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NCT02702180 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis
A Phase 2 study, sponsored by Savara.
- Completed
- Registry status
- Phase 2
- Development phase
- 139
- Enrollment target
NCT02702180: Completed Phase 2 study, sponsored by Savara.
NCT02702180 is a Phase 2 study that has completed, run by Savara. The registered enrollment target is 139 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02702180, a Phase 2 study, has completed, sponsored by Savara.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 139 participants
- Enrollment target
Study Summary
This study evaluates inhaled molgramostim (recombinant human granulocyte macrophage-colony stimulating factor \[rhGM-CSF\]) in the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) patients. A third of the patients will receive inhaled molgramostim once daily for 24 weeks, a third will receive inhaled molgramostim intermittently (7 days on, 7 days off) for 24 weeks and a third will receive inhaled matching placebo for 24 weeks.
Primary Outcome
Measurement of (A-a)DO2 was done by blood gas analysis. An arterial blood sample was collected in the supine position, after resting for at least 10 minutes (or longer if required to achieve stable oxygen saturation). The sample was analyzed for arterial oxygen tension (PaO2) and partial pressure of carbon dioxide (PaCO2). The calculation of (A-a)DO2 was done centrally by using a formula described in the protocol.
Interventions
- DRUG Placebo
- DRUG Molgramostim
- DEVICE PARI eFlow nebulizer system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2016-03-21 |
| Est. Completion | 2019-09-27 |
| Phase | Phase 2 |
What the finished NCT02702180 record still lists
NCT02702180 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02702180 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02702180 about?
NCT02702180 is a clinical study titled "Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis". This study evaluates inhaled molgramostim (recombinant human granulocyte macrophage-colony stimulating factor \[rhGM-CSF\]) in the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) patients. A third of the patients will receive inhaled molgramostim once daily for 24 weeks, a third will r...
What is the current status of trial NCT02702180?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 139 participants. The study started on 2016-03-21. Estimated completion is 2019-09-27.
What interventions are being tested in trial NCT02702180?
The interventions under investigation include: Placebo (DRUG), Molgramostim (DRUG), PARI eFlow nebulizer system (DEVICE).
Who is sponsoring clinical trial NCT02702180?
This trial is sponsored by Savara, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02702180's enrollment target sits among peer trials
139 525th of 2000 higher than 1,476 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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