Asthma (Diagnosis)NCT05776537
Assessment of Asthma Mimics Among Newly Diagnosed Bronchial Asthma Patients
A study testing Fibreoptic bronchoscopy in people with Asthma (Diagnosis), run by Zagazig University at 1 site in Egypt.
Trial summary
The aim of the study was to identify the percentage of patients in whom the diagnosis of current asthma was confirmed or ruled out after clinical, spirometric assessment and utilizing all the possible investigations with a six month follow up period for both groups. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Asthma (Diagnosis)
- What is being tested?
- Fibreoptic bronchoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Jun 2022
- Phase
- Interventional
- 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 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Patients aged ≥ 18 years who had newly clinically diagnosed bronchial asthma (the diagnosis was achieved in the previous one year, to allow us to get the previous diagnostic reports) whether the diagnosis of asthma was initially made based on clinical assessment alone or both clinical and spirometric assessment. 2) Both sexes were included.
Who cannot join
- 1) Patients who were using long-term oral steroids that may mask the diagnosis; 2) unable to do spirometry or contra-indicated. 3) pregnancy. 4) Definite diagnosis of other chest diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Asthma Mimics Among Newly Diagnosed Bronchial Asthma Patients in Zagazig University Hospitals.
The aim of the study was to identify the percentage of patients in whom the diagnosis of current asthma was confirmed or ruled out after clinical, spirometric assessment and utilizing all the possible investigations with a six month follow up period for both groups.
Read the detailed description
The diagnosis of bronchial asthma relies on the existence of characteristic respiratory symptoms which are reversible and variable (diurnal and seasonal) with variable airflow limitation. Unfortunately, bronchial asthma may mimic different pulmonary and non-pulmonary diseases regarding their similar clinical presentations so accurate assessment is required to exclude other possible diagnosis before confirming the diagnosis of bronchial asthma.
There are various phenotypes of asthma as; atopic, non-atopic, and late-onset asthma, which may not be easily diagnosed in the community. Also, asthma may show intermittent versus a relapsing /remitting course, so it is difficult to be diagnosed by a single physician visit. Different studies have found that patients with bronchial asthma were treated empirically without full assessment either to ensure or exclude the asthma diagnosis.
Some symptoms as chest wheezes and breathlessness may be presented commonly in bronchial asthma and other mimic diseases as; chronic obstructive pulmonary disease, bronchiectasis, congestive heart failure, vocal cord disorders, hypersensitivity pneumonitis, endobronchial tumours, pulmonary embolism, aspiration syndromes, tracheal compression by a mediastinal mass and tracheomalacia. So, different physicians should put in mind those asthma mimics to be differentiated from asthmatic patients specially whose asthma symptoms are poorly controlled by anti- asthmatic medications.
- Conditions
- Asthma (Diagnosis)
- Being tested
- Fibreoptic bronchoscopy
- Keywords
- asthma, mimic diseases, spirometry
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibreoptic bronchoscopyDevice
Also called Upper Gastrointestinal (GI) endoscopy
different endoscopies used for confirmation of diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Group (1) confirmed bronchial asthma and group (2) bronchial asthma rule out | Other | After completing all the clinical, functional, radiologic, and endoscopic assessment, the patients were classified into two groups: Group (1) (89 patients) whose diagnosis confirmed to be bronchial asthma and group (2) (111 patients) with diagnoses other than bronchial asthma. Receives: Device: Fibreoptic bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of patients in whom the diagnosis of current asthma was confirmed or ruled out after clinical, spirometric assessment and utilizing all the possible investigations with a six month follow up period for both groups.
History of how patients were diagnosed as asthma: whether the diagnosis of asthma was initially made based on clinical assessment alone, or based on symptoms, physical findings, and diagnostic tests such as spirometry, reversibility test and peak expiratory flows.
general and local chest examination. Spirometry The Asthma Control Questionnaire (ACQ-6) Sputum smear cytologic analysis Chest X-ray Electrocardiogram (ECG) and Echocardiography (ECHO). Chest computed tomography (Chest CT) Fibreoptic bronchoscopy with bronchial aspirate, lavage or biopsy if needed. Upper Gastrointestinal (GI) endoscopy and oesophageal motility assessment, Ear, Nose, and Throat (ENT) consultation and laryngoscopy Psychiatric consultation and psychotherapy, if indicated After completing all the previous clinical, functional, radiologic, and endoscopic assessment, A six month follow up period for both groups,
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Dec 2020
- Primary completion1 Dec 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Zagazig 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Samah M. Shehata, M.D., Principal investigator, chest department, Zagazig university,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776537
- Sponsor's protocol ID
- ZU-IRB # 6576/6-12-2020
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blakey JD, Zaidi S, Shaw DE. Defining and managing risk in asthma. Clin Exp Allergy. 2014 Aug;44(8):1023-32. doi: 10.1111/cea.12334.
PubMed 24773229Aaron SD, Vandemheen KL, FitzGerald JM, Ainslie M, Gupta S, Lemiere C, Field SK, McIvor RA, Hernandez P, Mayers I, Mulpuru S, Alvarez GG, Pakhale S, Mallick R, Boulet LP; Canadian Respiratory Research Network. Reevaluation of Diagnosis in Adults With Physician-Diagnosed Asthma. JAMA. 2017 Jan 17;317(3):269-279. doi: 10.1001/jama.2016.19627.
PubMed 28114551
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Asthma Mimics Among Newly Diagnosed Bronchial Asthma Patients in Zagazig University Hospitals.
- ClinicalTrials.gov ID
- NCT05776537
- Acronym / sponsor ID
- ZU-IRB # 6576/6-12-2020
- Conditions
- Asthma (Diagnosis)
- Keywords
- asthma, mimic diseases, spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 20 Mar 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.
The aim of the study was to identify the percentage of patients in whom the diagnosis of current asthma was confirmed or ruled out after clinical, spirometric assessment and utilizing all the possible investigations with a six month follow up period for both groups.
Detailed description
The diagnosis of bronchial asthma relies on the existence of characteristic respiratory symptoms which are reversible and variable (diurnal and seasonal) with variable airflow limitation. Unfortunately, bronchial asthma may mimic different pulmonary and non-pulmonary diseases regarding their similar clinical presentations so accurate assessment is required to exclude other possible diagnosis before confirming the diagnosis of bronchial asthma.
There are various phenotypes of asthma as; atopic, non-atopic, and late-onset asthma, which may not be easily diagnosed in the community. Also, asthma may show intermittent versus a relapsing /remitting course, so it is difficult to be diagnosed by a single physician visit. Different studies have found that patients with bronchial asthma were treated empirically without full assessment either to ensure or exclude the asthma diagnosis.
Some symptoms as chest wheezes and breathlessness may be presented commonly in bronchial asthma and other mimic diseases as; chronic obstructive pulmonary disease, bronchiectasis, congestive heart failure, vocal cord disorders, hypersensitivity pneumonitis, endobronchial tumours, pulmonary embolism, aspiration syndromes, tracheal compression by a mediastinal mass and tracheomalacia. So, different physicians should put in mind those asthma mimics to be differentiated from asthmatic patients specially whose asthma symptoms are poorly controlled by anti- asthmatic medications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group (1) confirmed bronchial asthma and group (2) bronchial asthma rule out | Other | Device: Fibreoptic bronchoscopyAfter completing all the clinical, functional, radiologic, and endoscopic assessment, the patients were classified into two groups: Group (1) (89 patients) whose diagnosis confirmed to be bronchial asthma and group (2) (111 patients) with diagnoses other than bronchial asthma. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Patients aged ≥ 18 years who had newly clinically diagnosed bronchial asthma (the diagnosis was achieved in the previous one year, to allow us to get the previous diagnostic reports) whether the diagnosis of asthma was initially made based on clinical assessment alone or both clinical and spirometric assessment. 2) Both sexes were included.
Key exclusion criteria (1 listed)
- 1) Patients who were using long-term oral steroids that may mask the diagnosis; 2) unable to do spirometry or contra-indicated. 3) pregnancy. 4) Definite diagnosis of other chest diseases.
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 |
|---|---|---|
| Fibreoptic bronchoscopyAlso: Upper Gastrointestinal (GI) endoscopydifferent endoscopies used for confirmation of diagnosis | Device | Group (1) confirmed bronchial asthma and group (2) bronchial asthma rule out |
Primary outcome
the percentage of patients in whom the diagnosis of current asthma was confirmed or ruled out after clinical, spirometric assessment and utilizing all the possible investigations with a six month follow up period for both groups.
Time frame: one month
History of how patients were diagnosed as asthma: whether the diagnosis of asthma was initially made based on clinical assessment alone, or based on symptoms, physical findings, and diagnostic tests such as spirometry, reversibility test and peak expiratory flows. general and local chest examination. Spirometry The Asthma Control Questionnaire (ACQ-6) Sputum smear cytologic analysis Chest X-ray Electrocardiogram (ECG) and Echocardiography (ECHO). Chest computed tomography (Chest CT) Fibreoptic bronchoscopy with bronchial aspirate, lavage or biopsy if needed. Upper Gastrointestinal (GI) endoscopy and oesophageal motility assessment, Ear, Nose, and Throat (ENT) consultation and laryngoscopy Psychiatric consultation and psychotherapy, if indicated After completing all the previous clinical, functional, radiologic, and endoscopic assessment, A six month follow up period for both groups,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Background: PubMed 24773229Blakey JD, Zaidi S, Shaw DE. Defining and managing risk in asthma. Clin Exp Allergy. 2014 Aug;44(8):1023-32. doi: 10.1111/cea.12334.
- Background: PubMed 28114551Aaron SD, Vandemheen KL, FitzGerald JM, Ainslie M, Gupta S, Lemiere C, Field SK, McIvor RA, Hernandez P, Mayers I, Mulpuru S, Alvarez GG, Pakhale S, Mallick R, Boulet LP; Canadian Respiratory Research Network. Reevaluation of Diagnosis in Adults With Physician-Diagnosed Asthma. JAMA. 2017 Jan 17;317(3):269-279. doi: 10.1001/jama.2016.19627.
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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.
Samah M. Shehata, M.D. principal investigator
chest department, Zagazig university,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibreoptic bronchoscopy in people with Asthma (Diagnosis), run by Zagazig 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: finished, as of the sponsor's last update on 20 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of patients in whom the diagnosis of current asthma was confirmed or ruled out after clinical, spirometric assessment and utilizing all the possible investigations with a six month follow up period for both groups. (time frame: one month). 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 NCT05776537, which also lists 2 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 20 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.