Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis (BENE)
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|ClinicalTrials.gov Identifier: NCT02088216|
Recruitment Status : Completed
First Posted : March 14, 2014
Results First Posted : February 18, 2019
Last Update Posted : March 14, 2019
Objective: To evaluate whether long-term oral N-acetylcysteine as an expectorant drug can reduce the frequency of acute exacerbations of patients with non-cystic fibrosis bronchiectasis and improve their quality of life.
Methods: Patients with non-cystic fibrosis bronchiectasis will be randomly assigned to the observer group (participants receive 600 mg of oral N-acetylcysteine BID for 12 months) or the control group (participants receive oral tablet BID for 12 months). The primary endpoint was the frequency of acute exacerbations.
Expected results: Compared with the control group, the frequency of acute exacerbations of the observer Group will decrease significantly.
Hypothesis: Long-term oral N-acetylcysteine can reduce the frequency of acute exacerbations of patients with non-cystic fibrosis bronchiectasis and improve their quality of life.
|Condition or disease||Intervention/treatment||Phase|
|Non-Cystic Fibrosis Bronchiectasis||Drug: N-acetylcysteine Other: On-demand treatment||Not Applicable|
Objective: N-acetylcysteine is a classic mucolytic agent. This study aimed to investigate the efficacy and safety of N-acetylcysteine on the risk of exacerbations in bronchiectasis patients.
Methods: A prospective, randomized, controlled trial was conducted between April 1, 2014 and December 31, 2016 in five general hospitals in Shandong Province, China. Adult bronchiectasis patients with at last two exacerbations in the past year were potentially eligible. Patients were randomly assigned to receive oral N-acetylcysteine (600 mg, twice daily, 12 months) or on-demand treatment.
Results: A total of 161 patients were eligible for randomization (81 to the N-acetylcysteine group and 80 to the control group). During the 12-month follow-up, the incidence of exacerbations in the N-acetylcysteine group was significantly lower than that in the control group (1.31 vs. 1.98 exacerbations per patient-year; risk ratio, 0.41; 95% CI, 0.17-0.66; P = 0.0011). The median number of exacerbations in the N-acetylcysteine group was 1 (0.5-2), compared with 2 (1-2) in the control group (U=-2.95, P = 0.003). No severe adverse events were reported in the intervention group.
Conclusion: The long-term use of N-acetylcysteine is able to reduce the risk of exacerbations for bronchiectasis patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||161 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of N-acetylcysteine on Exacerbations of Bronchiectasis (BENE): a Randomized Controlled Trial|
|Actual Study Start Date :||April 1, 2014|
|Actual Primary Completion Date :||December 1, 2017|
|Actual Study Completion Date :||March 30, 2018|
Active Comparator: N-Acetylcysteine group
Participants received 600 mg of oral N-acetylcysteine BID for 12 months.
600mg po twice a day for 12 months
Participants received as-needed therapy.
Other: On-demand treatment
receive as-needed therapy
- Median Number of Exacerbations [ Time Frame: 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).
- Change of Volume of Sputum From Baseline Parameters After the 12-month Follow-up. [ Time Frame: 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.
- Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa [ Time Frame: 12 months ]The values in the table were calculated as the value at baseline minus the value at 12 months.
- Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines [ Time Frame: 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.
- Change in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines [ Time Frame: 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.
- Change of Forced Expiratory Volume in One Second (FEV1) (L) From Baselines [ Time Frame: 12 months ]
- Change of Forced Vital Capacity (FVC) From Baselines [ Time Frame: 12 months ]
- Time to the First Exacerbation [ Time Frame: 12 months ]
- Time to Recurrent Exacerbations [ Time Frame: 12 months ]
- Nature of Sputum (Number of Patients With Yellow Purulent) [ Time Frame: 12 months ]
- Adverse Events (AEs) (Elevation of Liver Enzymes) [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088216
|Qilu Hospital of Shandong University|
|Jinan, Shandong, China, 250012|
|Study Director:||Yu Li, Professor||Director|