Non-Cystic Fibrosis BronchiectasisBENENCT02088216
Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis
A study testing N-acetylcysteine and On-demand treatment in people with Non-Cystic Fibrosis Bronchiectasis, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Cystic Fibrosis Bronchiectasis
- What is being tested?
- N-acetylcysteine and On-demand treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2014to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects were aged 18-80 years old;
- a diagnosis of idiopathic or post-infective bronchiectasis was made;
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of N-acetylcysteine on Exacerbations of Bronchiectasis (BENE): a Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Being tested
- N-acetylcysteine, On-demand treatment
- Keywords
- N-acetylcysteine；, Bronchiectasis；, Acute exacerbations；, Antioxidant；, Anti-inflammatory
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
600mg po twice a day for 12 months
On-demand treatmentOther
receive as-needed therapy
| Study group | Role | What they receive |
|---|---|---|
| N-Acetylcysteine group | Active comparator | Participants received 600 mg of oral N-acetylcysteine BID for 12 months. Receives: Drug: N-acetylcysteine |
| Control group | Other | Participants received as-needed therapy. Receives: Other: On-demand treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Number of Exacerbations
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).
Measured: 12 months
Secondary outcomes (10)
Change of Volume of Sputum From Baseline Parameters After the 12-month Follow-up.
The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.
Measured: 12 months
Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa
The values in the table were calculated as the value at baseline minus the value at 12 months.
Measured: 12 months
Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines
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.
Measured: 12 months
Change in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines
The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.
Measured: 12 months
Change of Forced Expiratory Volume in One Second (FEV1) (L) From Baselines
The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.
Measured: 12 months
Change of Forced Vital Capacity (FVC) From Baselines
The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.
Measured: 12 months
Time to the First Exacerbation
Measured: 12 months
Time to Recurrent Exacerbations
Measured: 12 months
Nature of Sputum (Number of Patients With Yellow Purulent)
Measured: 12 months
Adverse Events (AEs) (Elevation of Liver Enzymes)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study start1 Apr 2014
- Primary completion1 Dec 2017
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Qi, Qilu Hospital of Shandong University
- Investigators
- Yu Li, Professor, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088216
- Sponsor's protocol ID
- NCFB-FLS-01
- Acronym
- BENE
- Status last verified
- Dec 2017
- First submitted
- 5 Mar 2014
- Last updated
- 14 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Qi Q, Ailiyaer Y, Liu R, Zhang Y, Li C, Liu M, Wang X, Jing L, Li Y. Effect of N-acetylcysteine on exacerbations of bronchiectasis (BENE): a randomized controlled trial. Respir Res. 2019 Apr 11;20(1):73. doi: 10.1186/s12931-019-1042-x.
PubMed 30975143
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of N-acetylcysteine on Exacerbations of Bronchiectasis (BENE): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02088216
- Acronym / sponsor ID
- BENE / NCFB-FLS-01
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Keywords
- N-acetylcysteine；, Bronchiectasis；, Acute exacerbations；, Antioxidant；, Anti-inflammatory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Posted 18 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-Acetylcysteine group | Active comparator | Drug: N-acetylcysteineParticipants received 600 mg of oral N-acetylcysteine BID for 12 months. |
| Control group | Other | Other: On-demand treatmentParticipants received as-needed therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects were aged 18-80 years old;
- a diagnosis of idiopathic or post-infective bronchiectasis was made;
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteine600mg po twice a day for 12 months | Drug | N-Acetylcysteine group |
| On-demand treatmentreceive as-needed therapy | Other | Control group |
Primary outcome
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).
10 secondary outcomes
Change of Volume of Sputum From Baseline Parameters After the 12-month Follow-up.
Time frame: 12 months
Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa
Time frame: 12 months
Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines
Time frame: 12 months
Change in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines
Time frame: 12 months
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30975143Qi Q, Ailiyaer Y, Liu R, Zhang Y, Li C, Liu M, Wang X, Jing L, Li Y. Effect of N-acetylcysteine on exacerbations of bronchiectasis (BENE): a randomized controlled trial. Respir Res. 2019 Apr 11;20(1):73. doi: 10.1186/s12931-019-1042-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Li, Professor study director
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-acetylcysteine and On-demand treatment in people with Non-Cystic Fibrosis Bronchiectasis, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Number of Exacerbations (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02088216, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.