Citramel, a locally developed therapy with potential to improve the lives of thousands worldwide living with cystic fibrosis is now being tested in a Phase IIa clinical trial in Christchurch and Auckland. This follows on from the completion of a Phase I trial of Citramel in healthy subjects which indicated that the treatment was well tolerated.
The Phase IIa clinical trial compares Citramel inhalation with a placebo inhalation, and all study participants will receive both therapies for 4 weeks each. The study takes 12-14 weeks to complete and involves 13 visits to the study site during that time. The regular assessments will include lung function tests, you will be required to provide blood and sputum samples, and your vital signs (blood pressure, pulse, temperature and weight) will be measured.
To be eligible for the trial, potential participants must meet all the study entry criteria and be able to attend all visits to the study site in Christchurch or Auckland. The main entry criteria for participants are:
- Aged at least 16 years, with a confirmed diagnosis of cystic fibrosis
- An FEV1 of 40-100% of predicted normal for age, gender and height
- Other medications are on stable doses
- No hospital admissions in the previous month
- Pregnant and nursing women are excluded
- Those with significant other diseases or conditions may not be suitable
Detailed information on this Phase IIa trial can be found on the ANZCTR website: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368708