Back to resultsStudy of Nasal Mucosa Histopathological Changes in Chronic Hypersensitivity Pneumonitis
Primary Purpose
Hypersensitivity Pneumonitis, Nasal Mucosal Disorder
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
nasal endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypersensitivity Pneumonitis focused on measuring hypersensitivity pneumonitis, nasal mucosa histopaholgical changes
Eligibility Criteria
Inclusion Criteria: all patients with clinical and radiological features of HP Exclusion Criteria: respiratory failure patients on anticoagulants
Sites / Locations
- Kasr alainy school of medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
chronic HP patients
Arm Description
Outcomes
Primary Outcome Measures
percentage of patients with HP developed nasal mucosa granuloma and lymphocytic infiltrations as detected by nasal endoscopy
nasal endoscopy and nasal mucosa biopsy was done for all patients to measure the % of patients with nasal granuloma and lymphocytic infiltrations
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05723796
Brief Title
Study of Nasal Mucosa Histopathological Changes in Chronic Hypersensitivity Pneumonitis
Official Title
Study of Nasal Mucosa Histopathological Changes in Patients With Chronic Hypersensitivity Pneumonitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Background:Hypersensitivity pneumonitis (HP) is an interstitial lung disease that develops after inhalation of organic or inorganic antigens in susceptible individuals. The nasal mucosa is constantly exposed to these antigens that can irritate the respiratory mucosa.
Objectives: to assess the burden of sinonasal symptoms in HP patients and to evaluate the nasal histopathology in those patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity Pneumonitis, Nasal Mucosal Disorder
Keywords
hypersensitivity pneumonitis, nasal mucosa histopaholgical changes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chronic HP patients
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
nasal endoscopy
Intervention Description
nasal endoscopy and mucosal biopsy
Primary Outcome Measure Information:
Title
percentage of patients with HP developed nasal mucosa granuloma and lymphocytic infiltrations as detected by nasal endoscopy
Description
nasal endoscopy and nasal mucosa biopsy was done for all patients to measure the % of patients with nasal granuloma and lymphocytic infiltrations
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients with clinical and radiological features of HP
Exclusion Criteria:
respiratory failure
patients on anticoagulants
Facility Information:
Facility Name
Kasr alainy school of medicine
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of Nasal Mucosa Histopathological Changes in Chronic Hypersensitivity Pneumonitis
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