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Evaluation of the Safety and Tolerability of Inhaled Nitric Oxide to Subjects With Cystic Fibrosis
Bu çalışma, kistik fibrozis (cystic fibrosis) hastalarında solunum yoluyla verilen nitrik oksidin (nitric oxide) güvenliliğini ve tolere edilebilirliğini değerlendirmiştir. Araştırmaya, kistik fibrozis tanısı doğrulanmış, 10 yaş ve üzeri, Pseudomonas aeruginosa ile kolonize olmuş hastalar dahil edilmiştir. Çalışma Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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.