Trial · NCT01216735
Effect of an Inhaled Glucocorticosteroid (ICS) on Endothelial Dysfunction in Cigarette Smokers
NCT01216735, Not applicable, Completed, University of Miami; results first posted 2014-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of an Inhaled Glucocorticosteroid (ICS) on Endothelial Dysfunction in Cigarette Smokers. Trials, record NCT01216735. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01216735
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of an Inhaled Glucocorticosteroid (ICS) on Endothelial Dysfunction in Cigarette Smokers
- NCT number
- NCT01216735
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 32 participants, actual
- Lead sponsor
- University of Miami
- Conditions
- Tobacco Abuse Smoke
- Interventions
- Fluticasone, Placebo
- First posted
- 2010-10-07
- Last updated
- 2016-06-29
- Results first posted
- 2014-12-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo | 3 weeks treatment period of ICS or placebo | Airway Blood flow (Qaw) will be measured before and 15 minutes after albuterol inhalation (delta Qaw). |
| Secondary | Flow-mediated Brachial Vasodilation (FMD% Peak Delta) | 3 weeks of treatment | Flow-mediated vasodilation response in the brachial artery will be measured before and 15 minutes.after albuterol inhalation |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo | 3 weeks treatment period of ICS or placebo | % change | MEAN | |
| SECONDARY | Flow-mediated Brachial Vasodilation (FMD% Peak Delta) | 3 weeks of treatment | % change | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo | Fluticasone | 40.9 | Standard Error 7.3 | % change | |
| Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo | Placebo | 0.0 | Standard Error 3.2 | % change | |
| Flow-mediated Brachial Vasodilation (FMD% Peak Delta) | Fluticasone | 3.9 | Standard Error 0.6 | % change | |
| Flow-mediated Brachial Vasodilation (FMD% Peak Delta) | Placebo | 4.8 | Standard Error 0.6 | % change |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (3 Weeks) | STARTED | Fluticasone First, Then Placebo | 8 | |
| First Intervention (3 Weeks) | STARTED | Placebo First, Then Fluticasone | 7 | |
| First Intervention (3 Weeks) | COMPLETED | Fluticasone First, Then Placebo | 8 | |
| First Intervention (3 Weeks) | COMPLETED | Placebo First, Then Fluticasone | 7 | |
| First Intervention (3 Weeks) | NOT COMPLETED | Fluticasone First, Then Placebo | 0 | |
| First Intervention (3 Weeks) | NOT COMPLETED | Placebo First, Then Fluticasone | 0 | |
| Washout (3 Weeks) | STARTED | Fluticasone First, Then Placebo | 8 | |
| Washout (3 Weeks) | STARTED | Placebo First, Then Fluticasone | 7 | |
| Washout (3 Weeks) | COMPLETED | Fluticasone First, Then Placebo | 8 | |
| Washout (3 Weeks) | COMPLETED | Placebo First, Then Fluticasone | 7 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluticasone | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Fluticasone | 0 | 15 |
| Total, other adverse events | Placebo | 0 | 15 |
| Total, serious adverse events | Fluticasone | 0 | 15 |
| Total, serious adverse events | Placebo | 0 | 15 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Fluticasone 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/NCT01216735
GET https://conductscience.org/api/trials/v1/NCT01216735/registered