Status:
COMPLETED
Bronchial Thermoplasty: Effect on Neuronal and Chemosensitive Component of the Bronchial Mucosa
Lead Sponsor:
Azienda USL Reggio Emilia - IRCCS
Conditions:
Severe Persistent Asthma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In severe bronchial asthma the mechanism of inflammation and bronchospasm is complex and still not clarified. The smooth muscle cells play an important role from the mechanical point of view, as a cul...
Detailed Description
The mechanism of action the bronchial thermoplasty exerts the positive action demonstrated by the studies through is not yet well understood yet. The only action on the denaturation and destruction of...
Eligibility Criteria
Inclusion
- Patient with severe persistent asthma uncontrolled found in stable for at least 3 weeks
- Patient receiving regular treatment with inhaled corticosteroids (beclomethason\> 1000 mcg or equivalent) and LABA (salmeterol\> = 100 mcg or equivalent)
- AQLQ score \<6.25
- FEV1\> = 60% predicted
- Patients not smoking for at least one year
Exclusion
- acute asthma with life threatening
- concomitant respiratory diseases (eg, COPD or emphysema)
- use of ß-blocker drugs
- severe active infection in the last 2 weeks
- Pacemaker, internal defibrillator or other implanted electronic device.
- Known sensitivity to medications used to perform bronchoscopy, including lidocaine, atropine and benzodiazepines.
- Currently known bleeding disorder is not well controlled.
- Inability to stop prior to the procedure taking anticoagulants, antiplatelet agents, aspirin or non-steroidal anti-inflammatory drugs
- 18 years
- Pregnant women
Key Trial Info
Start Date :
March 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01839591
Start Date
March 11 2013
End Date
May 11 2016
Last Update
June 25 2025
Active Locations (1)
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1
REGGIO EMILIA IRCCS, Santa Maria Nuova Hospital
Reggio Emilia, Italy, Italy, 42024