WheezingNCT06603584
Phenotypes of Preschool Wheezing Among Children Attending Sohag University Hospital
An observational study of Wheezing, run by Sohag University at 1 site in Egypt.
Trial summary
Wheezing in preschool children is very common, with a wide differential diagnosis. It is essential to be sure of the exact sound that parents are describing; the term 'wheeze' is often applied to non-specific sound.Approximately one-third of children are diagnosed with wheeze in the first 3 years of life, making… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Wheezing
- What is being tested?
- Chest x- Rays
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jun 2024to 4 Apr 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 6 years
- All sexes
- No healthy volunteers
- Child
Study population: - patients from the age of one to five years with recurrent wheezing
Who may be able to join
- patients from the age of one to five years with recurrent wheezing
Who cannot join
- Children above 5 years and below one year old.
- Failure to obtain informed consent.
- Children below 6 years with chest diseases other than wheezing
Trial locations and contacts
1 site in 1 country.
Mostfa A Mohammed, assistant professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
Wheezing in preschool children is very common, with a wide differential diagnosis. It is essential to be sure of the exact sound that parents are describing; the term 'wheeze' is often applied to non-specific sound.Approximately one-third of children are diagnosed with wheeze in the first 3 years of life, making wheeze one of the commonest respiratory symptoms.The differential diagnosis of wheeze is wide, and different management strategies are needed depending on the underlying phenotype. The word 'wheeze' is used to describe many different sounds. That can be heard by both clincians and parent. Even if true wheeze is heard, this should not be automatically assumed to be due to bronchospasm. Airway narrowing by mucus will produce true wheeze but does not respond to bronchodilators. Similarly, airway malacia, either related to intrinsic airway wall defects or loss of alveolar tethering points, are also causes of bronchodilatorunresponsive wheeze; indeed, bronchodilators, by reducing airway smooth muscle tone, may actually worsen airway narrowing.
- Conditions
- Wheezing
- Being tested
- Chest x- Rays
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest x- RaysRadiation
prebronchial Thicknening - Right upper lobe Patches suggesting Aspiration -Collapsing lobe
| Study group | Role | What they receive |
|---|---|---|
| group A | Bronchial Asthma Receives: Radiation: Chest x- Rays | |
| group B | Chronic Aspiration Receives: Radiation: Chest x- Rays | |
| group C | Primary Ciliary Dyskinesia Receives: Radiation: Chest x- Rays | |
| group D | Cystic Fibrosis Receives: Radiation: Chest x- Rays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume
Changes in Forced Expiratory Volume in bronchial Asthmatic Patient
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Jun 2024
- Primary completion4 Apr 2025 (estimated)
- Study completion4 Apr 2025 (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 WheezingStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ahmed Gamal Eldin, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603584
- Sponsor's protocol ID
- soh-Med-24-06-20MS
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fitzpatrick AM, Bacharier LB, Guilbert TW, Jackson DJ, Szefler SJ, Beigelman A, Cabana MD, Covar R, Holguin F, Lemanske RF Jr, Martinez FD, Morgan W, Phipatanakul W, Pongracic JA, Zeiger RS, Mauger DT; NIH/NHLBI AsthmaNet. Phenotypes of Recurrent Wheezing in Preschool Children: Identification by Latent Class Analysis and Utility in Prediction of Future Exacerbation. J Allergy Clin Immunol Pract. 2019 Mar;7(3):915-924.e7. doi: 10.1016/j.jaip.2018.09.016. Epub 2018 Sep 26.
PubMed 30267890Lowe LA, Simpson A, Woodcock A, Morris J, Murray CS, Custovic A; NAC Manchester Asthma and Allergy Study Group. Wheeze phenotypes and lung function in preschool children. Am J Respir Crit Care Med. 2005 Feb 1;171(3):231-7. doi: 10.1164/rccm.200406-695OC. Epub 2004 Oct 22.
PubMed 15502115Salehian S, Fleming L, Saglani S, Custovic A. Phenotype and endotype based treatment of preschool wheeze. Expert Rev Respir Med. 2023 Jul-Dec;17(10):853-864. doi: 10.1080/17476348.2023.2271832. Epub 2023 Nov 24.
PubMed 37873657Kwong CG, Bacharier LB. Phenotypes of wheezing and asthma in preschool children. Curr Opin Allergy Clin Immunol. 2019 Apr;19(2):148-153. doi: 10.1097/ACI.0000000000000516.
PubMed 30640211
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypes of Preschool Wheezing Among Children Attending Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06603584
- Acronym / sponsor ID
- soh-Med-24-06-20MS
- Conditions
- Wheezing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 4 Apr 2025 (estimated)
- Study completion
- 4 Apr 2025 (estimated)
- First posted
- 19 Sep 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.
Wheezing in preschool children is very common, with a wide differential diagnosis. It is essential to be sure of the exact sound that parents are describing; the term 'wheeze' is often applied to non-specific sound.Approximately one-third of children are diagnosed with wheeze in the first 3 years of life, making wheeze one of the commonest respiratory symptoms.The differential diagnosis of wheeze is wide, and different management strategies are needed depending on the underlying phenotype. The word 'wheeze' is used to describe many different sounds. That can be heard by both clincians and parent. Even if true wheeze is heard, this should not be automatically assumed to be due to bronchospasm. Airway narrowing by mucus will produce true wheeze but does not respond to bronchodilators. Similarly, airway malacia, either related to intrinsic airway wall defects or loss of alveolar tethering points, are also causes of bronchodilatorunresponsive wheeze; indeed, bronchodilators, by reducing airway smooth muscle tone, may actually worsen airway narrowing.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group A | – | Radiation: Chest x- RaysBronchial Asthma |
| group B | – | Radiation: Chest x- RaysChronic Aspiration |
| group C | – | Radiation: Chest x- RaysPrimary Ciliary Dyskinesia |
| group D | – | Radiation: Chest x- RaysCystic Fibrosis |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- - patients from the age of one to five years with recurrent wheezing
Key inclusion criteria (1 listed)
- patients from the age of one to five years with recurrent wheezing
Key exclusion criteria (3 listed)
- Children above 5 years and below one year old.
- Failure to obtain informed consent.
- Children below 6 years with chest diseases other than wheezing
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 |
|---|---|---|
| Chest x- Raysprebronchial Thicknening - Right upper lobe Patches suggesting Aspiration -Collapsing lobe | Radiation | group A, group B, group C, group D |
Primary outcome
Forced Expiratory Volume
Time frame: 6 months
Changes in Forced Expiratory Volume in bronchial Asthmatic Patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 30267890Fitzpatrick AM, Bacharier LB, Guilbert TW, Jackson DJ, Szefler SJ, Beigelman A, Cabana MD, Covar R, Holguin F, Lemanske RF Jr, Martinez FD, Morgan W, Phipatanakul W, Pongracic JA, Zeiger RS, Mauger DT; NIH/NHLBI AsthmaNet. Phenotypes of Recurrent Wheezing in Preschool Children: Identification by Latent Class Analysis and Utility in Prediction of Future Exacerbation. J Allergy Clin Immunol Pract. 2019 Mar;7(3):915-924.e7. doi: 10.1016/j.jaip.2018.09.016. Epub 2018 Sep 26.
- Background: PubMed 15502115Lowe LA, Simpson A, Woodcock A, Morris J, Murray CS, Custovic A; NAC Manchester Asthma and Allergy Study Group. Wheeze phenotypes and lung function in preschool children. Am J Respir Crit Care Med. 2005 Feb 1;171(3):231-7. doi: 10.1164/rccm.200406-695OC. Epub 2004 Oct 22.
- Background: PubMed 37873657Salehian S, Fleming L, Saglani S, Custovic A. Phenotype and endotype based treatment of preschool wheeze. Expert Rev Respir Med. 2023 Jul-Dec;17(10):853-864. doi: 10.1080/17476348.2023.2271832. Epub 2023 Nov 24.
- Background: PubMed 30640211Kwong CG, Bacharier LB. Phenotypes of wheezing and asthma in preschool children. Curr Opin Allergy Clin Immunol. 2019 Apr;19(2):148-153. doi: 10.1097/ACI.0000000000000516.
- Individual participant dataSharing planned: Undecided
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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.
Mostfa A Mohammed, assistant 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 Wheezing, 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 3 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 19 Sep 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?
Contact Amr A Farghal, resident (01020479524, amrahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Expiratory Volume (time frame: 6 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 NCT06603584, 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 19 Sep 2024.