N-Acetylcysteine for Patients With COPD and Chronic Bronchitis

COPD Clinical Trial

Official title:

Effects of High-Dose N-Acetylcysteine on Respiratory Health Status in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis: A Randomized, Placebo-Controlled Trial-3

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01739790
• Other study ID #: 1210M21542
• Status: Terminated
• Phase: N/A
• First received: November 29, 2012
• Last updated: January 25, 2016
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Abnormalities in screening blood work defined as:

• WBC < 3.0 or > 15.0 K/cmm

• Hemoglobin < 9.0 or > 17.0 gm/dl

• Platelets < 75 or > 400 K/cmm

• ALT > 3 times the upper limit of normal

• INR > 1.5 unless on warfarin therapy

• Any concomitant condition that might endanger the patient through participation in the study or interfere with study procedures, as assessed by the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• N-Acetylcysteine
1800 mg twice daily for 8 weeks
• Identical Placebo manufactured to mimic appearance of intervention drug with identical frequency and duration

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Saint George's Respiratory Questionnaire		Baseline to 8 weeks	No