Study of Nasal Mucosa Histopathological Changes in Chronic Hypersensitivity Pneumonitis

February 9, 2023 updated by: Eman Kamal Ibrahim Hassan, Cairo University

Study of Nasal Mucosa Histopathological Changes in Patients With Chronic Hypersensitivity Pneumonitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Kasr Alainy School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

29 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients with clinical and radiological features of HP

Exclusion Criteria:

  • respiratory failure
  • patients on anticoagulants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: chronic HP patients
Procedure: nasal endoscopy
nasal endoscopy and mucosal biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of patients with HP developed nasal mucosa granuloma and lymphocytic infiltrations as detected by nasal endoscopy
Time Frame: 6 months
nasal endoscopy and nasal mucosa biopsy was done for all patients to measure the % of patients with nasal granuloma and lymphocytic infiltrations
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2021

Primary Completion (ACTUAL)

October 31, 2022

Study Completion (ACTUAL)

December 15, 2022

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (ACTUAL)

February 13, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-138-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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