NCT00321893

Randomized Phase II Trial of Budesonide Turbuhaler® 800 Micrograms/Twice Daily Versus Placebo in High-Risk Population With Undetermined Lung Nodules Detected at Screening Low Dose CT Scan

Completed Phase 2 Results posted Last updated 21 December 2015

What this trial tests

Phase 2 trial testing Budesonide in Lung Cancer in 225 participants. Completed in 1 September 2008.

Timeline

1 January 2006

Primary endpoint
1 September 2008

1 September 2008

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	225
Start date	1 January 2006
Primary completion	1 September 2008
Estimated completion	1 September 2008
Sites	1 location across Italy

Drugs / interventions tested

• Budesonide (BUDESONIDE) — full drug profile →
• Placebo

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

50 and older, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number CT- Detected Lung Nodules by Participant
  Time frame: Baseline assessment
  Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection: Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (\< 5 mm does not require additional diagnostic foll
• Size of CT- Detected Lung Nodules by Participant
  Time frame: Baseline assessment
  Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection. Nodule type categorized as: Nonsolid, Partially Solid, or Solid. Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4\&5 mm. Nodules may be stable or grown from the p
• Number of Participant Overall Responses as Measured by RECIST Criteria at 12 Months
  Time frame: 12 Months
  For single nodules \>5 mm, clinical meaningful shrinkage of 30% or \> longest diameter (LD) considered treatment success after 1 year treatment; for \<5 mm, complete disappearance considered treatment success. Multiple lesions success is complete response (CR) or partial response (PR) according to RECIST while failure when progression disease (PD) or stable disease (SD). CR: disappearance all targ
• Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months
  Time frame: 12 Months
  Number of participants with response according to RECIST criteria. For single nodules \> 5 mm, clinical meaningful shrinkage of 30% or \> of longest diameter (LD) considered treatment success after 1 year of treatment. For single nodules with LD \<5 mm, complete disappearance considered treatment success. In case of multiple lesions success of treatment is when complete response (CR) or partial re

Sponsor's own description

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of budesonide may keep lung cancer from forming in patients with lung nodules.

PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in treating patients with lung nodules who are at high risk of lung cancer.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized phase II trial of inhaled budesonide versus placebo in high-risk individuals with CT screen-detected lung nodules.
   Veronesi G, Szabo E, Decensi A, Guerrieri-Gonzaga A, et al · · 2011 · cited 44× · PMID 21163939 · DOI 10.1158/1940-6207.capr-10-0182
2. Long-term effects of inhaled budesonide on screening-detected lung nodules.
   Veronesi G, Lazzeroni M, Szabo E, Brown PH, et al · · 2015 · cited 16× · PMID 25672894 · DOI 10.1093/annonc/mdv064
3. Circulating and tissue biomarkers in early-stage non-small cell lung cancer.
   Fumagalli C, Bianchi F, Raviele PR, Vacirca D, et al · · 2017 · cited 15× · PMID 28194229 · DOI 10.3332/ecancer.2017.717
4. Chemoprevention studies within lung cancer screening programmes.
   Veronesi G, Guerrieri-Gonzaga A, Infante M, Bonanni B. · · 2015 · cited 10× · PMID 26635901 · DOI 10.3332/ecancer.2015.597
5. Budesonide versus placebo in high-risk population with screen-detected lung nodules: rationale, design and methodology.
   Lazzeroni M, Guerrieri-Gonzaga A, Serrano D, Varricchio MC, et al · · 2010 · cited 7× · PMID 20719253 · DOI 10.1016/j.cct.2010.08.006
6. The Modulation of Cell Plasticity by Budesonide: Beyond the Metabolic and Anti-Inflammatory Actions of Glucocorticoids.
   Patriarca EJ, D'Aniello C, De Cesare D, Cobellis G, et al · · 2025 · PMID 40284499 · DOI 10.3390/pharmaceutics17040504
7. A Systematic Review and Pooled Analysis of Hypothesized versus Observed Effect Sizes in Early Phase Cancer Prevention Clinical Trials.
   Eickhoff J, Zaborek J, Chen G, Sahasrabuddhe VV, et al · · 2023 · PMID 37258421 · DOI 10.1158/1940-6207.capr-23-0060