Bronchial AsthmaNCT06472596
Risk of Chronic Kidney Disease in Bronchial Asthma
An observational study of Bronchial Asthma, run by Sohag University at 1 site in Egypt.
Trial summary
the study aims to determine the frequency and factors associated with chronic kidney disease among asthmatic patients in order to determine persons who are at risk of developing chronic kidney disease and require strict follow up in long run , to evaluate severity of asthma as a potential risk for developing kidney… 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
- What is being tested?
- CBC, CRP ,ESR, ABG , interleukin 6, tumor necrotic factor alpha
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 11 Jul 2025
- 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: cases (asthmatics) and control ( healthy ) from age of 2 years to 18 years
Who may be able to join
- all children diagnosed as bronchial asthma at sohag university hospitals from age of 2 years to age of 18 years and donot have any associated disease
Who cannot join
- persons who have any chronic illness persons who have any associated disease with bronchial asthma persons who missing clinical and laboratory investigations persons who refusing to give written informed consent for the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Marihan Nazmy Shehata
Sohag
Marihan Nazmy, 01224699399, marihan.nazmy@med.sohag.edu.eg
About this study
Official title: Risk of Developing Chronic Kidney Disease in Patients With Bronchial Asthma at Sohag University Hospitals
the study aims to determine the frequency and factors associated with chronic kidney disease among asthmatic patients in order to determine persons who are at risk of developing chronic kidney disease and require strict follow up in long run , to evaluate severity of asthma as a potential risk for developing kidney injury , to evaluate relationship between different inflammatory markers with severity of asthma and risk of deneloping chronic kidney disease
- Conditions
- Bronchial Asthma
- Being tested
- CBC, CRP ,ESR, ABG , interleukin 6, tumor necrotic factor alpha
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBC, CRP ,ESR, ABG , interleukin 6, tumor necrotic factor alphaDiagnostic test
compare results of investigations in asthmatics and non asthmatics
| Study group | Role | What they receive |
|---|---|---|
| cases ( asthmatic patients) | asthmatics investigated by serum creatinine , GFR calculation , ESR,CRP,ABG,CBC , serum electrolytes , interleukin6, tumor necrotic factor alpha Receives: Diagnostic Test: CBC, CRP ,ESR, ABG , interleukin 6, tumor necrotic factor alpha | |
| control (healthy persons) | healthy persons investigated by same investigations and compare results with asthmatics Receives: Diagnostic Test: CBC, CRP ,ESR, ABG , interleukin 6, tumor necrotic factor alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in kidney function in asthmatics
change in serum creatinine , GFR calculation
Measured: change in kidney function in asthmatics after diagnosis and start treatment through out the duration of study (an average 1 year )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion11 Jul 2025 (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 Sohag 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marihan Nazmy Shehata, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472596
- Sponsor's protocol ID
- soh-Med-24-05-11MS
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Developing Chronic Kidney Disease in Patients With Bronchial Asthma at Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT06472596
- Acronym / sponsor ID
- soh-Med-24-05-11MS
- Conditions
- Bronchial Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 11 Jul 2025 (estimated)
- First posted
- 25 Jun 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.
the study aims to determine the frequency and factors associated with chronic kidney disease among asthmatic patients in order to determine persons who are at risk of developing chronic kidney disease and require strict follow up in long run , to evaluate severity of asthma as a potential risk for developing kidney injury , to evaluate relationship between different inflammatory markers with severity of asthma and risk of deneloping chronic kidney disease
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases ( asthmatic patients) | – | Diagnostic Test: CBC, CRP ,ESR, ABG , interleukin 6, tumor necrotic factor alphaasthmatics investigated by serum creatinine , GFR calculation , ESR,CRP,ABG,CBC , serum electrolytes , interleukin6, tumor necrotic factor alpha |
| control (healthy persons) | – | Diagnostic Test: CBC, CRP ,ESR, ABG , interleukin 6, tumor necrotic factor alphahealthy persons investigated by same investigations and compare results with asthmatics |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- cases (asthmatics) and control ( healthy ) from age of 2 years to 18 years
Key inclusion criteria (1 listed)
- all children diagnosed as bronchial asthma at sohag university hospitals from age of 2 years to age of 18 years and donot have any associated disease
Key exclusion criteria (1 listed)
- persons who have any chronic illness persons who have any associated disease with bronchial asthma persons who missing clinical and laboratory investigations persons who refusing to give written informed consent for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBC, CRP ,ESR, ABG , interleukin 6, tumor necrotic factor alphacompare results of investigations in asthmatics and non asthmatics | Diagnostic test | cases ( asthmatic patients), control (healthy persons) |
Primary outcome
change in kidney function in asthmatics
Time frame: change in kidney function in asthmatics after diagnosis and start treatment through out the duration of study (an average 1 year )
change in serum creatinine , GFR calculation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Bronchial 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in kidney function in asthmatics (time frame: change in kidney function in asthmatics after diagnosis and start treatment through out the duration of study (an average 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 25 Jun 2024.