Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT03145051
Eligibility Criteria:
Inclusion Criteria:
* • Patient with Cystic Fibrosis with or without lung transplant;
* Patients with allergic chronic rhino sinusitis or no allergic diagnosed by the clinical investigator on the basis of the following signs in variable combination: nasal congestion, headache, sneezing, itchy nose and eyes, runny nose, nosebleeds and nasal crusts, redness and eye discharge present more than 3 months per year.
* Patient treated on an outpatient basis;
* Patient agreeing not to take sea baths for the duration of the study;
* Patient agreeing to respect the procedures for conducting the study, in particular the washout period and follow-up visits;
* Patient capable of understanding and self-completing the questionnaires;
* For juvenile patients, the holder (s) of parental authority have accepted the participation of the young person (by signing the informed consent after having taken note of the information note)
* Member or beneficiary of a social security program
Exclusion Criteria:
* Patients with significant obstruction of the nasal passages due to:
* a mucocele,
* polyposis causing nasal obstruction\> 90% or
* severe malformation of the septum causing a nasal obstruction\> 90% in whom surgical treatment is recommended;
* Patients with signs of severity that may require hospitalization, such as: severe impairment of general health, dyspnoea with cyanosis, high fever (\> 40 ° C).
* Patients requiring corticosteroid therapy during the study, with the exception of patients who received pulmonary transplant and were treated with oral corticosteroids at no more than 0.2 mg / kg / day.
* Patients with known systemic immunodeficiency status with the exception of patients receiving pulmonary transplantation and immunosuppressed.
* Patient pregnant (urine test) or without effective contraception (birth control pill, contraceptive patch, contraceptive implant, vaginal ring, intrauterine device or intrauterine device, male condom).
* Nursing patient.
* Patient with a contraindication to nasal irrigations as defined in the product leaflet.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
65 Years
Study:
NCT03145051
Study Brief:
Protocol Section:
NCT03145051