Trial · NCT03006146
Evaluation of a Single Dose of Inhaled Sargramostim in Patients With Autoimmune Pulmonary Alveolar Proteinosis
NCT03006146, Phase 1, Completed, Children's Hospital Medical Center, Cincinnati
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of a Single Dose of Inhaled Sargramostim in Patients With Autoimmune Pulmonary Alveolar Proteinosis. Trials, record NCT03006146. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03006146
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of a Single Dose of Inhaled Sargramostim in Patients With Autoimmune Pulmonary Alveolar Proteinosis
- NCT number
- NCT03006146
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Autoimmune Pulmonary Alveolar Proteinosis
- Interventions
- Sargramostim
- First posted
- 2016-12-30
- Last updated
- 2021-08-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of any treatment-emergent adverse events and serious adverse events | 1 year | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
| Secondary | Maximum plasma GM-CSF Concentration (Cmax) | 1 year | Maximum concentration of free and toal GM-CSF in the plasma following a single administration of inhaled sargramostim |
| Secondary | Time to maximum plasma GM-CSF concentration (TMax) | 1 year | Time to maximum plasma concentrations of free and total GM-CSF following a single administration of inhaled sargramostim |
| Secondary | GM-CSF Area Under the Curve (AUC) | 1 year | Systemic exposure to GM-CSF in plasma samples collected at regular intervals following a single administration of inhaled sargramostim |
| Secondary | Half-life of inhaled GM-CSF (t1/2) | 1 year | Half-life of GM-CSF following a single administration of inhaled sargramostim |
| Secondary | Complete cell counts and differentials in blood and BAL fluid | 1 year | Cell Counts and differentials in blood and BAL fluid following a single administration of inhaled sargramostim will be compared to baseline values (pre-study drug administration) |
| Secondary | GM-CSF autoantibody levels in blood and BAL fluid | 1 year | GM-CSF autoantibody concentrations in blood and BAL fluid following a single administration of inhaled sargramostim will be compared to baseline values (pre-study drug administration) |
| Secondary | GM-CSF signaling levels in blood and BAL fluid | 1 year | Responsiveness of blood and BAL cells to in vitro stimulation with GM-CSF in blood and BAL fluid following a single administration of inhaled sargramostim will be compared to baseline values (pre-study drug administration) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1TR001425 | Center for Clinical and Translational Science and Training | MEINZEN-DERR, JAREEN; STRAWN, JEFFREY ROBERT; VAGAL, ACHALA SAMEER | UNIVERSITY OF CINCINNATI | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2015 to 2024 |
Source NIH RePORTER
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/NCT03006146
GET https://conductscience.org/api/trials/v1/NCT03006146/registered