Clinical trial NCT05776537: Assessment of Asthma Mimics Among Newly Diagnosed Bronchial Asthma Patients
Official title: Assessment of Asthma Mimics Among Newly Diagnosed Bronchial Asthma Patients in Zagazig University Hospitals.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma (Diagnosis)
Keywords: asthma, mimic diseases, spirometry
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-03-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
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.
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Chest Department,Faculty of Medicine
Study officials:
affiliation: chest department, Zagazig university,Egypt
name: Samah M. Shehata, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Aaron 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.