N-Acetylcysteine for Patients With COPD and ChronicBronchitis

Chronic Obstructive Pulmonary Disease 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-1

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01599884
• Other study ID #: MVMREF-001
• Status: Unknown status
• Phase: N/A
• First received: May 15, 2012
• Last updated: May 15, 2012
• Start date: June 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2012
• Source: Minnesota Veterans Medical Research and Education Foundation
• Contact: Dennis Niewoehner
• Phone: 612-467-4412
• Is FDA regulated: No
• 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 pulmonary disease (COPD), particularly for those who have accompanying symptoms of chronic cough and sputum production. Randomized, placebo controlled indicate that it is safe and that it may have some clinical benefit when used at relatively low doses. It is postulated that substantially higher doses of NAC will be well-tolerated and will provide better symptom control while also decreasing blood makers of oxidant stress and inflammation.

Other known NCT identifiers

• NCT01639963

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 65
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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 (see Appendix A). 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 o Any concomitant condition that might endanger the patient through participation in the study or interfere with study procedures, as assessed by the investigator

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• N-acetylcysteine
1800 mg twice daily for 8 weeks
• Oral acetylcysteine
Identical placebo pills twice daily for 8 weeks

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minnesota Veterans Medical Research and Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the St. George's Respiratory Questionnaire		1 year