How Airway Remodeling and Hyperresponsiveness Contribute to Airflow Obstruction in Asthma

NCT00186693 | Withdrawn

• 1 other identifier: 05-2453
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Airway hyperresponsiveness is a characteristic feature of the asthma. It is known that there is an association between airway hyperresponsiveness and eosinophilic airway inflammation. However, even though inflammation can be reduced with appropriate asthma therapy, it is typical that airway hyperresponsiveness improves only modestly with treatment. The determinants of airway hyperresponsiveness are unclear. It is also not clear as to the site of airway narrowing in asthma. It is hypothesized that airways beyond the 4th order have the greatest resistance. We hope to determine the relationships between the airway inflammation, remodeling of the airway and airway hyperresponsiveness. Through local instillation of methacholine at bronchoscopy we will be able to study proximal and distal airways and the extent to which they constrict in vivo

Conditions

Asthma

Keywords

Airway remodeling; Asthma; Hyper-responsiveness

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adults with asthma

You may not qualify if:

• adults age 18 - 65 years
• stable asthma, defined as no need for new medical intervention in previous 4 weeks
• pre FEV1 \> or = to 70% and able to have a methacholine challenge
• hyper-responsiveness as measured by methacholine challenge PC20 \< or = 16 mg/ml
• steroid naive or stable inhaled corticosteroid medication in previous 8 weeks
• symptomatic treatment with bronchodilators permitted
• able to give written informed consent
• no other active/unstable medical conditions as judged by investigator
• subjects must be suitable for bronchoscopy in opinion of the investigator
• female subjects must no be pregnant, nursing or unwilling to use appropriate contraception

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

St Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Asthma; Airway Remodeling

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerard Cox, MB FRCPC FRCPI

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2006
• Study Completion: June 1, 2009
• Last Updated: July 26, 2011

Record last verified: 2006-07

Locations

CA (1)