Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis
Condition: Rhinosinusitis
MeSH terms: Sinusitis
Intervention: acetylcysteine; Placebo
Intervention description: 600 mg tablet; Placebo to acetylcysteine
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 944.0
Sex: All
Minimum age: 14 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: acute uncomplicated rhinosinusitis, acetylcysteine

Summary:

      The trial was conducted as a prospective, randomized, multinational, multicenter,
      double-blind study in 4 parallel groups of patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects aged between 14 and 75 years inclusive on the date of consent

          2. Diagnosis of acute, uncomplicated rhinosinusitis defined at screening visit 1 and at
             Visit 2 as:

               1. major symptom score (MSS) assessed by the patient ≥8 and ≤12 points for the
                  following: rhinorrhea/ anterior discharge, postnasal drip, nasal congestion,
                  headache, and facial pain/pressure, whereupon the nasal congestion is mandatory
                  and no more than 3 of the 5 symptoms are rated as severe

               2. individual score for facial pain/pressure ≥1 (mild) and ≤2 (moderate)

               3. presence of symptoms ≤3 days prior to screening visit

          3. For adults (≥18 years): Informed consent to participate in the trial provided in
             written form; For adolescents (≥14 - <18 years): own subject informed consent/ assent
             to participate in the trial and the informed consent from all parent(s)/ legal
             guardian(s) provided in written form.

        Exclusion Criteria:

          1. History of hypersensitivity or intolerance to the active substance or any of the
             excipients of the trial medication

          2. Patient with history of hereditary fructose intolerance, galactose intolerance,
             lactase deficiency or glucose-galactose malabsorption

          3. Chronic rhinosinusitis (symptoms lasting longer than 3 months)

          4. Subjects who have undergone sinus or nasal surgery for chronic rhinosinusitis in the 6
             months prior to screening visit

          5. Sinus lavage within 7 days prior to screening visit

          6. Odontogenic rhinosinusitis

          7. Allergic (perennial or seasonal) rhinitis

          8. Bronchial asthma or chronic obstructive pulmonary disease

          9. Nasal polyposis or clinically relevant nasal septum deviation

         10. Concomitant otitis

         11. Intranasal or systemic use of corticosteroids within 30 days prior to screening visit

         12. Intranasal or systemic use of antibiotics within 30 days prior to screening visit

         13. Use of nasal decongestants within 2 days prior to screening visit

         14. Concomitant treatment of common cold-like symptoms within 7 days prior to screening
             visit with any of the following:

               1. Analgesics

               2. Non-steroidal anti-inflammatory drugs

               3. Antihistamines

         15. Concomitant use of intranasal saline irrigation

         16. Use of immunosuppressive agents within 30 days prior to screening visit

         17. Immunocompromised state

         18. Suspicion for acute bacterial rhinosinusitis (defined as presence of purulence for 3
             to 4 days with fever ≥ 38.3°C)

         19. Pregnant or breast-feeding female patient

         20. Female patient of childbearing potential (not surgically sterilized/hysterectomized or
             postmenopausal for at least 1 year) who is not currently using (documented at
             screening visit) and not willing to use medically reliable methods of contraception
             for the entire trial duration such as oral, injectable or implantable contraceptives,
             intrauterine contraceptive devices (IUD), sexual abstinence or vasectomized partner

         21. Any other condition of the patient (e.g. serious or unstable medical or psychological
             condition, acute psychosis) that in the opinion of the investigator may compromise
             evaluation of the trial treatment or may jeopardize patient's safety, compliance or
             adherence to protocol requirements

         22. Participation in ANY research study involving another investigational medicinal
             product (IMP) within 30 days prior to screening visit, or simultaneous participation
             in another clinical study or previous participation in present study

         23. Suspected alcohol/ drug dependence or abuse (including heavy smoking: ≥ 20 cigarettes
             daily)

         24. Use of snuff tobacco

         25. Legal incapacity and/or other circumstances rendering the patient unable to understand
             the nature, scope and possible consequences of the trial

         26. Subjects who are known or suspected:

               -  not to comply with the trial directives

               -  not to be reliable or trustworthy

               -  to be a dependent person, e.g. a relative, family member, or member/employee of
                  the investigator's or sponsor's staff

               -  subject is in custody or submitted to an institution due to a judicial order.