Ignite Creation Date:
2024-05-05 @ 9:47 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00969904
Status:
COMPLETED
Last Update Posted:
2012-07-03
First Post:
2009-08-31
Brief Title:
Pilot Study to Assess the Effect of High Dose N-acetylcysteine NAC in Chronic Obstructive Pulmonary Disease COPD Patients
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EC 840128 | None | None | None |