Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis: a Prospective, Randomized, Double-blind, Placebo-controlled Trial

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

Sponsors

Lead sponsor: Sandoz

Source Sandoz
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

Overall Status Not yet recruiting
Start Date September 7, 2020
Completion Date March 31, 2021
Primary Completion Date March 24, 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean change from baseline in the daily Major Symptoms Score (MSS) over the entire treatment period 15 days
Secondary Outcome
Measure Time Frame
Time to onset of action 15 days
MSS development over the course of the study daily from Baseline to Day 15
SNOT-22 by visit and changes versus baseline Baseline (Day 1), Day 8, Day 15
Percentage of responders and non-responders Day 4, Day 7, Day 10, Day 15
Enrollment 900
Condition
Intervention

Intervention type: Drug

Intervention name: acetylcysteine

Description: 600 mg tablet

Intervention type: Drug

Intervention name: Placebo

Description: Placebo to acetylcysteine

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.

Gender: All

Minimum age: 14 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Sandoz Study Director Sandoz
Overall Contact

Last name: Novartis Pharmaceuticals

Phone: +41-61-3241111

Email: [email protected]

Location
facility
Sandoz Investigative Site | Burgas, 8000, Bulgaria
Sandoz Investigative Site | Gabrovo, 5300, Bulgaria
Sandoz Investigative Site | Plovdiv, 4000, Bulgaria
Sandoz Investigative Site | Plovdiv, 4001, Bulgaria
Sandoz Investigative Site | Shumen, 9700, Bulgaria
Sandoz Investigative Site | Sliven, 8800, Bulgaria
Sandoz Investigative Site | Sofia, 1000, Bulgaria
Sandoz Investigative Site | Sofia, 1408, Bulgaria
Sandoz Investigative Site | Sofia, 1510, Bulgaria
Sandoz Investigative Site | Sofia, 1527, Bulgaria
Sandoz Investigative Site | Sofia, 1606, Bulgaria
Sandoz Investigative Site | Yambol, 8600, Bulgaria
Sandoz Investigative Site | Aachen, 52074, Germany
Sandoz Investigative Site | Arnsberg, 59759, Germany
Sandoz Investigative Site | Berlin, 12157, Germany
Sandoz Investigative Site | Berlin, 12623, Germany
Sandoz Investigative Site | Dreieich, 63303, Germany
Sandoz Investigative Site | Dresden, 01067, Germany
Sandoz Investigative Site | Dresden, 01139, Germany
Sandoz Investigative Site | Duisburg, 47051, Germany
Sandoz Investigative Site | Erfurt, 99084, Germany
Sandoz Investigative Site | Essen, 45355, Germany
Sandoz Investigative Site | Chișinău, 2004, Moldova, Republic of
Sandoz Investigative Site | Chișinău, 2009, Moldova, Republic of
Sandoz Investigative Site | Chișinău, 2012, Moldova, Republic of
Sandoz Investigative Site | Chișinău, 2023, Moldova, Republic of
Sandoz Investigative Site | Chișinău, 2028, Moldova, Republic of
Sandoz Investigative Site | Chișinău, 2032, Moldova, Republic of
Sandoz Investigative Site | Chișinău, 2038, Moldova, Republic of
Sandoz Investigative Site | Chișinău, 2051, Moldova, Republic of
Sandoz Investigative Site | Chișinău, 2064, Moldova, Republic of
Sandoz Investigative Site | Chișinău, Moldova, Republic of
Sandoz Investigative Site | Orhei, 3005, Moldova, Republic of
Sandoz Investigative Site | Ekaterinburg, 620014, Russian Federation
Sandoz Investigative Site | Ivanovo, 153012, Russian Federation
Sandoz Investigative Site | Kazan, 420012, Russian Federation
Sandoz Investigative Site | Kemerovo, 650066, Russian Federation
Sandoz Investigative Site | Moscow, 115409, Russian Federation
Sandoz Investigative Site | Moscow, 119121, Russian Federation
Sandoz Investigative Site | Moscow, 119416, Russian Federation
Sandoz Investigative Site | Moscow, 119571, Russian Federation
Sandoz Investigative Site | Moscow, 121359, Russian Federation
Sandoz Investigative Site | Moscow, 123098, Russian Federation
Sandoz Investigative Site | Moscow, 127473, Russian Federation
Sandoz Investigative Site | Moscow, 142190, Russian Federation
Sandoz Investigative Site | Ryazan, 390026, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 191015, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 191025, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 191186, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 192007, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 192177, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 192283, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 193232, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 194291, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 194334, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 194354, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 195197, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 196084, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 196158, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 197372, Russian Federation
Sandoz Investigative Site | Saint Petersburg, 198205, Russian Federation
Sandoz Investigative Site | Smolensk, 214031, Russian Federation
Sandoz Investigative Site | Vsevolozhsk, 188643, Russian Federation
Sandoz Investigative Site | Yaroslavl, 15054, Russian Federation
Location Countries

Bulgaria

Germany

Moldova, Republic of

Russian Federation

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: acetylcysteine 600 mg

Arm group type: Experimental

Description: 600 mg acetylcysteine: one tablet test product plus three tablets placebo per day

Arm group label: acetylcysteine 1200 mg

Arm group type: Experimental

Description: two tablets test product plus two tablets placebo per day

Arm group label: acetylcysteine 2400 mg

Arm group type: Experimental

Description: four tablets test product per day

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: four tablets placebo per day

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov