Status:
COMPLETED
Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis
Lead Sponsor:
Sandoz
Conditions:
Rhinosinusitis
Eligibility:
All Genders
14-75 years
Phase:
PHASE3
Brief Summary
The trial was conducted as a prospective, randomized, multinational, multicenter, double-blind study in 4 parallel groups of patients.
Detailed Description
The study was the prospective, randomized, multinational, multicenter, double-blind study in 4 parallel groups of patients. Patients underwent screening examinations at Visit 1. Patients who met all ...
Eligibility Criteria
Inclusion
- Male or female subjects aged between 14 and 75 years inclusive on the date of consent
- Diagnosis of acute, uncomplicated rhinosinusitis defined at screening visit 1 and at Visit 2 as:
- 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
- individual score for facial pain/pressure ≥1 (mild) and ≤2 (moderate)
- presence of symptoms ≤3 days prior to screening visit
- 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
- History of hypersensitivity or intolerance to the active substance or any of the excipients of the trial medication
- Patient with history of hereditary fructose intolerance, galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Chronic rhinosinusitis (symptoms lasting longer than 3 months)
- Subjects who have undergone sinus or nasal surgery for chronic rhinosinusitis in the 6 months prior to screening visit
- Sinus lavage within 7 days prior to screening visit
- Odontogenic rhinosinusitis
- Allergic (perennial or seasonal) rhinitis
- Bronchial asthma or chronic obstructive pulmonary disease
- Nasal polyposis or clinically relevant nasal septum deviation
- Concomitant otitis
- Intranasal or systemic use of corticosteroids within 30 days prior to screening visit
- Intranasal or systemic use of antibiotics within 30 days prior to screening visit
- Use of nasal decongestants within 2 days prior to screening visit
- Concomitant treatment of common cold-like symptoms within 7 days prior to screening visit with any of the following:
- Analgesics
- Non-steroidal anti-inflammatory drugs
- Antihistamines
- Concomitant use of intranasal saline irrigation
- Use of immunosuppressive agents within 30 days prior to screening visit
- Immunocompromised state
- Suspicion for acute bacterial rhinosinusitis (defined as presence of purulence for 3 to 4 days with fever ≥ 38.3°C)
- Pregnant or breast-feeding female patient
- 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
- 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
- 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
- Suspected alcohol/ drug dependence or abuse (including heavy smoking: ≥ 20 cigarettes daily)
- Use of snuff tobacco
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial
- 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.
Key Trial Info
Start Date :
October 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2021
Estimated Enrollment :
944 Patients enrolled
Trial Details
Trial ID
NCT04123405
Start Date
October 22 2020
End Date
April 20 2021
Last Update
November 19 2021
Active Locations (37)
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1
Sandoz Investigative Site
Burgas, Bulgaria, 8000
2
Sandoz Investigative Site
Gabrovo, Bulgaria, 5300
3
Sandoz Investigative Site
Plovdiv, Bulgaria, 4000
4
Sandoz Investigative Site
Sliven, Bulgaria, 8800