AsthmaNCT00957281
The Effect of Asthma on Systemic Inflammation, Oxidative Stress and Cardiovascular Morbidity
An observational study of Asthma, run by The University of Hong Kong at 4 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 74 years
- Conditions the study is for
- Asthma
- How many people
- 748 participants
- Where
- 4 sitesHong Kong
- Study dates
- Sep 2008to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Asthma patients with stable persistent asthma
- Current inhaled corticosteroid users
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Hong Kong4 sites
Kowloon Hospital
Hong Kong
Kwong Wah Hospital
Hong Kong
Queen Elizabeth Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
About this study
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
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.
Read the detailed description
Asthma is a chronic inflammatory airway disorder, associated with airflow obstruction and bronchial hyper-responsiveness, which affects about 10% of population in Hong Kong. It has been a major respiratory disease in Hong Kong that carries significant morbidity and high hospitalization burden in all ages. The use of long-term inhaled corticosteroid treatment in recent decades has become the cornerstone in the treatment of most patients with persistent asthma with reduction in its mortality. The ultimate goal of treatment is to achieve optimal control of airway inflammation and asthma-related mortality and morbidity.
In recent studies on the evaluation of airway and systemic inflammation in patients with asthma, various biomarkers have been measured in exhaled breath condensate (EBC), like nitric oxide, nitrates/nitrites and 8-isoprostane. Similarly, measurement of biomarkers in blood, notably high-sensitivity c-reactive protein (hs-CRP), 8-isoprostane and antioxidants (catalase, superoxide dismutase, glutathione peroxidase, glutathione), has also been used to reflect the levels of systemic inflammation and oxidative stress.
There has been substantial evidence from landmark epidemiological studies in the past 10 years, predominantly based on plasma hs-CRP, that chronic low grade systemic inflammation is an independent predictor for the development of hypertension, myocardial infarction, stroke, cardiovascular death and peripheral vascular disease. A dose-dependent risk association between hs-CRP and these cardiovascular morbidities has also been consistently demonstrated. Moreover, there has been overwhelming data to suggest the association between oxidative stress and the development cardiovascular disease. This association is easily understood in light of the cellular damages and endothelial dysfunction due to oxidative stress, which may lead to the development of atherosclerosis and cardiovascular morbidity.
In chronic obstructive pulmonary disease (COPD), a chronic inflammatory airway disorder characterized by irreversible airflow obstruction induced mainly by tobacco smoking, studies have demonstrated that, in acute exacerbations of COPD and smoking, there is a marked imbalance of redox status. The increased oxidative stress results in the inactivation of alveolar antiproteases, airspace epithelial damage, increased influx of neutrophils into lung tissue and the expression of pro-inflammatory mediators. Similarly, patients with COPD also have increase neutrophils, lymphocytes and TNF-α in the peripheral blood. In fact, many studies have demonstrated the existence of low grade systemic inflammation and oxidative stress in patients with COPD. Important studies published in recent 5 years have also linked the elevation of these systemic biomarkers, in a dose-dependent manner, to COPD severity and increased prevalence of cardiovascular and cerebrovascular morbidity and mortality in patients with COPD.
On the other hand, chronic airway inflammation is also the hallmark of asthma which involves the interplay of different types of inflammatory cells, including T-lymphocytes, eosinophils, neutrophils, macrophages and cytokines in the airway. Although the pathogenesis of asthma is incompletely understood, studies have shown that it is associated with a state of increased free radical formation, because cells derived from airways and peripheral blood of patients with asthma generate increased amount of reactive oxygen species, the level of which is related to severity of asthma. Besides, airway biomarkers indicating airway inflammation and oxidative stress have been consistently shown to be positively related to asthma severity and asthma control, which can be alleviated with treatment by inhaled corticosteroids. Additionally, recent preliminary studies have indicated that, apart from the presence of chronic airway inflammation (elevated EBC nitric oxide, EBC nitrites/nitrates and EBC 8-isoprostane), asthma may also be associated with chronic low grade systemic inflammation (elevation of plasma hs-CRP) and increased oxidative stress (increased 8-isoprostane; altered erythrocyte superoxide dismutase, catalase, glutathione peroxidase and glutathione).
Whether the presence of systemic inflammation and oxidative stress in asthma is actually a consequence of "overspill" of uncontrolled airway inflammation or the existence of an extrapulmonary source of inflammation remains unknown. At the moment, there is only little evidence on the correlation of airway and systemic inflammation in asthma, as well as the relation of systemic inflammation and oxidative stress to asthma severity. Intuitively, as in COPD, asthma-related systemic inflammation may as well increase the propensity for development of cardiovascular and cerebrovascular diseases. However, there is also a lack of study that describes the risk of cardiovascular outcomes of asthma-related systemic inflammation and oxidative stress.
Therefore, we conduct the current study with the primary objective to investigate the association of asthma severity with systemic inflammation and oxidative stress, and its effect on the risk of various cardiovascular morbidities. The secondary objective is to correlate airway inflammation and oxidative stress with systemic inflammation and oxidative stress in stable asthmatics.
- Conditions
- Asthma
- Keywords
- Asthma, Systemic inflammation, Oxidative stress, Cardiovascular morbidity, Airway inflammation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Asthma patients on inhaled corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
Correlation coefficient of levels of EBC biomarkers with levels of hs-CRP and oxidative stress
Measured: 1 year
Interaction effect of airway inflammation on the association between asthma severity and systemic inflammation, and vice versa
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startSep 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 748 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Chung-man James Ho, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957281
- Sponsor's protocol ID
- UW 08-306
- Status last verified
- Aug 2009
- First submitted
- 9 Aug 2009
- Last updated
- 12 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00957281
- Acronym / sponsor ID
- UW 08-306
- Conditions
- Asthma
- Keywords
- Asthma, Systemic inflammation, Oxidative stress, Cardiovascular morbidity, Airway inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 748 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 12 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asthma is a chronic inflammatory airway disorder, associated with airflow obstruction and bronchial hyper-responsiveness, which affects about 10% of population in Hong Kong. It has been a major respiratory disease in Hong Kong that carries significant morbidity and high hospitalization burden in all ages. The use of long-term inhaled corticosteroid treatment in recent decades has become the cornerstone in the treatment of most patients with persistent asthma with reduction in its mortality. The ultimate goal of treatment is to achieve optimal control of airway inflammation and asthma-related mortality and morbidity.
In recent studies on the evaluation of airway and systemic inflammation in patients with asthma, various biomarkers have been measured in exhaled breath condensate (EBC), like nitric oxide, nitrates/nitrites and 8-isoprostane. Similarly, measurement of biomarkers in blood, notably high-sensitivity c-reactive protein (hs-CRP), 8-isoprostane and antioxidants (catalase, superoxide dismutase, glutathione peroxidase, glutathione), has also been used to reflect the levels of systemic inflammation and oxidative stress.
There has been substantial evidence from landmark epidemiological studies in the past 10 years, predominantly based on plasma hs-CRP, that chronic low grade systemic inflammation is an independent predictor for the development of hypertension, myocardial infarction, stroke, cardiovascular death and peripheral vascular disease. A dose-dependent risk association between hs-CRP and these cardiovascular morbidities has also been consistently demonstrated. Moreover, there has been overwhelming data to suggest the association between oxidative stress and the development cardiovascular disease. This association is easily understood in light of the cellular damages and endothelial dysfunction due to oxidative stress, which may lead to the development of atherosclerosis and cardiovascular morbidity.
In chronic obstructive pulmonary disease (COPD), a chronic inflammatory airway disorder characterized by irreversible airflow obstruction induced mainly by tobacco smoking, studies have demonstrated that, in acute exacerbations of COPD and smoking, there is a marked imbalance of redox status. The increased oxidative stress results in the inactivation of alveolar antiproteases, airspace epithelial damage, increased influx of neutrophils into lung tissue and the expression of pro-inflammatory mediators. Similarly, patients with COPD also have increase neutrophils, lymphocytes and TNF-α in the peripheral blood. In fact, many studies have demonstrated the existence of low grade systemic inflammation and oxidative stress in patients with COPD. Important studies published in recent 5 years have also linked the elevation of these systemic biomarkers, in a dose-dependent manner, to COPD severity and increased prevalence of cardiovascular and cerebrovascular morbidity and mortality in patients with COPD.
On the other hand, chronic airway inflammation is also the hallmark of asthma which involves the interplay of different types of inflammatory cells, including T-lymphocytes, eosinophils, neutrophils, macrophages and cytokines in the airway. Although the pathogenesis of asthma is incompletely understood, studies have shown that it is associated with a state of increased free radical formation, because cells derived from airways and peripheral blood of patients with asthma generate increased amount of reactive oxygen species, the level of which is related to severity of asthma. Besides, airway biomarkers indicating airway inflammation and oxidative stress have been consistently shown to be positively related to asthma severity and asthma control, which can be alleviated with treatment by inhaled corticosteroids. Additionally, recent preliminary studies have indicated that, apart from the presence of chronic airway inflammation (elevated EBC nitric oxide, EBC nitrites/nitrates and EBC 8-isoprostane), asthma may also be associated with chronic low grade systemic inflammation (elevation of plasma hs-CRP) and increased oxidative stress (increased 8-isoprostane; altered erythrocyte superoxide dismutase, catalase, glutathione peroxidase and glutathione).
Whether the presence of systemic inflammation and oxidative stress in asthma is actually a consequence of "overspill" of uncontrolled airway inflammation or the existence of an extrapulmonary source of inflammation remains unknown. At the moment, there is only little evidence on the correlation of airway and systemic inflammation in asthma, as well as the relation of systemic inflammation and oxidative stress to asthma severity. Intuitively, as in COPD, asthma-related systemic inflammation may as well increase the propensity for development of cardiovascular and cerebrovascular diseases. However, there is also a lack of study that describes the risk of cardiovascular outcomes of asthma-related systemic inflammation and oxidative stress.
Therefore, we conduct the current study with the primary objective to investigate the association of asthma severity with systemic inflammation and oxidative stress, and its effect on the risk of various cardiovascular morbidities. The secondary objective is to correlate airway inflammation and oxidative stress with systemic inflammation and oxidative stress in stable asthmatics.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | –Asthma patients on inhaled corticosteroids |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Asthma patients with stable persistent asthma
- Current inhaled corticosteroid users
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Correlation coefficient of levels of EBC biomarkers with levels of hs-CRP and oxidative stress
Time frame: 1 year
Interaction effect of airway inflammation on the association between asthma severity and systemic inflammation, and vice versa
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2009.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung-man James Ho principal investigator
The University of Hong Kong
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by The University of Hong Kong at 4 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2009.