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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT01334892
Eligibility Criteria:
Inclusion Criteria:
1. Patient's written informed consent
2. Received a single lung, bilateral lung or heart/lung transplantation between 6 weeks and 26 weeks prior to first IMP administration.
3. Male or female, 18 years of age
4. Capable of self-administration of medications
5. Capable of understanding the purpose and risk of the clinical trial
6. Received the following immunosuppressive agents and dosages for maintenance therapy:
1. Tacrolimus and
2. Mycophenolate mofetil (MMF) 1 to 3 g/day and
3. Prednisone or any other steroid therapy; tapered down
7. Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration.
8. Estimated life expectancy \> 6 month
Exclusion Criteria:
1. Any previous episode of bronchiolitis obliterans (BO) or bronchiolitis obliterans syndrome (BOS) of grade 1 or higher
2. Any active invasive bacterial, viral or fungal infection
3. Received systemic maintenance immunosuppressive therapy other than listed in the inclusion criteria
4. Received any systemic or topical ciclosporin A within
5. Received any systemic or topical Rosuvastatin
6. Current mechanical ventilation
7. Received a lung re-transplantation
8. Pregnant or breast feeding woman
9. Has known hypersensitivity to ciclosporin A
10. Has a serum creatinine value of more than 265 µmol/L (3 mg/dL)
11. Unlikely to comply with visits, inhalation procedures or spirometric measurements
12. Receipt of an investigational drug within 4 weeks prior to first administration of IMP
13. Any co-existing medical condition that in the investigator's judgement
14. Psychiatric disorders or altered mental status
15. Patient was previously enrolled in the present clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01334892
Study Brief:
Protocol Section:
NCT01334892