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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005874-65-BE

Enrollment

Registered

2006-01-11

Start date

2006-01-13

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

asthma

Interventions

Product Name: Symbicort Turbohaler Pharmaceutical Form: Inhalation powder

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparison between: -clinical symptoms and lung function variables (“gold standard” – primary outcome) and -eNO and markers of inflammation in exhaled breath condensate (secondary outcome) During step-down therapy with combined preparations (Symbicort 160/4.5, budesonide /formoterol) in stable and moderately severe asthma from Symbicort 160/4.5 2 * 2 inhalations to 2 * 1 inhalation. ;Secondary Objective: ;Primary end point(s): -symptom scores, peak flow variability, dynamic lung volumes (FEV1 and FEV1/FV), extra use of bronchodilators (short acting ß2), nocturnal symptoms and -eNO and inflammatory markers in EBC (cytokines, markers of oxidative stress)	—

Measure

Time frame

Main Objective: Comparison between: -clinical symptoms and lung function variables (“gold standard” – primary outcome) and -eNO and markers of inflammation in exhaled breath condensate (secondary outcome) During step-down therapy with combined preparations (Symbicort 160/4.5, budesonide /formoterol) in stable and moderately severe asthma from Symbicort 160/4.5 2 * 2 inhalations to 2 * 1 inhalation. ;Secondary Objective: ;Primary end point(s): -symptom scores, peak flow variability, dynamic lung volumes (FEV1 and FEV1/FV), extra use of bronchodilators (short acting ß2), nocturnal symptoms and -eNO and inflammatory markers in EBC (cytokines, markers of oxidative stress)

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Countries

Belgium

Outcome results

None listed

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