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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04611516
Other study ID # EPIC-PCD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 2, 2020
Est. completion date December 2030

Study information

Verified date October 2023
Source University of Bern
Contact Myrofora Goutaki, MD-PhD
Phone 0041 316315973
Email myrofora.goutaki@unibe.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Ear-Nose-Throat (ENT) Prospective International Cohort of patients with Primary Ciliary Dyskinesia (EPIC-PCD) is a prospective observational clinical cohort study, set up as a multinational multi-centre study. It is embedded into routine patient care of participating reference centres for PCD and patients keep being managed according to local procedures and guidelines.


Description:

The EPICD-PCD is hosted at the Institute of Social and Preventive Medicine (ISPM) at the University of Bern, Switzerland. Research is performed in close collaboration with all data contributors. This study aims to characterise ENT disease in PCD patients and its association with lower respiratory disease, and to identify determinants of its prognosis. The investigators aim to: 1. Assess the prevalence and severity of sinonasal and otologic symptoms and the frequency and range of signs and physiological findings assessed during standardised ENT physical examination, and describe differences by age; 2. Study the association of sinonasal and otologic disease with lower respiratory disease in PCD patients; 3. Identify determinants of disease course and prognosis of sinonasal and otologic disease in PCD patients. Study design: The EPIC-PCD is a prospective observational clinical cohort study, set up as a multinational multi-centre study. It is embedded into routine patient care of participating reference centres for PCD and patients will keep being managed according to local procedures and guidelines. Patients with PCD are followed regularly at each centre, at 3-month to 6-month intervals. Each patient undergoes a detailed ENT sinonasal and otologic examination by ENT specialists, at minimum once a year, during a programmed follow-up visit. Additional ENT examinations are performed if indicated during in-between follow-up visits. Patients will not be subjected to additional invasive measurements solely for the purposes of the study. What information is collected: The study collect clinical data from patients assessment at regular consultations at the outpatient clinics. For the collection of clinical data, participating centres will use FOLLOW-PCD, a disease-specific form for standardised prospective data collection during routine clinical follow-up of PCD patients. Study database: The EPIC-PCD database is web-based, using the Research Electronic Data Capture (REDCap) platform developed at Vanderbilt University. REDCap is widely used in academic research and allows data entry and extraction in various formats. How to participate: Centres that wish to participate to the project and contribute data can contact the EPIC-PCD managing centre to sign a data delivery agreement. They then will receive a password to access the online software REDCap and they will be able to enter their data directly. They can also upload follow-up data or add additional patients at a later time point. Funding: The setting up of the EPIC-PCD (salaries, consumables and equipment) was funded by the Swiss National Science Foundation. Data collection and management at each site was funded according to local arrangements. Most participating researchers and data contributors participate in the European Respiratory Society Clinical Research collaboration "Better Evidence to Advance Therapeutic options for PCD" (BEAT-PCD) (https://beat-pcd.squarespace.com/). Infrastructure is provided for free by the University of Bern, where the data are pooled and stored.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 2030
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Diagnosis of PCD (clinical and test certified) - Patient must undergo an ENT examination minimum once a year as part of their clinical follow-up Exclusion Criteria: None

Study Design


Locations

Country Name City State
Switzerland University of Bern Bern

Sponsors (11)

Lead Sponsor Collaborator
University of Bern Amsterdam UMC, location VUmc, Bicetre Hospital, Centre Hospitalier Intercommunal Creteil, Hacettepe University, Hospital Universitario La Fe, Insel Gruppe AG, University Hospital Bern, Marmara University, Universitaire Ziekenhuizen KU Leuven, University Hospital Southampton NHS Foundation Trust, University of Cyprus

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sinonasal symptoms and signs Prevalence of reported clinical symptoms at different age groups, including rhinitis, sinusitis, snoring at baseline
Primary Course of sinonasal symptoms and signs (year 1) Change from baseline prevalence of reported clinical symptoms at different age groups, including rhinitis, sinusitis, snoring, at 12 months at 12 months from recruitment
Primary Course of sinonasal symptoms and signs (year 2) Change from baseline prevalence of reported clinical symptoms at different age groups, including rhinitis, sinusitis, snoring, at 24 months at 24 months from recruitment
Primary Otological symptoms and signs Prevalence of reported clinical symptoms at different age groups, including ear pain, hearing problems, ear discharge at baseline
Primary Course of otological symptoms and signs (year 1) Change from baseline prevalence of reported clinical symptoms at different age groups, including ear pain, hearing problems, ear discharge, at 12 months at 12 months from recruitment
Primary Course of otological symptoms and signs (year 2) Change from baseline prevalence of reported clinical symptoms at different age groups, including ear pain, hearing problems, ear discharge, at 24 months at 24 months from recruitment
Primary Nasal endoscopy (description of nasal mucosa) Description of nasal mucosa as seen via nasal endoscopy examination at baseline
Primary Nasal endoscopy (changes of nasal mucosa at year 1) Changes in nasal mucosa from baseline as seen via nasal endoscopy examination at 12 months at 12 months from recruitment
Primary Nasal endoscopy (changes of nasal mucosa at year 2) Changes in nasal mucosa from baseline as seen via nasal endoscopy examination at 24 months at 24 months from recruitment
Primary Nasal endoscopy (nasal polyps) Prevalence of nasal polyps at baseline at baseline
Primary Nasal endoscopy (nasal polyps at year 1) Changes in prevalence of nasal polyps from baseline to 12 months at 12 months from recruitment
Primary Nasal endoscopy (nasal polyps at year 2) Changes in prevalence of nasal polyps from baseline to 24 months at 24 months from recruitment
Primary Sinonasal examination (Lidholdt score) Lidholdt score at baseline at baseline
Primary Sinonasal examination (Lidholdt score at year 1) Changes in Lidholdt score from baseline to 12 months at 12 months from recruitment
Primary Sinonasal examination (Lidholdt score at year 2) Changes in Lidholdt score from baseline to 24 months at 24 months from recruitment
Primary Ear examination (ear discharge) Prevalence of ear discharge at baseline at baseline
Primary Ear examination (ear discharge at year 1) Changes in prevalence of ear discharge from baseline to 12 months at 12 months from recruitment
Primary Ear examination (ear discharge at year 2) Changes in prevalence of ear discharge from baseline to 24 months at 24 months from recruitment
Primary Otoscopy (description of the tympanic membrane) Description of tympanic membrane as seen via otoscopy examination at baseline
Primary Otoscopy (description of the tympanic membrane at year 1) Changes in the tympanic membrane from baseline to 12 months as seen via otoscopy examination at 12 months from recruitment
Primary Otoscopy (description of the tympanic membrane at year 2) Changes in the tympanic membrane from baseline to 24 months as seen via otoscopy examination at 24 months from recruitment
Primary Tympanometry Results of tympanometry (tympanogram type for both ears) at baseline at baseline
Primary Tympanometry (at year 1) Changes in tympanogram (for both ears) from baseline to 12 months at 12 months from recruitment
Primary Tympanometry (at year 2) Changes in tympanogram (for both ears) from baseline to 24 months at 24 months from recruitment
Primary Audiometry Results of audiometry: type of audiometry and results based on WHO hearing loss grades (for both ears) at baseline
Primary Audiometry (at year 1) Changes in audiometry results from baseline to 12 months at 12 months from recruitment
Primary Audiometry (at year 2) Changes in audiometry results from baseline to 24 months at 24 months from recruitment
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