- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01839591
Bronchial Thermoplasty: Effect on Neuronal and Chemosensitive Component of the Bronchial Mucosa (BT-ASMN)
Treatment of Bronchial Severe Asthma With Bronchial Thermoplasty. Assessment of Efficacy and Safety of Treatment, Study of Effects on Neuronal and Chemosensitive Component of the Bronchial Mucosa Pre and Post Treatment
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:
- Irritants on the bronchial mucosa stimulate the TRANSIENT RECEPTOR POTENTIAL VANILLOID TYPE 1 present on afferent endings of sensory fibers, unmyelinated C (chemiosensitive neurons)
- 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)
The activation of TRPV1 (through release of Ca2 + +) determines two efferent responses:
- CENTRALLY-MEDIATED
- LOCAL AXON Reflex
Investigators hypothesized that BT may have a strong influence on the destruction of nerve receptors TRPV1 and unmyelinated nerve fibers located in the mucosa going to stop reflections both central and local authorities responsible for the activation of bronchospasm. In support of this hypothesis, there are some anatomical studies4, which show that these receptors are more numerous at the level of main bronchi which are the main target of BT. Please note in this context that it is already known that in thermoablations commonly used in cardiology it is used a radio frequency with development of heat controlled to 65 °, as in the BT, able to interrupt the circuit nervous responsible for the activation of the circuit causing the abnormal 'arrhythmia.
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicola Facciolongo NF Facciolongo, M D
- Phone Number: +39 0522-295956
- Email: nicola.facciolongo@asmn.re.it
Study Contact Backup
- Name: Carla CG Galeone, phD
- Email: carla.galeone@asmn.re.it
Study Locations
-
-
-
Reggio Emilia, Italy, 42024
- Recruiting
- REGGIO EMILIA IRCCS, Santa Maria Nuova Hospital
-
Contact:
- Nicola NF Facciolongo, MD
- Phone Number: +39 0522-295956
- Email: nicola.facciolongo@asmn.re.it
-
Principal Investigator:
- Nicola NF Facciolongo, MD
-
Sub-Investigator:
- Roberto RP Piro, MD
-
Sub-Investigator:
- Gianluigi GB Bajocchi, MD
-
Sub-Investigator:
- Francesco FM Menzella, MD
-
Sub-Investigator:
- Claudia CC Castagnetti, MD
-
Sub-Investigator:
- Alberto AC Cavazza, MD
-
Sub-Investigator:
- Vladimiro VP Pietrini, MD
-
Sub-Investigator:
- Luisa LS Savoldi, Statistics
-
Sub-Investigator:
- Carla CG Galeone, Biologist
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bronchial Thermoplasty
bronchoscopy bronchial thermoplasty catheter ALAIR Boston SCientific asthma
|
Catheter ALAIR Radiofrequency 65°
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
analysis of the risk and benefit profile with questionnaire ACT and AQLQ
Time Frame: Change from Baseline in ACT and AQLQ Questionaire one year after the end of the procedure
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analyze the changes in the state of innervation and nerve receptors before and after BT on histological samples of the bronchial mucosa
Time Frame: biopsies every 4 weeks( during the treatment)
|
first biopsies in left lower lobe non yet treated; second biopsies in right lower lobe already treated; third biopsies in upper lobe already treated;
|
biopsies every 4 weeks( during the treatment)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: biopsies every 4 weeks (during the treatment)
|
first biopsies in left lower lobe non yet treated; second biopsies in right lower lobe already treated; third biopsies in upper lobe already treated;
|
biopsies every 4 weeks (during the treatment)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nicola NF Facciolongo, M.D.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BT-01-ASMN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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