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

NCT ID: NCT04123405

Last Updated: 2021-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 944 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-22
• Study Completion Date: 2021-04-20

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 inclusion/ no exclusion criteria were randomized at the baseline visit (Day 1) to the double-blind treatment for a duration of 14 days but in case of delayed final visit (Day 15) the patient could voluntarily take reserve study medication for a maximum of 3 additional days.

After the end of the double-blind treatment phase, the patients underwent an end-of-treatment (EOT) examinations on Day 15 (+3).

A follow-up phone call within 7 days after Day 15 (or earlier in case of premature termination) was performed.

Conditions

Rhinosinusitis

Keywords

acute uncomplicated rhinosinusitis, acetylcysteine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A: 600 mg acetylcysteine

one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)

Group Type: EXPERIMENTAL

acetylcysteine

Intervention Type: DRUG

600 mg tablet

Placebo

Intervention Type: DRUG

Placebo to acetylcysteine

Group B: 1200 mg acetylcysteine

two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)

Group Type: EXPERIMENTAL

acetylcysteine

Intervention Type: DRUG

600 mg tablet

Placebo

Intervention Type: DRUG

Placebo to acetylcysteine

Group C: 2400 mg acetylcysteine

four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)

Group Type: EXPERIMENTAL

acetylcysteine

Intervention Type: DRUG

600 mg tablet

Group D: Placebo

four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to acetylcysteine

Interventions

acetylcysteine

600 mg tablet

Intervention Type: DRUG

Placebo

Placebo to acetylcysteine

Intervention Type: DRUG

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandoz

Role: STUDY_DIRECTOR

Sandoz

Locations

Sandoz Investigative Site

Burgas, , Bulgaria

Sandoz Investigative Site

Gabrovo, , Bulgaria

Sandoz Investigative Site

Plovdiv, , Bulgaria

Sandoz Investigative Site

Sliven, , Bulgaria

Sandoz Investigative Site

Sofia, , Bulgaria

Sandoz Investigative Site

Sofia, , Bulgaria

Sandoz Investigative Site

Sofia, , Bulgaria

Sandoz Investigative Site

Sofia, , Bulgaria

Sandoz Investigative Site

Yambol, , Bulgaria

Sandoz Investigative Site

Aachen, , Germany

Sandoz Investigative Site

Dresden, , Germany

Sandoz Investigative Site

Duisburg, , Germany

Sandoz Investigative Site

Chisinau, , Moldova

Sandoz Investigative Site

Chisinau, , Moldova

Sandoz Investigative Site

Chisinau, , Moldova

Sandoz Investigative Site

Chisinau, , Moldova

Sandoz Investigative Site

Chisinau, , Moldova

Sandoz Investigative Site

Chisinau, , Moldova

Sandoz Investigative Site

Orhei, , Moldova

Sandoz Investigative Site

Kazan', , Russia

Sandoz Investigative Site

Kemerovo, , Russia

Sandoz Investigative Site

Moscow, , Russia

Sandoz Investigative Site

Moscow, , Russia

Sandoz Investigative Site

Moscow, , Russia

Sandoz Investigative Site

Moscow, , Russia

Sandoz Investigative Site

Novosibirsk, , Russia

Sandoz Investigative Site

Ryazan, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Smolensk, , Russia

Sandoz Investigative Site

Yaroslavl, , Russia

Countries

Bulgaria; Germany; Moldova; Russia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-000060-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2018-08-EFT-1

Identifier Type: -

Identifier Source: org_study_id