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Completed

NCT Number: NCT05776537

Assessment of Asthma Mimics Among Newly Diagnosed Bronchial Asthma Patients

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.

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Key information

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chest Department,Faculty of Medicine

Zagazig, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fibreoptic bronchoscopy

Device

different endoscopies used for confirmation of diagnosis

Other names: Upper Gastrointestinal (GI) endoscopy

Primary outcomes

  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.

    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,

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Assessment of Asthma Mimics Among Newly Diagnosed Bronchial Asthma Patients in Zagazig University Hospitals.

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 20, 2023
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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