Trial · NCT00084409
Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease
NCT00084409, Phase 2, Completed, University of Colorado, Denver; results first posted 2013-02-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease. Trials, record NCT00084409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00084409
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease
- NCT number
- NCT00084409
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 152 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Lung Cancer, Precancerous Condition
- Interventions
- iloprost, placebo
- First posted
- 2004-06-11
- Last updated
- 2020-05-14
- Results first posted
- 2013-02-13
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Average (Follow-up - Baseline) From All Biopsies | Nine years | This outcome measure is created for each subject as follows: From all biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated. From all biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.Histology on bronchial biopsies pre-treatment and post-treatment will be compared. All biopsies will be graded according to the WHO classification for bronchial epithelium for this outcome, and all the following outcomes. WHO Classification Grade Normal 1.0 Reserve Cell Hyperplasia 2.0 Metaplasia 3.0 Mild Dysplasia 4.0 Moderate Dysplasia 5.0 Severe Dysplasia 6.0 Carcinoma in Situ 7.0 Carcinoma 8.0 The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject. |
| Secondary | Change in Dysplasia Index (Follow-up - Baseline) Using All Biopsies | 9 Years | This outcome measure is created for each subject as follows: From all biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)). From all biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated. The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject. |
| Secondary | Change in Average (Follow-up - Baseline) Using Reference Sites | 9 Years | This outcome measure is created for each subject as follows: The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL (Right upper lobe: the superior region of the right lung), RML (Right middle lobe: an anatomic portion of the right lung), RB6 (The carina in the right lower lobe at the entrance to the superior segment), LUL (Left upper lobe: the superior portion of the lung), LUDB (Left upper division bronchus: the carina between the lingular orifice and the left upper lobe), and LB6 (The carina in the left lower lobe at the entrance to the superior segment). From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated. From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated. The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject. |
| Secondary | Change in Maximum (Follow-up - Baseline) Using Reference Sites | 9 Years | This outcome measure is created for each subject as follows: The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL, RML, RB6, LUL, LUDB, and LB6. From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used. From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used. The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject. |
| Secondary | Change in Dysplasia Index (Follow-up - Baseline) Using Reference Sites | 9 Years | This outcome measure is created for each subject as follows: The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL, RML, RB6, LUL, LUDB, and LB6. From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)). From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated. The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject. |
| Secondary | Change in Average (Follow-up - Baseline) Using Matched Sites | 9 Years | This outcome measure is created for each subject as follows: The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating "pairs" of biopsies. From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated. From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated. The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject. |
| Secondary | Change in Maximum (Follow-up - Baseline) Using Matched Sites | 9 Years | This outcome measure is created for each subject as follows: The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies. From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used. From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used. The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject. |
| Secondary | Change in Dysplasia Index (Follow-up - Baseline) Using Matched Sites | 9 Years | This outcome measure is created for each subject as follows: The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies. From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)). From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated. The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject. |
| Secondary | Change in Average (Follow-up - Baseline) Using Baseline Non-Normal Pairs | 9 Years | This outcome measure is created for each subject as follows: The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating "pairs" of biopsies. Any "pair" for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis. From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated. From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated. The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject. |
| Secondary | Change in Maximum (Follow-up - Baseline) Using Baseline Non-Normal Pairs | 9 Years | This outcome measure is created for each subject as follows: The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating "pairs" of biopsies. Any "pair" for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis. From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used. From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used. The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Average (Follow-up - Baseline) From All Biopsies | Nine years | WHO Units | MEAN | |
| SECONDARY | Change in Dysplasia Index (Follow-up - Baseline) Using All Biopsies | 9 Years | Percentage points | MEAN | |
| SECONDARY | Change in Average (Follow-up - Baseline) Using Reference Sites | 9 Years | WHO Units | MEAN | |
| SECONDARY | Change in Maximum (Follow-up - Baseline) Using Reference Sites | 9 Years | WHO Units | MEAN | |
| SECONDARY | Change in Dysplasia Index (Follow-up - Baseline) Using Reference Sites | 9 Years | Percentage points | MEAN | |
| SECONDARY | Change in Average (Follow-up - Baseline) Using Matched Sites | 9 Years | WHO Units | MEAN | |
| SECONDARY | Change in Maximum (Follow-up - Baseline) Using Matched Sites | 9 Years | WHO Units | MEAN | |
| SECONDARY | Change in Dysplasia Index (Follow-up - Baseline) Using Matched Sites | 9 Years | Percentage points | MEAN | |
| SECONDARY | Change in Average (Follow-up - Baseline) Using Baseline Non-Normal Pairs | 9 Years | The analysis was restricted to the 107 subjects (52 in the iloprost group, 55 in the placebo group) with at least 1 non-normal biopsy at baseline, thereby excluding the 18 subjects (8 in the iloprost group and 10 in the placebo group) who had only normal biopsy tissue at baseline. | WHO Units | MEAN |
| SECONDARY | Change in Maximum (Follow-up - Baseline) Using Baseline Non-Normal Pairs | 9 Years | The analysis was restricted to the 107 subjects (52 in the iloprost group, 55 in the placebo group) with at least 1 non-normal biopsy at baseline, thereby excluding the 18 subjects (8 in the iloprost group and 10 in the placebo group) who had only normal biopsy tissue at baseline. | WHO Units | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Average (Follow-up - Baseline) From All Biopsies | Iloprost | -0.23 | Standard Deviation 0.77 | WHO Units | |
| Change in Average (Follow-up - Baseline) From All Biopsies | Placebo | -0.02 | Standard Deviation 0.79 | WHO Units | |
| Change in Dysplasia Index (Follow-up - Baseline) Using All Biopsies | Iloprost | -7.70 | Standard Deviation 21.76 | Percentage points | |
| Change in Dysplasia Index (Follow-up - Baseline) Using All Biopsies | Placebo | -0.92 | Standard Deviation 25.23 | Percentage points | |
| Change in Average (Follow-up - Baseline) Using Reference Sites | Iloprost | -0.23 | Standard Deviation 0.82 | WHO Units | |
| Change in Average (Follow-up - Baseline) Using Reference Sites | Placebo | -0.01 | Standard Deviation 0.82 | WHO Units | |
| Change in Maximum (Follow-up - Baseline) Using Reference Sites | Iloprost | -0.35 | Standard Deviation 1.58 | WHO Units | |
| Change in Maximum (Follow-up - Baseline) Using Reference Sites | Placebo | 0.11 | Standard Deviation 1.30 | WHO Units | |
| Change in Dysplasia Index (Follow-up - Baseline) Using Reference Sites | Iloprost | -7.61 | Standard Deviation 23.43 | Percentage points | |
| Change in Dysplasia Index (Follow-up - Baseline) Using Reference Sites | Placebo | 0.15 | Standard Deviation 26.41 | Percentage points |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Iloprost | 75 | |
| Overall Study | STARTED | Placebo | 77 | |
| Overall Study | COMPLETED | Iloprost | 60 | |
| Overall Study | COMPLETED | Placebo | 65 | |
| Overall Study | NOT COMPLETED | Iloprost | 15 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Iloprost | 40 | 75 | |
| other | Headache | Nervous system disorders | Placebo | 17 | 77 | |
| other | Flushing | Vascular disorders | Iloprost | 18 | 75 | |
| other | Flushing | Vascular disorders | Placebo | 6 | 77 | |
| other | Nausea | Gastrointestinal disorders | Iloprost | 12 | 75 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 77 | |
| other | Pain - Other | General disorders | Iloprost | 12 | 75 | |
| other | Pain - Other | General disorders | Placebo | 6 | 77 | |
| other | Myalgia (muscle pain) | Musculoskeletal and connective tissue disorders | Iloprost | 13 | 75 | |
| other | Myalgia (muscle pain) | Musculoskeletal and connective tissue disorders | Placebo | 1 | 77 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Iloprost | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Iloprost | 52 | 75 |
| Total, other adverse events | Placebo | 32 | 77 |
| Total, serious adverse events | Iloprost | 3 | 75 |
| Total, serious adverse events | Placebo | 6 | 77 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21636546 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Iloprost vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00084409
GET https://conductscience.org/api/trials/v1/NCT00084409/results?page=2