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High-dose N-acetylcysteine in Moderate COPD
NCT00969904Phase 4
Key facts
- Status
- Completed
- Start
- Mar 2009
- Primary completion
- Jan 2011
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- acetylcysteine
- Conditions
- chronic obstructive pulmonary disease (COPD)
01
Overview
Phase 4, randomised, double-blind trial of acetylcysteine in chronic obstructive pulmonary disease (COPD). Started Mar 2009; status: completed.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Patients aged 40+ with moderate COPD (GOLD 2), FEV1 50-80%, and a smoking history of at least 10 pack-years who have quit for at least 1 month.
04
Registry description
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…
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