Study of Nasal Mucosa Histopathological Changes in Chronic Hypersensitivity Pneumonitis
Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT05723796
Collaborator
(none)
40
1
1
17.5
2.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Study of Nasal Mucosa Histopathological Changes in Patients With Chronic Hypersensitivity Pneumonitis
Actual Study Start Date
:
Jul 1, 2021
Actual Primary Completion Date
:
Oct 31, 2022
Actual Study Completion Date
:
Dec 15, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: chronic HP patients
|
Procedure: nasal endoscopy
nasal endoscopy and mucosal biopsy
|
Outcome Measures
Primary Outcome Measures
- percentage of patients with HP developed nasal mucosa granuloma and lymphocytic infiltrations as detected by nasal endoscopy [6 months]
nasal endoscopy and nasal mucosa biopsy was done for all patients to measure the % of patients with nasal granuloma and lymphocytic infiltrations
Eligibility Criteria
Criteria
Ages Eligible for Study:
29 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- all patients with clinical and radiological features of HP
Exclusion Criteria:
-
respiratory failure
-
patients on anticoagulants
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kasr alainy school of medicine | Cairo | Egypt | 11562 |
Sponsors and Collaborators
- Cairo University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eman Kamal Ibrahim Hassan,
Assistant Professor of pulmonology,
Cairo University
ClinicalTrials.gov Identifier:
NCT05723796
Other Study ID Numbers:
- MD-138-2021
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eman Kamal Ibrahim Hassan,
Assistant Professor of pulmonology,
Cairo University
Additional relevant MeSH terms: