Pilot Study to Assess the Effect of High Dose N-acetylcysteine (NAC) in Chronic Obstructive Pulmonary Disease (COPD) Patients
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|ClinicalTrials.gov Identifier: NCT00969904|
Recruitment Status : Completed
First Posted : September 1, 2009
Last Update Posted : July 3, 2012
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 or disease||Intervention/treatment||Phase|
|COPD||Drug: N-acetylcysteine Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
|Active Comparator: 1||
600 mg TID for 12 weeks
|Placebo Comparator: 2||
placebo tablet TID for 12 weeks
- 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 ]
- 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. ]
- To assess dynamic and static lung volumes by spirometry, body plethysmography and diffusion [ Time Frame: will be assessed at all visits ]
- To assess quality of life by the SGRQ [ Time Frame: will be assessed at all visits ]
- To assess the tolerability and safety of high dose NAC [ Time Frame: all visits ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969904
|University Hospital Antwerp|
|Edegem, Antwerp, Belgium, 2650|
|Principal Investigator:||Wilfried A De Backer, MD, PhD||University Hospital, Antwerp|