Acute rhinosinusitis MedDRA version: 20.0 Level: LLT Classification code 10052106 Term: Rhinosinusitis System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Acetylcystein HEXAL 600 mg Brausetabletten
Product Name: Acetylcysteine 600 mg effervescent tablet
Product Code: ACC 600
Pharmaceutical Form: Effervescent tablet
INN or Proposed INN: ACETY
Sponsors
HEXAL AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Male or female subjects aged between 18 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: a) 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 b) individual score for facial pain/pressure =1 (mild) and =2 (moderate) c) presence of symptoms =3 days prior to screening visit [3] Informed consent to participate in the trial provided in written form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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: a) Analgesics b) Non-steroidal anti-inflammatory drugs c) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the present trial is the assessment of the efficacy of three different total daily doses of the investigational product containing 600 mg acetylcysteine per effervescent tablet compared to placebo for the treatment of acute uncomplicated rhinosinusitis.;Secondary Objective: The secondary objective of the present trial is the assessment of safety and tolerability of three different total daily doses of the investigational product containing 600 mg acetylcysteine per effervescent tablet compared to placebo for the treatment of acute uncomplicated rhinosinusitis.;Primary end point(s): Mean change from baseline in the daily MSS over the entire treatment period.;Timepoint(s) of evaluation of this end point: After the end of the clinical part of the trial, following database lock and unblinding. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are: Time to onset of action defined as first day of active treatment on which MSS shows statistically significant difference from placebo; MSS (major symptom score) development over the course of the study; SNOT-22 (sino-nasal outcome test) by visit and changes versus baseline; Percentage of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator. The safety endpoints are: • Incidence and severity of adverse events • Incidence and severity of drug-related adverse events • Clinically relevant changes in laboratory parameters, vital signs, physical and ENT examination parameters from Visit 1 to Visit 6 (or early termination) • Overall assessment of tolerability by patient and by investigator.;Timepoint(s) of evaluation of this end point: After the end of the clinical part of the trial, following database lock and unblinding. | — |
Countries
Bulgaria, Germany, Moldova, Republic of, Russian Federation
Contacts
Public ContactMaja Radivojša Matanovic
Lek Pharmaceuticals d.d.
Outcome results
None listed