RhinosinusitisPhase 3NCT04123405
Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis
A Phase 3 study testing acetylcysteine in people with Rhinosinusitis, run by Sandoz at 37 sites in 4 countries.
Trial summary
The trial was conducted as a prospective, randomized, multinational, multicenter, double-blind study in 4 parallel groups of patients. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Rhinosinusitis
- What is being tested?
- acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 944 participants
- Where
- 37 sitesin 4 countries
- Study dates
- 22 Oct 2020to 20 Apr 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 33Show fewer
- 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.
Trial locations and contacts
37 sites in 4 countries.
37 sites in 4 countries
Russia18 sites
Sandoz Investigative Site
Kazan', 420029
Sandoz Investigative Site
Kemerovo, 650066
Sandoz Investigative Site
Moscow, 117552
Sandoz Investigative Site
Moscow, 119571
Sandoz Investigative Site
Moscow, 123184
Sandoz Investigative Site
Moscow, 142190
Sandoz Investigative Site
Novosibirsk, 630051
Sandoz Investigative Site
Ryazan, 390026
Sandoz Investigative Site
Saint Petersburg, 191025
Sandoz Investigative Site
Saint Petersburg, 191186
Sandoz Investigative Site
Saint Petersburg, 192283
Sandoz Investigative Site
Saint Petersburg, 194291
Sandoz Investigative Site
Saint Petersburg, 195197
Sandoz Investigative Site
Saint Petersburg, 196084
Sandoz Investigative Site
Saint Petersburg, 196158
Sandoz Investigative Site
Saint Petersburg, 197376
Sandoz Investigative Site
Smolensk, 214031
Sandoz Investigative Site
Yaroslavl, 150000
Bulgaria9 sites
Sandoz Investigative Site
Burgas, 8000
Sandoz Investigative Site
Gabrovo, 5300
Sandoz Investigative Site
Plovdiv, 4000
Sandoz Investigative Site
Sliven, 8800
Sandoz Investigative Site
Sofia, 1000
Sandoz Investigative Site
Sofia, 1408
Sandoz Investigative Site
Sofia, 1527
Sandoz Investigative Site
Sofia, 1606
Sandoz Investigative Site
Yambol, 8600
Moldova7 sites
Sandoz Investigative Site
Chisinau, 2012
Sandoz Investigative Site
Chisinau, 2025
Sandoz Investigative Site
Chisinau, 2032
Sandoz Investigative Site
Chisinau, 2044
Sandoz Investigative Site
Chisinau, 2051
Sandoz Investigative Site
Chisinau, 37
Sandoz Investigative Site
Orhei, 3005
Germany3 sites
Sandoz Investigative Site
Aachen, 52074
Sandoz Investigative Site
Dresden, 01139
Sandoz Investigative Site
Duisburg, 47051
About this study
Official title: Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis: a Prospective, Randomized, Double-blind, Placebo-controlled Trial
The trial was conducted as a prospective, randomized, multinational, multicenter, double-blind study in 4 parallel groups of patients.
Read the 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
- Being tested
- acetylcysteine, Placebo
- Keywords
- acute uncomplicated rhinosinusitis, acetylcysteine
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylcysteineDrug
600 mg tablet
PlaceboDrug
Placebo to acetylcysteine
| Study group | Role | What they receive |
|---|---|---|
| Group A: 600 mg acetylcysteine | Experimental | one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) Receives: Drug: acetylcysteine; Drug: Placebo |
| Group B: 1200 mg acetylcysteine | Experimental | two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) Receives: Drug: acetylcysteine; Drug: Placebo |
| Group C: 2400 mg acetylcysteine | Experimental | four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily) Receives: Drug: acetylcysteine |
| Group D: Placebo | Placebo comparator | four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set
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). The patient rated 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 MSS is then the sum of single ratings with a possible range from 0 to 15.
Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.
Measured: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set
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). The patient rated 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 MSS is then the sum of single ratings with a possible range from 0 to 15.
Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.
Measured: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Secondary outcomes (10)
Time to Onset of Action, Full Analysis Set
Time to onset of action was defined as first day of active treatment on which MSS showed statistically significant (p value<0.05) improvement from placebo.
Measured: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Time to Onset of Action, Per-Protocol Set
Time to onset of action was defined as first day of active treatment on which MSS showed statistically significant (p value<0.05) improvement from placebo.
Measured: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
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). The patient rated 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 MSS is then the sum of single ratings with a possible range from 0 to 15.
Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.
Measured: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
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). The patient rated 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 MSS is then the sum of single ratings with a possible range from 0 to 15.
Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.
Measured: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Sino-Nasal Outcome Test (SNOT-22) by Visit, Full Analysis Set
SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL.
Measured: Baseline (Day 1), Day 7 and Day 14
Sino-Nasal Outcome Test (SNOT-22) by Visit, Per Protocol Set
SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL.
Measured: Baseline (Day 1), Day 7 and Day 14
Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Full Analysis Set
SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. A negative change from baseline in SNOT-22 is considered a favorable outcome.
Measured: Baseline (Day 1), Day 7 and Day 14
Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Per Protocol Set
SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. A negative change from baseline in SNOT-22 is considered a favorable outcome.
Measured: Baseline (Day 1), Day 7 and Day 14
Number of Responders and Non-responders to Treatment, Full Analysis Set
Number of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator were reported.
Measured: Day 4, 7, 10 and 15
Number of Responders and Non-responders to Treatment, Per-Protocol Set
Number of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator were reported.
Measured: Day 4, 7, 10 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start22 Oct 2020
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 944 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandoz, Study director, Sandoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123405
- Sponsor's protocol ID
- 2018-08-EFT-1
- Other IDs
- 2019-000060-20, 2019
- Status last verified
- Oct 2021
- First submitted
- 9 Oct 2019
- Last updated
- 19 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis: a Prospective, Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04123405
- Acronym / sponsor ID
- 2018-08-EFT-1
- Conditions
- Rhinosinusitis
- Keywords
- acute uncomplicated rhinosinusitis, acetylcysteine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 944 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Posted 19 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: 600 mg acetylcysteine | Experimental | Drug: acetylcysteine, Drug: Placeboone tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
| Group B: 1200 mg acetylcysteine | Experimental | Drug: acetylcysteine, Drug: Placebotwo tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
| Group C: 2400 mg acetylcysteine | Experimental | Drug: acetylcysteinefour tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily) |
| Group D: Placebo | Placebo comparator | Drug: Placebofour tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetylcysteine600 mg tablet | Drug | Group A: 600 mg acetylcysteine, Group B: 1200 mg acetylcysteine, Group C: 2400 mg acetylcysteine |
| PlaceboPlacebo to acetylcysteine | Drug | Group A: 600 mg acetylcysteine, Group B: 1200 mg acetylcysteine, Group D: Placebo |
Primary outcome
Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set
Time frame: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 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). The patient rated 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 MSS is then the sum of single ratings with a possible range from 0 to 15. Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.
Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set
Time frame: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 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). The patient rated 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 MSS is then the sum of single ratings with a possible range from 0 to 15. Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.
10 secondary outcomes
Time to Onset of Action, Full Analysis Set
Time frame: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Time to Onset of Action, Per-Protocol Set
Time frame: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Time frame: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Time frame: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Sino-Nasal Outcome Test (SNOT-22) by Visit, Full Analysis Set
Time frame: Baseline (Day 1), Day 7 and Day 14
Sino-Nasal Outcome Test (SNOT-22) by Visit, Per Protocol Set
Time frame: Baseline (Day 1), Day 7 and Day 14
Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Full Analysis Set
Time frame: Baseline (Day 1), Day 7 and Day 14
Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Per Protocol Set
Time frame: Baseline (Day 1), Day 7 and Day 14
Number of Responders and Non-responders to Treatment, Full Analysis Set
Time frame: Day 4, 7, 10 and 15
Number of Responders and Non-responders to Treatment, Per-Protocol Set
Time frame: Day 4, 7, 10 and 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandoz study director
Sandoz
37 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acetylcysteine in people with Rhinosinusitis, run by Sandoz at 37 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Russia, Bulgaria, Moldova, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set (time frame: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.