Bronchial AsthmaNCT06331897
Bronchial Asthma & Its Exacerbation
An observational study of Bronchial Asthma, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchial Asthma
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jun 2026
- How long will I take part?
- 2 Years
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children group aged (2-18 years old ) who have bronchial asthma and its exacerbation
Who may be able to join
- 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 .
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
emad hammad el daly, Professor of Pediatrics contact
About this study
Official title: Assessment of Bronchial Asthma & Its Exacerbation : the Utility of Laboratory Investigation , Chest Imaging , Pulmonary Function Tests
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
Read the detailed 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 .
- Conditions
- Bronchial Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ragab Kamel Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331897
- Sponsor's protocol ID
- Bronchial asthma
- Status last verified
- Mar 2024
- First submitted
- 16 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bronchial Asthma & Its Exacerbation : the Utility of Laboratory Investigation , Chest Imaging , Pulmonary Function Tests
- ClinicalTrials.gov ID
- NCT06331897
- Acronym / sponsor ID
- Bronchial asthma
- Conditions
- Bronchial Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 26 Mar 2024 (actual)
- 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.
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
Detailed 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 .
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children group aged (2-18 years old ) who have bronchial asthma and its exacerbation
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (0 listed)
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
Assessment of Broncial asthma & its exacerbation : the utility of laboratory investigation , chest imaging , pulmonary function tests
Time frame: baseline
to assess : the role of spirometer in case of asthma exacerbation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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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.
emad hammad el daly, Professor of Pediatrics contact
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by Assiut University.
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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed ragab kamel, resident pediatrician (+20 109 610 6605, ibnragab34@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Broncial asthma & its exacerbation : the utility of laboratory investigation , chest imaging , pulmonary function tests (time frame: baseline). 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 26 Mar 2024.