Trial · NCT02484664
COLA: A Pilot Clinical Trial of COX-2 Inhibition in LAM and TSC
NCT02484664, Phase 2, Completed, Brigham and Women's Hospital; results first posted 2022-01-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. COLA: A Pilot Clinical Trial of COX-2 Inhibition in LAM and TSC. Trials, record NCT02484664. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02484664
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- COLA: A Pilot Clinical Trial of COX-2 Inhibition in LAM and TSC
- NCT number
- NCT02484664
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Lymphangioleiomyomatosis (LAM)
- Interventions
- Celecoxib
- First posted
- 2015-06-30
- Last updated
- 2022-01-20
- Results first posted
- 2022-01-20
- Limitations and caveats
- pilot study
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 1 year | Number of Participants with Adverse Events as a Measure of Safety and Tolerability in LAM patients |
| Secondary | FEV1 | 1 year | Forced expiratory volume in 1 second |
| Secondary | Angiomyolipoma Size Measured Volumetrically on MRI | 1 year | We are reporting the number of participants in this trial who had angiomyolipoma either at the beginning or end of the study. |
| Secondary | St. George's Respiratory Questionnaire | 1 year | St. George's Respiratory Questionnaire is a commonly used questionnaire to assess the respiratory function of an individual. The minimum and maximyum socres on this Questionnaire are: 0 and 100. A higher score shows more limitations, so a lower score is better in terms of respiratory function. There are no subscales. Below we are providing mean scores for all 9 participants in this trial. |
| Secondary | VEGF-D Serum Levels | 6 months | VEGF-D serum levels |
| Secondary | EBC Prostaglandin Metabolites | 1 year | We had intended to perform Exhaled breath condensate prostaglandin metabolites. However, this proved to be impossible, and no data was obtained. |
| Secondary | Circ LAM Cell Count | 1 year | We had planned to determine a circulating LAM cell count. However, this proved to be impossible. Therefore, no data was collected. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | FEV1 | 1 year | ml | LEAST_SQUARES_MEAN | |
| SECONDARY | Angiomyolipoma Size Measured Volumetrically on MRI | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | St. George's Respiratory Questionnaire | 1 year | Nine of 12 patients who enrolled on the study stayed on study until the end | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | VEGF-D Serum Levels | 6 months | those who stayed on study until the end | pg/mL | MEDIAN |
| SECONDARY | EBC Prostaglandin Metabolites | 1 year | |||
| SECONDARY | Circ LAM Cell Count | 1 year | all participants |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Celecoxib | 11 | Participants | ||
| FEV1 | Celecoxib | 2583 | Standard Error 166 | ml | |
| Angiomyolipoma Size Measured Volumetrically on MRI | Celecoxib | 3 | Participants | ||
| St. George's Respiratory Questionnaire | Celecoxib | 20.2 | Standard Deviation 4.9 | score on a scale | |
| VEGF-D Serum Levels | Celecoxib | 656 | Full Range 279 to 1865 | pg/mL |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Celecoxib | 12 | |
| Overall Study | COMPLETED | Celecoxib | 9 | |
| Overall Study | NOT COMPLETED | Celecoxib | 3 |
Source ClinicalTrials.gov
Adverse events4
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 | abdominal pain | Gastrointestinal disorders | Celecoxib | 3 | 12 | 6 |
| other | headache | Nervous system disorders | Celecoxib | 3 | 12 | 6 |
| other | fatigue | General disorders | Celecoxib | 3 | 12 | 3 |
| other | malaise | General disorders | Celecoxib | 2 | 12 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Celecoxib | 0 | 12 |
| Total, other adverse events | Celecoxib | 11 | 12 |
| Total, serious adverse events | Celecoxib | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32060062 | DERIVED |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02484664
GET https://conductscience.org/api/trials/v1/NCT02484664/registered