RecruitingPhase 2NCT06860542

Inhaled Budesonide for REcurrence Prevention and Adjuvant THerapy in Checkpoint Inhibitor Pneumonitis


Sponsor

AHS Cancer Control Alberta

Enrollment

94 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The introduction of immune checkpoint inhibitors (immunotherapy) that stimulate our immune system to recognize and attack cancer cells has been one of the most exciting advances in oncology over the last decade. These medications are now employed across almost half of cancer types and settings, however they come with a cost. In some patients, instead of attacking cancer cells alone, the stimulated immune system damages healthy tissues (immune related adverse events), with one of the most severe and potentially deadly such complications being immune attack on the lungs, or checkpoint inhibitor pneumonitis (CIP). When treated promptly with oral or intravenous steroids, acute CIP improves in many cases, however for approximately one-fifth of patients the lung inflammation is difficult to control, resulting in recurrent shortness of breath, the need for extended courses of oral or intravenous steroids, impacting quality of life and cancer therapy decisions. 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 of CIP may help the lung inflammation resolve and not return, without the repeated use of oral or intravenous medications that carry more side effects.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Arm 1- Usual care and a drug called Arm 2- Budesonide (Pulmicort® Turbuhaler®) + Usual care for people with immune-related adverse event and pneumonitis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGArm 2- Budesonide (Pulmicort® Turbuhaler®) + Usual care

Budesonide (Pulmicort® Turbuhaler®) 800ug inhaled twice daily (BID) will be taken in addition to usual care for 36 weeks.

OTHERArm 1- Usual care

The comparison arm will be usual care (UC) for Checkpoint inhibitor pneumonitis (CIP) (steroids).


Locations(1)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

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NCT06860542


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