Bronchial Thermoplasty: Effect on Neuronal and Chemosensitive Component of the Bronchial Mucosa

NCT01839591 | Completed FDA Device

• 1 other identifier: BT-01-ASMN
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 culmination of neurogenic stimuli and inflammatory cytokines that determine as final effect the bronchospasm and over time a hypertrophy of the muscular coat. There are some other hypothesis that the smooth muscle cells may play a role as central regulator of chemical mediators that cause bronchospasm and inflammation, although there are currently no firm conclusions 2 According to other studies3,the nerve receptors TRANSIENT RECEPTOR POTENTIAL VANILLOID TYPE 1 have a great importance in the complex mechanism of airway inflammation too. (There are at least 4) These receptors would intervene according to the following mechanism:

1. 1.Irritants on the bronchial mucosa stimulate the TRANSIENT RECEPTOR POTENTIAL VANILLOID TYPE 1 present on afferent endings of sensory fibers, unmyelinated C (chemiosensitive neurons)
2. 2.On the same afferent axon acting factors with the activation effect (lowering the activation threshold, increase the expression, promote the translocation of TRPV1 receptor on the membrane). Among these factors the neurotrophins of which the most important NERVE GROWTH FACTOR (NGF)
3. 3.The activation of TRPV1 (through release of Ca2 + +) determines two efferent responses:
4. 4.CENTRALLY-MEDIATED
5. 5.LOCAL AXON Reflex

Conditions

Severe Persistent Asthma

Outcome Measures

Primary Outcomes (1)

• analysis of the risk and benefit profile with questionnaire ACT and AQLQ

  Evaluation of symptom control through the questionnaire ACT (ASTHMA CONTROL TEST) and AQLQ (Asthma quality life Questionaire) according to GINA criteria. The questionnaires AQLQ and ACT will be collected 3 months before the TB, the day before the procedure, and 3, 6, 12 months after the end of the procedure.

  Change from Baseline in ACT and AQLQ Questionaire one year after the end of the procedure

Secondary Outcomes (1)

• Analyze the changes in the state of innervation and nerve receptors before and after BT on histological samples of the bronchial mucosa

  biopsies every 4 weeks( during the treatment)

Other Outcomes (1)

• Evaluate the effect of BT on the run neurogenic inflammation by analysis of the chemical mediators of inflammation on histological samples of the bronchial mucosa.

  biopsies every 4 weeks (during the treatment)

Study Arms (1)

Bronchial Thermoplasty

EXPERIMENTAL

bronchoscopy bronchial thermoplasty catheter ALAIR Boston SCientific asthma

Device: catheter ALAIR

Interventions

catheter ALAIR DEVICE

Catheter ALAIR Radiofrequency 65°

Also known as: Catheter ALAIR Boston Scientific, M005ATS25010 MOd ATS 2-5

Bronchial Thermoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• years
• Pregnant women

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

REGGIO EMILIA IRCCS, Santa Maria Nuova Hospital

Reggio Emilia, Italy, 42024, Italy

Location

Related Publications (1)

• Facciolongo N, Di Stefano A, Pietrini V, Galeone C, Bellanova F, Menzella F, Scichilone N, Piro R, Bajocchi GL, Balbi B, Agostini L, Salsi PP, Formisano D, Lusuardi M. Nerve ablation after bronchial thermoplasty and sustained improvement in severe asthma. BMC Pulm Med. 2018 Feb 8;18(1):29. doi: 10.1186/s12890-017-0554-8.

  PMID: 29422039 DERIVED

Study Officials

• Nicola NF Facciolongo, M.D.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 25, 2013
• Study Start: March 11, 2013
• Primary Completion: April 1, 2015
• Study Completion: May 11, 2016
• Last Updated: June 25, 2025

Record last verified: 2014-03

Locations

IT (1)