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Effects of Mepolizumab Compared to Placebo on Airway Physiology in Patients With Eosinophilic Asthma: MEMORY Study (MEMORY)

11 lipca 2017 zaktualizowane przez: PD Dr. Stephanie Korn, Johannes Gutenberg University Mainz

A Randomized, Double-blind, Placebo-controlled, Mono-center Study to Evaluate the Effects of Mepolizumab on Airway Physiology in Patients With Eosinophilic Asthma: the MEMORY Study

The purpose of the MEMORY trial is to compare the effects of mepolizumab with Placebo on airway physiology in patients with eosinophilic asthma

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Asthma with eosinophilic inflammation in the airways and/or blood eosinophilia is associated with clinical severity including the risk of exacerbations and relevant comorbidities (e.g. nasal polyposis). Interleukin-5 (IL-5) is a cytokine essential for eosinophil trafficking and survival. Clinical trials of blocking IL-5 with anti-IL-5 antibodies (mepolizumab and reslizumab) in patients with uncontrolled eosinophilic asthma resulted in an improvement in exacerbation rate and oral corticosteroid use. In some studies with mepolizumab and reslizumab there was a beneficial effect on lung function (FEV1). In addition, many patients described a profound impact on asthma symptoms and quality of life in personal reports which is not uniformly reflected in clinical trials.

The MEMORY trial is the first to primarily evaluate the effect of mepolizumab treatment on pulmonary function in patients with severe eosinophilic asthma. Importantly, using spirometry and bodyplethysmography will allow to evaluate additional parameters beyond FEV1 that more closely mirror the pathophysiological changes and functional aspects of airflow limitation in asthma in real life, e.g. airway resistance, hyperinflation and diffusion capacity. The proposed trial will answer the important questions: if, and if so, which parameters of airway (patho-) physiology as assessed by bodyplethysmography best reflect clinical response to mepolizumab therapy in patients with severe eosinophilic asthma. In addition, the time course to clinical response will be assessed. Equally important, there is only a loose correlation between FEV1 and parameters of asthma control and asthma-related quality of life. This is why another new and important aspect of this trial is to carefully monitor asthma control and asthma quality in life in correlation with lung function changes beyond FEV1. Finally, it is tempting to speculate that the proposed trial will contribute to the question how to best define clinical response to mepolizumab.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

29

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Niemcy
      • Mainz, Niemcy, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Pneumologie

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  1. Patients must be able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form.
  2. Male or female patients at least 18 years
  3. 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 .
  4. ICS dose must be ≥ 1000 μg/day BDP or equivalent daily with or without maintenance oral corticosteroids.
  5. Treatment in the past 12 months with an additional controller medication for at least 3 successive months, e.g., long-acting beta-2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline.
  6. Persistent airflow obstruction as indicated by a pre-bronchodilator FEV1 < 80% predicted recorded at Visit 1 or < 90% for patients on oral corticosteroids.
  7. An elevated peripheral blood eosinophil level of ≥ 300/µL that is related to asthma or ≥ 150/µL in patients treated with oral corticosteroids as maintenance therapy demonstrated at visit 1 or in the previous 12 months
  8. Confirmed history of two or more 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 patients receiving maintenance corticosteroids, the corticosteroid treatment for the exacerbations must have been a two-fold increase or greater in the dose.

Exclusion Criteria:

  1. Current smokers or former smokers with a smoking history of ≥ 10 pack years (number of pack years = (number of cigarettes per day / 20) x number of years smoked). Patients who have not smoked for ≥ 6 months before visit 1 and have < 10 pack years can be included into the study.
  2. Presence of a clinically important lung condition other than asthma. This includes current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
  3. Patients who have received omalizumab [Xolair] within 130 days of Visit 1.
  4. Patients who have received any biological to treat inflammatory disease within 5 half-lives of visit 1

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Mepolizumab
100 mg SC every 4 weeks for 13 injections
Lek: Mepolizumab
100 mg SC every 4 weeks for 13 injections
Eksperymentalny: Placebo
Amount of Placebo corresponding to mepolizumab dose SC every 4 weeks for 13 injections
Lek: Placebo

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
mean change from baseline in pre- and post-bronchodilator FVC at visit 10 (week 24) and at time of response
Ramy czasowe: week 24 and time of response
The primary outcome is the mean change from baseline in pre- and post-bronchodilator forced vital capacity (FVC) at visit 10 (week 24) and at time of response
week 24 and time of response
mean change from baseline in pre- and post-bronchodilator FEV1 at visit 10 (week 24) and at time of response
Ramy czasowe: week 24 and time of response
The primary outcome is the mean change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) at visit 10 (week 24) and at time of response
week 24 and time of response
mean change from baseline in pre- and post-bronchodilator RV at visit 10 (week 24) and at time of response
Ramy czasowe: week 24 and time of response
The primary outcome is the mean change from baseline in pre- and post-bronchodilator residual volume (RV) at visit 10 (week 24) and at time of response
week 24 and time of response
mean change from baseline in pre- and post-bronchodilator TLC at visit 10 (week 24) and at time of response
Ramy czasowe: week 24 and time of response
The primary outcome is the mean change from baseline in pre- and post-bronchodilator total lung capacity (TLC) at visit 10 (week 24) and at time of response
week 24 and time of response
mean change from baseline in pre- and post-bronchodilator airway resistance at visit 10 (week 24) and at time of response
Ramy czasowe: week 24 and time of response
The primary outcome is the mean change from baseline in pre- and post-bronchodilator airway resistance at visit 10 (week 24) and at time of response
week 24 and time of response
mean change from baseline in pre- and post-bronchodilator IC at visit 10 (week 24) and at time of response
Ramy czasowe: week 24 and time of response
The primary outcome is the mean change from baseline in pre- and post-bronchodilator inspiratory capacity (IC) at visit 10 (week 24) and at time of response
week 24 and time of response
mean change from baseline in pre- and post-bronchodilator CO diffusion capacity at visit 10 (week 24) and at time of response
Ramy czasowe: week 24 and time of response
The primary outcome is the mean change from baseline in pre- and post-bronchodilator CO diffusion capacity at visit 10 (week 24) and at time of response
week 24 and time of response

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mean change from baseline in pre- and post-bronchodilator forced vital capacity (FVC) over the 48-week treatment period at prespecified timepoints (1, 3, 6, 9 and 12 months)
Ramy czasowe: 1, 3, 6, 9 and 12 months
1, 3, 6, 9 and 12 months
Mean change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) over the 48-week treatment period at prespecified timepoints (1, 3, 6, 9 and 12 months)
Ramy czasowe: 1, 3, 6, 9 and 12 months
1, 3, 6, 9 and 12 months
Mean change from baseline in pre- and post-bronchodilator residual volume (RV) over the 48-week treatment period at prespecified timepoints (1, 3, 6, 9 and 12 months)
Ramy czasowe: 1, 3, 6, 9 and 12 months
1, 3, 6, 9 and 12 months
Mean change from baseline in pre- and post-bronchodilator total lung capacity (TLC) over the 48-week treatment period at prespecified timepoints (1, 3, 6, 9 and 12 months)
Ramy czasowe: 1, 3, 6, 9 and 12 months
1, 3, 6, 9 and 12 months
Mean change from baseline in pre- and post-bronchodilator airway resistance over the 48-week treatment period at prespecified timepoints (1, 3, 6, 9 and 12 months)
Ramy czasowe: 1, 3, 6, 9 and 12 months
1, 3, 6, 9 and 12 months
Mean change from baseline in pre- and post-bronchodilator inspiratory capacity (IC) over the 48-week treatment period at prespecified timepoints (1, 3, 6, 9 and 12 months)
Ramy czasowe: 1, 3, 6, 9 and 12 months
1, 3, 6, 9 and 12 months
Mean change from baseline in pre- and post-bronchodilator CO diffusion capacity over the 48-week treatment period at prespecified timepoints (1, 3, 6, 9 and 12 months)
Ramy czasowe: 1, 3, 6, 9 and 12 months
1, 3, 6, 9 and 12 months
Exercise tolerance in a subgroup of patients: Mean change from baseline in exercise endurance time
Ramy czasowe: 1, 3, 6, 9 and 12 month
Mean change from baseline in exercise endurance time during a sub-maximal constant-load cycle ergometry test after 1, 3, 6, 9 and 12 months of treatment.
1, 3, 6, 9 and 12 month
Exercise tolerance in a subgroup of patients: Mean change from baseline in inspiratory capacity (IC)
Ramy czasowe: 1, 3, 6, 9 and 12 month
Mean change from baseline in inspiratory capacity (IC) at rest and at peak during sub-maximal constant-load cycle ergometry test after 1, 3, 6, 9 and 12 months of treatment.
1, 3, 6, 9 and 12 month
Exercise tolerance in a subgroup of patients: Mean change from baseline in exertional dyspnea and leg discomfort (Borg CR10 Scale®)
Ramy czasowe: 1, 3, 6, 9 and 12 month
Mean change from baseline in exertional dyspnea and leg discomfort (Borg CR10 Scale®) during sub-maximal constant-load cycle ergometry test after 1, 3, 6, 9 and 12 months of treatment
1, 3, 6, 9 and 12 month
Time to clinical response and time to change of baseline parameters of clinical Response: sence of smell
Ramy czasowe: 52 weeks
52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: sense of taste
Ramy czasowe: 52 weeks
52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: lung volume
Ramy czasowe: 52 weeks
52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: CO Diffusion capacity
Ramy czasowe: 52 weeks
52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: FEV1 reversibility
Ramy czasowe: 52 weeks
52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: exhaled NO (eNO)
Ramy czasowe: 52 weeks
52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: blood eosinophils
Ramy czasowe: 52 weeks
52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: eosinophilic cationic Protein (ECP)
Ramy czasowe: 52 weeks
52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: blood periostin
Ramy czasowe: 52 weeks
52 weeks
Mean change from baseline in Asthma Control Questionnaire (ACQ)
Ramy czasowe: 52 weeks
52 weeks
Mean change from baseline in Asthma Quality of Life Questionnaire (AQLQ)
Ramy czasowe: 52 weeks
52 weeks
Mean change from baseline in St. George´s Respiratory Questionnaire (SQRG)
Ramy czasowe: 52 weeks
52 weeks
Mean change from baseline in Dyspnoe Index (BDI/TDI)
Ramy czasowe: 52 weeks
52 weeks
Mean change from baseline in fatique
Ramy czasowe: 52 weeks
52 weeks
Mean change from baseline in number of days off school/work over the 48-week treatment period
Ramy czasowe: 48 weeks
48 weeks
Time to first clinically significant exacerbation requiring oral or systemic corticosteroids, hospitalization, and/or emergency department (ED) visits
Ramy czasowe: 52 weeks
52 weeks
Frequency of clinically significant exacerbations
Ramy czasowe: 52 weeks
52 weeks
Time to first exacerbation requiring hospitalization or emergency department (ED) visit
Ramy czasowe: 52 weeks
52 weeks
Frequency of exacerbations requiring hospitalization (including intubation and admittance to an intensive care unit (ICU)) or ED visits
Ramy czasowe: 52 weeks
52 weeks
GETE rating by physician and patient at time of response and over the 52-week treatment period at pre-specified timepoints (1, 3, 6, 9 and 12 months)
Ramy czasowe: 1, 3, 6, 9 and 12 month
1, 3, 6, 9 and 12 month
Mean change in proportion of patients with nasal polyps, chronic sinusitis and loss of smell and taste
Ramy czasowe: 52 weeks
52 weeks
Clinical response to mepolizumab in relation to asthma parameters which potentially predict clinical response
Ramy czasowe: 52 weeks
Clinical response to mepolizumab in relation to asthma parameters which potentially predict clinical response (age at onset and duration of asthma, prior asthma medication, presence of nasal polyps, sense of smell and taste, allergic sensitization (skin prick test, total and specific IgE against aeroallergens and Staph. aureus enterotoxin), reversibility of airflow obstruction, eNO, blood eosinophils, eosinophilic cationic protein (ECP), blood periostin, ANA, ANCA, ECP.
52 weeks
Routine safety assessment (AE and SAE reporting, withdrawals, pregnancy, hematological and clinical chemistry parameters, ECG and vital signs (pulse rate and systolic and diastolic blood pressure))
Ramy czasowe: 52 weeks
Routine safety assessments are incorporated throughout and/or at the end of treatment period including AE and SAE reporting, withdrawals, pregnancy, hematological and clinical chemistry parameters, ECG and vital signs (pulse rate and systolic and diastolic blood pressure).
52 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Johannes Gutenberg University Mainz

Współpracownicy

GlaxoSmithKline

Śledczy

  • Główny śledczy: Stephanie Korn, MD, Johannes Gutenberg University Mainz

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

17 listopada 2015

Zakończenie podstawowe (Rzeczywisty)

22 maja 2017

Ukończenie studiów (Rzeczywisty)

22 maja 2017

Daty rejestracji na studia

Pierwszy przesłany

31 sierpnia 2015

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 listopada 2015

Pierwszy wysłany (Oszacować)

3 listopada 2015

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 lipca 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 lipca 2017

Ostatnia weryfikacja

1 lipca 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2015-001
  • 2015-001868-19 (Numer EudraCT)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

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