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IHMA-2121771-2

Clinical trials investigating IHMA-2121771-2 are studying treatment in people with cystic fibrosis and chronic Pseudomonas lung infection. The trial data focus on whether the study treatment can improve infection burden and how it performs in a randomized, double-blind phase 2 study.

Table of contents

Trial overview

The available trial for IHMA-2121771-2 is a phase 2 study in people with cystic fibrosis and chronic Pseudomonas lung infection.[1] The study title describes it as a randomized, double-blind study, and the brief summary says it looked at the effect of nebulized BX004 on sputum Pseudomonas burden.[1]

Who participated

The target population was people with cystic fibrosis and chronic Pseudomonas pulmonary infection.[1] Pulmonary infection means infection in the lungs, and chronic means it lasts a long time.[1] The trial enrolled 63 participants.[1]

Study design and phase

This was an interventional study, which means researchers gave a treatment and then measured the results.[1] It was randomized, so participants were assigned by chance to a study group.[1] It was also double-blind, meaning the participants and study team did not know who received BX004 or placebo during the study.[1]

The study compared BX004 given by inhalation with BX004 placebo.[1] A placebo is a look-alike treatment used to help show whether the study treatment makes a difference.[1]

What was measured

The main endpoint was the change from baseline in PsA CFU/g of sputum at 8 weeks of treatment, also called day 57 or end of treatment.[1] Baseline means the starting point before treatment began.[1] PsA CFU/g is a lab measure of how much Pseudomonas bacteria is found in sputum.[1]

This endpoint shows whether the study aimed to reduce the amount of bacteria in the sputum after treatment.[1] The brief summary states that the study tested the efficacy of nebulized BX004 on sputum PsA burden in subjects with chronic Pseudomonas pulmonary infection.[1]

Trial status and size

The trial status is listed as completed.[1] Completed means the study has finished collecting the planned data.[1] The enrollment was 63 participants, which is a relatively small phase 2 study focused on early evidence of effect.[1]

What the trial helps answer

This trial helps answer whether the study treatment may reduce Pseudomonas burden in the lungs of people with cystic fibrosis.[1] Because it was randomized and double-blind, the design was meant to make the comparison between BX004 and placebo more reliable.[1] The trial does not provide broader drug information beyond the study design, population, and the infection-related outcome it measured.[1]

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

FAQ

  • What clinical trial is listed for IHMA-2121771-2? The trial listed is a phase 2 randomized, double-blind study in people with cystic fibrosis and Pseudomonas lung infection. It is described as completed and included 63 participants.
  • Who could take part in the study? The target population was subjects with cystic fibrosis and chronic Pseudomonas pulmonary infection. This means the study focused on people who already had a long-term lung infection caused by Pseudomonas.
  • What was the main goal of the trial? The main goal was to measure the change in Pseudomonas CFU/g of sputum after 8 weeks of treatment. CFU/g means colony-forming units per gram, which is a way to count how much bacteria is present in sputum.
  • What does randomized and double-blind mean in this study? Randomized means participants were assigned to study groups by chance. Double-blind means neither the participants nor the study team knew who received the study drug or placebo during the trial.
  • What treatment was compared in the trial? The trial compared BX004 given by inhalation with a BX004 placebo. A placebo is a look-alike treatment that does not contain the active study drug.

Ongoing Clinical Trials on IHMA-2121771-2

  • 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 disease that can cause thick mucus in the lungs and make lung infections more likely.
  • Pseudomonas: A type of bacteria that can cause chronic, or long-lasting, lung infection in people with cystic fibrosis.
  • Pulmonary infection: An infection in the lungs.
  • Chronic infection: An infection that lasts a long time or keeps coming back.
  • Randomized: Assigned by chance to different study groups, so the comparison is fair.
  • Double-blind: A study design where participants and study staff do not know which treatment is being given.
  • Placebo: A look-alike treatment with no active study drug, used for comparison.
  • Phase 2: A trial stage that usually looks at early signs of benefit and continues to collect safety and performance data.
  • Interventional study: A study where researchers give a treatment and then measure what happens.
  • Sputum: Mucus from the lungs that is coughed up and can be tested for infection.
  • CFU/g: Colony-forming units per gram, a lab measure used to estimate how many bacteria are in a sample.

References