Trial · NCT02088216
Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis
NCT02088216, Not applicable, Completed, Qilu Hospital of Shandong University; results first posted 2019-02-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis. Trials, record NCT02088216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02088216
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis
- NCT number
- NCT02088216
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 161 participants, actual
- Lead sponsor
- Qilu Hospital of Shandong University
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Interventions
- N-acetylcysteine, On-demand treatment
- First posted
- 2014-03-14
- Last updated
- 2019-03-14
- Results first posted
- 2019-02-18
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Number of Exacerbations | 12 months | An exacerbation of bronchiectasis is defined as either a change in one or more of the common symptoms of bronchiectasis (sputum volume or purulence, dyspnea, cough, and fatigue/malaise) or the onset of new symptoms (fever, pleurisy, haemoptysis or need for antibiotic treatment). |
| Secondary | Change of Volume of Sputum From Baseline Parameters After the 12-month Follow-up. | 12 months | The change was calculated from two time points as the value at the later time point minus the value at the earlier time point. |
| Secondary | Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa | 12 months | The values in the table were calculated as the value at baseline minus the value at 12 months. |
| Secondary | Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines | 12 months | Chronic Obstructive Pulmonary Disease Assessment Test (CAT) scores: the minimum value is 0 and the maximum value is 40. 0-10 points: "slight impact"; 11-20 points: "medium impact"; 21-30 points: "serious impact"; 31-40 points: "very serious impact". The change was calculated from two time points as the value at the later time point minus the value at the earlier time point. |
| Secondary | Change in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines | 12 months | The change was calculated from two time points as the value at the later time point minus the value at the earlier time point. |
| Secondary | Change of Forced Expiratory Volume in One Second (FEV1) (L) From Baselines | 12 months | The change was calculated from two time points as the value at the later time point minus the value at the earlier time point. |
| Secondary | Change of Forced Vital Capacity (FVC) From Baselines | 12 months | The change was calculated from two time points as the value at the later time point minus the value at the earlier time point. |
| Secondary | Time to the First Exacerbation | 12 months | |
| Secondary | Time to Recurrent Exacerbations | 12 months | |
| Secondary | Nature of Sputum (Number of Patients With Yellow Purulent) | 12 months |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Number of Exacerbations | 12 months | exacerbations | MEDIAN | |
| SECONDARY | Change of Volume of Sputum From Baseline Parameters After the 12-month Follow-up. | 12 months | mL | MEAN | |
| SECONDARY | Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines | 12 months | score on a scale | MEAN | |
| SECONDARY | Change in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines | 12 months | percentage of predicted FEV1 | MEAN | |
| SECONDARY | Change of Forced Expiratory Volume in One Second (FEV1) (L) From Baselines | 12 months | L | MEAN | |
| SECONDARY | Change of Forced Vital Capacity (FVC) From Baselines | 12 months | L | MEAN | |
| SECONDARY | Time to the First Exacerbation | 12 months | days | MEDIAN | |
| SECONDARY | Time to Recurrent Exacerbations | 12 months | days | MEAN | |
| SECONDARY | Nature of Sputum (Number of Patients With Yellow Purulent) | 12 months | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Number of Exacerbations | N-acetylcysteine Group | 1 | Inter-Quartile Range 0.5 to 2 | exacerbations | |
| Median Number of Exacerbations | Control Group | 2 | Inter-Quartile Range 1 to 2 | exacerbations | |
| Change of Volume of Sputum From Baseline Parameters After the 12-month Follow-up. | N-acetylcysteine Group | -6.46 | Standard Deviation 22.93 | mL | |
| Change of Volume of Sputum From Baseline Parameters After the 12-month Follow-up. | Control Group | -18.28 | Standard Deviation 25.69 | mL | |
| Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa | N-acetylcysteine Group | 8 | Participants | ||
| Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa | Control Group | 5 | Participants | ||
| Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines | N-acetylcysteine Group | -3.79 | Standard Deviation 5.40 | score on a scale | |
| Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines | Control Group | -1.44 | Standard Deviation 6.19 | score on a scale | |
| Change in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines | N-acetylcysteine Group | 1.16 | Standard Deviation 16.50 | percentage of predicted FEV1 | |
| Change in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines | Control Group | 0.13 | Standard Deviation 7.78 | percentage of predicted FEV1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | N-acetylcysteine Group | 81 | |
| Overall Study | STARTED | Control Group | 80 | |
| Overall Study | COMPLETED | N-acetylcysteine Group | 69 | |
| Overall Study | COMPLETED | Control Group | 70 | |
| Overall Study | NOT COMPLETED | N-acetylcysteine Group | 12 | |
| Overall Study | NOT COMPLETED | Control Group | 10 |
Source ClinicalTrials.gov
Adverse events2
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 | Epigastric discomfort | Gastrointestinal disorders | N-acetylcysteine Group | 8 | 81 | 8 |
| other | Epigastric discomfort | Gastrointestinal disorders | Control Group | 6 | 80 | 6 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | N-acetylcysteine Group | 2 | 81 |
| Total, all-cause mortality | Control Group | 3 | 80 |
| Total, other adverse events | N-acetylcysteine Group | 8 | 81 |
| Total, other adverse events | Control Group | 6 | 80 |
| Total, serious adverse events | N-acetylcysteine Group | 0 | 81 |
| Total, serious adverse events | Control Group | 0 | 80 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30975143 | DERIVED |
Source PubMed
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| N-acetylcysteine Group vs Control Group: Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa | Trial comparisons |
| N-acetylcysteine Group vs Control Group: Adverse Events (AEs) (Elevation of Liver Enzymes) | Trial comparisons |
| N-acetylcysteine Group vs Control Group: Nature of Sputum (Number of Patients With Yellow Purulent) | Trial comparisons |
| N-acetylcysteine Group vs Control Group: deaths from any cause | Trial comparisons |
| N-acetylcysteine Group vs Control Group: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02088216
GET https://conductscience.org/api/trials/v1/NCT02088216/results?page=2