Yükleniyor... / Loading...
This study evaluated the safety and tolerability of inhaled nitric oxide in patients with cystic fibrosis. It included patients aged 10 and older with confirmed cystic fibrosis who were colonized with Pseudomonas aeruginosa. The study was conducted in Phase 1/Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria:
1. Subjects (Male or female) ≥10 years old
2. Confirmed diagnosis of CF
3. Resting awake oxygen saturation of at least 92% in room air
4. Approved and signed informed consent:
1. Subject aged over 10 years old (10 included) -
* signed an informed consent by the subject
* Parents/ legal guardian signed informed consent.
2. Subject aged over 18 years old (18 included) - • signed an informed consent by the subject
5. 80% ≥FEV1≥ 30%
6. Confirmed to be colonized with Pseudomonas aeruginosa
Exclusion Criteria:
1. Subjects younger than 10 years old
2. FEV1\< 30% or FEV1\> 80%
3. Pulmonary exacerbation resulting in antibiotic treatment (except prophylactic antibiotics) within1 month before enrollment
4. Subject is pregnant (when applicable, a negative pregnancy test result must be verified prior to enrollment and during treatment)
5. Subjects diagnosed with methemoglobinemia, immunodeficiency and/ or heart disease.
6. Use of an investigational drug within 30 days prior enrolment and/ or the subject is expected to participate in a new study within three months from enrollment to this study.
7. History of frequent epistaxis (\>1 episode/month)
8. Significant hemoptysis within 30 days (≥ 5 mL of blood in one coughing episode or \> 30 mL of blood in a 24 hour period)
9. Methemoglobin level\>3% at screening
10. Patients on systemic steroids (1mg/kg or \> 20mg of prednisone per day) within 30 days of screening;
11. Smokers;
12. History of illicit drug or medication abuse within 1 year of screening ;
13. history of lung transplantation;
14. Patients treated for high blood pressure
15. Subjects cannot comply with the study design
16. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
17. The subject is identified by the investigator as being unable or unwilling to perform study procedures.