Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06860542

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

250 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be 18 years of age or older and able to provide written informed consent
  • Histologically confirmed solid tumor undergoing immune checkpoint inhibitor therapy
  • First documented diagnosis of checkpoint inhibitor pneumonitis graded ≥2 by CTCAE v5.0, confirmed per ESMO/ASCO guidelines
  • Compatible clinical picture with supporting radiographic evidence and ruling out alternative causes including infections and pulmonary disease progression
  • Ability to effectively use budesonide delivery method (Turbuhaler®), independently or with caregiver aid throughout the trial
  • Adequate organ function as judged by the enrolling clinician
  • Females of childbearing potential must have a negative pregnancy test prior to study day 1
  • Females of childbearing potential must agree to use contraception or abstain from heterosexual sexual contact during the study
Not Eligible

You will not qualify if you...

  • Active interstitial lung disease within the last year prior to CIP diagnosis
  • Significant lung disease requiring inhaled steroids as standard care, such as moderate asthma or severe COPD
  • Current active and regular use of inhaled steroids or systemic corticosteroids (>10mg prednisone equivalent) for indications other than CIP
  • Receiving systemic non-chemotherapy immunosuppressive agents (except hydroxychloroquine) at randomization
  • Use of medications with significant interaction with inhaled budesonide unless deemed safe
  • Poorly controlled diabetes with A1c >10 before steroid initiation for CIP
  • History of unstable systemic diseases such as NYHA class III/IV heart failure, advanced cirrhosis, severe renal failure, or other life-limiting conditions
  • Participation in other investigational agent or device studies within 4 weeks prior to randomization
  • Conditions or therapies that might interfere with trial participation or results, per investigator judgment
  • Immediate family members directly involved in this trial without ethics board approval
  • Breastfeeding during trial participation not permitted

AI-Screening

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Trial Site Locations

Total: 1 location

1

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada, T2N 5G2

Actively Recruiting

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Research Team

A

Alexander Watson, MD

CONTACT

A

Amy Abel

CONTACT

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