV1 at visit 10 (week 24) and at time of response

  3. Mean change from baseline in pre‐ and post‐bronchodilator RV at visit 10 (week 24) and at time of response

  4. Mean change from baseline in pre‐ and post‐bronchodilator TLC at visit 10 (week 24) and at time of response

  5. Mean change from baseline in pre‐ and post‐bronchodilator airway resistance at visit 10 (week 24) and at time of response

  6. Mean change from baseline in pre‐ and post‐bronchodilator IC at visit 10 (week 24) and at time of response

  7. Mean change from baseline in pre‐ and post‐bronchodilator CO diffusion capacity at visit 10 (week 24) and at time of response


Secondary outcome measures

  1. Mean change from baseline in pre‐ and post‐bronchodilator FVC over the 48‐week treatment period at prespecified time points (1, 3, 6, 9 and 12 months)

  2. Mean change from baseline in pre‐ and post‐bronchodilator FEV1 over the 48‐week treatment period at prespecified time points (1, 3, 6, 9 and 12 months)

  3. Mean change from baseline in pre‐ and post‐bronchodilator RV over the 48‐week treatment period at prespecified time points (1, 3, 6, 9 and 12 months)

  4. Mean change from baseline in pre‐ and post‐bronchodilator TLC over the 48‐week treatment period at prespecified time points (1, 3, 6, 9 and 12 months)

  5. Mean change from baseline in pre‐ and post‐bronchodilator airway resistance over the 48‐week treatment period at prespecified time points (1, 3, 6, 9 and 12 months)

  6. Mean change from baseline in pre‐ and post‐bronchodilator (IC) over the 48‐week treatment period at prespecified time points (1, 3, 6, 9 and 12 months)

  7. Mean change from baseline in pre‐ and post‐bronchodilator CO diffusion capacity over the 48‐week treatment period at prespecified time points (1, 3, 6, 9 and 12 months)

  8. Exercise tolerance in a subgroup of patients: Mean change from baseline in exercise endurance time (time frame: 1, 3, 6, 9 and 12 months)

  9. Exercise tolerance in a subgroup of participants: mean change from baseline in IC (time frame: 1, 3, 6, 9 and 12 months)

  10. Exercise tolerance in a subgroup of participants: mean change from baseline in exertional dyspnoea and leg discomfort (Borg CR10 Scale®) (time frame: 1, 3, 6, 9 and 12 months)

  11. Time to clinical response and time to change of baseline parameters of clinical response: sense of smell (time frame: 52 weeks)

  12. Time to clinical response and time to change of baseline parameters of clinical response: sense of taste (time frame: 52 weeks)

  13. Time to clinical response and time to change of baseline parameters of clinical response: lung volume (time frame: 52 weeks)

  14. Time to clinical response and time to change of baseline parameters of clinical response: CO diffusion capacity (time frame: 52 weeks)

  15. Time to clinical response and time to change of baseline parameters of clinical response: FEV1 reversibility (time frame: 52 weeks)

  16. Time to clinical response and time to change of baseline parameters of clinical response: exhaled NO (eNO) (time frame: 52 weeks)

  17. Time to clinical response and time to change of baseline parameters of clinical response: blood eosinophils (time frame: 52 weeks)

  18. Time to clinical response and time to change of baseline parameters of clinical response: eosinophilic cationic protein (time frame: 52 weeks)

  19. Time to clinical response and time to change of baseline parameters of clinical response: blood periostin (time frame: 52 weeks)

  20. Mean change from baseline in Asthma Control Questionnaire (ACQ) (time frame: 52 weeks)

  21. Mean change from baseline in Asthma Quality of Life Questionnaire (AQLQ) (time frame: 52 weeks)

  22. Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) (time frame: 52 weeks)

  23. Mean change from baseline in Dyspnoe Index (BDI/TDI) (time frame: 52 weeks)

  24. Mean change from baseline in fatigue (time frame: 52 weeks)

  25. Mean change from baseline in number of days off school/work over the 48‐week treatment period (time frame: 48 weeks)

  26. Time to first clinically significant exacerbation requiring oral or systemic corticosteroids, hospitalisation, and/or ED visits (time frame: 52 weeks)

  27. Frequency of clinically significant exacerbations (time frame: 52 weeks)

  28. Time to first exacerbation requiring hospitalisation or ED visit (time frame: 52 weeks)

  29. Frequency of exacerbations requiring hospitalisation (including intubation and admittance to ICU) or ED visits (time frame: 52 weeks)

  30. GETE rating by physician and participant at time of response and over the 52‐week treatment period at pre‐specified time points (1, 3, 6, 9 and 12 months) (time frame: 1, 3, 6, 9 and 12 months)

  31. Mean change in proportion of participants with nasal polyps, chronic sinusitis and loss of smell and taste (time frame: 52 weeks)

  32. Clinical response to mepolizumab in relation to asthma parameters which potentially predict clinical response (time frame: 52 weeks)

  33. Routine safety assessment (adverse events and serious adverse events reporting, withdrawals, pregnancy, haematological and clinical chemistry parameters, ECG and vital signs (pulse rate and systolic and diastolic blood pressure)) (time frame: 52 weeks)
Starting date November 2015
Contact information PI Dr. Stephanie Korn, Johannes Gutenberg University Mainz
Notes GlaxoSmithKline collaborator
Estimated study completion date August 2018