Trial · NCT03482752
Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis
NCT03482752, Phase 3, Terminated, Savara Inc.; results first posted 2024-07-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis. Trials, record NCT03482752. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03482752
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis
- NCT number
- NCT03482752
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 60 participants, actual
- Lead sponsor
- Savara Inc.
- Conditions
- Autoimmune Pulmonary Alveolar Proteinosis
- Interventions
- Molgramostim
- First posted
- 2018-03-29
- Last updated
- 2024-07-03
- Other registries' IDs
- eudract:2017-004078-32
- Results first posted
- 2024-07-03
- Limitations and caveats
No hypothesis/statistical testing was planned for any of the endpoints of this study but only descriptive statistics were to be used. Efficacy endpoints were secondary endpoints. Due to early study termination, only limited efficacy data were available for evaluation and in general, no firm conclusion based on efficacy data are applicable. No deaths occurred during the study but 1 participant died due to COVID-19 24 days after last dose, i.e. outside the definition of 'treatment-emergent'.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment-emergent Adverse Events (TEAEs) | 139 weeks | The primary objective of this trial was safety assessed by adverse event (AE) reporting. Definitions and reporting procedures for AEs were done according to current regulatory standards. AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns. Treatment-emergent was defined as events occurring on study drug and up to 7 days after last dose of study drug. |
| Primary | Number of Serious TEAEs | 139 weeks | Serious TEAEs were defined as any untoward medicinal occurrence or effect that at any dose: * Results in death * Is life-threatening * Requires hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability or incapacity * Is a congenital abnormality or birth defect * May jeopardise the participant or may require medical intervention to prevent one or more of the outcomes listed above (Important Medical Events). |
| Primary | Number of Treatment-emergent Adverse Drug Reactions (ADRs) | 139 weeks | All AEs were assessed by the investigator for causality (unlikely, possible, probable, not applicable) according to current regulatory standards. AEs which had a 'possible' or 'probable' causality were classified as ADRs. |
| Primary | Number of TEAEs Leading to Treatment Discontinuation | 139 weeks |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment-emergent Adverse Events (TEAEs) | 139 weeks | Safety analysis set. | events | NUMBER |
| PRIMARY | Number of Serious TEAEs | 139 weeks | Safety analysis set. | events | NUMBER |
| PRIMARY | Number of Treatment-emergent Adverse Drug Reactions (ADRs) | 139 weeks | Safety analysis set. | events | NUMBER |
| PRIMARY | Number of TEAEs Leading to Treatment Discontinuation | 139 weeks | Safety analysis set. | events | NUMBER |
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 |
|---|---|---|---|---|---|
| Number of Treatment-emergent Adverse Events (TEAEs) | Molgramostim Nebulizer Solution (300 μg) | 165 | events | ||
| Number of Serious TEAEs | Molgramostim Nebulizer Solution (300 μg) | 8 | events | ||
| Number of Treatment-emergent Adverse Drug Reactions (ADRs) | Molgramostim Nebulizer Solution (300 μg) | 3 | events | ||
| Number of TEAEs Leading to Treatment Discontinuation | Molgramostim Nebulizer Solution (300 μg) | 0 | events |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Molgramostim Nebulizer Solution (300 μg) | 60 | |
| Overall Study | Safety Analysis Set | Molgramostim Nebulizer Solution (300 μg) | 59 | |
| Overall Study | COMPLETED | Molgramostim Nebulizer Solution (300 μg) | 56 | |
| Overall Study | NOT COMPLETED | Molgramostim Nebulizer Solution (300 μg) | 4 |
Source ClinicalTrials.gov
Adverse events16
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 | Cough | Respiratory, thoracic and mediastinal disorders | Molgramostim Nebulizer Solution (300 μg) | 7 | 59 | 7 |
| other | Alveolar proteinosis | Respiratory, thoracic and mediastinal disorders | Molgramostim Nebulizer Solution (300 μg) | 4 | 59 | 5 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Molgramostim Nebulizer Solution (300 μg) | 3 | 59 | 4 |
| other | Fatigue | General disorders | Molgramostim Nebulizer Solution (300 μg) | 3 | 59 | 3 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Molgramostim Nebulizer Solution (300 μg) | 4 | 59 | 6 |
| other | Nasopharyngitis | Infections and infestations | Molgramostim Nebulizer Solution (300 μg) | 7 | 59 | 7 |
| other | Respiratory tract infection | Infections and infestations | Molgramostim Nebulizer Solution (300 μg) | 4 | 59 | 7 |
| other | COVID-19 | Infections and infestations | Molgramostim Nebulizer Solution (300 μg) | 4 | 59 | 4 |
| other | Bronchitis | Infections and infestations | Molgramostim Nebulizer Solution (300 μg) | 3 | 59 | 6 |
| other | Pneumonia | Infections and infestations | Molgramostim Nebulizer Solution (300 μg) | 3 | 59 | 4 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Molgramostim Nebulizer Solution (300 μg) | 1 | 59 |
| Total, other adverse events | Molgramostim Nebulizer Solution (300 μg) | 38 | 59 |
| Total, serious adverse events | Molgramostim Nebulizer Solution (300 μg) | 8 | 59 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03482752
GET https://conductscience.org/api/trials/v1/NCT03482752/registered