Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00321893
First received: May 2, 2006
Last updated: April 24, 2015
Last verified: October 2014
Results First Received: October 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Lung Cancer
Interventions: Drug: Budesonide
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: April 2006 to July 2007. Participants were recruited in Milan, Italy at the European Institute of Oncology.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 225 participants registered, 23 participants were excluded from the trial before assignment to groups.

Reporting Groups
  Description
Arm I: Budesonide Inhaled Budesonide 800 micrograms (ug) twice daily for 1 year
Arm II: Placebo Inhaled placebo twice daily for 1 year

Participant Flow:   Overall Study
    Arm I: Budesonide     Arm II: Placebo  
STARTED     101     101  
COMPLETED     77     87  
NOT COMPLETED     24     14  
Non-Compliance/Refusal                 16                 10  
Lost to Follow-up                 2                 1  
Adverse Event                 6                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Three (3) participants in Arm I: Budesonide, and one (1) in Arm II: Placebo later refused follow up CT and were excluded from overall analysis.

Reporting Groups
  Description
Arm I: Budesonide Inhaled Budesonide 800 ug twice daily for 1 year
Arm II: Placebo Inhaled placebo twice daily for 1 year
Total Total of all reporting groups

Baseline Measures
    Arm I: Budesonide     Arm II: Placebo     Total  
Number of Participants  
[units: participants]
  101     101     202  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     96     94     190  
>=65 years     5     7     12  
Age  
[units: years]
Median (Full Range)
  59    (52 to 72)     59    (51 to 75)     59    (51 to 75)  
Gender  
[units: participants]
     
Female     23     22     45  
Male     78     79     157  
Region of Enrollment  
[units: participants]
     
Italy     101     101     202  



  Outcome Measures
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1.  Primary:   Number CT- Detected Lung Nodules by Participant   [ Time Frame: Baseline assessment ]

2.  Primary:   Size of CT- Detected Lung Nodules by Participant   [ Time Frame: Baseline assessment ]

3.  Primary:   Number of Participant Overall Responses as Measured by RECIST Criteria at 12 Months   [ Time Frame: 12 Months ]

4.  Primary:   Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months   [ Time Frame: 12 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Powel H. Brown, MD, PhD/Professor of Medicine and Cancer Prevention
Organization: University of Texas MD Anderson
e-mail: CR_Study_Registration@mdanderson.org


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00321893     History of Changes
Other Study ID Numbers: NCI-2014-02166, MDA-05-5-01, MDA-S262/505, MDA-2005-0953, EUDRACT-2005-004614-32, CDR0000470861, NCI-2012-02113
Study First Received: May 2, 2006
Results First Received: October 8, 2014
Last Updated: April 24, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government