Actively Recruiting
Inhaled Budesonide for Recurrence Prevention and Adjuvant Therapy in Checkpoint Inhibitor Pneumonitis
Led by AHS Cancer Control Alberta · Updated on 2026-03-23
94
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of inhaled steroids to prevent the recurrence and improve recovery from checkpoint inhibitor pneumonitis (CIP), a serious lung inflammation caused by immune checkpoint inhibitor cancer treatments. This condition can lead to harmful inflammation in the lungs, requiring steroid treatment, but sometimes the inflammation is hard to control and affects quality of life and cancer therapy. The trial aims to see if inhaled budesonide, commonly used for asthma, can help reduce flare-ups and lessen the need for oral or intravenous steroids over one year. The study compares two groups: one receiving usual care with systemic steroids according to guidelines, and the other receiving usual care plus inhaled budesonide 800 micrograms twice daily for 36 weeks. Usual care involves oral or intravenous steroids tapered over weeks depending on severity. Both groups receive treatment for their CIP flare-ups as per standard guidelines, with the experimental group adding the inhaled steroid as an adjuvant therapy. Participants will be monitored for one year with assessments including lung inflammation recurrence, steroid side effects, time to improvement, and patient-reported outcomes. Researchers will collect data on steroid use, lung inflammation control, and quality of life. Throughout the trial, participants' ability to use the inhaler will be supported, and safety will be evaluated. The total study duration covers the treatment and follow-up periods to assess the effectiveness of inhaled budesonide in preventing CIP recurrence.
CONDITIONS
Brief Title
Inhaled Budesonide for REcurrence Prevention and Adjuvant THerapy in Checkpoint Inhibitor Pneumonitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years of age or older and able to provide written consent
- Must have a histologically confirmed solid tumor and be receiving immune checkpoint inhibitor therapy
- First documented diagnosis of grade 2 or higher checkpoint inhibitor pneumonitis (CIP) per guidelines
- Able to use the budesonide inhaler (Turbuhaler) independently or with caregiver support
- Adequate organ function as judged by clinician
- Females of childbearing potential must have a negative pregnancy test before study start
- Females of childbearing potential must agree to use contraception or abstain from heterosexual contact during the study
You will not qualify if you...
- Active interstitial lung disease within the last year before CIP diagnosis
- Moderate asthma or severe COPD needing inhaled steroids where no inhaled steroids would be unsafe
- Current regular use of inhaled steroids or systemic corticosteroids (more than 10mg prednisone equivalent) for reasons other than CIP
- Using systemic immunosuppressive drugs (except hydroxychloroquine) at time of randomization
- Use of medications that interact with budesonide unless approved by investigator
- Poorly controlled diabetes (A1c over 10) before steroid treatment for CIP
- Unstable serious systemic diseases such as severe heart failure, cirrhosis, or kidney failure
- Participation in another investigational study within 4 weeks before randomization
- Any condition or therapy that would interfere with trial participation or results
- Immediate family member involved in this trial unless approved
- Breastfeeding during trial participation not allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 weeks
Participants receive either inhaled budesonide twice daily in addition to usual care or usual care alone to manage Checkpoint Inhibitor Pneumonitis (CIP).
Regular visits as per clinical guidelines
Trial Site Locations
Total: 1 location
1
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
Research Team
A
Alexander Watson, MD
A
Amy Abel
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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