Table of Contents
Trial overview
The available trial for IHMA-2121771-1 studied people with cystic fibrosis and a chronic Pseudomonas lung infection.[1] The study title describes it as a Phase 2b randomized, double-blind study with phage for CF subjects with Pseudomonas lung infection.[1]
The brief summary says the trial looked at the efficacy of nebulized BX004 on sputum PsA burden in CF subjects with chronic PsA pulmonary infection at 8 weeks of treatment.[1] In simple words, the researchers wanted to see whether the study treatment could reduce the amount of Pseudomonas bacteria in mucus from the lungs.[1]
Who was studied
The trial focused on subjects with cystic fibrosis who also had chronic Pseudomonas lung infection.[1] The source data do not list more detailed eligibility rules, such as age limits or other health requirements.[1]
- Cystic fibrosis means a long-term inherited disease that can cause thick mucus to build up in the lungs.[1]
- Chronic means the infection lasts a long time or keeps coming back.[1]
- Pseudomonas is the bacterium being tracked in the study outcome.[1]
Study design and phase
This was an interventional trial, which means the researchers gave a treatment and then measured what happened.[1] It was also randomized and double-blind.[1] Randomized means people are assigned to study groups by chance, and double-blind means neither the participants nor the researchers know who gets the study treatment or placebo during the trial.[1]
The phase was listed as Phase 2.[1] Phase 2 studies usually focus on whether a treatment seems to work and continue to observe safety, although the source only directly shows the phase and does not list a full safety plan.[1]
The intervention list names BX004 given by inhalation and BX004 placebo.[1] The source also describes the study as involving phage, but it does not provide more detail about that in the trial record.[1]
What was measured
The main outcome was the change from baseline in PsA CFU/g of sputum at 8 weeks of treatment.[1] Baseline means the starting point before treatment begins.[1]
PsA CFU/g of sputum is a lab measure of how many Pseudomonas bacteria are found in a mucus sample from the lungs.[1] CFU/g stands for colony-forming units per gram, which is a standard way to count bacteria in a sample.[1]
The brief summary says the trial assessed sputum PsA burden at 8 weeks of treatment, also called end of treatment, or EOT.[1] This means the study was designed to check whether the treatment changed the amount of bacteria by the end of the planned treatment period.[1]
Trial status and size
The trial status is listed as completed.[1] The enrollment was 63, which means 63 people took part in the study.[1]
Because only one trial is provided in the source data, this article focuses on that single completed Phase 2 study.[1]
