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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06331897
Other study ID # Bronchial asthma
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2025
Est. completion date June 1, 2026

Study information

Verified date March 2024
Source Assiut University
Contact Mohamed ragab kamel, resident pediatrician
Phone +20 109 610 6605
Email ibnragab34@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Our goals is to assess : 1¬_ the role of spirometer in case of asthma exacerbation 2_hematological parameters (N/L ratio & platelet indices &CRP )in asthma exacerbation for diagnosing and classifying asthma severity and its exacerbation


Description:

Bronchial asthma is a chronic inflammatory disease characterized by bronchial hyper-reactivity, reversible airway obstruction, and excessive mucus production that arises from an inappropriate stimulation of the immune system, especially by environmental aeroallergens .Bronchial asthma exacerbations are episodes described by progressive increase in symptoms of cough, wheezing, shortness of breath, and/or chest tightness, with a progressive decrease in lung function . Few tests are being used for diagnosis of asthma, but at present, no established biomarker is available that may be used for diagnosis and prognosis of asthma . Platelet indices and C-reactive protein (CRP) are markers that reflect a systemic inflammatory response . Bronchial obstruction, variable over time and reversible after using bronchodilator is the hallmark of the respiratory function in bronchial asthma. There are patients with "atypical" functional tests or in whom routine tests (spirometry, peak-flowmetry) are not sufficient for asthma diagnosis (thus necessitating more complex functional tests). Pulmonary function evaluation confirms the diagnostic, establishes disease severity and contributes to disease monitoring. Quality criteria verification (e.g. acceptability of the measurements and reproducibility of the parameters) should precede any interpretation . Neutrophilic, eosinophilic, paucigranulocytic or mixed granulocytic types are four various endotypes of asthma [6] depending on cell counts of peripheral blood . Neutrophilic inflammations have been studied to be associated with a poor asthma control . In addition to persistent asthma symptoms and atopy, they have been reported to be associated with the presence of eosinophilic inflammation in asthmatic patients . Accordingly, NLR increase in asthmatics was considered. However, data related to NLR in Asthmatic patients is inadequate . Though association between asthma and NLR, was discovered by earlier researches in adults, recent researches did not study NLR relation to neutrophilic asthma . So, we aimed to assess the relation of NLR and bronchial asthma severity and to determine NLR discriminative performance between controlled and uncontrolled asthma . Platelet indices, which include the mean platelet volume (MPV), platelet distribution width (PDW), plateletcrit (PCT), and platelet large cell correlated with white blood cells, PaO2, and symptoms duration, and negatively correlated with forced expiratory volume in the first second, symptoms duration, and hs-CRP (P<0.001). Higher autophagy of neutrophils has been described in many pulmonary disorders as well as neutrophil extracellular traps and exosomes that has been newly studied as deriving from neutrophil . So neutrophils role in pulmonary diseases have been established. Despite pulmonary diseases pathogeneses are being studied widely, there is still more and more to get clarification of the discrepancy and complexity, particularly the contribution of different immune mechanisms in the progress of pulmonary disorders .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 1, 2026
Est. primary completion date January 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of Bronchial asthma Disease - must be able to applied to spirometer Exclusion Criteria: patients have 1-other chest diseases 2- diabetes mellitus and hypertension 3- malignancies and hematological disorder 4- valvular lesions , coronaries disease and heart failure 5- autoimmune diseases .

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of Broncial asthma & its exacerbation : the utility of laboratory investigation , chest imaging , pulmonary function tests to assess : the role of spirometer in case of asthma exacerbation baseline
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