A research study for adults 18 years of age and older, who have been diagnosed with Cystic Fibrosis is now enrolling. This study is being conducted to evaluate the safety and efficacy an experimental treatment for people with Cystic Fibrosis who also have a bacterial infection in their lungs.
You may qualify if you:
- Are at least 18 years of age
- Have been diagnosed with Cystic Fibrosis
- Are currently being treated with inhaled antibiotics (for at least 3 months)
Study staff will determine eligibility based on additional study criteria. Participants in this clinical trial that finish all trial and testing procedures will receive a maximum of $2,160 for their time and effort.
Please Call to learn more about this study:
Please call Phone 714-786-5014
About the Study:
This study is being done to evaluate an experimental treatment of inhaling nitric oxide gas for people with Cystic Fibrosis who have a bacterial infection in their lungs to see if it is safe and effective. If you decide to volunteer and are accepted for this study, you will be randomized (selected by chance) to either be treated with the nitric oxide gas that is mixed with room air or breathe nitrogen that is mixed with room air.
Early animal experiments in a laboratory and tests in subjects with Cystic Fibrosis indicate that nitric oxide gas may help fight bacterial infections. We can make no representations, promises, or guarantees to you about the safety or effectiveness of this gas in subjects with Cystic Fibrosis. If you are eligible for the study you will be randomized to either the investigational nitric oxide group or the placebo control group.
If you agree to be in this study, you will have some screening tests done to ensure that you are eligible to participate.
If you are eligible, you will be an outpatient at the hospital for 7 and one-half days of treatment and/or measurements.
All your treatment visits will be completed within a two-week period. You will be treated three times a day on the first and last day. You will be treated four times a day over a 12-hour period each of the other days with 2 days off after the first five days. You will be asked to return to the hospital 2 more times for follow-up after the treatment is finished (5 days after your last treatment and 26 days after your last treatment).
If you want to participate but find the commute to the hospital/clinic for treatment too difficult or too far, the Sponsor may agree to pay for plane, train or mileage to participate and would rent a hotel room close to the hospital/clinic as long as appropriate for participation in the study.
Participants in this clinical trial that finish all trial and testing procedures will receive a maximum of $2,160 for their time and effort.
Novoteris is a privately held limited liabilities corporation (Nevada) that is managed by a group of international industry veterans and clinicians involved in developing and producing innovative, cutting-edge medical products.
Novoteris was formed in 2013 for the sole purpose of bringing a novel inhaled antimicrobial drug product to the market for the treatment of Cystic Fibrosis. The science and intellectual property that formed the basis of Novoteris was acquired primarily from 12th Man Technologies, Inc. (Garden Grove, CA) and Nitric Solutions Inc. (Vancouver, BC) and includes drug delivery technology, the science base for the drug product and clinical trial data.
Information on Clinical Research Studies:
What is a clinical research study?
A clinical research study, also called a clinical trial, is a study in human volunteers to answer specific health questions and participate in investigational treatments.
What is informed consent?
Informed consent is the dialogue between potential participants and researchers that takes place before anyone decides whether to take part in a study. This process of communication should be free of pressure or rushing, should include all key information and a chance to ask questions and have them answered. Informed consent can be more than just a one-time conversation. As a study goes on, participants can renew their agreement to be in the study, and they can also decide to quit without penalty. The important thing is open and clear communication.
The Informed Consent Document (ICD) is the form participants sign to agree to be in the study. The ICD includes details about the study, such as its purpose, duration, required procedures, risk, benefits, and who to contact for further information. The ICD is not a contract. Participants do not give up any legal rights by signing an ICD. Participants are free to withdraw at any time.
About Cystic Fibrosis
Cystic Fibrosis (CF) is a rare hereditary disease affecting mostly Caucasians. Case finding studies resulted in incidence rates of ~1:2500 Caucasian children, with a carrier frequency of 1:25. Estimates from non-Caucasian populations from the US give incidence rates of 1:14,000 for black Americans and 1:11,500 for Hispanic births.
The considerable difficulty to resolve bacterial infections associated with CF (and other infectious diseases) is thought to be mostly a reflection of the world wide increasing proportions of antibiotic resistant strains. To combat infections, various classes of potent anti-microbial drugs have been developed in the past 80 years, which have considerably improved the management of infectious diseases. This “golden age” of antibiotics engendered such optimism that it was commonly thought bacterial infections would be rapidly eliminated as a cause of mortality. Unfortunately, bacterial resistance to all classes of antibiotics soon appeared. Heavy antibiotic use and person-to-person spread of bacteria have greatly increased antibiotic resistance, and this problem is continually increasing in severity. As a result, multi drug-resistant bacteria are no longer limited to hospitals; they have arisen and spread in the community and represent today a global health risk.
In addition to increasing resistance rates towards antibiotics worldwide, antibiotics may be less effective in CF airways due to sputum adsorption. Thus, there is an urgent need to develop alternative treatment strategies. The global increase in antimicrobial resistance of bacterial pathogens is a major threat for CF patients who routinely are visiting hospitals and are frequently treated with antibiotics. The speed of development of novel antibiotics by the pharmaceutical industry has been unfortunately slower than the emergence of resistance. To face the unmet medical need of lung infection in CF, the proposed gaseous Thiolanox® inhalation therapy has been developed.