Overview

This trial is active, not recruiting.

Condition non-cystic fibrosis bronchiectasis
Treatments n-acetylcysteine, placebo
Phase phase 4
Sponsor Qilu Hospital
Start date March 2014
End date September 2016
Trial size 150 participants
Trial identifier NCT02088216, NCFB-FLS-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Participants received 600 mg of oral N-acetylcysteine BID for 12 months.
n-acetylcysteine
600mg po twice a day for 12 months
(Placebo Comparator)
Placebo was administered oral tablet BID for 12 months.
placebo
Oral tablet po twice a day for 12 months

Primary Outcomes

Measure
Acute exacerbations
time frame: 3 months

Secondary Outcomes

Measure
Volume of sputum for 24 hours
time frame: 3 months
Nature of sputum
time frame: 3 months
Sputum culture
time frame: 3 months
Chronic Obstructive Pulmonary Disease Assessment Test (CAT)
time frame: 3 months
Change in forced expiratory volume in one second (FEV1) (Percent of Predicted for Age)
time frame: 3 months
Forced expiratory volume in one second (FEV1) (L)
time frame: 3 months
Forced vital capacity (FVC) (L)
time frame: 3 months
Adverse Events (AEs)
time frame: 3 months
Time to the first exacerbation
time frame: 3 months
Time to recurrent exacerbations
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Male or female study subjects ≥18 years of age and ≤80 years of age; - Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis - Stable Bronchiectasis - One month later after the acute exacerbation of bronchiectasis - There are more than 2 times exacerbations of bronchiectasis during one year before enrollment. Exclusion Criteria: - Bronchiectasis due to special causes - Smokers - Are associated with bronchial asthma - Have any serious or active medical or psychiatric illness.

Additional Information

Official title Effect of Long-term, High-dose N-acetylcysteine on Acute Exacerbations of Patients With Non-cystic Fibrosis Bronchiectasis: the BENE Randomized, Controlled Trial
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Qilu Hospital.