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NCT03803787
Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients
Phase 2 trial testing Inhaled budesonide in Radiation Pneumonitis in 72 participants. Currently enrolling.
1 December 2026
Quick facts
| Lead sponsor | Instituto Nacional de Cancerologia de Mexico |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 72 |
| Start date | 1 September 2018 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2027 |
| Sites | 2 locations across Mexico |
Drugs / interventions tested
- Inhaled budesonide — full drug profile →
Conditions studied
- Radiation Pneumonitis — all drugs for Radiation Pneumonitis →
Sponsor
Instituto Nacional de Cancerologia de Mexico — full company profile →
Who can join
Adults 18 to 75, any sex, with Radiation Pneumonitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized clinical study aims to assess whether prophylactic treatment with inhaled steroids in patients with locally advanced or concomitantly treated non-small cell lung carcinoma who are candidates for combination treatment with QT/RT or IMT + QT/RT. The main questions it aims to answer are: Whether prophylactic treatment decreases the severity of NPR on CTCAE v4.0 and RTOG scales. Whether inhaled steroid use modifies the response to radiation therapy treatment compared to patients who do not receive prophylactic inhaled steroids.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Ionizing radiation: molecular mechanisms, biological effects, and therapeutic targets.
Wei W, Ren Y, Lan J, Yi J, et al · · 2026 · PMID 41507636 · DOI 10.1186/s43556-025-00358-4
Verify or expand the search:
- PubMed search for NCT03803787
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Inhaled budesonide
Trials testing the same drug.
- NCT04355637 — Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia · Phase 4 · completed
- NCT01895075 — Inhaled Budesonide for Non-ventilated Infants at High Risk of Bronchopulmonary Dysplasia: the i-BUD Pilot Study · Phase 2 · withdrawn
Other recruiting trials for Radiation Pneumonitis
Currently open trials in the same condition.
- NCT07339644 — Functional Lung Avoidance Radiotherapy Guided by 4DCT Pulmonary Ventilation Function Imaging: A Prospective Single-arm C · NA · recruiting
- NCT07312682 — Application of 4DCT-Based Pulmonary Ventilation Imaging in Lung Cancer Radiotherapy · active not recruiting
- NCT06570317 — Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC · recruiting
- NCT06069115 — Radiotherapy Exposed Lung Injury: Effect on Functioning - Cohort · recruiting
- NCT05189496 — Hyperbaric Oxygen in the Prevention of Radiation Pneumonitis · NA · recruiting
Other Instituto Nacional de Cancerologia de Mexico trials
Trials by the same sponsor.
- NCT06422533 — Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia in Hemato-oncological Patients · NA · recruiting
- NCT06477302 — Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer · recruiting
- NCT06090747 — Improving Lifestyle Behavior by "Joven, Fuerte y Saludable" Multidisciplinary Program. · NA · recruiting
- NCT06238882 — Nitroglycerin Plus Radiotherapy Versus Conventional Radiotherapy in Patients With Lung Cancer. · NA · recruiting
- NCT06883409 — Laparoscopic Interval Cytoreductive Surgery in Advance Ovarian Cancer · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03803787 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto Nacional de Cancerologia de Mexico
- Last refreshed: 8 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03803787.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing