The Ear-Nose-Throat (ENT) Prospective International Cohort of PCD Patients (EPIC-PCD) (EPIC-PCD)
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ClinicalTrials.gov Identifier: NCT04611516 |
Recruitment Status :
Recruiting
First Posted : November 2, 2020
Last Update Posted : May 18, 2022
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Condition or disease |
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Primary Ciliary Dyskinesia Kartagener Syndrome |

Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Ear-Nose-Throat (ENT) Prospective International Cohort of PCD Patients (EPIC-PCD) |
Actual Study Start Date : | March 2, 2020 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2030 |

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

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04611516
Contact: Myrofora Goutaki, MD-PhD | 0041 316315973 | myrofora.goutaki@ispm.unibe.ch | |
Contact: Yin Ting Lam, MD | 0041 316315973 | yin.lam@ispm.unibe.ch |
Switzerland | |
University of Bern | Recruiting |
Bern, Switzerland | |
Contact: Yin Ting Lam, MD yin.lam@ispm.unibe.ch |
Principal Investigator: | Myrofora Goutaki, MD-PhD | University of Bern |
Responsible Party: | University of Bern |
ClinicalTrials.gov Identifier: | NCT04611516 |
Other Study ID Numbers: |
EPIC-PCD |
First Posted: | November 2, 2020 Key Record Dates |
Last Update Posted: | May 18, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Not all participating centres have ethical approval to share IPD to external researchers. Researchers wanting to use the dataset can propose a research topic and draft a concept sheet describing the planned analyses and publication. All concept sheets have to be approved by all participating centres contributing data to the proposed analysis under question. After the participating centres agree to contribute their data and sign a publication agreement, the EPIC-PCD managing centre (University of Bern) will prepare a partial dataset for the proposed analysis and will work closely with the lead researchers offering methodological input and support. In case additional data is collected to complete the partial dataset for a specific project, this will be added to the EPIC-PCD dataset to enrich it after each project. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ciliary Motility Disorders Kartagener Syndrome Dyskinesias Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Respiratory Tract Diseases Otorhinolaryngologic Diseases Ciliopathies Abnormalities, Multiple |
Congenital Abnormalities Genetic Diseases, Inborn Bronchiectasis Bronchial Diseases Respiratory System Abnormalities Dextrocardia Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Situs Inversus |