Budesonide for Lung Inflammation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether inhaled budesonide, commonly used for asthma, can reduce lung inflammation in patients with checkpoint inhibitor pneumonitis (CIP), a side effect of certain cancer treatments. The researchers aim to determine if using budesonide for a year can prevent the recurrence of lung issues without resorting to more potent medications with challenging side effects. The trial includes two groups: one receiving usual care and the other receiving usual care plus budesonide. This trial may suit individuals recently diagnosed with CIP during cancer treatment who can effectively use an inhaler. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that Budesonide is likely to be safe for humans?
Studies have shown that budesonide is generally safe when inhaled. Often used to treat asthma, it is considered safe for long-term use. Research indicates that inhaled budesonide, at doses similar to those for asthma, did not cause serious side effects in smokers over six months. This suggests it may be safe for others as well. While no treatment is entirely risk-free, inhaled budesonide has a history of being relatively safe for people with lung conditions.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatment for Checkpoint Inhibitor Pneumonitis (CIP), which primarily involves systemic steroids like oral or IV steroids, Budesonide offers a unique approach. Budesonide is an inhaled medication, specifically using the Pulmicort® Turbuhaler®, which directly targets lung inflammation with potentially fewer systemic side effects than traditional oral or IV steroids. Researchers are excited about this treatment because it combines the benefits of usual care with Budesonide's targeted delivery, potentially improving lung inflammation management while reducing the need for high doses of systemic steroids.
What evidence suggests that Budesonide might be an effective treatment for lung inflammation?
Research has shown that inhaling budesonide can improve lung function by increasing oxygen levels and reducing swelling. One study found that it decreased lung swelling and reduced the number of certain white blood cells in the lungs. Budesonide, commonly used for asthma, has also shown potential in treating other lung issues. In this trial, participants in one arm will receive Budesonide (Pulmicort® Turbuhaler®) alongside usual care, which might help manage lung inflammation from checkpoint inhibitor pneumonitis (CIP). These findings suggest it could reduce lung inflammation without the side effects of stronger treatments.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive inhaled Budesonide (Pulmicort® Turbuhaler®) 800ug twice daily in addition to usual care for 36 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of systemic steroid requirements and steroid toxicities
What Are the Treatments Tested in This Trial?
Interventions
- Budesonide
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Budesonide (Pulmicort® Turbuhaler®) 800ug inhaled twice daily (BID) will be taken in addition to usual care for 36 weeks. Checkpoint Inhibitor Pneumonitis (CIP) flare/recurrence will be treated as initial episode/per guidelines.
The comparison arm will be usual care (UC) for Checkpoint Inhibitor Pneumonitis (CIP); recommended guideline management consists of systemic steroids 1-2mg/kg via oral (grade 2) or IV (grade 3/4) until clinical improvement, then taper over 6 weeks (grade 2) or 8 weeks (grade 3/4). Final CIP management decisions at treating physicians discretion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AHS Cancer Control Alberta
Lead Sponsor
Citations
Study Details | NCT06860542 | Inhaled Budesonide for ...
The goal of the trial is to assess whether use of inhaled steroids, a type of medication commonly used in asthma patients, for one year after a first diagnosis ...
The Effect of Budesonide Delivered by High-Frequency ... - PMC
Budesonide therapy improved the lung function (P/F ratio, oxygenation index, and compliance), decreased the cytokine levels, reduced lung edema and neutrophils ...
iScience - Association between inhaled corticosteroids and ...
Impact of chronic obstructive pulmonary dis- ease on immune checkpoint inhibitor efficacy in advanced lung cancer and the potential prognostic ...
Autumn F. Burnette, MD, highlights new data ...
Burnette, MD, highlights new data showing improved lung function with albuterol-budesonide. ... Albuterol does not treat the inflammation in the ...
The potential to treat lung cancer via inhalation of ...
When inhaled budesonide/BDP was administered as the sole agent (10 μg/kg), an approximate 30% reduction in lung tumor formation was observed. The incorporation ...
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ctv.veeva.com
ctv.veeva.com/study/inhaled-budesonide-for-recurrence-prevention-and-adjuvant-therapy-in-checkpoint-inhibitor-pneumonitiInhaled Budesonide for REcurrence Prevention and Adjuvant ...
The goal of the trial is to assess whether use of inhaled steroids, a type of medication commonly used in asthma patients, for one year after a ...
Inhaled Budesonide for Prevention in Checkpoint Inhibitor ...
This study explores whether using inhaled steroids for a year after an initial occurrence of checkpoint inhibitor pneumonitis (CIP) can help ...
A randomized phase IIb trial of pulmicort turbuhaler ... - PubMed
Conclusions: Our results suggest that in smokers, inhaled budesonide in the dose of 1600 microg daily for 6 months had no effect in regression of bronchial ...
Heterogeneity of Checkpoint Inhibitor–Associated Pneumonitis
This multicenter retrospective study included 113 CIP patients without pathogen infection, aiming to classify CIP based on peripheral blood ...
Checkpoint Inhibitor Pneumonitis: Updates in Management
Ichimura, T., et al., Safety of immune checkpoint inhibitors in non-small-cell lung cancer patients with idiopathic interstitial pneumonia: a ...
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