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Pilot Study to Assess the Effect of High Dose N-acetylcysteine (NAC) in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wilfried De Backer, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00969904
First received: August 31, 2009
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

Studies suggest that N-acetylcysteine (NAC) potentially reduces inflammation and hyperinflation in patients with COPD.

In this pilot study the efficacy, safety and tolerability of high dose NAC in 12 patients with moderate COPD will be examined. These patients will receive a placebo for 12 weeks and NAC for 12 weeks in a dosage of 3 times 600 mg a day on top of their usual medication in a randomized crossover design. All subjects will be followed for 28 weeks.

The effect of high dose NAC on small airways will be assessed by measuring the total and peripheral airway resistance calculated with Computational Fluid Dynamics (CFD). The effect on oxidative stress will be assessed by measuring exhaled NO and specific markers (CRP, erythrocyte sedimentation rate, IL-6, 8-isoprostane, H2O2, TNF-alfa, glutathione, GPX, SOD and IL-8) in blood and Exhaled Breath Condensate (EBC). Dynamic and static lung volumes will be assessed by spirometry, body plethysmography and diffusion. Quality of life and symptoms will be assessed by the St George Respiratory Questionnaire.


Condition Intervention Phase
COPD
 Drug: N-acetylcysteine
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind, Randomized, Placebo-controlled, Two-way Crossover, Pilot Study to Assess the Effect of High Dose N-acetylcysteine on Small Airways and on Inflammation and Oxidative Stress in COPD Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • To assess the effect of high dose NAC (1800 mg)on small airways by measuring the total and peripheral airway resistance calculated with CFD [ Time Frame: at baseline, after 12 weeks of placebo and after 12 weeks of NAC ] [ Designated as safety issue: No ]
  • To assess the effect of high dose NAC (1800 mg)on oxidative stress by measuring exhaled NO and oxidative stress markers in blood and EBC [ Time Frame: at baseline, after 12 weeks of placebo and after 12 weeks of NAC. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess dynamic and static lung volumes by spirometry, body plethysmography and diffusion [ Time Frame: will be assessed at all visits ] [ Designated as safety issue: No ]
  • To assess quality of life by the SGRQ [ Time Frame: will be assessed at all visits ] [ Designated as safety issue: No ]
  • To assess the tolerability and safety of high dose NAC [ Time Frame: all visits ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: March 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: N-acetylcysteine
600 mg TID for 12 weeks
Placebo Comparator: 2 Drug: placebo
placebo tablet TID for 12 weeks

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with documented COPD based on the following criteria:

    • Smoking history of at least 10 pack-years
    • Decreased Tiffeneau index (FEV1/(FVC < 0.70)
  2. Patients aged ≥ 40 years
  3. Patients who stopped smoking since more than 1 month
  4. Patients who present moderate COPD with an FEV1 between 50 and 80% of predicted (GOLD 2)
  5. Patients should be treated according to GOLD guidelines

Exclusion Criteria:

  1. Unstable patients who developed an exacerbation during the last 8 weeks
  2. Patients who are current smokers or stopped less than 1 month
  3. Patients who are allergic to acetylcysteine or to another element of the product
  4. Patients with phenylketonuria or an untreated active peptic ulcer
  5. Patients with any stage kidney and/or heart insufficiency or hypertension
  6. Patients already treated with NAC for more than 6 months or during the last 3 months
  7. Patients on continuous treatment with oral, inhalation, intravenous or intramuscular corticosteroids
  8. Patients who are pregnant or are breast-feeding
  9. Patients who are treated with orally administered cephalosporins
  10. Patients using supplements containing antioxidants as vitamins C or E
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969904

Locations
Belgium
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Principal Investigator: Wilfried A De Backer, MD, PhD University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: Wilfried De Backer, MD PhD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT00969904     History of Changes
Other Study ID Numbers: PML_DOC_0804, EC 8/40/128
Study First Received: August 31, 2009
Last Updated: June 29, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on May 23, 2013