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Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04123405
Recruitment Status : Not yet recruiting
First Posted : October 10, 2019
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Sandoz

Tracking Information
First Submitted Date  ICMJE October 9, 2019
First Posted Date  ICMJE October 10, 2019
Last Update Posted Date March 26, 2020
Estimated Study Start Date  ICMJE September 7, 2020
Estimated Primary Completion Date March 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
Mean change from baseline in the daily Major Symptoms Score (MSS) over the entire treatment period [ Time Frame: 15 days ]
The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure) and has been employed as primary efficacy criterion in several clinical trials. Assessment of symptom severity. The user will rate the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The daily outcome will be the sum all symptom scores.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Time to onset of action [ Time Frame: 15 days ]
    Time to onset of action is defined as first day of active treatment on which MSS shows statistically significant difference from placebo
  • MSS development over the course of the study [ Time Frame: daily from Baseline to Day 15 ]
    The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure) and has been employed as primary efficacy criterion in several clinical trials. Assessment of symptom severity. The user will rate the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The daily outcome will be the sum all symptom scores.
  • SNOT-22 by visit and changes versus baseline [ Time Frame: Baseline (Day 1), Day 8, Day 15 ]
    The 22-item Sino-Nasal Outcome Test (SNOT-22) is a commonly utilized outcome measure for rhinosinusitis. 22 items are assessed according to their severity. Additionally five most important items can be selected.
  • Percentage of responders and non-responders [ Time Frame: Day 4, Day 7, Day 10, Day 15 ]
    Percentage of responders and non-responders to treatment is based on the assessment of overall response to treatment by the investigator
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
  • Time to onset of action [ Time Frame: 15 days ]
    Time to onset of action is defined as first day of active treatment on which MSS shows statistically significant difference from placebo
  • MSS development over the course of the study [ Time Frame: daily from Baseline to Day 15 ]
    The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure) and has been employed as primary efficacy criterion in several clinical trials. Assessment of symptom severity. The user will rate the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The daily outcome will be the sum all symptom scores.
  • SNOT-22 by visit and changes versus baseline [ Time Frame: Baseline (Day 1), Day 8, Day 15 ]
    The 22-item Sino-Nasal Outcome Test (SNOT-22) is a commonly utilized outcome measure for rhinosinusitis. 22 items are assessed accroding to their severity. Additionally five most important items can be selected.
  • Percentage of responders and non-responders [ Time Frame: Day 4, Day 7, Day 10, Day 15 ]
    Percentage of responders and non-responders to treatment is based on the assessment of overall response to treatment by the investigator
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis
Official Title  ICMJE Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis: a Prospective, Randomized, Double-blind, Placebo-controlled Trial
Brief Summary The trial will be conducted as a prospective, randomized, multinational, multicenter, double-blind study in 4 parallel groups of patients. Approximately 900 patients with acute, uncomplicated rhinosinusitis will be randomized.
Detailed Description

The test product (Acetylcysteine 600 mg effervescent tablet) is registered in many EU as well as non-EU countries for the secretolytic therapy in acute and chronic bronchopulmonary diseases.

The primary aim of this trial is to assess 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.

The trial design was chosen according to the recommendation of the current guidelines EMA/CHMP/ICH/135/19953 and CPMP/ICH/291/95

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rhinosinusitis
Intervention  ICMJE
  • Drug: acetylcysteine
    600 mg tablet
  • Drug: Placebo
    Placebo to acetylcysteine
Study Arms  ICMJE
  • Experimental: acetylcysteine 600 mg
    600 mg acetylcysteine: one tablet test product plus three tablets placebo per day
    Interventions:
    • Drug: acetylcysteine
    • Drug: Placebo
  • Experimental: acetylcysteine 1200 mg
    two tablets test product plus two tablets placebo per day
    Interventions:
    • Drug: acetylcysteine
    • Drug: Placebo
  • Experimental: acetylcysteine 2400 mg
    four tablets test product per day
    Intervention: Drug: acetylcysteine
  • Placebo Comparator: Placebo
    four tablets placebo per day
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2019)
900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date March 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals +41-61-3241111 novartis.email@novartis.com
Listed Location Countries  ICMJE Bulgaria,   Germany,   Moldova, Republic of,   Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04123405
Other Study ID Numbers  ICMJE 2018-08-EFT-1
2019-000060-20 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sandoz
Study Sponsor  ICMJE Sandoz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sandoz Sandoz
PRS Account Sandoz
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP