regulatory issues

Proof-of-concept study with a novel nasal spray in chronic rhinitis or chronic sinusitis. The study will involve 25 patients completing the study for a per protocol analysis.

Visit 1 (Day 0): Screening visit. Assessment of outcome measures

Visit 2 (Day 7): Enrollment visit after a 1-week wash-out period. Enrolled to the Study are only patients who show a severe enough and stable disease (SNOT score >20 and change of SNOT score <15% compared to Visit 1, respectively).

Visit 3 (Day 21): Assessment of outcome measures after 2-week treatment phase

Visit 4 (Day 49): Follow-up visit

Inclusion Criteria:

• Clinically diagnosed chronic allergic rhinitis or chronic sinusitis with no or a mild status of nasal polyp activity
• Disease lasting 12 weeks or longer
• Patients with moderate or severe symptoms (SNOT-22 score >20)
• Male or female at least 18 years old
• Females in childbearing age are requested to make a pregnancy test and to confirm in writing to take contraceptive measures until Follow-up Visit (Day 49).
• Patient understands German

Exclusion Criteria:

• Severely purulent forms of sinusitis

• History of medication during the last four weeks

  • not allowed: antibiotics, systemic or topical steroids
  • allowed: nasal saline spray or irrigation, analgesics, decongestants, antihistamines

• Patient has a status of moderate or severe polyp activity in the nose

• Patient had sinus surgery in the past 6 months

• Patient needs O2 substitution

• Patient has cystic fibrosis

• Patient has primary ciliary dyskinesia

• Patient is demented or otherwise incapable of judgement