Treatment of systemic effects in patients with COPD

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000978-68-NL

Enrollment

100

Registered

2006-08-23

Start date

2006-12-18

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease state characterized by airflow limitation that is not fully reverible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking.

Interventions

Product Name: acetylcysteine Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: rosuvastatin Pharmaceutical Form: Ta

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 50 clinically stable COPD patients (GOLD II, III, IV) with a low fat-free mass (=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exacerbation 6.3 kPa) Other chronic/exercise limiting disorders

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the effects of fluimucil and rosuvastatin on the systemic inflammation, oxidative stress and muscle damage in muscle depleted COPD patients.;Secondary Objective: Specify marker of muscle damage.;Primary end point(s): Lungfunction: Flow-volume before and after COMBIVENT Spirometric, FRC Diffusioncapacity Breathingmuscle strength (PIMAX PEMAX) Blood parameters: Lactate en bloodgas:Lactate, PaO2, PaCO2 pre-exercise. Subsequently every 3 minutes during cycle ergometry. On Wmax and 3 minutes post-exercise Systemic inflammation: CRP, Leukocytes Cytokines: IL-6, IL-8, IL-1ra, TNF-a Oxidative stress: ROS production by neutrofils Plasma antioxidantcapacity (FRAP) Proteinoxidation (proteincarbonyls, ELISA) Lipidperoxidation (TBARs) GSSG/GSH ratio Muscle breakdown/damage: Plasma proteasome concentration Plasma proteasome activity Plasma proteinbound ubiquitin concentration Serum skeletal muscle troponine I concentration Main endpoints cycle ergometry: When patient indicates he/she can’t go on. When patient reaches maximal ventilation	—

Measure

Time frame

Main Objective: To study the effects of fluimucil and rosuvastatin on the systemic inflammation, oxidative stress and muscle damage in muscle depleted COPD patients.;Secondary Objective: Specify marker of muscle damage.;Primary end point(s): Lungfunction: Flow-volume before and after COMBIVENT Spirometric, FRC Diffusioncapacity Breathingmuscle strength (PIMAX PEMAX) Blood parameters: Lactate en bloodgas:Lactate, PaO2, PaCO2 pre-exercise. Subsequently every 3 minutes during cycle ergometry. On Wmax and 3 minutes post-exercise Systemic inflammation: CRP, Leukocytes Cytokines: IL-6, IL-8, IL-1ra, TNF-a Oxidative stress: ROS production by neutrofils Plasma antioxidantcapacity (FRAP) Proteinoxidation (proteincarbonyls, ELISA) Lipidperoxidation (TBARs) GSSG/GSH ratio Muscle breakdown/damage: Plasma proteasome concentration Plasma proteasome activity Plasma proteinbound ubiquitin concentration Serum skeletal muscle troponine I concentration Main endpoints cycle ergometry: When patient indicates he/she can’t go on. When patient reaches maximal ventilation

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Countries

Netherlands

Outcome results

None listed

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