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The Effect of Asthma on Systemic Inflammation, Oxidative Stress and Cardiovascular Morbidity

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ClinicalTrials.gov Identifier: NCT00957281
Recruitment Status : Completed
First Posted : August 12, 2009
Last Update Posted : August 12, 2009
Sponsor:
Information provided by:
The University of Hong Kong

Brief Summary:
Asthma is a chronic airway inflammation which involves the interplay of different types of inflammatory cells and cytokines in the airway. The presence of systemic inflammation and oxidative stress in asthma suggests that it has a propensity to develop cardiovascular morbidity. Recent small scale studies have demonstrated that asthma severity may be associated with both airway and systemic inflammation. The investigators' study aims at linking asthma severity to airway and systemic inflammation, and subsequently to cardiovascular morbidity if a significant association of the aforementioned is present. The role of airway inflammation in contribution to systemic inflammation , and potential interaction between these two conditions will also be studied.

Condition or disease
Asthma

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 748 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Association of Asthma With Systemic Inflammation and Oxidative Stress, and Its Effect on the Risk of Cardiovascular Morbidity in Adult With Stable Asthma
Study Start Date : September 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
Asthma
Asthma patients on inhaled corticosteroids



Primary Outcome Measures :
  1. Change in level of hs-CRP and oxidative stress status in relation to change in asthma severity , in terms of median, interquartile range and 95% confidence interval [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Correlation coefficient of levels of EBC biomarkers with levels of hs-CRP and oxidative stress [ Time Frame: 1 year ]
  2. Interaction effect of airway inflammation on the association between asthma severity and systemic inflammation, and vice versa [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Plasma, serum, DNA and exhaled breath condensate


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Ages Eligible for Study:   35 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Asthma patients will be recruited from asthma clinics of 4 centres in Hong Kong, including Queen Mary Hospital, Queen Elizabeth Hospital, Kowloon Hospital and Kwong Wah Hospital.
Criteria

Inclusion Criteria:

  • Asthma patients with stable persistent asthma
  • Current inhaled corticosteroid users

Exclusion Criteria:

  • On maintenance oral steroid
  • Systemic steroid use in recent 1 month
  • Asthma exacerbation (GINA criteria) in recent 1 month (ie daytime or nocturnal symptoms increment, detectable wheezing on physical examination, drop in peak flow rate, drop in spirometry indexes, increase in asthma medication, emergency medical attendance for asthma, days off work for asthma etc)
  • Inhaled corticosteroid use for < 6 months
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957281


Locations
Hong Kong
Kowloon Hospital
Hong Kong, Hong Kong
Kwong Wah Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Chung-man James Ho The University of Hong Kong

Responsible Party: Dr Ho Chung Man James, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00957281     History of Changes
Other Study ID Numbers: UW 08-306
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: August 12, 2009
Last Verified: August 2009

Keywords provided by The University of Hong Kong:
Asthma
Systemic inflammation
Oxidative stress
Cardiovascular morbidity
Airway inflammation

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes