Study Overview
The PROMIS Study is designed to evaluate the safety and efficacy of an inhaled antibiotic in patients with Non-Cystic Fibrosis Bronchiectasis (NCFB) and Pseudomonas aeruginosa infection.
The study hopes to show that the inhaled antibiotic reduces the number of exacerbations in a year compared with a placebo treatment (a placebo looks like the study drug but does not contain any “active” medicine and is used as a “control” in clinical studies like this one), The antibiotics will be delivered by a portable nebuliser administered twice daily (morning and evening) for 12 months. Only adult patients affected by NCFB and who are chronically infected by Pseudomonas aeruginosa can be included in this study.
In order to take part in the PROMIS Study, you / the patient and the study doctor will need to review the full checklist of criteria. Some of the basic criteria that you / the patient must meet are:
- Be aged between 18–85 years old
- Have a history of NCFB that has been confirmed by your doctor with a CT scan
- Not be currently treated for nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
- Have had 2 exacerbations in the last year requiring oral antibiotics
- Not be pregnant, trying to become pregnant, or nursing a baby
- Meet all of the other requirements needed for participation in the study - to be checked by the Study Center doctor.
The PROMIS Study treatments and procedures carry a certain amount of risk, like all clinical trials of new medicines. The Study Center doctor will talk to you about possible side effects patients might experience during the study. As we do not know all the side effects of this treatment, there may be side effects that we cannot predict. It is important that, at each visit, you / patients report any and all symptoms or health problems to the Study Center doctor, whether or not you think these problems are related to the study treatment.
The patient may not get any direct medical benefit or effects on the underlying disease from the patient’s participation in the PROMIS study. It is hoped that this study treatment may reduce the frequency of pulmonary exacerbations in patients with NCFB chronically infected with P. aeruginosa; however, such a benefit cannot be guaranteed and is unlikely if the patient receives the placebo (dummy treatment).
