A Phase 2 interventional study of ASM8 in Asthma, sponsored by Syntara. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-12-03.
Sponsored by Syntara · Phase 2, Interventional, and Treatment
The purpose of the study is to determine the safety and tolerability of 8.0 mg of ASM8 when given daily for 14 days by the Aeroneb® Go nebulizer to subjects with moderate to severe asthma.
The safety and tolerability of ASM8 will be assessed by performing a physical exam and vital signs, measuring the use of concomitant medication, routine laboratory tests, urinalysis, sputum analysis, serum IL-1 and TNF-α, lung carbon monoxide diffusion capacity, pulse oximetry and measuring AEs
There are 5 study phases: screening (phase 1), run-in (phase 2), treatment A (phase 3) with Active or Placebo, treatment B(phase 4) with Active or Placebo and end of study (phase 5) that includes a wash out period and a final visit.
3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.
Browse Asthma studies →Syntara is the lead sponsor of 29 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Sputum total cells, differential and sputum levels of IL-1 and TNF alpha
Sputum total cells, differential (neutrophils, macrophages, bronchial cells and lymphocytes) and sputum levels of IL-1 and TNF alpha at the end of each treatment and at the final visit will be reported as absolute counts (10x6 cells/mL) and percentages (%) and change in % from baseline will also be presented.
Time frame: 56 days
No study locations are listed for this record.
This study is withdrawn, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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