AsthmaPhase 3MEMORYNCT02594332
Effects of Mepolizumab Compared to Placebo on Airway Physiology in Patients With Eosinophilic Asthma: MEMORY Study
A Phase 3 study testing Mepolizumab in people with Asthma, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The purpose of the MEMORY trial is to compare the effects of mepolizumab with Placebo on airway physiology in patients with eosinophilic asthma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Mepolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- 17 Nov 2015to 22 May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Male or female patients 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/day 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 beta-2-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 patients on oral corticosteroids.
- 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
- 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.
Who cannot join
- 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.
- 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.
- Patients who have received omalizumab [Xolair] within 130 days of Visit 1.
- Patients who have received any biological to treat inflammatory disease within 5 half-lives of visit 1
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Pneumologie
Mainz, 55131
About this study
Official title: 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
Read the detailed description
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.
- Conditions
- Asthma
- Being tested
- Mepolizumab, Placebo
- Keywords
- eosinophilic asthma, mepolizumab, treatment
- Medical subject headings
- Asthma, Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabDrug
100 mg SC every 4 weeks for 13 injections
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Mepolizumab | Experimental | 100 mg SC every 4 weeks for 13 injections Receives: Drug: Mepolizumab |
| Placebo | Experimental | Amount of Placebo corresponding to mepolizumab dose SC every 4 weeks for 13 injections Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean change from baseline in pre- and post-bronchodilator FVC at visit 10 (week 24) and at 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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: week 24 and time of response
Secondary outcomes (33)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1, 3, 6, 9 and 12 months
Exercise tolerance in a subgroup of patients: Mean change from baseline in exercise endurance time
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.
Measured: 1, 3, 6, 9 and 12 month
Exercise tolerance in a subgroup of patients: Mean change from baseline in inspiratory capacity (IC)
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.
Measured: 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®)
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
Measured: 1, 3, 6, 9 and 12 month
Time to clinical response and time to change of baseline parameters of clinical Response: sence of smell
Measured: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: sense of taste
Measured: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: lung volume
Measured: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: CO Diffusion capacity
Measured: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: FEV1 reversibility
Measured: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: exhaled NO (eNO)
Measured: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: blood eosinophils
Measured: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: eosinophilic cationic Protein (ECP)
Measured: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: blood periostin
Measured: 52 weeks
Mean change from baseline in Asthma Control Questionnaire (ACQ)
Measured: 52 weeks
Mean change from baseline in Asthma Quality of Life Questionnaire (AQLQ)
Measured: 52 weeks
Mean change from baseline in St. George´s Respiratory Questionnaire (SQRG)
Measured: 52 weeks
Mean change from baseline in Dyspnoe Index (BDI/TDI)
Measured: 52 weeks
Mean change from baseline in fatique
Measured: 52 weeks
Mean change from baseline in number of days off school/work over the 48-week treatment period
Measured: 48 weeks
Time to first clinically significant exacerbation requiring oral or systemic corticosteroids, hospitalization, and/or emergency department (ED) visits
Measured: 52 weeks
Frequency of clinically significant exacerbations
Measured: 52 weeks
Time to first exacerbation requiring hospitalization or emergency department (ED) visit
Measured: 52 weeks
Frequency of exacerbations requiring hospitalization (including intubation and admittance to an intensive care unit (ICU)) or ED visits
Measured: 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)
Measured: 1, 3, 6, 9 and 12 month
Mean change in proportion of patients with nasal polyps, chronic sinusitis and loss of smell and taste
Measured: 52 weeks
Clinical response to mepolizumab in relation to asthma parameters which potentially predict clinical response
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.
Measured: 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))
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).
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start17 Nov 2015
- Primary completion22 May 2017
- Study completion22 May 2017
Why it stopped: recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, PD Dr. Stephanie Korn, Johannes Gutenberg University Mainz
- Investigators
- Stephanie Korn, MD, Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594332
- Sponsor's protocol ID
- 2015-001
- Other IDs
- 2015-001868-19, 2015
- Acronym
- MEMORY
- Status last verified
- Jul 2017
- First submitted
- 31 Aug 2015
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02594332
- Acronym / sponsor ID
- MEMORY / 2015-001
- Conditions
- Asthma
- Keywords
- eosinophilic asthma, mepolizumab, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment problems
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 17 Nov 2015 (actual)
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the MEMORY trial is to compare the effects of mepolizumab with Placebo on airway physiology in patients with eosinophilic asthma
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepolizumab | Experimental | Drug: Mepolizumab100 mg SC every 4 weeks for 13 injections |
| Placebo | Experimental | Drug: PlaceboAmount of Placebo corresponding to mepolizumab dose SC every 4 weeks for 13 injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Male or female patients 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/day 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 beta-2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline.
Key exclusion criteria (4 listed)
- 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.
- 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.
- Patients who have received omalizumab [Xolair] within 130 days of Visit 1.
- Patients who have received any biological to treat inflammatory disease within 5 half-lives of visit 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mepolizumab100 mg SC every 4 weeks for 13 injections | Drug | Mepolizumab |
| Placebo | Drug | Placebo |
Primary outcome
mean change from baseline in pre- and post-bronchodilator FVC at visit 10 (week 24) and at time of response
Time frame: 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
mean change from baseline in pre- and post-bronchodilator FEV1 at visit 10 (week 24) and at time of response
Time frame: 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
mean change from baseline in pre- and post-bronchodilator RV at visit 10 (week 24) and at time of response
Time frame: 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
mean change from baseline in pre- and post-bronchodilator TLC at visit 10 (week 24) and at time of response
Time frame: 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
mean change from baseline in pre- and post-bronchodilator airway resistance at visit 10 (week 24) and at time of response
Time frame: 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
mean change from baseline in pre- and post-bronchodilator IC at visit 10 (week 24) and at time of response
Time frame: 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
mean change from baseline in pre- and post-bronchodilator CO diffusion capacity at visit 10 (week 24) and at time of response
Time frame: 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
33 secondary outcomes
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 1, 3, 6, 9 and 12 months
Exercise tolerance in a subgroup of patients: Mean change from baseline in exercise endurance time
Time frame: 1, 3, 6, 9 and 12 month
Exercise tolerance in a subgroup of patients: Mean change from baseline in inspiratory capacity (IC)
Time frame: 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®)
Time frame: 1, 3, 6, 9 and 12 month
Time to clinical response and time to change of baseline parameters of clinical Response: sence of smell
Time frame: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: sense of taste
Time frame: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: lung volume
Time frame: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: CO Diffusion capacity
Time frame: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: FEV1 reversibility
Time frame: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: exhaled NO (eNO)
Time frame: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: blood eosinophils
Time frame: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: eosinophilic cationic Protein (ECP)
Time frame: 52 weeks
Time to clinical response and time to change of baseline parameters of clinical Response: blood periostin
Time frame: 52 weeks
Mean change from baseline in Asthma Control Questionnaire (ACQ)
Time frame: 52 weeks
Mean change from baseline in Asthma Quality of Life Questionnaire (AQLQ)
Time frame: 52 weeks
Mean change from baseline in St. George´s Respiratory Questionnaire (SQRG)
Time frame: 52 weeks
Mean change from baseline in Dyspnoe Index (BDI/TDI)
Time frame: 52 weeks
Mean change from baseline in fatique
Time frame: 52 weeks
Mean change from baseline in number of days off school/work over the 48-week treatment period
Time frame: 48 weeks
Time to first clinically significant exacerbation requiring oral or systemic corticosteroids, hospitalization, and/or emergency department (ED) visits
Time frame: 52 weeks
Frequency of clinically significant exacerbations
Time frame: 52 weeks
Time to first exacerbation requiring hospitalization or emergency department (ED) visit
Time frame: 52 weeks
Frequency of exacerbations requiring hospitalization (including intubation and admittance to an intensive care unit (ICU)) or ED visits
Time frame: 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)
Time frame: 1, 3, 6, 9 and 12 month
Mean change in proportion of patients with nasal polyps, chronic sinusitis and loss of smell and taste
Time frame: 52 weeks
Clinical response to mepolizumab in relation to asthma parameters which potentially predict clinical response
Time frame: 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))
Time frame: 52 weeks
Results and safety
The study was stopped early (reason given: recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Korn, MD principal investigator
Johannes Gutenberg University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mepolizumab in people with Asthma, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: recruitment problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean change from baseline in pre- and post-bronchodilator FVC at visit 10 (week 24) and at time of response (time frame: week 24 and time of response). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.