Bronchial AsthmaNCT06141161
Assessment of Bronchial Asthma Among Patients Attending Sohag University Hospital
An observational study of Bronchial Asthma, run by Sohag University at 1 site in Egypt.
Trial summary
Asthma is a significant public health threat, affecting more than 300 million individuals globally. Asthma is classified as a non-communicable disease and leads to reduced quality of life, poor physical functioning and reduced emotional well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- corticosteroids
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 30 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: bronchial asthma patients aged more than 18 years of both sexes
Who may be able to join
- bronchial asthma patients aged more than 18 years, both sexes are included
Who cannot join
- children ,patients who are unable to do spiromerty or contrindecated
Trial locations and contacts
1 site in 1 country.
Kamal A Atta, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
Magdy M Amin, Professor
About this study
Asthma is a significant public health threat, affecting more than 300 million individuals globally. Asthma is classified as a non-communicable disease and leads to reduced quality of life, poor physical functioning and reduced emotional well-being. The impact of this disease can be widespread and extends beyond the person living with the disease, affecting the lives of their family members, carers, communities and the health care system (1).
Asthma is a variable chronic respiratory condition. It is characterized by symptoms of wheeze, cough, chest tightness, dyspnea and backed by variable airflow limitation, airway inflammation and airway hyper-responsiveness (AHR). The severity of asthma varies considerably, both between individuals and within individuals over time. Some people may have intermittent asthma and others may experience severe, potentially life-threatening disease (2, 3,4).
- Conditions
- Bronchial Asthma
- Being tested
- corticosteroids
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corticosteroidsDrug
inhailed or oral corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| group A, | group A (controlled bronchial asthma patients) Receives: Drug: corticosteroids | |
| group B | group B(uncontrolled bronchial asthma patients) Receives: Drug: corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of controlled bronchial asthma patients
to detect percent of controlled patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Nov 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doha Mohamed Ismail, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141161
- Sponsor's protocol ID
- Soh-Med-23-10-015MS
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dashash NA, Mukhtar SH. Prescribing for asthmatic children in primary care. Are we following guidelines? Saudi Med J. 2003 May;24(5):507-11.
PubMed 12847627Al-Moamary MS, Alhaider SA, Al-Hajjaj MS, Al-Ghobain MO, Idrees MM, Zeitouni MO, Al-Harbi AS, Al Dabbagh MM, Al-Matar H, Alorainy HS. The Saudi initiative for asthma - 2012 update: Guidelines for the diagnosis and management of asthma in adults and children. Ann Thorac Med. 2012 Oct;7(4):175-204. doi: 10.4103/1817-1737.102166.
PubMed 23189095Braido F, Canonica GW. Worldwide differences on the concept of control of asthma. Ther Adv Respir Dis. 2008 Feb;2(1):3-5. doi: 10.1177/1753465807087091.
PubMed 19124353National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.
PubMed 17983880
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bronchial Asthma Among Patients Attending Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06141161
- Acronym / sponsor ID
- Soh-Med-23-10-015MS
- Conditions
- Bronchial Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Nov 2023 (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.
Asthma is a significant public health threat, affecting more than 300 million individuals globally. Asthma is classified as a non-communicable disease and leads to reduced quality of life, poor physical functioning and reduced emotional well-being. The impact of this disease can be widespread and extends beyond the person living with the disease, affecting the lives of their family members, carers, communities and the health care system (1).
Asthma is a variable chronic respiratory condition. It is characterized by symptoms of wheeze, cough, chest tightness, dyspnea and backed by variable airflow limitation, airway inflammation and airway hyper-responsiveness (AHR). The severity of asthma varies considerably, both between individuals and within individuals over time. Some people may have intermittent asthma and others may experience severe, potentially life-threatening disease (2, 3,4).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A, | – | Drug: corticosteroidsgroup A (controlled bronchial asthma patients) |
| group B | – | Drug: corticosteroidsgroup B(uncontrolled bronchial asthma patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- bronchial asthma patients aged more than 18 years of both sexes
Key inclusion criteria (1 listed)
- bronchial asthma patients aged more than 18 years, both sexes are included
Key exclusion criteria (1 listed)
- children ,patients who are unable to do spiromerty or contrindecated
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 |
|---|---|---|
| corticosteroidsinhailed or oral corticosteroids | Drug | group A,, group B |
Primary outcome
percent of controlled bronchial asthma patients
Time frame: 12 months
to detect percent of controlled patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Background: PubMed 12847627Dashash NA, Mukhtar SH. Prescribing for asthmatic children in primary care. Are we following guidelines? Saudi Med J. 2003 May;24(5):507-11.
- Background: PubMed 23189095Al-Moamary MS, Alhaider SA, Al-Hajjaj MS, Al-Ghobain MO, Idrees MM, Zeitouni MO, Al-Harbi AS, Al Dabbagh MM, Al-Matar H, Alorainy HS. The Saudi initiative for asthma - 2012 update: Guidelines for the diagnosis and management of asthma in adults and children. Ann Thorac Med. 2012 Oct;7(4):175-204. doi: 10.4103/1817-1737.102166.
- Background: PubMed 19124353Braido F, Canonica GW. Worldwide differences on the concept of control of asthma. Ther Adv Respir Dis. 2008 Feb;2(1):3-5. doi: 10.1177/1753465807087091.
- Background: PubMed 17983880National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.
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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.
Kamal A Atta, Professor contact
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 21 Nov 2023. 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?
Contact Doha M ismail, Resident (01128028508, dohaismail@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent of controlled bronchial asthma patients (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06141161, which also lists 4 linked publications.
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 21 Nov 2023.