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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT04176328
Eligibility Criteria:
INCLUSION CRITERIA:
1. Male or female patients, aged ≥18 years with a confirmed diagnosis of cystic fibrosis.
2. Patients with body weight ≥50 kg and ≤100 kg
3. Patients with body mass index (BMI) between 18.0 and 30 kg/m2.
4. Patients with FEV1 \> 50% of predicted.
5. Patients with regular mucus production due to cystic fibrosis.
6. Patients who are able to understand the nature of the study and willing to comply with the protocol requirements.
7. Patients who have signed written informed consent to participate to the study after risks have been fully explained.
EXCLUSION CRITERIA:
1. Patients treated with nebulized antibiotics within 14 days or mucolytic agents, hypertonic saline solution within 48 hours before administration of the Investigational Product or during the study.
2. Patients with medical history of hemoptysis (\> 300 cc in 30 days).
3. Patients with decreased liver function (AST or ALT \> 3 times higher in comparison to reference values).
4. Patients with eGFR \< 60 mL/min/1.73 m2
5. Patients on the waiting list for lung transplantation.
6. Patients with known or suspected allergy or hypersensitivity to glycopeptides.
7. Patients treated with Teicoplanin for inhalation and systemic within 4 weeks before each dosing occasion.
8. Patients with known episodes of bronchoconstriction after drug inhalation.
9. Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
10. Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for one months later.
11. Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception. \* \* Methods at low risk of contraceptive failure (less than 1% per year) when used consistently, including: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), some intra-uterine devices, abstinence or vasectomized partner. Contraception should be maintained until 1 month after the last visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04176328
Study Brief:
Protocol Section:
NCT04176328