Atopic AsthmaNCT01420003

Kinetics of IgE Memory B Cells, Plasmablasts and Plasma Cells After Whole Lung Allergen Challenge in Mild Asthmatics

A study testing Bone Marrow Aspiration and Tonsil Biopsy in people with Atopic Asthma, run by Hamilton Health Sciences Corporation at 1 site in Canada.

Completed

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

Official record

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Trial summary

The purpose of this study is to characterize the time course of B cell activation after allergen challenge, and more specifically measure the M1 prime related biomarkers. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Atopic Asthma
What is being tested?: Bone Marrow Aspiration and Tonsil Biopsy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteCanada
Study dates: Nov 2011to Jul 2014
Phase: Interventional
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female volunteers 18 through 65 years of age.
Females must not be actively seeking pregnancy, must be using adequate and effective contraception
General good health
Mild to moderate, stable, allergic asthma
History of episodic wheeze and shortness of breath; FEV1 at baseline at least 70% of the predicted value
Able to understand and give written informed consent and has signed a written informed consent form approved by the investigator's REB

Show all 9Show fewer

Positive methacholine challenge
Positive skin-prick test to common aeroallergens (including cat, dust mite, grass, pollen)
Positive allergen-induced airway bronchoconstriction (a fall in FEV1 of at least 20% from baseline)

Who cannot join

A worsening of asthma or a respiratory tract infection within 6 weeks preceding study entry
History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness
History or symptoms of clinically significant autoimmune disease
History of clinically significant hematologic abnormality, including coagulopathy
Be pregnant or lactating
Use of corticosteroids, immunosuppressives, anticoagulants (warfarin or heparin) within 28 days prior to randomization into the study

Show all 12Show fewer

Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 48 hours of dosing or aspirin with 7 days of dosing
Have chronic use of any other medication for treatment of allergic lung disease other than short- and intermediate-acting ß2-agonists or ipratropium bromide
Use of caffeine-containing products or medications for 12 hours or alcohol or over the counter drugs including aspirin, cold and allergy medications for 48 hours or inhaled bronchodilators for 8 hours prior to methacholine and allergen challenges
Use of tobacco products of any kind currently or within the previous 12 months, or smoking history > 10 pack years.
Lung disease other than mild to moderate allergic asthma
Unwillingness or inability to comply with the study protocol for any other reason.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Cardio- Respiratory Research Laboratory, Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5

Other trials in Canada

About this study

The purpose of this study is to characterize the time course of B cell activation after allergen challenge, and more specifically measure the M1 prime related biomarkers.

Read the detailed description

M1 prime is a segment of IgE found only in the membrane form of IgE and not on soluble IgE found in serum. Membrane IgE (and M1prime) is expressed on IgE-switched B cells, IgE-memory B cels, and IgE-plasmablasts. Depletion of IgE-switched B cells and plasmablasts will reduce IgE-producing cells and serum IgE, and may be a target for treatment of allergic asthma. A humanized antibody targeting M1 prime is being developed by Genentech, Inc., as a potential therapeutic for asthma.

Currently, the efficacy of MEMP1972A is being assessed in an allergen challenge study in mild asthmatics (MOP4843g). Extensive biomarker samples have been incorporated in that study to characterize the mechanism of action (MOA) as well as the kinetics of the MOA of MEMP1972A, which are poorly understood at this time. Furthermore, samples for the B cell enriched peripheral blood flow cytometry and bone marrow aspirates to evaluate the kinetics and MOA of MEMP1972a are collected only 24 hr after allergen challenge due to visit and sample volume limitations. It is known that maximal B cell responses are expected ~7 days after allergen stimulation. Therefore, the purpose of this research study will be to characterize the time course of B cell activation after allergen challenge, and more specifically measure the M1 prime related biomarkers.

Conditions: Atopic Asthma
Being tested: Bone Marrow Aspiration, Tonsil Biopsy
Keywords: Allergen Challenge, B cell activation, M1 prime related biomarkers

What participants receive

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

Bone Marrow AspirationProcedure or surgery
3 per study
Tonsil BiopsyProcedure or surgery
Optional upon completion of study

Study groups in NCT01420003
Study group	Role	What they receive
Allergen Challenge	Experimental	Not described Receives: Procedure: Bone Marrow Aspiration; Procedure: Tonsil Biopsy

What is being measured

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

To characterize the time course of B cell activation after allergen challenge, and more specifically measure the M1 prime related biomarkers.
Measured: Within 7 days of allergen challenge

Timeline

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

Nov 2011Jul 2014

First posted19 Aug 2011 (estimated)
Study startNov 2011
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Atopic 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 N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01420003
Sponsor's protocol ID: MAC-GNE-07222011
Status last verified: Mar 2015
First submitted: 17 Aug 2011
Last updated: 20 Mar 2015
Results posted: No
Data monitoring committee: No

Publications

Bateman ED, Hurd SS, Barnes PJ, Bousquet J, Drazen JM, FitzGerald JM, Gibson P, Ohta K, O'Byrne P, Pedersen SE, Pizzichini E, Sullivan SD, Wenzel SE, Zar HJ. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008 Jan;31(1):143-78. doi: 10.1183/09031936.00138707.
PubMed 18166595
National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.
PubMed 17983880
Sears MR, Burrows B, Flannery EM, Herbison GP, Holdaway MD. Atopy in childhood. I. Gender and allergen related risks for development of hay fever and asthma. Clin Exp Allergy. 1993 Nov;23(11):941-8. doi: 10.1111/j.1365-2222.1993.tb00279.x.
PubMed 10779282
Boulet LP, Cartier A, Thomson NC, Roberts RS, Dolovich J, Hargreave FE. Asthma and increases in nonallergic bronchial responsiveness from seasonal pollen exposure. J Allergy Clin Immunol. 1983 Apr;71(4):399-406. doi: 10.1016/0091-6749(83)90069-6.
PubMed 6601124
Anto JM, Sunyer J, Rodriguez-Roisin R, Suarez-Cervera M, Vazquez L. Community outbreaks of asthma associated with inhalation of soybean dust. Toxicoepidemiological Committee. N Engl J Med. 1989 Apr 27;320(17):1097-102. doi: 10.1056/NEJM198904273201701.
PubMed 2710172
O'Hollaren MT, Yunginger JW, Offord KP, Somers MJ, O'Connell EJ, Ballard DJ, Sachs MI. Exposure to an aeroallergen as a possible precipitating factor in respiratory arrest in young patients with asthma. N Engl J Med. 1991 Feb 7;324(6):359-63. doi: 10.1056/NEJM199102073240602.
PubMed 1987459
Bellomo R, Gigliotti P, Treloar A, Holmes P, Suphioglu C, Singh MB, Knox B. Two consecutive thunderstorm associated epidemics of asthma in the city of Melbourne. The possible role of rye grass pollen. Med J Aust. 1992 Jun 15;156(12):834-7. doi: 10.5694/j.1326-5377.1992.tb136994.x.
PubMed 1603007
Platts-Mills TA, Tovey ER, Mitchell EB, Moszoro H, Nock P, Wilkins SR. Reduction of bronchial hyperreactivity during prolonged allergen avoidance. Lancet. 1982 Sep 25;2(8300):675-8. doi: 10.1016/s0140-6736(82)90709-7.
PubMed 6126624
HERXHEIMER H. The late bronchial reaction in induced asthma. Int Arch Allergy Appl Immunol. 1952;3(4):323-8. doi: 10.1159/000227979. No abstract available.
PubMed 13044326
O'Byrne PM, Dolovich J, Hargreave FE. Late asthmatic responses. Am Rev Respir Dis. 1987 Sep;136(3):740-51. doi: 10.1164/ajrccm/136.3.740. No abstract available.
PubMed 3115156
O'Byrne PM, Wood L. Interleukin-5 and allergic inflammation. Clin Exp Allergy. 1999 May;29(5):573-5. doi: 10.1046/j.1365-2222.1999.00556.x. No abstract available.
PubMed 10231314
Kloek J, Mortaz E, van Ark I, Lilly CM, Nijkamp FP, Folkerts G. Glutathione prevents the early asthmatic reaction and airway hyperresponsiveness in guinea pigs. J Physiol Pharmacol. 2010 Feb;61(1):67-72.
PubMed 20228417
Becker AB, Black C, Lilley MK, Bajwa K, Ford-Hutchinson AW, Simons FE, Tagari P. Antiasthmatic effects of a leukotriene biosynthesis inhibitor (MK-0591) in allergic dogs. J Appl Physiol (1985). 1995 Feb;78(2):615-22. doi: 10.1152/jappl.1995.78.2.615.
PubMed 7759431
Coyle AJ, Page CP, Atkinson L, Flanagan R, Metzger WJ. The requirement for platelets in allergen-induced late asthmatic airway obstruction. Eosinophil infiltration and heightened airway responsiveness in allergic rabbits. Am Rev Respir Dis. 1990 Sep;142(3):587-93. doi: 10.1164/ajrccm/142.3.587.
PubMed 2389910
Hamel R, McFarlane CS, Ford-Hutchinson AW. Late pulmonary responses induced by Ascaris allergen in conscious squirrel monkeys. J Appl Physiol (1985). 1986 Dec;61(6):2081-7. doi: 10.1152/jappl.1986.61.6.2081.
PubMed 3804916

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

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All Atopic Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Kinetics of IgE Memory B Cells, Plasmablasts and Plasma Cells After Whole Lung Allergen Challenge in Mild Asthmatics
ClinicalTrials.gov ID: NCT01420003
Acronym / sponsor ID: MAC-GNE-07222011
Conditions: Atopic Asthma
Keywords: Allergen Challenge, B cell activation, M1 prime related biomarkers
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Hamilton Health Sciences CorporationUniversity, hospital or other
Collaborators: Genentech, Inc.
Study start: Nov 2011
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 19 Aug 2011 (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 this study is to characterize the time course of B cell activation after allergen challenge, and more specifically measure the M1 prime related biomarkers.

Detailed description

Study design

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

Arm	Type	Receives
Allergen Challenge	Experimental	Procedure: Bone Marrow Aspiration, Procedure: Tonsil Biopsy

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male and female volunteers 18 through 65 years of age.
Females must not be actively seeking pregnancy, must be using adequate and effective contraception
General good health
Mild to moderate, stable, allergic asthma
History of episodic wheeze and shortness of breath; FEV1 at baseline at least 70% of the predicted value

Key exclusion criteria (12 listed)

A worsening of asthma or a respiratory tract infection within 6 weeks preceding study entry
History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness
History or symptoms of clinically significant autoimmune disease
History of clinically significant hematologic abnormality, including coagulopathy
Be pregnant or lactating

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
Bone Marrow Aspiration3 per study	Procedure or surgery	Allergen Challenge
Tonsil BiopsyOptional upon completion of study	Procedure or surgery	Allergen Challenge

Primary outcome

To characterize the time course of B cell activation after allergen challenge, and more specifically measure the M1 prime related biomarkers.
Time frame: Within 7 days of allergen challenge

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
Background: PubMed 18166595Bateman ED, Hurd SS, Barnes PJ, Bousquet J, Drazen JM, FitzGerald JM, Gibson P, Ohta K, O'Byrne P, Pedersen SE, Pizzichini E, Sullivan SD, Wenzel SE, Zar HJ. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008 Jan;31(1):143-78. doi: 10.1183/09031936.00138707.
Background: PubMed 17983880National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.
Background: PubMed 10779282Sears MR, Burrows B, Flannery EM, Herbison GP, Holdaway MD. Atopy in childhood. I. Gender and allergen related risks for development of hay fever and asthma. Clin Exp Allergy. 1993 Nov;23(11):941-8. doi: 10.1111/j.1365-2222.1993.tb00279.x.
Background: PubMed 6601124Boulet LP, Cartier A, Thomson NC, Roberts RS, Dolovich J, Hargreave FE. Asthma and increases in nonallergic bronchial responsiveness from seasonal pollen exposure. J Allergy Clin Immunol. 1983 Apr;71(4):399-406. doi: 10.1016/0091-6749(83)90069-6.
Background: PubMed 2710172Anto JM, Sunyer J, Rodriguez-Roisin R, Suarez-Cervera M, Vazquez L. Community outbreaks of asthma associated with inhalation of soybean dust. Toxicoepidemiological Committee. N Engl J Med. 1989 Apr 27;320(17):1097-102. doi: 10.1056/NEJM198904273201701.
Background: PubMed 1987459O'Hollaren MT, Yunginger JW, Offord KP, Somers MJ, O'Connell EJ, Ballard DJ, Sachs MI. Exposure to an aeroallergen as a possible precipitating factor in respiratory arrest in young patients with asthma. N Engl J Med. 1991 Feb 7;324(6):359-63. doi: 10.1056/NEJM199102073240602.
Background: PubMed 1603007Bellomo R, Gigliotti P, Treloar A, Holmes P, Suphioglu C, Singh MB, Knox B. Two consecutive thunderstorm associated epidemics of asthma in the city of Melbourne. The possible role of rye grass pollen. Med J Aust. 1992 Jun 15;156(12):834-7. doi: 10.5694/j.1326-5377.1992.tb136994.x.
Background: PubMed 6126624Platts-Mills TA, Tovey ER, Mitchell EB, Moszoro H, Nock P, Wilkins SR. Reduction of bronchial hyperreactivity during prolonged allergen avoidance. Lancet. 1982 Sep 25;2(8300):675-8. doi: 10.1016/s0140-6736(82)90709-7.
Background: PubMed 13044326HERXHEIMER H. The late bronchial reaction in induced asthma. Int Arch Allergy Appl Immunol. 1952;3(4):323-8. doi: 10.1159/000227979. No abstract available.
Background: PubMed 3115156O'Byrne PM, Dolovich J, Hargreave FE. Late asthmatic responses. Am Rev Respir Dis. 1987 Sep;136(3):740-51. doi: 10.1164/ajrccm/136.3.740. No abstract available.
Background: PubMed 10231314O'Byrne PM, Wood L. Interleukin-5 and allergic inflammation. Clin Exp Allergy. 1999 May;29(5):573-5. doi: 10.1046/j.1365-2222.1999.00556.x. No abstract available.
Background: PubMed 20228417Kloek J, Mortaz E, van Ark I, Lilly CM, Nijkamp FP, Folkerts G. Glutathione prevents the early asthmatic reaction and airway hyperresponsiveness in guinea pigs. J Physiol Pharmacol. 2010 Feb;61(1):67-72.

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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.

Gail M Gauvreau, PhD principal investigator

McMaster Health Sciences

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

Questions about this trial

What is this clinical trial studying?

A study testing Bone Marrow Aspiration and Tonsil Biopsy in people with Atopic Asthma, run by Hamilton Health Sciences Corporation at 1 site in Canada.

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 9 inclusion and 12 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 20 Mar 2015. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To characterize the time course of B cell activation after allergen challenge, and more specifically measure the M1 prime related biomarkers. (time frame: Within 7 days of allergen challenge). 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 NCT01420003, which also lists 17 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 20 Mar 2015.