Assessment of Asthma Mimics Among Newly Diagnosed Bronchial Asthma Patients

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT05776537
Collaborator
(none)
200
1
1
18
11.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Fibreoptic bronchoscopy
N/A

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

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assessment of Asthma Mimics Among Newly Diagnosed Bronchial Asthma Patients in Zagazig University Hospitals.
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Group (1) confirmed bronchial asthma and group (2) bronchial asthma rule out

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.

Device: Fibreoptic bronchoscopy
different endoscopies used for confirmation of diagnosis
Other Names:
  • Upper Gastrointestinal (GI) endoscopy
  • Outcome Measures

    Primary Outcome Measures

    1. 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. [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,

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 68 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chest Department,Faculty of Medicine Zagazig Egypt 44519

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    • Principal Investigator: Samah M. Shehata, M.D., chest department, Zagazig university,Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Zagazig University
    ClinicalTrials.gov Identifier:
    NCT05776537
    Other Study ID Numbers:
    • ZU-IRB # 6576/6-12-2020
    First Posted:
    Mar 20, 2023
    Last Update Posted:
    Mar 20, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zagazig University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 20, 2023