Respiratory Tract DiseasesPhase 3NCT03843541
A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions
A Phase 3 study testing N-acetylcysteine (NAC) 600 mg and Ambroxol hydrochloride 30 mg in people with Respiratory Tract Diseases and Abnormal Mucus Secretions, run by Zambon SpA at 32 sites in China.
Trial summary
This is a phase 3, multicenter, randomized, rater- and patient-blind, placebo- and active-controlled, 3-arm parallel group clinical trial. Patients will be randomized to N-acetylcysteine (NAC) or ambroxol or placebo in a 1:1:1 ratio. A total of approximately 333 patients in China will be randomized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Diseases, Abnormal Mucus Secretions
- What is being tested?
- N-acetylcysteine (NAC) 600 mg and Ambroxol hydrochloride 30 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 32 sitesChina
- Study dates
- 25 Jun 2019to 5 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adult (≥18 years old) hospitalized patients with respiratory tract diseases and abnormal mucus secretions such as: acute bronchitis, chronic bronchitis and exacerbations, emphysema, mucoviscidosis and bronchiectasis.
- Chinese ethnicity and/or Chinese
- Signed the informed consent form before any study-related procedure
- Sputum viscosity score ≥ 2 at randomization visit
- Expectoration difficulty score ≥ 2 at randomization visit
- Willingness and ability to comply with study procedures
Who cannot join
- Intolerance or contra-indication to treatment with NAC or ambroxol or allergy to any component of the study treatments
- (For female patients) ongoing pregnancy or lactation, or childbearing potential but unwillingness to adopt abstinence or contraception measures during the study
- Intake of an investigational drug within 1 month before the screening visit
- Use of expectorants or drugs with expectorant effect within 2 days before randomization visit
- Diagnosis of active tuberculosis, lung cancer, pulmonary fibrosis, acute pulmonary thromboembolism or any other respiratory condition that might, in the opinion of the investigator, compromise the safety of the patient or affect the interpretation of the results
- Medical history of and/or illness (including laboratory abnormality) and/or treatment that in the investigator's opinion may interfere with the patient's safety, compliance, or study evaluations
Show all 10Show fewer
- Serum alanine aminotransferase and/or aspartate transaminase more than 3 times above the upper limit of normal at screening visit
- Serum creatinine more than 3 times above the upper limit of normal at screening visit
- Addiction to alcohol or drugs
- Mental illness, or other reasons for non-cooperation in the investigator's opinion
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
China32 sites
Inner Mongolia Baogang Hospital
Baotou
Beijing Hospital
Beijing
Beijing Tongren Hospital
Beijing
China-Japan Friendship Hospital
Beijing
Peking University Shougang Hospital
Beijing
Jilin Province People's Hospital
Changchun
The First Bethune Hospital of Jilin University
Changchun
Chengdu Fifth People's Hospital
Chengdu
West China Hospital, Sichuan University
Chengdu
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Deyang People's Hospital
Deyang
Inner Mongolia People's Hospital
Hohhot
Jinhua city central hospital/Jinhua hospital ,School of Medicine,Zhejiang UNIVERSITY
Jinhua
Nanchang University-The Second Affiliated Hospital
Nanchang
Nanjing First Hospital
Nanjing
Zhongda Hospital, Southeast University - Pulmonology
Nanjing
Jiangxi Pingxiang People's Hospital
Pingxiang
Qingdao Municipal Hospital
Qingdao
Minhang District Central Hospital
Shanghai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai General Hospital
Shanghai
Shanghai Pulmonary Hospital
Shanghai
Suining Central Hospital
Suining
First Hospital of Shanxi Medical University
Taiyuan
The First Hospital of Shanxi Medical University
Taiyuan
Tongji Hospital, Tongji Medical College of Huazhong University Science and Technology
Wuhan
Wuxi Peoples' Hospital affiliated to Nanjing Medical University
Wuxi, No. 299, Qing Yang Rd., Wuxi City, Jiangsu
Wuxi Peoples' Hospital affiliated to Nanjing Medical University
Wuxi
Yangzhou First People's Hospital
Yangzhou
General Hospital of Ningxia Medical University
Yinchuan
Affiliated Hospital of Guangdong Medical University - Respiration
Zhanjiang
The First People's Hospital of Zigong
Zigong
About this study
Official title: A Phase III, Multi-centre, Randomized, Rater- and Patient-blind, Placebo- and Active-controlled, Parallel Group Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily (Active Test Treatment), Ambroxol Hydrochloride 30 mg Twice Daily (Active Control Treatment) and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions
This is a phase 3, multicenter, randomized, rater- and patient-blind, placebo- and active-controlled, 3-arm parallel group clinical trial. Patients will be randomized to N-acetylcysteine (NAC) or ambroxol or placebo in a 1:1:1 ratio. A total of approximately 333 patients in China will be randomized. The total study duration will be approximately 8 months including the enrolment period of approximately 7 months and the patient participation duration of 1 month or 4 weeks. Each patient will undergo a screening period of up to 1 week, a 1-week treatment period and a 2-week follow-up period. This study will be conducted in approximately 15-25 sites in China.
- Being tested
- N-acetylcysteine (NAC) 600 mg, Ambroxol hydrochloride 30 mg, placebo
- Keywords
- N-acetylcysteine (NAC), ambroxol hydrochloride, bronchitis, cystic fibrosis, fibrosis bronchiectasis, increased sputum viscosity, cough, Chronic Obstructive Pulmonary Disease (COPD)
- Medical subject headings
- Respiratory Tract Diseases, Bronchitis, Cystic Fibrosis, Cough, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteine (NAC) 600 mgDrug
Also called Fluimucil®
NAC will be administered twice a day, morning and evening, during treatment period.
Ambroxol hydrochloride 30 mgDrug
Also called Mucosolvan®, Fluibron®
Ambroxol hydrochloride will be administered twice a day, morning and evening, during treatment period.
placeboOther
Placebo will be administered twice a day, morning and evening, during treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Active test treatment-NAC | Experimental | NAC 600mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period. Receives: Drug: N-acetylcysteine (NAC) 600 mg |
| Active control treatment-Ambroxol hydrochloride | Active comparator | Ambroxol hydrochloride 30 mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period. Receives: Drug: Ambroxol hydrochloride 30 mg |
| Placebo | Placebo comparator | Placebo will be administered by slow intravenous infusion twice daily for the 1-week treatment period. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo
The superiority of slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum viscosity score was demonstrated. Sputum viscosity was assessed by ordinal categorical 4-point scales [0 = Liquid (normal viscosity), 1= Fluid (mildly increased viscosity), 2 = Viscous (moderately increased viscosity), 3 = Sticky (severely increased viscosity)] with 0 = best and 3= worst.
Measured: From baseline upto Day 7
Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo
The superiority of slow intravenous infusion of NAC 600 mg twice daily to placebo in terms of change from baseline in expectoration difficulty score was demonstrated. Expectoration difficulty was assessed by ordinal categorical 4-point scales [0 = No difficulty, 1 = Mild difficulty, 2 = Moderate difficulty, 3 = Marked difficulty] with 0 = best and 3 = worst.
Measured: From Baseline upto Day 7
Secondary outcomes (12)
Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo
The superiority of slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum viscosity score was demonstrated. Sputum viscosity was assessed by ordinal categorical 4-point scales [0 = Liquid (normal viscosity), 1= Fluid (mildly increased viscosity), 2 = Viscous (moderately increased viscosity), 3 = Sticky (severely increased viscosity)] with 0 = best and 3= worst.
Measured: From Baseline to Day 3
Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo
The superiority of slow intravenous infusion of NAC to placebo in terms of change from baseline in expectoration difficulty score was demonstrated. Expectoration difficulty was assessed by ordinal categorical 4-point scales [0 = No difficulty, 1 = Mild difficulty, 2 = Moderate difficulty, 3 = Marked difficulty] with 0 = best and 3 = worst.
Measured: From Baseline to Day 3
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo
The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum color score was demonstrated. Sputum color was assessed by means of ordinal categorical 4-point scales [0 = Mostly white, 1= Mostly pale yellow, 2 = Mostly dark yellow, 3 = Very dark yellow /green] with 0 = best and 3= worst.
Measured: From Baseline upto Day 3 and Day 7
Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of NAC and Placebo
The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in cough score was demonstrated. Cough score was assessed by means of ordinal categorical 4-point scales [0 = No cough, 1= Sporadic and mild cough, 2 = Moderate cough, 3 = Severe Cough] with 0 = best and 3= worst.
Measured: From Baseline upto Day 3 and Day 7
Change From Baseline to Day 3 and to Day 7 of Mean Sputum Volume of NAC and Placebo
The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum volume was demonstrated. Patients collected 24-hour sputum (morning to same time of the following morning) in a graduated cup and volume was expressed as mL/24h.
Measured: From Baseline upto Day 3 and Day 7
Change From Baseline to Day 7 in Mean Sputum Viscosity Score of NAC and Ambroxol Hydrochloride
The non-inferiority of NAC versus ambroxol in terms of change from baseline to Day 7 of mean sputum viscosity score was demonstrated. Sputum viscosity was assessed by ordinal categorical 4-point scales [0 = Liquid (normal viscosity), 1= Fluid (mildly increased viscosity), 2 = Viscous (moderately increased viscosity), 3 = Sticky (severely increased viscosity)] with 0 = best and 3= worst.
Measured: From baseline upto Day 7
Change From Baseline to Day 7 in Mean Expectoration Difficulty Score of NAC and Ambroxol Hydrochloride
The non-inferiority of NAC versus ambroxol in terms of change from baseline to Day 7 of mean expectoration difficulty score was demonstrated. Expectoration difficulty was assessed by ordinal categorical 4-point scales [0 = No difficulty, 1 = Mild difficulty, 2 = Moderate difficulty, 3 = Marked difficulty] with 0 = best and 3= worst
Measured: From Baseline upto Day 7
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Viscosity Score of Ambroxol Hydrochloride and Placebo
The superiority of the slow intravenous infusion ambroxol hydrochloride to placebo in terms of change from baseline in sputum viscosity score was demonstrated. Sputum viscosity was assessed by ordinal categorical 4-point scales [0 = Liquid (normal viscosity), 1= Fluid (mildly increased viscosity), 2 = Viscous (moderately increased viscosity), 3 = Sticky (severely increased viscosity)] with 0 = best and 3= worst.
Measured: From Baseline upto Day 3 and Day 7
Change From Baseline to Day 3 and to Day 7 in Mean Expectoration Difficulty Score of Ambroxol Hydrochloride and Placebo
The superiority of the slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in expectoration difficulty score was demonstrated. Expectoration difficulty was assessed by ordinal categorical 4-point scales [0 = No difficulty, 1 = Mild difficulty, 2 = Moderate difficulty, 3 = Marked difficulty] with 0 = best and 3 = worst.
Measured: From Baseline upto Day 3 and Day 7
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of Ambroxol Hydrochloride and Placebo
The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in sputum color was demonstrated. Sputum color was assessed by means of ordinal categorical 4-point scales [0 = Mostly white, 1= Mostly pale yellow, 2 = Mostly dark yellow, 3 = Very dark yellow /green] with 0 = best and 3= worst.
Measured: From Baseline upto Day 3 and Day 7
Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of Ambroxol Hydrochloride and Placebo
The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in cough score was demonstrated. Cough score was assessed by means of ordinal categorical 4-point scales [0 = No cough, 1= Sporadic and mild cough, 2 = Moderate cough, 3 = Severe Cough] with 0 = best and 3= worst.
Measured: From Baseline upto Day 3 and Day 7
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Volume of Ambroxol Hydrochloride and Placebo
The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in mean sputum volume was demonstrated. Patients collected 24-hour sputum (morning to same time of the following morning) in a graduated cup and volume was expressed as mL/24h.
Measured: From Baseline upto Day 3 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start25 Jun 2019
- Primary completion23 Jan 2021
- Study completion5 Feb 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 Respiratory Tract DiseasesStudies 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
- Model description
- There will be 3 treatment groups of NAC, ambroxol and placebo. A total of 333 patients will be randomized to NAC or ambroxol or placebo in a 1:1:1 ratio. Approximately 111 patients will be randomized in each treatment group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zambon SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843541
- Sponsor's protocol ID
- Z7244L01
- Status last verified
- Sep 2025
- First submitted
- 13 Feb 2019
- Last updated
- 5 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-centre, Randomized, Rater- and Patient-blind, Placebo- and Active-controlled, Parallel Group Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily (Active Test Treatment), Ambroxol Hydrochloride 30 mg Twice Daily (Active Control Treatment) and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions
- ClinicalTrials.gov ID
- NCT03843541
- Acronym / sponsor ID
- Z7244L01
- Keywords
- N-acetylcysteine (NAC), ambroxol hydrochloride, bronchitis, cystic fibrosis, fibrosis bronchiectasis, increased sputum viscosity, cough, Chronic Obstructive Pulmonary Disease (COPD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Zambon SpAIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 23 Jan 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Posted 5 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 3, multicenter, randomized, rater- and patient-blind, placebo- and active-controlled, 3-arm parallel group clinical trial. Patients will be randomized to N-acetylcysteine (NAC) or ambroxol or placebo in a 1:1:1 ratio. A total of approximately 333 patients in China will be randomized. The total study duration will be approximately 8 months including the enrolment period of approximately 7 months and the patient participation duration of 1 month or 4 weeks. Each patient will undergo a screening period of up to 1 week, a 1-week treatment period and a 2-week follow-up period. This study will be conducted in approximately 15-25 sites in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- There will be 3 treatment groups of NAC, ambroxol and placebo. A total of 333 patients will be randomized to NAC or ambroxol or placebo in a 1:1:1 ratio. Approximately 111 patients will be randomized in each treatment group.
| Arm | Type | Receives |
|---|---|---|
| Active test treatment-NAC | Experimental | Drug: N-acetylcysteine (NAC) 600 mgNAC 600mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period. |
| Active control treatment-Ambroxol hydrochloride | Active comparator | Drug: Ambroxol hydrochloride 30 mgAmbroxol hydrochloride 30 mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period. |
| Placebo | Placebo comparator | Other: placeboPlacebo will be administered by slow intravenous infusion twice daily for the 1-week treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female adult (≥18 years old) hospitalized patients with respiratory tract diseases and abnormal mucus secretions such as: acute bronchitis, chronic bronchitis and exacerbations, emphysema, mucoviscidosis and bronchiectasis.
- Chinese ethnicity and/or Chinese
- Signed the informed consent form before any study-related procedure
- Sputum viscosity score ≥ 2 at randomization visit
- Expectoration difficulty score ≥ 2 at randomization visit
Key exclusion criteria (10 listed)
- Intolerance or contra-indication to treatment with NAC or ambroxol or allergy to any component of the study treatments
- (For female patients) ongoing pregnancy or lactation, or childbearing potential but unwillingness to adopt abstinence or contraception measures during the study
- Intake of an investigational drug within 1 month before the screening visit
- Use of expectorants or drugs with expectorant effect within 2 days before randomization visit
- Diagnosis of active tuberculosis, lung cancer, pulmonary fibrosis, acute pulmonary thromboembolism or any other respiratory condition that might, in the opinion of the investigator, compromise the safety of the patient or affect the interpretation of the results
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 |
|---|---|---|
| N-acetylcysteine (NAC) 600 mgAlso: Fluimucil®NAC will be administered twice a day, morning and evening, during treatment period. | Drug | Active test treatment-NAC |
| Ambroxol hydrochloride 30 mgAlso: Mucosolvan®, Fluibron®Ambroxol hydrochloride will be administered twice a day, morning and evening, during treatment period. | Drug | Active control treatment-Ambroxol hydrochloride |
| placeboPlacebo will be administered twice a day, morning and evening, during treatment period. | Other | Placebo |
Primary outcome
Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo
Time frame: From baseline upto Day 7
The superiority of slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum viscosity score was demonstrated. Sputum viscosity was assessed by ordinal categorical 4-point scales [0 = Liquid (normal viscosity), 1= Fluid (mildly increased viscosity), 2 = Viscous (moderately increased viscosity), 3 = Sticky (severely increased viscosity)] with 0 = best and 3= worst.
Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo
Time frame: From Baseline upto Day 7
The superiority of slow intravenous infusion of NAC 600 mg twice daily to placebo in terms of change from baseline in expectoration difficulty score was demonstrated. Expectoration difficulty was assessed by ordinal categorical 4-point scales [0 = No difficulty, 1 = Mild difficulty, 2 = Moderate difficulty, 3 = Marked difficulty] with 0 = best and 3 = worst.
12 secondary outcomes
Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo
Time frame: From Baseline to Day 3
Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo
Time frame: From Baseline to Day 3
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo
Time frame: From Baseline upto Day 3 and Day 7
Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of NAC and Placebo
Time frame: From Baseline upto Day 3 and Day 7
Change From Baseline to Day 3 and to Day 7 of Mean Sputum Volume of NAC and Placebo
Time frame: From Baseline upto Day 3 and Day 7
Change From Baseline to Day 7 in Mean Sputum Viscosity Score of NAC and Ambroxol Hydrochloride
Time frame: From baseline upto Day 7
Change From Baseline to Day 7 in Mean Expectoration Difficulty Score of NAC and Ambroxol Hydrochloride
Time frame: From Baseline upto Day 7
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Viscosity Score of Ambroxol Hydrochloride and Placebo
Time frame: From Baseline upto Day 3 and Day 7
Change From Baseline to Day 3 and to Day 7 in Mean Expectoration Difficulty Score of Ambroxol Hydrochloride and Placebo
Time frame: From Baseline upto Day 3 and Day 7
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of Ambroxol Hydrochloride and Placebo
Time frame: From Baseline upto Day 3 and Day 7
Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of Ambroxol Hydrochloride and Placebo
Time frame: From Baseline upto Day 3 and Day 7
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Volume of Ambroxol Hydrochloride and Placebo
Time frame: From Baseline upto Day 3 and Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N-acetylcysteine (NAC) 600 mg and Ambroxol hydrochloride 30 mg in people with Respiratory Tract Diseases and Abnormal Mucus Secretions, run by Zambon SpA at 32 sites in China.
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 10 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in China. 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 5 Jan 2023). 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?
Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo (time frame: From baseline upto Day 7). 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 5 Sep 2025.