N-Acetylcysteine for Patients With COPD and Chronic Bronchitis

NCT01739790 | Terminated Results DMC

• 1 other identifier: 1210M21542
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is widely prescribed for patients with chronic obstructive lung disease (COPD), particularly for those who have accompanying symptoms of chronic cough and sputum production. Compared to placebo, high-dose NAC will improve Saint George Respiratory Questionnaire scores in patients with COPD and chronic bronchitis.

Conditions

COPD; Chronic Bronchitis

Keywords

COPD; Chronic Bronchitis; N-acetylcysteine

Outcome Measures

Primary Outcomes (1)

• Changes in the Saint George's Respiratory Questionnaire

  The St. George's Respiratory Questionnaire (SGRQ) is scored on a scale of 1 to 100 with 100 representing the worst respiratory health status. The instrument is self-administered at baseline and again after 8-weeks of treatment.

  Baseline to 8 weeks

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Identical placebo pills twice daily for 8 weeks Placebo pills manufactured to mimic appearance of intervention drug n-acetylcysteine and prescribed with identical frequency and duration.

Drug: Placebo

N-Acetylcysteine

ACTIVE COMPARATOR

1800 mg twice daily for 8 weeks

Drug: N-Acetylcysteine

Interventions

N-Acetylcysteine DRUG

1800 mg twice daily for 8 weeks

N-Acetylcysteine

Placebo DRUG

Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.

Sugar Pill

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capability to provide written informed consent
• Age ≥ 40 years and ≤ 85 years
• FEV1/FVC ratio (post bronchodilator) \< 70%
• FEV1 (post bronchodilator) \< 65%
• Presence of chronic cough and sputum production defined as the following:
• Presence of chronic cough and sputum will be defined by responses to the first two questions on the SGRQ. Subjects who respond positively to both question 1 (cough) and question 2 (sputum) on the SGRQ as either "several days per week" or "almost every day" will be eligible
• Current or former smoker with lifetime cigarette consumption of at least 10 pack-years
• Negative serum pregnancy test at the baseline visit if patient is a pre-menopausal female (menopause defined as absence of a menstrual cycle in the last 12 months)
• Must be fluent in speaking the English language

You may not qualify if:

• Not fully recovered for at least 30 days from a COPD exacerbation characterized by typical symptoms and treated with antibiotics or prednisone
• Known allergy or sensitivity to NAC or albuterol
• Any patient with unstable cardiac disease
• Any patient with a documented history of uncompensated congestive heart failure in the last 2 years
• Clinical diagnosis of asthma, bronchiectasis, cystic fibrosis, or severe alpha-1 antitrypsin deficiency
• Active lung cancer or history of lung cancer if it has been less than 2 years since lung resection or other treatment. If history of lung cancer, must have no evidence of recurrence in the 2 years preceding the baseline visit.
• Undergoing active treatment for malignancy except for hormonal therapy (i.e. prostate cancer, breast cancer) or non-metastatic skin cancer and are not symptomatic
• Chronic kidney disease with an estimated GFR of \< 30 ml/min. GFR will be estimated using the Modification of Diet in Renal Disease (MDRD) formula
• History of cirrhosis with evidence of portal hypertension (ascites, chronic edema)
• Participation in a pulmonary rehabilitation program or completion within past 6 weeks
• Prisoners or institutionalized patients
• Participation in another study involving an investigational product within 30 days of the baseline visit
• Pregnant or breast-feeding patients.
• Use of guaifenesin in the last 30 days
• Currently on long acting nitrates for angina or heart failure

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Johnson K, McEvoy CE, Naqvi S, Wendt C, Reilkoff RA, Kunisaki KM, Wetherbee EE, Nelson D, Tirouvanziam R, Niewoehner DE. High-dose oral N-acetylcysteine fails to improve respiratory health status in patients with chronic obstructive pulmonary disease and chronic bronchitis: a randomized, placebo-controlled trial. Int J Chron Obstruct Pulmon Dis. 2016 Apr 21;11:799-807. doi: 10.2147/COPD.S102375. eCollection 2016.

  PMID: 27143871 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dennis E. Niewoehner, MD
• Organization: Minneapolis VA Healthcare System

niewo001@umn.edu

612-467-4412

Study Officials

• Dennis E Niewoehner, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 3, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 13, 2017
• Results First Posted: September 13, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)