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RejuvenAir® System Trial for COPD With Chronic Bronchitis

Study acronym: SPRAY-CB
StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 3, 2024 (before its estimated May 2025 completion). Its status may not reflect the trial's current state.

Record History

The 49 most recent of 66 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since May 2024); last known: Active, Not Recruiting
  2. Notable Primary completion date: Apr 2024 to May 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 30 to 27
    v66
  3. Minor Re-verified, no change to tracked fieldsv65
  4. Minor Primary completion date: Oct 2023 to Apr 2024
    • Study completion date: Sep 2024 to Sep 2026
    • Site details revised at 1 of 30 sites
    v64
  5. Minor Site details revised at 1 of 30 sitesv63
Show 45 earlier versionsHide 45 earlier versions
  1. Minor Site details revised at 1 of 30 sitesv62
  2. Minor Study sites: 29 to 30v61
  3. Minor Site contacts updated at 2 of 29 sitesv60
  4. Minor Study sites: 28 to 29v59
  5. Minor Site details revised at 1 of 28 sitesv58
  6. Minor Site details revised at 2 of 28 sitesv57
  7. Notable Primary completion date: Oct 2022 to Oct 2023
    • Study sites: 27 to 28
    v56
  8. Minor Site contacts updated at 5 of 27 sitesv55
  9. Minor Site details revised at 1 of 27 sitesv54
  10. Minor Site details revised at 1 of 27 sitesv53
  11. Minor Site details revised at 1 of 27 sitesv52
  12. Minor Study sites revised (27)v51
  13. Minor Site details revised at 1 of 27 sitesv50
  14. Minor Study sites: 26 to 27v49
  15. Minor Study sites: 25 to 26v48
  16. Minor Study sites: 24 to 25v47
  17. Minor Study sites: 23 to 24v46
  18. Minor Study sites: 22 to 23v45
  19. Minor Study sites: 21 to 22v44
  20. Minor Study sites: 22 to 21v43
  21. Minor Site details revised at 1 of 22 sitesv42
  22. Minor Site details revised at 2 of 22 sitesv41
  23. Minor Study sites: 21 to 22v40
  24. Minor Study sites: 20 to 21v39
  25. Minor Site details revised at 2 of 20 sitesv38
  26. Minor Site contacts updated at 1 of 20 sitesv37
  27. Notable Enrollment target: 330 to 210v36 Show 4 more changesShow less
    • Primary endpoints: 2 to 1
    • Study sites: 21 to 20
    • Eligibility criteria shortened, about 22 words
    • Secondary endpoints revised (5)
  28. Minor Study sites: 18 to 21v35
  29. Minor Site details revised at 1 of 18 sitesv34
  30. Minor Site details revised at 3 of 18 sitesv33
  31. Minor Site details revised at 1 of 18 sitesv32
  32. Minor Study sites: 17 to 18v31
  33. Minor Site details revised at 1 of 17 sitesv30
  34. Minor Site contacts updated at 1 of 17 sitesv29
  35. Minor Site contacts updated at 1 of 17 sitesv28
  36. Minor Study sites: 16 to 17v27
  37. Minor Site contacts updated at 1 of 16 sitesv26
  38. Minor Site details revised at 1 of 16 sitesv25
  39. Minor Site details revised at 1 of 16 sitesv24
  40. Minor Site details revised at 1 of 16 sitesv23
  41. Minor Study sites: 15 to 16v22
  42. Minor Study sites: 14 to 15v21
  43. Minor Site details revised at 2 of 14 sitesv20
  44. Minor Site details revised at 1 of 14 sitesv19
  45. Minor Site contacts updated at 1 of 14 sitesv18
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,119 trials monitored
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Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality.
Trial Details
NCT Number NCT03893370
Lead Sponsor CSA Medical, Inc.
Conditions
(from sponsor)
Chronic Bronchitis
Related terms Bronchitis, Chronic
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov