Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621056
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
A Cohort Study of Risk Factors and Prognosis for Frequent Acute Asthma Exacerbations Phenotype
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Cohort Study of Risk Factors and Prognosis for Frequent Acute Asthma Exacerbations Phenotype
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute asthma exacerbations are an important public health problem and a major cause of disease progression and healthcare burden for people with asthma Frequent acute exacerbations are likely to be a distinct asthma phenotype Further research is needed to identify risk factors for frequent acute exacerbations but previous studies have mostly been cross-sectional studies at a single time point or prospective studies based on smaller sample sizes Moreover most of the studies on frequent acute exacerbations have been conducted in severe or refractory asthma whereas a certain proportion of non-severe asthmatics may also experience frequent acute exacerbations the risk factors of which remain to be further evaluated The main objectives of this project are to compare the baseline clinical inflammatory pathophysiological comorbidities environmental pollutants and meteorological exposure characteristics of patients with frequent acute exacerbations and those with non-frequent acute exacerbations irrespective of asthma severity and to develop a disease prediction model for frequent acute exacerbations and to develop a cohort of patients with frequent acute exacerbations of asthma observe their prognosis and response to treatment and search for prognostic factors associated with them The successful implementation of this study will help in the early identification of patients with frequent acute exacerbations clarify the factors associated with poor prognosis in this group of patients and thus provide an individualized plan for the treatment and prevention of this type of patients which is of great significance in achieving good asthma control reducing the burden of disease decreasing the cost of healthcare and saving clinical healthcare resources and costs
Detailed Description:
Asthma is an important respiratory disease Asthma affects 1-18 of the population worldwideThe prevalence of asthma in adults 20 years old in China is 42 numbering 457 million An acute asthma exacerbation is defined as a rapid increase in symptoms such as wheezing shortness of breath chest tightness and cough in a short period of time and deterioration of lung function that requires additional reliever medications to treat Acute asthma exacerbations are important events in the course of poorly controlled asthma leading to increased mortality decreased quality of life and extensive use of health care resources Reducing the frequency of acute asthma exacerbations is an important principle of asthma treatment It has been found that some patients with asthma are prone to acute exacerbations and these patients develop a stable phenotype Compared to patients with infrequent acute exacerbations asthma patients with frequent exacerbations are characterized by higher doses of inhaled glucocorticoids andor oral hormones poorer asthma control lower quality of life increased CRP and sputum eosinophils more rapid decline in lung function and a greater likelihood of continuing to have frequent acute exacerbations thereafter A high proportion of patients with frequent acute exacerbations are present in patients with asthma of varying severity Although treatment adherence and self-management skills are thought to be associated with acute asthma exacerbations however a higher proportion of asthma patients with good adherence and self-management skills still seem to be prone to acute exacerbations Furthermore reduction in asthma symptoms does not always correspond to the number or severity of acute attacks Unlike what has been previously observed in severe asthma there was no significant correlation between frequent acute exacerbations of asthma and asthma duration age of onset race and socioeconomic background The above studies suggest that frequent asthma exacerbations may represent a distinct asthma phenotype and that the underlying mechanisms of asthma severity and frequent acute exacerbations may be different We need more research on the pathogenic mechanisms and treatments for frequent acute exacerbations
Studies on risk factors for frequent acute exacerbations of asthma have yielded inconsistent results Some studies have shown that asthma severity is an independent risk factor for frequent acute asthma exacerbations However other findings show that when patients are compliant with treatment there are no specific characteristics that distinguish frequent acute exacerbations from infrequent acute exacerbations of the same asthma severity Poorly controlled asthma also greatly increases the risk of acute exacerbations but inconsistencies between the current level of control and the risk of acute exacerbations have also been reported A significant proportion of patients with mild to moderate asthma who have well controlled asthma have frequent exacerbations suggesting that the underlying mechanisms of baseline disease control and acute exacerbations may be driven by different factors in patients with mild to moderate asthma and that a reduction in asthma symptoms does not always coincide with the number or severity of acute exacerbations The pathophysiological mechanisms that cause frequent asthma exacerbations are unclear and a few studies have explored the inflammatory mechanisms underlying frequent asthma exacerbations with a multicenter cohort study of severe asthma showing that blood eosinophils were associated with asthma with a predisposition to acute exacerbations When asthma treatment is aimed at minimizing airway eosinophil counts the occurrence of frequent exacerbations can be prevented in moderate to severe asthmaHigh FeNO levels are also a risk factor for frequent acute exacerbations However sputum eosinophil percentages below 2 have also been reported in patients with frequent exacerbations Mechanisms related to viral infection may also play a role in frequent acute attacks One study evaluated the concentrations of interferon-gamma protein 10 IP-10 and neopterin and the results compared to the stable phase suggested that these two biomarkers of inflammation involved in viral infection were increased during acute episodes However the study did not confirm a difference in the concentrations of the two biomarkers between frequent and infrequent acute episodes There is still a need to identify biomarkers which may help to predict frequent acute episodes
In summary frequent acute exacerbations are likely to be a distinct asthma phenotype Further studies are needed to identify risk factors for frequent acute exacerbations but previous studies have mostly been cross-sectional studies at a single time point or prospective studies based on smaller sample sizes Moreover most of the studies on frequent acute exacerbations have been conducted in severe or refractory asthma whereas a certain proportion of patients with nonsevere asthma may also have frequent acute exacerbations and their risk factors still need to be further evaluated in addition previous studies have rarely looked at the effect of comorbidities on frequent acute exacerbations furthermore there have been no prospective studies to look at the prognosis of patients with frequent acute exacerbations and the response to treatments and prognostic factors associated with such attacks Finally the pathophysiologic mechanisms underlying frequent acute exacerbations of asthma require further investigation
Therefore the main objectives of this study were to compare the baseline clinical inflammatory pathophysiologic comorbid and environmental characteristics of patients with frequent acute exacerbations and those with infrequent acute exacerbations regardless of asthma severity and to develop a predictive model for frequent acute exacerbations and to develop a cohort of patients with frequent acute exacerbations of asthma to observe their prognosis and response to therapy and to search for prognostic-related factors The successful implementation of this study will help early identification of patients with frequent acute exacerbations clarify the factors associated with poor prognosis in this group of patients and thus provide individualized solutions for the treatment and prevention of patients with this type of asthma exploring the inflammatory mechanisms of frequent acute exacerbations of asthma will help to elucidate the pathogenesis of this subtype and to discover new specific therapeutic targets for this subtype
Studies on risk factors for frequent acute exacerbations of asthma have yielded inconsistent results Some studies have shown that asthma severity is an independent risk factor for frequent acute asthma exacerbations However other findings show that when patients are compliant with treatment there are no specific characteristics that distinguish frequent acute exacerbations from infrequent acute exacerbations of the same asthma severity Poorly controlled asthma also greatly increases the risk of acute exacerbations but inconsistencies between the current level of control and the risk of acute exacerbations have also been reported A significant proportion of patients with mild to moderate asthma who have well controlled asthma have frequent exacerbations suggesting that the underlying mechanisms of baseline disease control and acute exacerbations may be driven by different factors in patients with mild to moderate asthma and that a reduction in asthma symptoms does not always coincide with the number or severity of acute exacerbations The pathophysiological mechanisms that cause frequent asthma exacerbations are unclear and a few studies have explored the inflammatory mechanisms underlying frequent asthma exacerbations with a multicenter cohort study of severe asthma showing that blood eosinophils were associated with asthma with a predisposition to acute exacerbations When asthma treatment is aimed at minimizing airway eosinophil counts the occurrence of frequent exacerbations can be prevented in moderate to severe asthmaHigh FeNO levels are also a risk factor for frequent acute exacerbations However sputum eosinophil percentages below 2 have also been reported in patients with frequent exacerbations Mechanisms related to viral infection may also play a role in frequent acute attacks One study evaluated the concentrations of interferon-gamma protein 10 IP-10 and neopterin and the results compared to the stable phase suggested that these two biomarkers of inflammation involved in viral infection were increased during acute episodes However the study did not confirm a difference in the concentrations of the two biomarkers between frequent and infrequent acute episodes There is still a need to identify biomarkers which may help to predict frequent acute episodes
In summary frequent acute exacerbations are likely to be a distinct asthma phenotype Further studies are needed to identify risk factors for frequent acute exacerbations but previous studies have mostly been cross-sectional studies at a single time point or prospective studies based on smaller sample sizes Moreover most of the studies on frequent acute exacerbations have been conducted in severe or refractory asthma whereas a certain proportion of patients with nonsevere asthma may also have frequent acute exacerbations and their risk factors still need to be further evaluated in addition previous studies have rarely looked at the effect of comorbidities on frequent acute exacerbations furthermore there have been no prospective studies to look at the prognosis of patients with frequent acute exacerbations and the response to treatments and prognostic factors associated with such attacks Finally the pathophysiologic mechanisms underlying frequent acute exacerbations of asthma require further investigation
Therefore the main objectives of this study were to compare the baseline clinical inflammatory pathophysiologic comorbid and environmental characteristics of patients with frequent acute exacerbations and those with infrequent acute exacerbations regardless of asthma severity and to develop a predictive model for frequent acute exacerbations and to develop a cohort of patients with frequent acute exacerbations of asthma to observe their prognosis and response to therapy and to search for prognostic-related factors The successful implementation of this study will help early identification of patients with frequent acute exacerbations clarify the factors associated with poor prognosis in this group of patients and thus provide individualized solutions for the treatment and prevention of patients with this type of asthma exploring the inflammatory mechanisms of frequent acute exacerbations of asthma will help to elucidate the pathogenesis of this subtype and to discover new specific therapeutic targets for this subtype
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None