Hypersensitivity PneumonitisNCT05723796
Study of Nasal Mucosa Histopathological Changes in Chronic Hypersensitivity Pneumonitis
A study testing nasal endoscopy in people with Hypersensitivity Pneumonitis and Nasal Mucosal Disorder, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 to 55 years
- Conditions the study is for
- Hypersensitivity Pneumonitis, Nasal Mucosal Disorder
- What is being tested?
- nasal endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all patients with clinical and radiological features of HP
Who cannot join
- respiratory failure
- patients on anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- nasal endoscopy
- Keywords
- hypersensitivity pneumonitis, nasal mucosa histopaholgical changes
- Medical subject headings
- Alveolitis, Extrinsic Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal endoscopyProcedure or surgery
nasal endoscopy and mucosal biopsy
| Study group | Role | What they receive |
|---|---|---|
| chronic HP patients | Experimental | Not described Receives: Procedure: nasal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Jul 2021
- Primary completion31 Oct 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypersensitivity PneumonitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Kamal Ibrahim Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723796
- Sponsor's protocol ID
- MD-138-2021
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37258647
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Nasal Mucosa Histopathological Changes in Patients With Chronic Hypersensitivity Pneumonitis
- ClinicalTrials.gov ID
- NCT05723796
- Acronym / sponsor ID
- MD-138-2021
- Keywords
- hypersensitivity pneumonitis, nasal mucosa histopaholgical changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic HP patients | Experimental | Procedure: nasal endoscopy |
Who may qualify
- Ages
- 29 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients with clinical and radiological features of HP
Key exclusion criteria (2 listed)
- respiratory failure
- patients on anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasal endoscopynasal endoscopy and mucosal biopsy | Procedure or surgery | chronic HP patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Derived from this study: PubMed 37258647Akl 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal endoscopy in people with Hypersensitivity Pneumonitis and Nasal Mucosal Disorder, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with HP developed nasal mucosa granuloma and lymphocytic infiltrations as detected by nasal endoscopy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05723796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.