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Prevention study for Pneumonitis
Official title Inhaled Budesonide for REcurrence Prevention and Adjuvant THerapy in Checkpoint Inhibitor Pneumonitis
ClinicalTrials.gov ID: NCT06860542
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must be 18 years of age, or older on the day of signing informed consent and be willing and able to provide written informed consent/assent...
- Patients require histologically confirmed solid tumour undergoing immune checkpoint inhibitor (ICI) therapy
- Diagnosis of first documented diagnosis of Checkpoint Inhibitor Pneumonitis (CIP) made per European Society for Medical Oncology (ESMO)/American...
- Be able to effectively operate and use budesonide delivery method (Turbuhaler®), either independently or with aid of caregiver who anticipates being...
- Have adequate organ function, as judged by enrolling clinician
You likely can't join if
- Diagnosis of interstitial lung disease (ILD) active (clinically and radiologically evident) within last year prior to diagnosis of CIP
- Clinically suspected significant lung disease for which inhaled steroid would be standard of care (moderate asthma or severe chronic obstructive...
- Current (within last two weeks), active (not medically able or unwilling to discontinue prior to treatment start) and regular (2 or more times per...
- Receiving systemic, non-chemotherapy immunosuppressive agent at time of randomization (hydroxychloroquine is acceptable)
- Use of a medication with significant interaction with inhaled budesonide (HIV protease inhibitors, ketoconazole or other potent CYP3A4 inhibitors)...
- Known poorly controlled diabetes, defined as A1c \>10, prior to initiation of steroids for CIP
See the full eligibility criteria
Who can join
- Patients must be 18 years of age, or older on the day of signing informed consent and be willing and able to provide written informed consent/assent and, in the opinion of the Investigator, comply with protocol tests...
- Patients require histologically confirmed solid tumour undergoing immune checkpoint inhibitor (ICI) therapy
- Diagnosis of first documented diagnosis of Checkpoint Inhibitor Pneumonitis (CIP) made per European Society for Medical Oncology (ESMO)/American Society for Medical Oncology (ASCO) guidelines with severity \>/grade 2 by...
- Be able to effectively operate and use budesonide delivery method (Turbuhaler®), either independently or with aid of caregiver who anticipates being able to do so throughout trial period
- Have adequate organ function, as judged by enrolling clinician
- Females of childbearing potential have a negative urine or serum pregnancy test prior to study day 1. Patients of childbearing potential are those who have not been surgically sterilized or have not been free of menses...
- Females of childbearing potential are willing to use contraception or abstain from heterosexual sexual contact for the course of the study
What rules you out
- Diagnosis of interstitial lung disease (ILD) active (clinically and radiologically evident) within last year prior to diagnosis of CIP
- Clinically suspected significant lung disease for which inhaled steroid would be standard of care (moderate asthma or severe chronic obstructive pulmonary disease (COPD)) and for which randomization to no inhaled...
- Current (within last two weeks), active (not medically able or unwilling to discontinue prior to treatment start) and regular (2 or more times per week) use of inhaled steroids (for any indication) or systemic (\>10mg...
- Receiving systemic, non-chemotherapy immunosuppressive agent at time of randomization (hydroxychloroquine is acceptable)
- Use of a medication with significant interaction with inhaled budesonide (HIV protease inhibitors, ketoconazole or other potent CYP3A4 inhibitors), unless deemed required and safe by co-investigator.
- Known poorly controlled diabetes, defined as A1c \>10, prior to initiation of steroids for CIP
- History of active and unstable systemic disease, including heart failure New York Heart Association (NYHA) III or IV, cirrhosis with Child Pugh B or C, Renal Failure with creatinine clearance (CrCl) \<30 per...
- Current or prior participation in a study of an investigational agent or device within 4 weeks of randomization
- History or current evidence of any condition, therapy, or laboratory abnormalities which might confound trial results, interfere with the patient's participation for the full duration of the trial, or otherwise causing...
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is directly involved with this trial, unless prospective ethics board approval (by chair or designee) is given allowing...
- Breastfeeding is not permitted during the duration of trial participation.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.