In short
Clinical trials investigating "IHMA-2121908-1" are studying a treatment approach in people with cystic fibrosis and chronic Pseudomonas lung infection. The main goal is to evaluate how well it works and to measure outcomes such as changes in bacterial burden during treatment.
Key points
- Clinical trial data for "IHMA-2121908-1" show one completed Phase 2 study in people with cystic fibrosis and chronic Pseudomonas lung infection. The study compared BX004 with placebo in an interventional, randomized, double-blind design. It enrolled 63 participants. The main goal was to measure the change in Pseudomonas burden in sputum after 8 weeks of treatment. This trial focused on adults or other eligible patients with cystic fibrosis and ongoing lung infection, but the detailed entry rules were not provided.
Trial overview
The available clinical trial data for IHMA-2121908-1 describe one study in people with cystic fibrosis and a chronic Pseudomonas lung infection. The trial was designed to see whether the study treatment could lower the amount of bacteria in sputum, which is the mucus coughed up from the lungs.
Study design and treatment groups
This was an interventional study, which means researchers assigned a treatment and watched what happened. It was also randomized and double-blind, meaning treatment assignment was by chance and neither the participants nor the study team knew who received the active study treatment or the placebo during the trial.
The study compared BX004 given by inhalation with a BX004 placebo. The trial title also describes it as a Phase 2b randomized, double-blind study, while the trial record lists the phase as Phase 2.
Who could participate
The target population was people with cystic fibrosis who also had a chronic pulmonary infection, meaning an ongoing infection in the lungs. The data do not provide more detailed inclusion or exclusion rules, so the full eligibility list is not available here.
What the trial measured
The main outcome was the change from baseline in PsA CFU/g of sputum after 8 weeks of treatment, also described as the end of treatment. PsA stands for Pseudomonas, and CFU/g is a lab measure of how many live bacteria are found in one gram of sputum.
In simple terms, the study asked whether the treatment could reduce the amount of Pseudomonas in the lungs over the treatment period.
Trial status and size
The study is listed as completed, which means the planned trial activities and data collection have finished. The enrollment was 63 participants, so the study was relatively small.