AsthmaNCT00802438

Eosinophilic Airway Inflammation and Mepolizumab

A study testing mepolizumab in people with Asthma, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A drug (mepolizumab) that reduces allergic inflammation will affect the function of allergy cells called eosinophils which are produced by the body in response to allergen exposure. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Asthma
What is being tested?: mepolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2008to 1 Mar 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Males or females age 18 to 50 yrs,
History of asthma based upon presence of asthma symptoms such as cough, shortness of breath, wheeze or chest tightness,
positive skin-prick test to a House Dust Mite extract,
Forced expiratory volume at one second >70% predicted pre-albuterol, > 80% predicted post albuterol
>12% increase in Forced expiratory volume at one second following inhaled albuterol (180 µg) and/or
airway responsiveness to methacholine (PC20 <8mg/ml).

Show all 10Show fewer

> 20% immediate drop in FEV1 following inhaled antigen challenge.
Safety laboratory assessments within normal ranges (labs to include complete blood count with differential, blood urea nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, Prothrombin time, Partial Thromboplastin Time, and platelet count)
Female subjects of child-bearing potential must have a negative urine pregnancy test (urine HCG) within 48 hours of the methacholine challenge at Visit 2 and agree to use a reliable method of birth control for the duration of the study (reliable methods of birth control can include abstinence, barrier methods, oral contraceptives, injection contraceptives or skin absorption contraceptives).
In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements.

Who cannot join

Use of inhaled or systemic corticosteroids or leukotriene inhibitors within 1 month of screening.
Treatment with Omalizumab (anti-IgE) within 9 months of screening visit
Concomitant use of any other monoclonal antibody
Respiratory infection within 4 weeks of study
Unstable asthma as indicated by self-report of increased symptoms or increased beta-agonist use over the previous 2 weeks.
Female subjects who are pregnant, nursing or have a pregnancy planned during the course of study

Show all 14Show fewer

Current smokers (defined as smoked within the last year) or a former smoker with a history of >5 pack years.
Major health problems such as heart disease, type I and II diabetes or lung diseases other than asthma. Decisions regarding this criteria will be based upon the judgment of the investigator.
Previous malignancy.
Medication other than for asthma, allergies or contraception and that the investigator feels may interfere with the conduct of study (e.g. monoamine oxidase inhibitors and B-adrenergic antagonists in any form)
Known history of allergic reaction to previous antibody administration.
Prior treatment with an anti-interleukin-5 monoclonal antibody,
Use of an investigational drug within 30 days of entering the study,
History of noncompliance with medical regimens or subjects who are considered unreliable.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin- Madison
Madison, Wisconsin, 53792-9988

Other trials in United States

About this study

Official title: Eosinophilic Airway Inflammation: Relationship to Remodeling and Modulation by Mepolizumab

A drug (mepolizumab) that reduces allergic inflammation will affect the function of allergy cells called eosinophils which are produced by the body in response to allergen exposure.

Conditions: Asthma
Being tested: mepolizumab
Keywords: asthma, allergic inflammation, interleukin-5
Medical subject headings: Asthma

What participants receive

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

mepolizumabBiological
Also called anti-interleukin 5
up to three monthly doses of 750mg i.v. mepolizumab

Study groups in NCT00802438
Study group	Role	What they receive
Mepolizumab	Experimental	up to 3 monthly doses of 750mg i.v. mepolizumab Receives: Biological: mepolizumab

What is being measured

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

The Primary Endpoint of the Study is the Percent of Eosinophils in the Bronchoalveolar Lavage Fluid After Segmental Allergen Challenge, Before and After Mepolizumab Administration (Bronchoscopy #2 vs. Bronchoscopy #4).
Percent of eosinophils was determined in the bronchoalveolar lavage fluid collected from the participant after segmental allergen challenge. This was done via differential cell count using Hema-3 stain. Cell differentials were determined by counting a total of 1000 cells on two cytospin preparations. The percent eosinophils were done before and after administration of mepolizumab for a specified amount of time (up to 3 months of administration).
Measured: before and after up to 3 months of Mepo.

Secondary outcomes (1)

Effect of Mepolizumab on Bronchoalveolar Lavage Fluid Concentrations of IL-5 Cytokine Before and After Mepolizumab
IL-5 was measured via ELISA on bronchoalveolar lavage fluid before and after mepolizumab administration (up to 3 months of administration). Fluid was prepared in LowCross-Buffer to minimize potential matrix effects. A 1/2 dilution of 1X bronchoalveolar fluid was used for IL-5 detection. Data are expressed as pg/mL and are extrapolated to 1X.
Measured: before and after up to 3 months of Mepo

Timeline

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

1 Jun 20081 Mar 2013

First posted5 Dec 2008 (estimated)
Study start1 Jun 2008
Primary completion1 Mar 2013
Study completion1 Mar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
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 N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00802438
Sponsor's protocol ID: H-2007-0311
Status last verified: Mar 2019
First submitted: 4 Dec 2008
Last updated: 10 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Kelly EA, Esnault S, Liu LY, Evans MD, Johansson MW, Mathur S, Mosher DF, Denlinger LC, Jarjour NN. Mepolizumab Attenuates Airway Eosinophil Numbers, but Not Their Functional Phenotype, in Asthma. Am J Respir Crit Care Med. 2017 Dec 1;196(11):1385-1395. doi: 10.1164/rccm.201611-2234OC.
PubMed 28862877

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Eosinophilic Airway Inflammation: Relationship to Remodeling and Modulation by Mepolizumab
ClinicalTrials.gov ID: NCT00802438
Acronym / sponsor ID: H-2007-0311
Conditions: Asthma
Keywords: asthma, allergic inflammation, interleukin-5
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: 1 Jun 2008 (actual)
Primary completion: 1 Mar 2013 (actual)
Study completion: 1 Mar 2013 (actual)
First posted: 5 Dec 2008 (estimated)
Results: Posted 12 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A drug (mepolizumab) that reduces allergic inflammation will affect the function of allergy cells called eosinophils which are produced by the body in response to allergen exposure.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Mepolizumab	Experimental	Biological: mepolizumabup to 3 monthly doses of 750mg i.v. mepolizumab

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Males or females age 18 to 50 yrs,
History of asthma based upon presence of asthma symptoms such as cough, shortness of breath, wheeze or chest tightness,
positive skin-prick test to a House Dust Mite extract,
Forced expiratory volume at one second >70% predicted pre-albuterol, > 80% predicted post albuterol
>12% increase in Forced expiratory volume at one second following inhaled albuterol (180 µg) and/or

Key exclusion criteria (14 listed)

Use of inhaled or systemic corticosteroids or leukotriene inhibitors within 1 month of screening.
Treatment with Omalizumab (anti-IgE) within 9 months of screening visit
Concomitant use of any other monoclonal antibody
Respiratory infection within 4 weeks of study
Unstable asthma as indicated by self-report of increased symptoms or increased beta-agonist use over the previous 2 weeks.

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
mepolizumabAlso: anti-interleukin 5up to three monthly doses of 750mg i.v. mepolizumab	Biological	Mepolizumab

Primary outcome

The Primary Endpoint of the Study is the Percent of Eosinophils in the Bronchoalveolar Lavage Fluid After Segmental Allergen Challenge, Before and After Mepolizumab Administration (Bronchoscopy #2 vs. Bronchoscopy #4).
Time frame: before and after up to 3 months of Mepo.
Percent of eosinophils was determined in the bronchoalveolar lavage fluid collected from the participant after segmental allergen challenge. This was done via differential cell count using Hema-3 stain. Cell differentials were determined by counting a total of 1000 cells on two cytospin preparations. The percent eosinophils were done before and after administration of mepolizumab for a specified amount of time (up to 3 months of administration).

1 secondary outcome

Effect of Mepolizumab on Bronchoalveolar Lavage Fluid Concentrations of IL-5 Cytokine Before and After Mepolizumab
Time frame: before and after up to 3 months of Mepo

Results and safety

Results posted to the registry on 12 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mepolizumab	38	10

Primary outcome: The Primary Endpoint of the Study is the Percent of Eosinophils in the Bronchoalveolar Lavage Fluid After Segmental Allergen Challenge, Before and After Mepolizumab Administration (Bronchoscopy #2 vs. Bronchoscopy #4).

Time frame: before and after up to 3 months of Mepo.. Median (Inter-Quartile Range). Unit: percent of bronchoalveolar eosinophils

Measure	Mepolizumab n = 10
Pre Mepolizumab	73 (52 to 81)
Post Mepolizumab	31 (4 to 49)

Mepolizumab: p <0.0001, t-test, 2 sided

Population analysed: Participants had mild allergic asthma with a positive skin-prick test to house dust mite, ragweed, or a standardized extract of cat, a pre-180 4g albuterol FEV1 ≥70%, a post-albuterol FEV1 ≥ 80%; airway reversibility to albuterol (180 4g) ≥12% and/or airway hyper-reactivity to methacholine (PC20 ≤8 mg/ml).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Each participant was followed anywhere between 36 weeks to 45 weeks depending on treatment path.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mepolizumab	0 of 38 (0%)	8 of 38 (21.1%)	0 of 38

Limitations and caveats (from the sponsor): Our small sample size limits any meaningful consideration about the mechanisms of mepolizumab's clinical action. The prolonged time commitment and inclusion of four bronchoscopies affected subject retention and limited the sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28862877Kelly EA, Esnault S, Liu LY, Evans MD, Johansson MW, Mathur S, Mosher DF, Denlinger LC, Jarjour NN. Mepolizumab Attenuates Airway Eosinophil Numbers, but Not Their Functional Phenotype, in Asthma. Am J Respir Crit Care Med. 2017 Dec 1;196(11):1385-1395. doi: 10.1164/rccm.201611-2234OC.
Individual participant dataSharing planned: Undecided

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

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.

Nizar N Jarjour, MD principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing mepolizumab in people with Asthma, run by University of Wisconsin, Madison at 1 site in United States.

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 14 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: finished, as of the sponsor's last update on 10 Apr 2019. 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 United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Primary Endpoint of the Study is the Percent of Eosinophils in the Bronchoalveolar Lavage Fluid After Segmental Allergen Challenge, Before and After Mepolizumab Administration (Bronchoscopy #2 vs. Bronchoscopy #4). (time frame: before and after up to 3 months of Mepo.). 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 NCT00802438, which also lists 1 linked publication.

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 10 Apr 2019.