Effect of in Vitro Blocking the Common Beta Chain on Cell Viability in Asthma

NCT01759849 | Completed

• 1 other identifier: Bc in vitro study
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines in vitro blockade of signaling through the β-chain, on viability, activation and differentiation of eosinophils and their progenitors collected in sputum, blood and bone marrow samples pre and post-allergen challenge from mild atopic asthmatic subjects.

Conditions

Asthma

Keywords

Asthma; β-chain signaling; allergen inhalation challenges; sputum; bone marrow aspirate; blood collection; -methacholine challenge

Outcome Measures

Primary Outcomes (1)

• Sputum Collection

  Three baseline sample collections will ensure sufficient numbers of cells are collected for proposed outcomes. Post allergen cells will be examined at time points when these populations are known to be at their highest frequency.

  7 hours post allergen

Study Arms (1)

Allergen challenge

Determination of the effects of a β-chain monoclonal antibody (MAb) on the function of cells naturally activated by in vivo allergen exposure, from donors with allergen-induced asthma

Other: Allergen

Interventions

Allergen OTHER

Allergen extract is administered by inhalation.

Allergen challenge

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with mild allergic asthma.

You may qualify if:

• Male and female volunteers 18 through 65 years of age.
• 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
• 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)

You may not qualify if:

• A worsening of asthma or a respiratory tract infection within 6 weeks preceding study entry
• Use of corticosteroids, immunosuppressives, anticoagulants (warfarin or heparin) within 28 days prior to randomization into the study
• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• CSL Limited: collaborator

Study Sites (1)

McMaster University Medical Center

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Links

• Study publication

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, bone marrow and induced sputum.

MeSH Terms

Conditions

Asthma

Interventions

Allergens

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Study Officials

• Gail M Gauvreau, PhD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: January 3, 2013
• Study Start: November 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: July 13, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)