Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis

NCT02088216 | Completed Results

• 1 other identifier: NCFB-FLS-01
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Cystic Fibrosis Bronchiectasis

Keywords

N-acetylcysteine；; Bronchiectasis；; Acute exacerbations；; Antioxidant；; Anti-inflammatory

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (10)

• Change of Volume of Sputum From Baseline Parameters After the 12-month Follow-up.

  12 months

• Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa

  12 months

• Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines

  12 months

• Change in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines

  12 months

• Change of Forced Expiratory Volume in One Second (FEV1) (L) From Baselines

  12 months

Study Arms (2)

N-Acetylcysteine group

ACTIVE COMPARATOR

Participants received 600 mg of oral N-acetylcysteine BID for 12 months.

Drug: N-acetylcysteine

Control group

OTHER

Participants received as-needed therapy.

Other: On-demand treatment

Interventions

N-acetylcysteine DRUG

600mg po twice a day for 12 months

N-Acetylcysteine group

On-demand treatment OTHER

receive as-needed therapy

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (1)

• 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.

  PMID: 30975143 DERIVED

MeSH Terms

Conditions

Bronchiectasis

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Yu Li
• Organization: Qilu Hospital of Shandong University

qlliyu@163.com

13791122770

Study Officials

• Yu Li, Professor

  Director

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant director

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 14, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: March 30, 2018
• Last Updated: March 14, 2019
• Results First Posted: February 18, 2019

Record last verified: 2017-12

Locations

CN (1)