NCT05723796

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 24, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

January 24, 2023

Last Update Submit

February 9, 2023

Conditions

Hypersensitivity PneumonitisNasal Mucosal Disorder

Keywords

hypersensitivity pneumonitisnasal mucosa histopaholgical changes

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Study Arms (1)

chronic HP patients

EXPERIMENTAL
Procedure: nasal endoscopy

Interventions

nasal endoscopyPROCEDURE

nasal endoscopy and mucosal biopsy

chronic HP patients

Eligibility Criteria

Age29 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • all patients with clinical and radiological features of HP

You may not qualify if:

  • respiratory failure
  • patients on anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr alainy school of medicine

Cairo, 11562, Egypt

Location

Related Publications (1)

  • Akl Y, Ibrahim EK, Algarf TM, Mostafa RR, Abdel-Hamid HM, Muhammed AI. Study of nasal mucosa histopathological changes in patients with hypersensitivity pneumonitis. Sci Rep. 2023 May 31;13(1):8868. doi: 10.1038/s41598-023-35871-5.

    PMID: 37258647DERIVED

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of pulmonology

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 13, 2023

Study Start

July 1, 2021

Primary Completion

October 31, 2022

Study Completion

December 15, 2022

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations

EG(1)