COPD Clinical Trial
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.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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