Causes, Characteristics and Mechanisms of Infective Exacerbations in Subjects With Asthma and Chronic Obstructive Pulmonary Disease (COPD)

NCT00512954 | Completed

• 1 other identifier: 06-2671
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Diseases of the airways (bronchi) of the lungs include asthma and chronic obstructive pulmonary disease (COPD), which are leading causes of reduced quality of life, loss of work, hospital admissions and deaths and result in a major economic burden to the patient and society. Worsening (exacerbation) of these conditions is common and is frequently due to viral or bacterial infection, which causes inflammation in the bronchi, i.e. bronchitis. Ways to objectively measure the inflammation are needed to improve diagnosis, cause and severity and to guide treatment. The investigators also need to understand changes in the body's defense (immune) mechanisms that make some patients have more frequent infective bronchitis. At present, sputum cell counts are able to identify different types of bronchitis, their severity and may be able to differentiate viral from bacterial infection. Other measurements in sputum, exhaled breath, blood and urine are also available to measure this inflammation. Measurement of immune cells in the blood gives us an idea about the working capacity of the immune system of the body. The investigators plan to study patients with asthma or COPD at the time of worsening of their condition to identify,

1. 1.To what extent viral or bacterial bronchitis can be diagnosed from tests of inflammation?
2. 2.How clearing of infection relates to clearing of inflammation?
3. 3.What are the changes in the body's defense mechanisms that make a patient more prone to frequent infective bronchitis?
4. 4.How do the measurements in sputum, exhaled breath, blood and urine relate to viral and bacterial bronchitis?
5. 5.What are the differences in the measurements in sputum, exhaled breath, blood and urine in asthma and COPD?

Conditions

Asthma; COPD

Keywords

airway inflammation; susceptibility to infections; inflammatory response in blood and urine; infective exacerbations; asthma; COPD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Asthmatics with 1 or more exacerbation in last calendar year.

You may qualify if:

• Male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects between 18 - 80 years.
• Any severity of exacerbation of obstructive airway disease attending the outpatient clinic.
• History of at least two exacerbations in the past 12 months prior to recruitment that required a course of prednisone or antibiotic or long acting bronchodilator or inhaled corticosteroid, in addition to the daily maintenance therapy.
• Signed written informed consent to participate in the protocol and ability to return to the outpatient clinic for repeated clinic visits.

You may not qualify if:

• If the exacerbation is severe enough to warrant hospitalization.
• Active malignancy.
• Significant gastrointestinal, hematological, cardiovascular or cerebrovascular disorder that would affect compliance with follow up visits.
• Recent (within the past 2 months) or planned (within the study period) lung surgery.
• Psychosis, alcoholism, active substance abuse or any personality disorder that would make compliance with the follow up visits problematic.
• Pregnant or nursing females, as this could affect the compliance during the trial.
• Any other medical or social condition, which in the opinion of the investigator could confound the interpretation of the data derived from this study.

Sponsors & Collaborators

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

Study Sites (1)

Firestone Institute for Respiratory Health, St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (9)

• Jayaram L, Pizzichini MM, Cook RJ, Boulet LP, Lemiere C, Pizzichini E, Cartier A, Hussack P, Goldsmith CH, Laviolette M, Parameswaran K, Hargreave FE. Determining asthma treatment by monitoring sputum cell counts: effect on exacerbations. Eur Respir J. 2006 Mar;27(3):483-94. doi: 10.1183/09031936.06.00137704.

  PMID: 16507847 BACKGROUND

• Johnston SL. Overview of virus-induced airway disease. Proc Am Thorac Soc. 2005;2(2):150-6. doi: 10.1513/pats.200502-018AW.

  PMID: 16113484 BACKGROUND

• Papi A, Bellettato CM, Braccioni F, Romagnoli M, Casolari P, Caramori G, Fabbri LM, Johnston SL. Infections and airway inflammation in chronic obstructive pulmonary disease severe exacerbations. Am J Respir Crit Care Med. 2006 May 15;173(10):1114-21. doi: 10.1164/rccm.200506-859OC. Epub 2006 Feb 16.

  PMID: 16484677 BACKGROUND

• Chaudhuri N, Dower SK, Whyte MK, Sabroe I. Toll-like receptors and chronic lung disease. Clin Sci (Lond). 2005 Aug;109(2):125-33. doi: 10.1042/CS20050044.

  PMID: 16033327 BACKGROUND

• Akbari O, Faul JL, Hoyte EG, Berry GJ, Wahlstrom J, Kronenberg M, DeKruyff RH, Umetsu DT. CD4+ invariant T-cell-receptor+ natural killer T cells in bronchial asthma. N Engl J Med. 2006 Mar 16;354(11):1117-29. doi: 10.1056/NEJMoa053614.

  PMID: 16540612 BACKGROUND

• Silkoff PE, Carlson M, Bourke T, Katial R, Ogren E, Szefler SJ. The Aerocrine exhaled nitric oxide monitoring system NIOX is cleared by the US Food and Drug Administration for monitoring therapy in asthma. J Allergy Clin Immunol. 2004 Nov;114(5):1241-56. doi: 10.1016/j.jaci.2004.08.042.

  PMID: 15536442 BACKGROUND

• Simon L, Gauvin F, Amre DK, Saint-Louis P, Lacroix J. Serum procalcitonin and C-reactive protein levels as markers of bacterial infection: a systematic review and meta-analysis. Clin Infect Dis. 2004 Jul 15;39(2):206-17. doi: 10.1086/421997. Epub 2004 Jul 2.

  PMID: 15307030 BACKGROUND

• Leuppi JD, Salome CM, Jenkins CR, Anderson SD, Xuan W, Marks GB, Koskela H, Brannan JD, Freed R, Andersson M, Chan HK, Woolcock AJ. Predictive markers of asthma exacerbation during stepwise dose reduction of inhaled corticosteroids. Am J Respir Crit Care Med. 2001 Feb;163(2):406-12. doi: 10.1164/ajrccm.163.2.9912091.

  PMID: 11179114 BACKGROUND

• Kharitonov SA, Barnes PJ. Exhaled biomarkers. Chest. 2006 Nov;130(5):1541-6. doi: 10.1378/chest.130.5.1541.

  PMID: 17099035 BACKGROUND

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Parameswaran K Nair, MD, PhD

  Firestone Institute for Respiratory Health, St. Joseph's Healthcare, Hamilton, Ontario

  PRINCIPAL INVESTIGATOR

• Frederick E Hargreave, MD

  Firestone Institute for Respiratory Health, St. Joseph's Healthcare, Hamilton, Ontario

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 8, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: January 19, 2011

Record last verified: 2009-07

Locations

CA (1)