Non-Cystic Fibrosis Bronchiectasis Clinical Trial
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.
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01792440 -
The Sputum Colour Chart as a Predictor of Lung Inflammation and Proteolysis in Non-cystic Fibrosis Bronchiectasis
|
N/A | |
| Completed |
NCT05523180 -
A Study to Evaluate the Effect of Probiotic Supplement on Quality of Life
|
N/A | |
| Completed |
NCT03218917 -
Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis
|
Phase 2 | |
| Completed |
NCT05495243 -
Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-CF Bronchiectasis With Excess Mucus and Cough
|
Phase 2 | |
| Recruiting |
NCT06237348 -
Simeox Therapy at Home Versus Standard of Care in NCFB Patients With CMH
|
N/A | |
| Completed |
NCT03056326 -
A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects
|
Phase 1 | |
| Not yet recruiting |
NCT02614300 -
The Role of Pulmonary Rehabilitation and Airways Clearance Techniques in the Multidisciplinary Management of Non CF Bronchiectasis
|
N/A | |
| Recruiting |
NCT04322929 -
Roflumilast in Non-CF Bronchiectasis Study (2019)
|
Phase 2 | |
| Completed |
NCT05369624 -
Exercise Capacity in Non-cystic Fibrosis Bronchiectasis After a Pulmonary Rehabilitation Home-based Program
|
N/A | |
| Completed |
NCT04010799 -
A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF) and in Patients With Non Cystic Fibrosis (NCFB) Bronchiectasis
|
Phase 1 | |
| Completed |
NCT03428334 -
Roflumilast in Non-CF Bronchiectasis Study
|
Phase 2 | |
| Recruiting |
NCT06164470 -
Impact of Support Groups for Patients With Non-Cystic Fibrosis Bronchiectasis
|
N/A | |
| Completed |
NCT04656275 -
A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation
|
Phase 1 | |
| Not yet recruiting |
NCT06151366 -
Early Detection of Pulmonary Exacerbations in Non-cystic Fibrosis Bronchiectasis
|
||
| Completed |
NCT02081963 -
Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
|
Phase 4 | |
| Completed |
NCT02883101 -
The Effects of Pulmonary Rehabilitation in Patients With Non-cystic Fibrosis Bronchiectasis
|
N/A | |
| Completed |
NCT01792427 -
Mortality in Non-cystic Fibrosis Bronchiectasis
|
N/A | |
| Recruiting |
NCT04278040 -
Inhalations of Ultra-low Doses of Melphalan for the Treatment of Non-cystic Fibrosis Bronchiectasis
|
Phase 2 | |
| Completed |
NCT05006573 -
Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis
|
Phase 3 | |
| Not yet recruiting |
NCT06352944 -
Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children
|