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Completed

NCT Number: NCT00969904

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unstable patients who developed an exacerbation during the last 8 weeks
  • Patients who are current smokers or stopped less than 1 month
  • Patients who are allergic to acetylcysteine or to another element of the product
  • Patients with phenylketonuria or an untreated active peptic ulcer
  • Patients with any stage kidney and/or heart insufficiency or hypertension
  • Patients already treated with NAC for more than 6 months or during the last 3 months
  • Patients on continuous treatment with oral, inhalation, intravenous or intramuscular corticosteroids
  • Patients who are pregnant or are breast-feeding
  • Patients who are treated with orally administered cephalosporins
  • Patients using supplements containing antioxidants as vitamins C or E

Treatment and study plan

N-acetylcysteine

Drug

600 mg TID for 12 weeks

Placebo

Drug

placebo tablet TID for 12 weeks

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. To assess dynamic and static lung volumes by spirometry, body plethysmography and diffusion

    Time frame: will be assessed at all visits

  2. To assess quality of life by the SGRQ

    Time frame: will be assessed at all visits

  3. To assess the tolerability and safety of high dose NAC

    Time frame: all visits

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 1, 2009
Registry last updated
Jul 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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