Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Parion Sciences
Age
14–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male and female patients aged \> 14 years.
2. Patients who are diagnosed with cystic fibrosis.
3. Patients who have a FEV1 ≥ 50% predicted (post-bronchodilator) at screening.
4. Patients who are able to perform reproducible spirometry according to ATS guidelines.
5. Patients who have an oxygen saturation of ≥ 92% on room air as determined by pulse oximetry at screening.
You may not be if
1. Patients who have a FEV1 change ≥ 15% after bronchodilator use at screening.
2. Patients who have unstable lung disease as defined by the requirement for intravenous antibiotics during the four weeks prior to screening, a change in medical regimen within 14 days prior to administration of the first dose of study drug or during the 14 day treatment period, a FEV1 ≥ 15% below recent (within six months) clinical measurements, or significant new findings on chest radiograph (pneumothorax, lobar/segmental collapse) that are not considered a part of the usual, chronic progression of cystic fibrosis lung disease.
3. Patients on angiotensin converting enzyme (ACE) inhibitors.
4. Patients with renal insufficiency as evidenced by hyperkalemia (blood potassium levels greater than 5.5 mEq/L) or serum creatinine \> 2.0 mg/dL.
5. Patients who have a history of drug allergies to any medicine chemically related to the study drug (e.g. amiloride, Moduretic, Midamor; triamterene).
6. Patients who are pregnant, have a positive pregnancy test, or are nursing.
7. Patients who have had a lung transplant.
Clareo Health | Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients
