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IHMA-2121908-1

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.

Table of Contents

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.[1] 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.[1]

Study design and treatment groups

This was an interventional study, which means researchers assigned a treatment and watched what happened.[1] 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.[1]

The study compared BX004 given by inhalation with a BX004 placebo.[1] The trial title also describes it as a Phase 2b randomized, double-blind study, while the trial record lists the phase as Phase 2.[1]

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.[1] 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.[1] PsA stands for Pseudomonas, and CFU/g is a lab measure of how many live bacteria are found in one gram of sputum.[1]

In simple terms, the study asked whether the treatment could reduce the amount of Pseudomonas in the lungs over the treatment period.[1]

Trial status and size

The study is listed as completed, which means the planned trial activities and data collection have finished.[1] The enrollment was 63 participants, so the study was relatively small.[1]

Trial ID Phase Condition studied Status Enrollment
2024-519856-94-00 Phase 2 Cystic fibrosis with chronic Pseudomonas lung infection Completed 63

FAQ

  • What are the clinical trials of IHMA-2121908-1 studying? The trial is studying whether the treatment can reduce Pseudomonas bacteria in sputum, which is mucus from the lungs. It focuses on people with cystic fibrosis who have a chronic lung infection.
  • Who may be able to join these trials? The trial is for people with cystic fibrosis and chronic Pseudomonas pulmonary infection. The study data do not list more detailed entry rules.
  • What phase is the IHMA-2121908-1 trial? The study is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment works and continue safety checks.
  • What outcome is being measured in the trial? The main outcome is the change in PsA CFU/g of sputum after 8 weeks of treatment. This measures how much Pseudomonas is present in the sputum.
  • Is the trial completed? Yes, the study status is listed as completed. That means the trial has finished collecting its planned data.

Ongoing Clinical Trials on IHMA-2121908-1

  • Study of inhaled BX004 bacteriophage treatment for adults with cystic fibrosis who have chronic Pseudomonas aeruginosa lung infection

    Not recruiting

    1
    Investigated drugs:
    Czechia France Germany Ireland Italy The Netherlands +2

Glossary

  • Cystic fibrosis: A long-term genetic condition that can cause thick mucus to build up in the lungs and other organs.
  • Pseudomonas: A type of bacteria that can cause lung infections, especially in people with cystic fibrosis.
  • Pulmonary infection: An infection in the lungs.
  • Sputum: Mucus that is coughed up from the lungs.
  • CFU/g: A lab measure that estimates how many live bacteria are present in one gram of sputum.
  • Baseline: The starting point before treatment begins, used for comparison later.
  • End of treatment (EOT): The time when the planned treatment period ends.
  • Phase 2: A study stage that looks more closely at whether a treatment works and continues to track safety.
  • Randomized: Participants are assigned to treatment groups by chance.
  • Double-blind: Neither the participants nor the study team knows who gets the active treatment or placebo during the trial.
  • Placebo: An inactive treatment used for comparison in a study.
  • Interventional study: A study where researchers assign a treatment to see what happens.

References

  1. https://clinicaltrials.gov/study/2024-519856-94-00