In short
Clinical trials investigating IHMA-2121771-1 are studying a treatment approach in people with cystic fibrosis and chronic Pseudomonas lung infection. The trials aim to evaluate how well the study treatment works and measure changes in sputum bacteria levels. The available trial is a Phase 2 study in adults with this lung infection.
Key points
- Clinical trials investigating IHMA-2121771-1 are focused on cystic fibrosis with chronic Pseudomonas lung infection. The available study is a Phase 2 interventional trial with 63 participants. It used a randomized, double-blind design and compared a study treatment with placebo. The main goal was to measure the change in Pseudomonas bacteria levels in sputum after 8 weeks of treatment. The trial is marked as completed.
Trial overview
The available trial for IHMA-2121771-1 studied people with cystic fibrosis and a chronic Pseudomonas lung infection. The study title describes it as a Phase 2b randomized, double-blind study with phage for CF subjects with Pseudomonas lung infection.
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. In simple words, the researchers wanted to see whether the study treatment could reduce the amount of Pseudomonas bacteria in mucus from the lungs.
Who was studied
The trial focused on subjects with cystic fibrosis who also had chronic Pseudomonas lung infection. The source data do not list more detailed eligibility rules, such as age limits or other health requirements.
- Cystic fibrosis means a long-term inherited disease that can cause thick mucus to build up in the lungs.
- Chronic means the infection lasts a long time or keeps coming back.
- Pseudomonas is the bacterium being tracked in the study outcome.
Study design and phase
This was an interventional trial, which means the researchers gave a treatment and then measured what happened. It was also randomized and double-blind. 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.
The phase was listed as Phase 2. 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.
The intervention list names BX004 given by inhalation and BX004 placebo. The source also describes the study as involving phage, but it does not provide more detail about that in the trial record.
What was measured
The main outcome was the change from baseline in PsA CFU/g of sputum at 8 weeks of treatment. Baseline means the starting point before treatment begins.
PsA CFU/g of sputum is a lab measure of how many Pseudomonas bacteria are found in a mucus sample from the lungs. CFU/g stands for colony-forming units per gram, which is a standard way to count bacteria in a sample.
The brief summary says the trial assessed sputum PsA burden at 8 weeks of treatment, also called end of treatment, or EOT. This means the study was designed to check whether the treatment changed the amount of bacteria by the end of the planned treatment period.
Trial status and size
The trial status is listed as completed. The enrollment was 63, which means 63 people took part in the study.
Because only one trial is provided in the source data, this article focuses on that single completed Phase 2 study.