A Phase 3 interventional study of N-acetylcysteine (NAC) 600 mg and Ambroxol hydrochloride 30 mg in Respiratory Tract Diseases and Abnormal Mucus Secretions, sponsored by Zambon SpA. Completed at 32 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by Zambon SpA · Phase 3, Interventional, and Treatment
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.
410 studies on the registry are indexed under Respiratory Tract Diseases; 59 are open to participants now.
This study's enrollment of 333 is above the median of 117 across 316 interventional studies indexed under Respiratory Tract Diseases.
Browse Respiratory Tract Diseases studies →Zambon SpA is the lead sponsor of 23 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NAC 600mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
Drug: N-acetylcysteine (NAC) 600 mg
Ambroxol hydrochloride 30 mg will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
Drug: Ambroxol hydrochloride 30 mg
Placebo will be administered by slow intravenous infusion twice daily for the 1-week treatment period.
Other: placebo
NAC will be administered twice a day, morning and evening, during treatment period.
Also known as: Fluimucil®
Ambroxol hydrochloride will be administered twice a day, morning and evening, during treatment period.
Also known as: Mucosolvan®, Fluibron®
Placebo will be administered twice a day, morning and evening, during treatment period.
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.
Time frame: 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.
Time frame: From Baseline upto Day 7
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.
Time frame: 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.
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
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.
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
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.
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
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.
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
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.
Time frame: 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
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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: From Baseline upto Day 3 and Day 7
Number of Participants With Adverse Events
The safety and tolerability of intravenous NAC 600 mg twice daily was demonstrated.
Time frame: From screening to follow-up after the last administration of the investigational medicinal product (IMP) [assessed up to 19 months]
The study was conducted between 21-June-2019 and 5-February-2021 in 28 sites in China.
| Milestone | N-Acetylcysteine | Ambroxol Hydrochloride | Placebo |
|---|---|---|---|
| Started | 111 | 111 | 111 |
| Modified itt | 108 | 110 | 110 |
| Completed | 96 | 95 | 97 |
| Not completed | 15 | 16 | 14 |
| Withdrew: Adverse event | 4 | 2 | 3 |
| Withdrew: Death | 1 | 0 | 0 |
| Withdrew: Lack of adherence to study medication | 0 | 0 | 1 |
| Withdrew: Physician decision | 1 | 2 | 2 |
| Withdrew: Study subject withdrawal by parent or guardian | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 6 | 9 | 7 |
| Withdrew: Administration of rescue mucolytic | 0 | 0 | 1 |
| Withdrew: Reporting drug over temperature, patients plan to transfer to hospital, and discharge from hospital. | 2 | 3 | 0 |
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.
| Score | N-Acetylcysteine | Placebo |
|---|---|---|
| Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo | -1.2 ± 0.74 | -1.0 ± 0.78 |
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.
| Score | N-Acetylcysteine | Placebo |
|---|---|---|
| Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo | -1.4 ± 0.78 | -1.1 ± 0.78 |
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.
| Score | N-Acetylcysteine | Placebo |
|---|---|---|
| Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo | -0.6 ± 0.59 | -0.6 ± 0.64 |
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.
| Score | N-Acetylcysteine | Placebo |
|---|---|---|
| Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo | -0.8 ± 0.61 | -0.7 ± 0.64 |
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.
| Score | N-Acetylcysteine | Placebo |
|---|---|---|
| Change from baseline to Day 3 | -0.5 ± 0.72 | -0.5 ± 0.82 |
| Change from baseline to Day 7 | -0.8 ± 0.89 | -0.8 ± 0.97 |
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.
| Score | N-Acetylcysteine | Placebo |
|---|---|---|
| Change from baseline to Day 3 | -0.4 ± 0.55 | -0.5 ± 0.60 |
| Change from baseline to Day 7 | -0.8 ± 0.77 | -0.6 ± 0.72 |
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.
| mL/24h | N-Acetylcysteine | Placebo |
|---|---|---|
| Change from baseline to Day 3 | -1.601 ± 16.2611 | -4.144 ± 12.2348 |
| Change from baseline to Day 7 | -9.405 ± 35.2191 | -7.391 ± 15.9992 |
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.
| Score | N-Acetylcysteine | Ambroxol Hydrochloride |
|---|---|---|
| Change From Baseline to Day 7 in Mean Sputum Viscosity Score of NAC and Ambroxol Hydrochloride | -1.2 ± 0.74 | -1.2 ± 0.78 |
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
| Score | N-Acetylcysteine | Ambroxol Hydrochloride |
|---|---|---|
| Change From Baseline to Day 7 in Mean Expectoration Difficulty Score of NAC and Ambroxol Hydrochloride | -1.4 ± 0.78 | -1.3 ± 0.75 |
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.
| Score | Ambroxol Hydrochloride | Placebo |
|---|---|---|
| Change from baseline to Day 3 | -0.6 ± 0.55 | -0.6 ± 0.64 |
| Change from baseline to Day 7 | -1.2 ± 0.78 | -1.0 ± 0.78 |
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.
| Score | Ambroxol Hydrochloride | Placebo |
|---|---|---|
| Change from baseline to Day 3 | -0.7 ± 0.57 | -0.7 ± 0.64 |
| Change from baseline to Day 7 | -1.3 ± 0.75 | -1.1 ± 0.78 |
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.
| Score | Ambroxol Hydrochloride | Placebo |
|---|---|---|
| Change from baseline to Day 3 | -0.5 ± 0.77 | -0.5 ± 0.82 |
| Change from baseline to Day 7 | -0.9 ± 0.99 | -0.8 ± 0.97 |
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.
| Score | Ambroxol Hydrochloride | Placebo |
|---|---|---|
| Change from baseline to Day 3 | -0.4 ± 0.52 | -0.5 ± 0.60 |
| Change from baseline to Day 7 | -0.7 ± 0.68 | -0.6 ± 0.72 |
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.
| mL/24h | Ambroxol Hydrochloride | Placebo |
|---|---|---|
| Change from baseline to Day 3 | -4.53 ± 12.018 | -4.14 ± 12.235 |
| Change from baseline to Day 7 | -9.73 ± 15.149 | -7.39 ± 15.999 |
The safety and tolerability of intravenous NAC 600 mg twice daily was demonstrated.
| Participants | N-Acetylcysteine | Ambroxol Hydrochloride | Placebo |
|---|---|---|---|
| At least one AE | 82 | 76 | 71 |
| At least one TEAE | 67 | 66 | 58 |
| At least one IMP-related TEAE | 11 | 11 | 0 |
| At least one TEAE leading to drug withdrawal | 5 | 2 | 3 |
| At least one TEAE leading to drug interruption | 0 | 0 | 1 |
| At least one TEAE leading to fatal outcome | 1 | 0 | 0 |
| At least one severe TEAE | 5 | 4 | 7 |
| At least one TEAE of COVID-19 | 0 | 0 | 0 |
| At least one SAE | 2 | 5 | 7 |
| At least one TESAE | 2 | 5 | 7 |
| At least one TESAE leading to drug withdrawal | 1 | 1 | 1 |
| At least one TESAE leading to drug interruption | 0 | 0 | 1 |
| At least one TESAE leading to fatal outcome | 1 | 0 | 0 |
| At least one TESAE of COVID-19 | 0 | 0 | 0 |
Collected over From screening to follow-up after the last administration of the investigational medicinal product (IMP) [assessed up to 19 months].. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| N-Acetylcysteine | 1/108 (0.9%) | 2/108 (1.9%) | 67/108 (62%) |
| Ambroxol Hydrochloride | 0/110 (0%) | 5/110 (4.5%) | 66/110 (60%) |
| Placebo | 0/110 (0%) | 7/110 (6.4%) | 58/110 (52.7%) |
| Event | N-Acetylcysteine | Ambroxol Hydrochloride | Placebo |
|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/108 | 0/110 | 2/110 |
| Cardiac failureCardiac disorders | 1/108 | 0/110 | 0/110 |
| Non-small lung cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/108 | 0/110 | 0/110 |
| Arteriosclerosis coronary arteryCardiac disorders | 0/108 | 1/110 | 0/110 |
| Anti-neutrophil cytoplasmic antibody positive vasculitisImmune system disorders | 0/108 | 1/110 | 0/110 |
| HemoptysisRespiratory, thoracic and mediastinal disorders | 0/108 | 1/110 | 0/110 |
| Coronary artery diseaseCardiac disorders | 0/108 | 1/110 | 0/110 |
| Bronchopulmonary aspergillosis allergicInfections and infestations | 0/108 | 1/110 | 0/110 |
| Benign prostatic hyperplasiaReproductive system and breast disorders | 0/108 | 0/110 | 1/110 |
| Thyroid massEndocrine disorders | 0/108 | 0/110 | 1/110 |
| Event | N-Acetylcysteine | Ambroxol Hydrochloride | Placebo |
|---|---|---|---|
| HypokalaemiaMetabolism and nutrition disorders | 13/108 | 9/110 | 9/110 |
| Renal cystRenal and urinary disorders | 1/108 | 6/110 | 3/110 |
| Chronic gastritisGastrointestinal disorders | 4/108 | 1/110 | 1/110 |
| PneumoniaInfections and infestations | 4/108 | 3/110 | 2/110 |
| NephrolithiasisRenal and urinary disorders | 4/108 | 3/110 | 3/110 |
| ConstipationGastrointestinal disorders | 2/108 | 4/110 | 2/110 |
| DiarrhoeaGastrointestinal disorders | 3/108 | 0/110 | 4/110 |
| Pulmonary massRespiratory, thoracic and mediastinal disorders | 1/108 | 4/110 | 1/110 |
| Hepatic cystHepatobiliary disorders | 2/108 | 3/110 | 4/110 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/108 | 4/110 | 0/110 |
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 Investigational Medicinal Product (IMP).
| Age, Continuous(years) | N-Acetylcysteine | Ambroxol Hydrochloride | Placebo | Total |
|---|---|---|---|---|
| Mean | 64.7 ± 11.65 | 64.7 ± 12.76 | 64.5 ± 12.79 | 64.6 ± 12.38 |
| Sex: Female, Male(Participants) | N-Acetylcysteine | Ambroxol Hydrochloride | Placebo | Total |
|---|---|---|---|---|
| Female | 36 | 31 | 32 | 99 |
| Male | 72 | 79 | 78 | 229 |
| Ethnicity (NIH/OMB)(Participants) | N-Acetylcysteine | Ambroxol Hydrochloride | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 108 | 110 | 110 | 328 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2019 to primary completion in Jan 2021, 18 months.
Results were first posted in Jan 2023, 1 year 11 months after primary completion.
Of 35 industry-sponsored phase 3 interventional studies under Respiratory Tract Diseases, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 45. This study's 18 months is below that.
Counting every sponsor, half of 41 studies reached it within 27 months; a quarter within 9 and three quarters within 47.
Respiratory Tract Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetylcysteine