on-invasive monitoring of airway inflammation in asthmatic patients during adaptation of inhaled steroid therapy

niversity Hospital Antwerp0 sites40 target enrollmentJanuary 11, 2006

Overview

No summary available.

Registry

who.int

Start Date

January 11, 2006

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Hospital Antwerp

•\-Informed consent
•\-Male and female patients between 18 and 65 years
•\-Established diagnosis of asthma at least 3 months before the start of the study and based on: documented reversible airway obstruction of \>\= 9% of predicted or documented positive metacholine provocation test
•\-Treatment with Symbicort 160/4\.5 2\*2 during the last 2 months
•\-Clinical stable patients with asthma symptoms \< 1 a week, no nocturnal symptoms, PEF variability \< 20%
•\-Patients are able to use Symbicort T (and Bricanyl T) correctly
•\-Patients are able to use Peak flow measurements correctly
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•\-Patients with severe cardiovascular disease
•\-Recent upper airway infection (within one month before the start of the study)
•\-Chronic rhino\-sinusitis
•\-Use of systemic steroids 30 days before the start of the study
•\-Use of ß blocking agents
•\-Pregnancy and breast feeding during the study
•\-Addiction to alcohol or drugs that may interfere with the overall compliance
•\-Planned surgical interventions during the study period
•\-Concomitant treatment with anticholinergics, theophyllines and LTRA
•\-At visit 2: infections and unstable asthma (symptoms more than 1time a week, nocturnal symptoms, PEF variability of \>20%) or upper respiratory tract infection during run\-in