Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in Japan
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|ClinicalTrials.gov Identifier: NCT02835742|
Recruitment Status : Completed
First Posted : July 18, 2016
Last Update Posted : February 7, 2019
Objective: Determine the safety and efficacy of GM-CSF inhalation in patients with aPAP.
Study Design: multi-center, randomized, double-blind, placebo- controlled, safety/efficacy study.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Alveolar Proteinosis, Autoimmune||Drug: Sargramostim Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in Japan|
|Actual Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||June 2018|
Active Comparator: Group1
Treatments for Group 1 include GM-CSF inhalation with 250 mcg/day/body of sargramostim (125 mcg BID on Days 1-7, none on Days 8-14) for twelve 2-week cycles.
Placebo Comparator: Group2
Treatments for Group 2 include placebo inhalation (Placebo BID on Days 1-7, none on Days 8-14) for twelve 2-week cycles.
- Change value of AaDO2 between baseline and 24 weeks [ Time Frame: 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835742
|Niigata University Med & Dental Hospital|