Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376617
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
Pattern Of Isolated Fungi From Bronchoalveolar Lavage Among Patients With Bronchial Asthma
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Pattern Of Isolated Fungi From Bronchoalveolar Lavage Among Patients With Bronchial Asthma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to assess the pattern of isolated fungi from the respiratory air way bronchial tree from bronchoalvealar lavage BAL in asthmatic patients with uncontrolled or difficult to treat asthma
Detailed Description:
Asthma is a heterogeneous disease usually characterized by chronic airway inflammation and hyper responsiveness It is defined by the history of respiratory symptoms such as wheeze shortness of breath chest tightness and cough that vary over time and in intensity together with variable expiratory airflow limitation Airflow limitation may later become persistent Making the diagnosis of asthma is based on identifying both a characteristic pattern of respiratory symptoms such as wheezing shortness of breath dyspnea chest tightness or cough and variable expiratory airflow limitation Levy ML et al2006 In asthma lung function may vary between completely normal and severely obstructed in the same patient Poorly controlled asthma is associated with greater variability in lung function than well-controlled asthma Graham BL et al2019 A reduced FEV1 may be found with many other lung diseases or poor spirometric technique but a reduced ratio of FEV1 to forced vital capacity FEV1FVC compared with the lower limit of normal indicates expiratory airflow limitation Most patients with asthma can be well-controlled with low doses of anti- inflammatory agents However up to 10 of patients with asthma manifest with severe disease which leads to considerable limitation of activities of daily life and can be fatal Moore et al2007
Severe asthma remains a challenge for patients and clinicians as these patients are not only difficult to treat but also contribute disproportionately to the overall costs of asthma
The reasons for the variation in severity of asthma from patient to patient are not fully understood Several environmental factors such as house dust mite animal dander from pets and environmental fungi especially their continued exposure are known to worsen asthma control GINA 2023
Fungal diseases are a concern in the medical and public health community because of the increasing number of people with weakened immune systems and the advances in health care practices
Fungi can be linked to severe asthma in a multitude of ways including inhalation of fungal spores fungal sensitizationand allergic bronchopulmonary aspergillosis ABPA a severe degree of fungal sensitization culminating in irreversible bronchopulmonary damage Fungal infections are difficult to diagnose because clinical symptoms signs and radiographic manifestations are unspecific Therefore a definitive diagnosis requires direct identification of fungi from the site of infection
Funal infection of air way can be diagnosed by
Microscopic Examination
Culture of respiratory secretions sputumBAL tissue samples or blood
Serology assay of serum that detect host antibodies reacting to fungal elements
Antigen antibodie detection of components of the fungal wall that are shed into the bloodstream or other body fluids as the organism proliferates
PCR Up to 70 of severe asthmatics are IgE sensitized to fungi compared with 10 of mild-to-moderate asthmatics and 5 of the general population RICK et al2020
Exposure to outdoor fungal spores has been associated with worsening asthma symptoms poor lung function hospital admissions and asthma- related deathAgarwal et al2011
Bronchoscopy is used as a diagnostic tool to observe endobronchial lesions and to obtain clinical specimens such as bronchoalveolar lavage BAL and bronchial washing Fungal culture examination from clinical specimen of bronchoscopy could assist in diagnosing pulmonary mycosis Hermansyah et al2021
Bronchoalveolar lavage BAL is a common and relatively safe diagnostic procedure for the evaluation of patients with lung disease It often provides valuable diagnostic information when clinical history physical exam routine laboratory testing pulmonary function testing and radiographic imaging are insufficient to reach a definitive diagnosis Compared to sputum analysis BAL allows for targeted sampling of the lower respiratory tract with less microbial contamination from the upper aerodigestive tract Davidson et al2020
Aim of Work
The aim of this study is to assess the pattern of isolated fungi from the respiratory air way bronchial tree from bronchoalvealar lavage BAL in asthmatic patients with uncontrolled or difficult to treat asthma
Study Design
Prospective cross sectional observational study study locality All adult patients 18 years with difficult to treat bronchial asthma or frequent exacerbation admitted to or follow in outpatient clinic in Mansoura University chest department and Damietta chest hospital
Sample Size
BAL will collected from 60 patients with bronchial asthma
Patients and Methods
Patients with Uncontrolled bronchial asthma frequent exacerbations and difficult to treat symptoms despite adherence to medication according to GINA 2023
Patients will classified according to Asthma Control Questionnaire ACQ GINA2023 Asthma Control Questionnaire ACQ
In the past 4 weeks has the patient had
Daytime asthma symptoms more than twiceweek Yes No
Any night waking due to asthma Yes No
SABA reliever for symptoms more than twiceweek Yes No
Any activity limitation due to asthma Yes NO Well controlled Non of these Partly controlled 1-2 Uncontrolled 3-4 Inclusion criteria
Age 18 years or more
Patients with Uncontrolled bronchial asthma frequent exacerbations and difficult to treat symptoms despite adherence to medication
Exclusion criteria
1 Age less than 18 years
2 Patients who do not give consent for the procedure
3 Patients with unstable cardiac conditions recent myocardial infarction cardiac arrhythmia etc
4 Pregnant women
5 Patient already on antifungal treatment
6 Bleeding profile abnormality
7 patients during acute sever attacks
All the patients will be subjected to the following
1 Clinical evaluation
- Full history taking and clinical examination
2 Laboratory work up
CBC
Bleeding profile INR
3 ECG
4 pulmonary function test pftswith reversibility test Positive bronchodilator BD responsiveness reversibility test Is consider in adults if increase in FEV1 of 12 and 200 mL greater confidence if increase is 15 and 400 mL
Measure change 10-15 minutes after 200-400 mcg salbutamol albuterol or equivalent compared with pre-BD readings
Before bronchodilator reversibility testing short-acting and long-acting inhaled bronchodilators were withheld 4 and 12 hours short-acting and long-acting oral bronchodilators were withheld 8 and 12 hours before testing respectively Radiological work up
- CT chest or chest x ray 6- Bronchoscopy with BAL Bronchoscopy with BAL was performed according to standardized procedures designed to minimize oral contamination BAL was performed by sequentially instilling and then withdrawing 50 ml aliquots of sterile normal saline
Bronchoalveolar lavage fluid specimens collected under aseptic precautions was immediately transported to the laboratory for fungal processing BAL fluid should be collected in a labeled sterile container and transported expediently to the laboratory for analysis
Microbiology work up
BAL will stained by fungal staining with lactophenol stain as well as culture on Sabouraud dextrose agar
Some pathogenic fungi grow slowly in culture and require plates to be held for up to 2 weeks and in some case up to 4 weeks before being discarded as negative However many common pathogenic fungi such as Aspergillus fumigatus and Candida albicans will produce identifiable colonies within 1-3days Cultures should be examined at frequent intervals at least three times weekly
Statistical analysis
The collected data will be coded processed and analyzed using SPSS program Version 26 for windows The appropriate statistical tests will be used when needed P values less than 005 5 will be considered to be statically significant
Ethical consideration
Study protocol will be submitted for approval by IRB
Approval of the mangers of the health care facilities in which the study will be conducted
Informed written consent will be obtained from each participant sharing in the study
Confidentiality and personal privacy will be respected in all levels of the study Collected data will not be used for any other purpose
Severe asthma remains a challenge for patients and clinicians as these patients are not only difficult to treat but also contribute disproportionately to the overall costs of asthma
The reasons for the variation in severity of asthma from patient to patient are not fully understood Several environmental factors such as house dust mite animal dander from pets and environmental fungi especially their continued exposure are known to worsen asthma control GINA 2023
Fungal diseases are a concern in the medical and public health community because of the increasing number of people with weakened immune systems and the advances in health care practices
Fungi can be linked to severe asthma in a multitude of ways including inhalation of fungal spores fungal sensitizationand allergic bronchopulmonary aspergillosis ABPA a severe degree of fungal sensitization culminating in irreversible bronchopulmonary damage Fungal infections are difficult to diagnose because clinical symptoms signs and radiographic manifestations are unspecific Therefore a definitive diagnosis requires direct identification of fungi from the site of infection
Funal infection of air way can be diagnosed by
Microscopic Examination
Culture of respiratory secretions sputumBAL tissue samples or blood
Serology assay of serum that detect host antibodies reacting to fungal elements
Antigen antibodie detection of components of the fungal wall that are shed into the bloodstream or other body fluids as the organism proliferates
PCR Up to 70 of severe asthmatics are IgE sensitized to fungi compared with 10 of mild-to-moderate asthmatics and 5 of the general population RICK et al2020
Exposure to outdoor fungal spores has been associated with worsening asthma symptoms poor lung function hospital admissions and asthma- related deathAgarwal et al2011
Bronchoscopy is used as a diagnostic tool to observe endobronchial lesions and to obtain clinical specimens such as bronchoalveolar lavage BAL and bronchial washing Fungal culture examination from clinical specimen of bronchoscopy could assist in diagnosing pulmonary mycosis Hermansyah et al2021
Bronchoalveolar lavage BAL is a common and relatively safe diagnostic procedure for the evaluation of patients with lung disease It often provides valuable diagnostic information when clinical history physical exam routine laboratory testing pulmonary function testing and radiographic imaging are insufficient to reach a definitive diagnosis Compared to sputum analysis BAL allows for targeted sampling of the lower respiratory tract with less microbial contamination from the upper aerodigestive tract Davidson et al2020
Aim of Work
The aim of this study is to assess the pattern of isolated fungi from the respiratory air way bronchial tree from bronchoalvealar lavage BAL in asthmatic patients with uncontrolled or difficult to treat asthma
Study Design
Prospective cross sectional observational study study locality All adult patients 18 years with difficult to treat bronchial asthma or frequent exacerbation admitted to or follow in outpatient clinic in Mansoura University chest department and Damietta chest hospital
Sample Size
BAL will collected from 60 patients with bronchial asthma
Patients and Methods
Patients with Uncontrolled bronchial asthma frequent exacerbations and difficult to treat symptoms despite adherence to medication according to GINA 2023
Patients will classified according to Asthma Control Questionnaire ACQ GINA2023 Asthma Control Questionnaire ACQ
In the past 4 weeks has the patient had
Daytime asthma symptoms more than twiceweek Yes No
Any night waking due to asthma Yes No
SABA reliever for symptoms more than twiceweek Yes No
Any activity limitation due to asthma Yes NO Well controlled Non of these Partly controlled 1-2 Uncontrolled 3-4 Inclusion criteria
Age 18 years or more
Patients with Uncontrolled bronchial asthma frequent exacerbations and difficult to treat symptoms despite adherence to medication
Exclusion criteria
1 Age less than 18 years
2 Patients who do not give consent for the procedure
3 Patients with unstable cardiac conditions recent myocardial infarction cardiac arrhythmia etc
4 Pregnant women
5 Patient already on antifungal treatment
6 Bleeding profile abnormality
7 patients during acute sever attacks
All the patients will be subjected to the following
1 Clinical evaluation
- Full history taking and clinical examination
2 Laboratory work up
CBC
Bleeding profile INR
3 ECG
4 pulmonary function test pftswith reversibility test Positive bronchodilator BD responsiveness reversibility test Is consider in adults if increase in FEV1 of 12 and 200 mL greater confidence if increase is 15 and 400 mL
Measure change 10-15 minutes after 200-400 mcg salbutamol albuterol or equivalent compared with pre-BD readings
Before bronchodilator reversibility testing short-acting and long-acting inhaled bronchodilators were withheld 4 and 12 hours short-acting and long-acting oral bronchodilators were withheld 8 and 12 hours before testing respectively Radiological work up
- CT chest or chest x ray 6- Bronchoscopy with BAL Bronchoscopy with BAL was performed according to standardized procedures designed to minimize oral contamination BAL was performed by sequentially instilling and then withdrawing 50 ml aliquots of sterile normal saline
Bronchoalveolar lavage fluid specimens collected under aseptic precautions was immediately transported to the laboratory for fungal processing BAL fluid should be collected in a labeled sterile container and transported expediently to the laboratory for analysis
Microbiology work up
BAL will stained by fungal staining with lactophenol stain as well as culture on Sabouraud dextrose agar
Some pathogenic fungi grow slowly in culture and require plates to be held for up to 2 weeks and in some case up to 4 weeks before being discarded as negative However many common pathogenic fungi such as Aspergillus fumigatus and Candida albicans will produce identifiable colonies within 1-3days Cultures should be examined at frequent intervals at least three times weekly
Statistical analysis
The collected data will be coded processed and analyzed using SPSS program Version 26 for windows The appropriate statistical tests will be used when needed P values less than 005 5 will be considered to be statically significant
Ethical consideration
Study protocol will be submitted for approval by IRB
Approval of the mangers of the health care facilities in which the study will be conducted
Informed written consent will be obtained from each participant sharing in the study
Confidentiality and personal privacy will be respected in all levels of the study Collected data will not be used for any other purpose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None