Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00957281
First received: August 9, 2009
Last updated: August 11, 2009
Last verified: August 2009
  Purpose

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
Asthma

Study Type: Observational
Study Design: 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

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation coefficient of levels of EBC biomarkers with levels of hs-CRP and oxidative stress [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Interaction effect of airway inflammation on the association between asthma severity and systemic inflammation, and vice versa [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma, serum, DNA and exhaled breath condensate


Enrollment: 748
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asthma
Asthma patients on inhaled corticosteroids

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years to 74 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 9, 2009
Last Updated: August 11, 2009
Health Authority: Hong Kong: Ethics Committee

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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014