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

• Conditions: asthma

• Registration Number: EUCTR2005-005874-65-BE
• Lead Sponsor: niversity Hospital Antwerp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-11
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

-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
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients with severe cardiovascular disease
-Smoking
-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified