Trial · NCT03843541
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
NCT03843541, Phase 3, Completed, Zambon SpA; results first posted 2023-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT03843541. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03843541
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT03843541
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 333 participants, actual
- Lead sponsor
- Zambon SpA
- Conditions
- Respiratory Tract Diseases, Abnormal Mucus Secretions
- Interventions
- N-acetylcysteine (NAC) 600 mg, Ambroxol hydrochloride 30 mg, placebo
- First posted
- 2019-02-18
- Last updated
- 2025-09-05
- Results first posted
- 2023-01-05
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo | 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. |
| Primary | Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo | 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. |
| Secondary | Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo | From Baseline to Day 3 | 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. |
| Secondary | Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo | From Baseline to Day 3 | 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. |
| Secondary | Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo | From Baseline upto Day 3 and Day 7 | 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. |
| Secondary | Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of NAC and Placebo | From Baseline upto Day 3 and Day 7 | 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. |
| Secondary | Change From Baseline to Day 3 and to Day 7 of Mean Sputum Volume of NAC and Placebo | From Baseline upto Day 3 and Day 7 | 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. |
| Secondary | Change From Baseline to Day 7 in Mean Sputum Viscosity Score of NAC and Ambroxol Hydrochloride | From baseline upto Day 7 | 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. |
| Secondary | Change From Baseline to Day 7 in Mean Expectoration Difficulty Score of NAC and Ambroxol Hydrochloride | From Baseline upto Day 7 | 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 |
| Secondary | Change From Baseline to Day 3 and to Day 7 in Mean Sputum Viscosity Score of Ambroxol Hydrochloride and Placebo | From Baseline upto Day 3 and Day 7 | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo | From baseline upto Day 7 | mITT population - The Modified ITT (mITT) Population comprised all participants in the ITT population who received at least 1 dose or partial dose of the IMP. | Score | MEAN |
| PRIMARY | Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo | From Baseline upto Day 7 | mITT population - The mITT population comprised all participants in the ITT population who received at least 1 dose or partial dose of the IMP. | Score | MEAN |
| SECONDARY | Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo | From Baseline to Day 3 | mITT population - The mITT population comprised all participants in the ITT population who received at least 1 dose or partial dose of the IMP. | Score | MEAN |
| SECONDARY | Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo | From Baseline to Day 3 | mITT population - The mITT population comprised all participants in the ITT population who received at least 1 dose or partial dose of the IMP. | Score | MEAN |
| SECONDARY | Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo | From Baseline upto Day 3 and Day 7 | mITT population - The mITT population comprised all participants in the ITT population who received at least 1 dose or partial dose of the IMP. | Score | MEAN |
| SECONDARY | Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of NAC and Placebo | From Baseline upto Day 3 and Day 7 | mITT population - The mITT population comprised all participants in the ITT population who received at least 1 dose or partial dose of the IMP. | Score | MEAN |
| SECONDARY | Change From Baseline to Day 3 and to Day 7 of Mean Sputum Volume of NAC and Placebo | From Baseline upto Day 3 and Day 7 | mITT population - The mITT population comprised all participants in the ITT population who received at least 1 dose or partial dose of the IMP. | mL/24h | MEAN |
| SECONDARY | Change From Baseline to Day 7 in Mean Sputum Viscosity Score of NAC and Ambroxol Hydrochloride | From baseline upto Day 7 | mITT population - The mITT population comprised all participants in the ITT population who received at least 1 dose or partial dose of the IMP. | Score | MEAN |
| SECONDARY | Change From Baseline to Day 7 in Mean Expectoration Difficulty Score of NAC and Ambroxol Hydrochloride | From Baseline upto Day 7 | mITT population - The mITT population comprised all participants in the ITT population who received at least 1 dose or partial dose of the IMP. | Score | MEAN |
| SECONDARY | Change From Baseline to Day 3 and to Day 7 in Mean Sputum Viscosity Score of Ambroxol Hydrochloride and Placebo | From Baseline upto Day 3 and Day 7 | mITT population - The mITT population comprised all participants in the ITT population who received at least 1 dose or partial dose of the IMP. | Score | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo | N-Acetylcysteine | -1.2 | Standard Deviation 0.74 | Score | |
| Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo | Placebo | -1.0 | Standard Deviation 0.78 | Score | |
| Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo | N-Acetylcysteine | -1.4 | Standard Deviation 0.78 | Score | |
| Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo | Placebo | -1.1 | Standard Deviation 0.78 | Score | |
| Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo | N-Acetylcysteine | -0.6 | Standard Deviation 0.59 | Score | |
| Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo | Placebo | -0.6 | Standard Deviation 0.64 | Score | |
| Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo | N-Acetylcysteine | -0.8 | Standard Deviation 0.61 | Score | |
| Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo | Placebo | -0.7 | Standard Deviation 0.64 | Score | |
| Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo | N-Acetylcysteine | Change from baseline to Day 3 | -0.5 | Standard Deviation 0.72 | Score |
| Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo | Placebo | Change from baseline to Day 3 | -0.5 | Standard Deviation 0.82 | Score |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | N-Acetylcysteine | 111 | |
| Overall Study | STARTED | Ambroxol Hydrochloride | 111 | |
| Overall Study | STARTED | Placebo | 111 | |
| Overall Study | Modified ITT | N-Acetylcysteine | 108 | |
| Overall Study | Modified ITT | Ambroxol Hydrochloride | 110 | |
| Overall Study | Modified ITT | Placebo | 110 | |
| Overall Study | COMPLETED | N-Acetylcysteine | 96 | |
| Overall Study | COMPLETED | Ambroxol Hydrochloride | 95 | |
| Overall Study | COMPLETED | Placebo | 97 | |
| Overall Study | NOT COMPLETED | N-Acetylcysteine | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events669
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | N-Acetylcysteine | 2 | 108 | 2 |
| other | Constipation | Gastrointestinal disorders | Ambroxol Hydrochloride | 4 | 110 | 4 |
| other | Constipation | Gastrointestinal disorders | Placebo | 2 | 110 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | N-Acetylcysteine | 3 | 108 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Ambroxol Hydrochloride | 0 | 110 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 4 | 110 | 5 |
| other | Nausea | Gastrointestinal disorders | N-Acetylcysteine | 2 | 108 | 2 |
| other | Nausea | Gastrointestinal disorders | Ambroxol Hydrochloride | 3 | 110 | 3 |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 110 | 2 |
| other | Chronic gastritis | Gastrointestinal disorders | N-Acetylcysteine | 4 | 108 | 4 |
1 to 10 of 669Source ClinicalTrials.gov
See all 669 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | N-Acetylcysteine | 1 | 108 |
| Total, all-cause mortality | Ambroxol Hydrochloride | 0 | 110 |
| Total, all-cause mortality | Placebo | 0 | 110 |
| Total, other adverse events | N-Acetylcysteine | 67 | 108 |
| Total, other adverse events | Ambroxol Hydrochloride | 66 | 110 |
| Total, other adverse events | Placebo | 58 | 110 |
| Total, serious adverse events | N-Acetylcysteine | 2 | 108 |
| Total, serious adverse events | Ambroxol Hydrochloride | 5 | 110 |
| Total, serious adverse events | Placebo | 7 | 110 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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