| Status | Acronym | ISRCTN | EudraCT | NCT (clinicaltrials.gov) | DRKS |
|---|---|---|---|---|---|
| Active |
Multi-center, observational study for the qualification of neutrophil elastase activity in induced sputum and to investigate other biomarker candidates in biological matrices (induced sputum, blood, urine) of bronchiectasis patients
Purpose / Objectives
Diagnosis
- pathogenic bacteria
- bronchiectasis
Target population
Inclusion criteria
- The informed consent must be signed before any study specific tests or procedures are done
- Pulmonary stable adult subjects of either sex with high resolution computed tomography (HRCT)- or MRT- confirmed non-CF Bronchiectasis who meet all inclusion and no exclusion criteria are to be enrolled
- Age 18≥years and <80 years
- Proven and documented diagnosis of non-CF idiophatic or post-infectious BE by HRCT scan including 2 or more lobes and dilated airways compatible with BE at initial diagnosis
- Stable pulmonary status as indicated by FEV1(percent of predicted)≥30% and <90% (post-bronchodilator)
- Stable regimen of standard treatment (e.g. bronchodilators,anticholinergics, inhaled corticosteroids, mucolytics, or macrolides if used as chronic treatment for BE) at least for the past 1 month prior to screening
- Cough on most days and sputum production on most days ( subject must be able to produce a sputum sample at enrollment.
Exclusion criteria
Subjects are to be excluded from the study if they display any of the follwing criteria:
- FEV1<30% or ≥90% predicted (post-bronchodilator)
- Active allergic bronchopulmonary aspergillosis (ABPA)
- Active and actively-treated non-tuberculosis mycobacterial (NTM) infection or tuberculosis
- Recent significant hemoptysis (≥300 mL or requiring blood transfusion) in the preceding 4 weeks before screening (and during the screening period)
- Known cystic fibrosis and / or documented chronic bronchial asthma
Study design
- Multicenter
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