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AsthmaPhase 3MATERIALNCT01520051

Mepolizumab Treatment for Rhinovirus-induced Asthma Exacerbations

A Phase 3 study testing Mepolizumab in people with Asthma and Viral Infection, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Asthma is a chronic inflammatory disorder of the airways characterized by lower respiratory tract (LRT) symptoms such as wheeze, cough and airway obstruction. Patients with asthma frequently suffer from exacerbations, which can be triggered by allergens and, in particular, viral respiratory infections. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Asthma, Viral Infection
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
48 participants
Where
1 siteNetherlands
Study dates
Jan 2012to Mar 2014
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 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age between 18 - 50 years
  • History of episodic chest tightness and wheezing
  • Intermittent or mild persistent asthma according to the criteria by the Global Initiative for Asthma
  • Non-smoking or stopped smoking more than 12 months ago and ≤ 5 pack years (PY)
  • Clinically stable, no history of exacerbations within the last 6 weeks prior to the study
  • Steroid-naïve or those patients who are currently not on corticosteroids and have not taken any corticosteroids by any dosing-routes within 2 weeks prior to the study. Occasional usage of inhaled short-acting beta2-agonists as rescue medication is allowed, prior and during the study
Show all 10Show fewer
  • Baseline FEV1 > 80% of predicted
  • Airway hyperresponsiveness, indicated by a positive acetyl-ß-methylcholine bromide (MeBr) challenge with PC20 < 9.8 mg/ml
  • Positive skin prick test (SPT) to one or more of the 12 common aeroallergen extracts, defined as a wheal with an average diameter of > 3mm
  • No other clinically significant abnormality on medical history and clinical examination

Who cannot join

  • Presence of antibodies directed against RV16 in serum (titer > 4), measured at visit 1
  • History of clinical significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness
  • Women who are pregnant, lactating or who have a positive urine pregnancy test at visit 1
  • Chronic use of any other medication for treatment of lung disease other than short-acting beta2-agonists
  • Participation in any clinical investigational drug treatment protocol within the preceding 3 months
  • Ongoing use of tobacco products of any kind or previous usage with ≥ 6 total PY
  • Concomitant disease or condition which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient
  • People with young children (< 2 years)

Trial locations and contacts

1 site in 1 country.

Suzanne M Bal, PhD contact

+31 205668043

s.m.bal@amc.uva.nl

Koenraad F van der Sluijs, PhD contact

+31 205668224

kvandersluijs@amc.uva.nl

Netherlands1 site, 1 recruiting

  • Academic Medical Center

    Amsterdam, 1105 AZ

    René Lutter, PhD

    Recruiting

Other trials in Netherlands

About this study

Official title: The Efficacy of Mepolizumab Treatment on Rhinovirus Induced Asthma Exacerbations

Asthma is a chronic inflammatory disorder of the airways characterized by lower respiratory tract (LRT) symptoms such as wheeze, cough and airway obstruction. Patients with asthma frequently suffer from exacerbations, which can be triggered by allergens and, in particular, viral respiratory infections. It has recently been shown that mepolizumab, a humanized monoclonal antibody that neutralizes interleukin(IL)-5, markedly reduces the exacerbation rate in asthma patients with eosinophilic airway inflammation. Previous studies have indicated that in a mixed population (eosinophilic and non eosinophilic) of mild asthma patients, mepolizumab did not have an impact on lung function and asthma symptom scores upon allergen provocation, although it did on markers such as sputum and blood eosinophils. Together, these observations led to the hypothesis that mepolizumab treatment reduces the exacerbation rate by limiting virus-induced asthma exacerbations.

The investigators hypothesize that neutralization of IL-5 during virus infection in patients with allergic asthma:

Read more
  1. Reduces virus-induced bronchial inflammation
  2. Attenuates virus-induced asthma symptoms, airflow limitation and bronchial hyperresponsiveness.
  3. Enhances cellular immune responses to the virus.

The aims of this study are to:

  1. To investigate whether IL-5 neutralization reduces the inflammatory response to viral airway infections in allergic asthma patients
  2. To investigate whether IL-5 neutralization prevents or reduces asthma symptoms during virus-induced asthma exacerbations
  3. To investigate whether IL-5 neutralization affects the cellular immune response to viral airway infections in allergic asthma patients
Read the detailed description

Mild allergic asthma subjects receive three times an infusion containing 750 mg of mepolizumab. Two weeks after the third infusion, subjects will be experimentally infected with RV16. One day before and six days after infection a bronchoscopy will be performed to collect bronchoalveolar lavage fluid and bronchial brushes. Blood will be collected at each infusion and each bronchoscopy and at least 6 weeks after infection. Lung function will be evaluated throughout the study.

Being tested
Mepolizumab, Placebo
Keywords
Asthma, Viral, Infection, Inflammation, Mepolizumab, Eosinophilia
Medical subject headings
Asthma, Virus Diseases, Infections, Inflammation, Eosinophilia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MepolizumabDrug

    Also called Mepolizumab, SB240563

    3 monthly intravenous infusions of 750 mg

  • PlaceboDrug

    3 monthly intravenous infusions with saline

Study groups in NCT01520051
Study groupRoleWhat they receive
MepolizumabExperimentalNot described
Receives: Drug: Mepolizumab
SalinePlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FEV1

    Change in pre-bronchodilator FEV1 between day 70 and day 77, i.e. 1 day prior and 6 days after RV16 challenge.

    Measured: 1 day prior and 6 days after RV16 challenge

  2. Questionnaire to score asthma and common cold complaints

    Measured: During 14 days following viral infection

Secondary outcomes (5)

  1. Viral load

    Viral load in nasal swab and bronchial brushes

    Measured: Day 6 after viral infection

  2. Sputum eosinophils

    Change in sputum eosinophils

    Measured: Before and after mepolizumab infusion

  3. Cell influx in bronchoalveolar lavage fluid

    Influx of neutrophils, eosinophils, macrophages, monocytes, T en B lymphocytes into the lungs

    Measured: 6 days after viral infection

  4. Pro-inflammatory cytokines in bronchoalveolar lavage fluid

    Measurement of IL-6, IL-8 and IFN-y in bronchoaveolar lavage fluid

    Measured: 6 days after viral infection

  5. Antibody production

    Anti RV-16 antibodies are measured in serum

    Measured: 6 weeks after infection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2013 (estimated)
  4. Study completionMar 2014 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01520051
Sponsor's protocol ID
MATERIAL
Acronym
MATERIAL
Status last verified
Feb 2012
First submitted
25 Jan 2012
Last updated
7 Feb 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Nair P, Pizzichini MM, Kjarsgaard M, Inman MD, Efthimiadis A, Pizzichini E, Hargreave FE, O'Byrne PM. Mepolizumab for prednisone-dependent asthma with sputum eosinophilia. N Engl J Med. 2009 Mar 5;360(10):985-93. doi: 10.1056/NEJMoa0805435.

    PubMed 19264687

  • Haldar P, Brightling CE, Hargadon B, Gupta S, Monteiro W, Sousa A, Marshall RP, Bradding P, Green RH, Wardlaw AJ, Pavord ID. Mepolizumab and exacerbations of refractory eosinophilic asthma. N Engl J Med. 2009 Mar 5;360(10):973-84. doi: 10.1056/NEJMoa0808991.

    PubMed 19264686

  • Leckie MJ, ten Brinke A, Khan J, Diamant Z, O'Connor BJ, Walls CM, Mathur AK, Cowley HC, Chung KF, Djukanovic R, Hansel TT, Holgate ST, Sterk PJ, Barnes PJ. Effects of an interleukin-5 blocking monoclonal antibody on eosinophils, airway hyper-responsiveness, and the late asthmatic response. Lancet. 2000 Dec 23-30;356(9248):2144-8. doi: 10.1016/s0140-6736(00)03496-6.

    PubMed 11191542

  • Message SD, Laza-Stanca V, Mallia P, Parker HL, Zhu J, Kebadze T, Contoli M, Sanderson G, Kon OM, Papi A, Jeffery PK, Stanciu LA, Johnston SL. Rhinovirus-induced lower respiratory illness is increased in asthma and related to virus load and Th1/2 cytokine and IL-10 production. Proc Natl Acad Sci U S A. 2008 Sep 9;105(36):13562-7. doi: 10.1073/pnas.0804181105. Epub 2008 Sep 3.

    PubMed 18768794

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mepolizumab in people with Asthma and Viral Infection, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

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 10 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Feb 2012. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Suzanne M Bal, PhD (+31 205668043, s.m.bal@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FEV1 (time frame: 1 day prior and 6 days after RV16 challenge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01520051, which also lists 4 linked publications.

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 7 Feb 2012; AzTrials last refreshed its copy on 7 Nov 2026.

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