Assessment of Asthma Mimics Among Newly Diagnosed Bronchial Asthma Patients

NCT05776537 | Completed

• 1 other identifier: ZU-IRB # 6576/6-12-2020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma (Diagnosis)

Keywords

asthma, mimic diseases, spirometry

Outcome Measures

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.

  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,

  one month

Study Arms (1)

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.

Device: Fibreoptic bronchoscopy

Interventions

Fibreoptic bronchoscopy DEVICE

different endoscopies used for confirmation of diagnosis

Also known as: Upper Gastrointestinal (GI) endoscopy

Group (1) confirmed bronchial asthma and group (2) bronchial asthma rule out

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Chest Department,Faculty of Medicine

Zagazig, 44519, Egypt

Location

Related Publications (2)

• 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.

  PMID: 24773229 BACKGROUND

• 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.

  PMID: 28114551 BACKGROUND

MeSH Terms

Conditions

Asthma; Disease

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Samah M. Shehata, M.D.

  chest department, Zagazig university,Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 20, 2023
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

EG (1)