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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-006837-28-BE
Enrollment
Unknown
Registered
2008-11-14
Start date
2008-12-08
Completion date
Unknown
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Trade Name: Lysomucil 600mg effervescent tablets Pharmaceutical Form: Effervescent tablet Pharmaceutical form of the placebo: Effervescent tablet Route of administration of the placebo: Oral use

Sponsors

University Hospital Antwerp; Department Respiratory Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 phenylketonurie 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 cefalosporines 10.Patients using supplements containing antioxidants as vitamins C or E

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary objectives of this study are to assess the effect of high dose NAC (1800 mg): •On small airways by measuring the total and peripheral airway resistance calculated with CFD •On oxidative stress by measuring exhaled NO and oxidative stress markers (CRP, erythrocyte sedimentation rate, glutathione, GPX, SOD, IL-8, IL-6 and 8-isoprostane) in blood and EBC measured at baseline, after 12 weeks of placebo and 12 weeks of NAC. ;Secondary Objective: The secondary objectives of this study are to assess: •Dynamic and static lung volumes by spirometry, body plethysmography and diffusion •Quality of life by the SGRQ •Tolerability and safety of high dose NAC. ;Primary end point(s): Effect of delivery treatment—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026