Clinical trial NCT01599884: N-Acetylcysteine for Patients With COPD and ChronicBronchitis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Keywords: Chronic obstructive pulmonary disease
Chronic bronchitis
N-acetylcysteine
Lead sponsor: Center for Veterans Research and Education
Sponsor class: OTHER
First posted: 2012-05-16
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in the St. George's Respiratory Questionnaire
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Dennis Niewoehner, MD
role: PRINCIPAL_INVESTIGATOR
References: