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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
Sponsor:
Information provided by (Responsible Party):
Qian Qi, Qilu Hospital of Shandong University

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: N-Acetylcysteine group
Participants received 600 mg of oral N-acetylcysteine BID for 12 months.
Drug: N-acetylcysteine
600mg po twice a day for 12 months

Control group
Participants received as-needed therapy.
Other: On-demand treatment
receive as-needed therapy




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.

  5. Change of Forced Expiratory Volume in One Second (FEV1) (L) 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.

  6. Change of Forced Vital Capacity (FVC) 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.

  7. Time to the First Exacerbation [ Time Frame: 12 months ]
  8. Time to Recurrent Exacerbations [ Time Frame: 12 months ]
  9. Nature of Sputum (Number of Patients With Yellow Purulent) [ Time Frame: 12 months ]
  10. Adverse Events (AEs) (Elevation of Liver Enzymes) [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. subjects were aged 18-80 years old;
  2. a diagnosis of idiopathic or post-infective bronchiectasis was made;
  3. patients had at least two exacerbations in the past year and were in a stable state for at least 4 weeks prior to the primary enrollment.

Exclusion Criteria:

Patients were excluded if they fulfilled any of the following criteria: current smokers; cigarette smoking within 6 months; cystic fibrosis or other etiologies (such as immunodeficiency, allergic bronchopulmonary aspergillosis, traction bronchiectasis caused by emphysema, advanced pulmonary fibrosis, etc.); pulmonary function test results showing a forced expiratory volume in 1 s (FEV1) ≤ 30% of the predicted value; a history of severe cardiovascular or neurological disease; comorbidity with liver disease, kidney disease, malignant tumor, gastric ulcer, or intestinal malabsorption; a known allergy to N-acetylcysteine; pregnancy or lactation (for women); a history of prior macrolide use of more than 1 week; and poor compliance.


Information from the National Library of Medicine

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


Locations
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China, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Qilu Hospital of Shandong University
Investigators
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Study Director: Yu Li, Professor Director
  Study Documents (Full-Text)

Documents provided by Qian Qi, Qilu Hospital of Shandong University:
Study Protocol  [PDF] November 2, 2018
Statistical Analysis Plan  [PDF] November 2, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Qian Qi, assistant director, Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT02088216    
Other Study ID Numbers: NCFB-FLS-01
First Posted: March 14, 2014    Key Record Dates
Results First Posted: February 18, 2019
Last Update Posted: March 14, 2019
Last Verified: December 2017
Keywords provided by Qian Qi, Qilu Hospital of Shandong University:
N-acetylcysteine;
Bronchiectasis;
Acute exacerbations;
Antioxidant;
Anti-inflammatory
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes