NCT00476736

Brief Summary

Treatment of COPD patients depends on the stage of the disease. First of all it is strongly recommended quit smoking, then bronchodilators drugs are added. In more advanced stages inhaled corticosteroids and pulmonary rehabilitation are added. In hypoxemic patients a long term supplemental oxygen is advised. The addition of sputum modifiers drugs is equivocal, since no objective improvement was documented. N-Acetylcystein (NAC) is a drug known for its anti-oxidant and mucolytic activity. In animal models of disease it showed its beneficial activity , whereas in human such changes weren't demonstrated. In all the studies FEV1 was used to demonstrate the beneficial effect of the drug, although the disease changes are at the level of small airways which is almost not expressed by the measurement FEV1. Purpose of the study

  1. 1.To estimate the damage severity at the small airways.
  2. 2.To estimate the change in quality of life.
  3. 3.To assess the pulmonary function changes at rest and following exercise, including parameters of air trapping (hyperinflation)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4 quality-of-life

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
Last Updated

May 22, 2007

Status Verified

May 1, 2007

First QC Date

May 21, 2007

Last Update Submit

May 21, 2007

Conditions

Quality of LifeExercise

Keywords

COPDPulmonary functionAir trappingAcetyl cystein

Outcome Measures

Primary Outcomes (1)

  • inspiratory capacity

    6 months

Interventions

Effect on small airways (N-Acetylcystein)DRUG

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate COPD (GOLD classification) , AGE 45-70, both sexes.
  • Treated with inhaled steroids and long acting beta agonists.

You may not qualify if:

  • Active ischemic heart disease, heart failure, orthopedic problems that preclude ergometric bicycle activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Institute, Assaf Harofeh Medical Center

Beer Yaakov, 70300, Israel

RECRUITING

Related Publications (1)

  • Stav D, Raz M. Effect of N-acetylcysteine on air trapping in COPD: a randomized placebo-controlled study. Chest. 2009 Aug;136(2):381-386. doi: 10.1378/chest.09-0421. Epub 2009 May 15.

    PMID: 19447919DERIVED

MeSH Terms

Conditions

Motor ActivityPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

BehaviorLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Stav

    Tel Aviv University

    STUDY CHAIR

Central Study Contacts

David Stav, MD

CONTACT

(972(89779024dstav@asaf.health.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 22, 2007

Study Start

May 1, 2007

Study Completion

May 1, 2007

Last Updated

May 22, 2007

Record last verified: 2007-05

Locations

IL(1)