Bronchial Thermoplasty for Severe Asthma With Dynamic Hyperinflation

Asthma Clinical Trial

— HEAT-SA  

Official title:

Evaluation of the Efficiency of Bronchial Thermoplasty on Dynamic Hyperinflation in Uncontrolled Severe Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618551
• Other study ID #: RC31/14/7422
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: May 6, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bronchial thermoplasty is a treatment for severe asthma that consist in decreasing the thickness of bronchial muscle by heat using a catheter inserted into the bronchi under direct vision with the help of an endoscope This treatment has shown efficacy on symptoms, quality of life and the number of exacerbations related to severe asthma.

This clinical study evaluates the efficiency of this treatment on the dynamic hyperinflation phenomenon (worsening of bronchial obstruction during exercise in patients with asthma contributing to worsening shortness of breath).

Description:

Bronchial thermoplasty is a recently validated bronchoscopic technique for the management of severe asthma that treats smooth muscle by radiofrequency to reduce its thickness. This procedure leads to improved asthma control and quality of life, but also to decreased exacerbations frequency and number of emergencies hospitalizations. This treatment requires 3 procedures every 3 to 4 weeks.

The pathophysiological mechanisms underlying its effectiveness need to be better understood for an improved selection of best candidates. In particular, there is a discrepancy between the improvement observed in symptoms (ACQ), quality of life (AQLQ) and the lack of improvement in forced expiratory volume in 1 second (FEV1). Investigator assume that this paradox is due to an efficiency appearing at effort, targeting dynamic hyperinflation phenomenon.

The objective of this study is to evaluate the influence of bronchial thermoplasty on dynamic hyperinflation in severe asthma. The secondary objectives are to assess the effectiveness of bronchial thermoplasty (ACQ, AQLQ) in a selected population of patients with dynamic hyperinflation and to describe bronchial wall structural changes by probe-based confocal LASER endomicroscopy (pCLE).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 6, 2021
• Est. primary completion date: May 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Severe asthma, uncontrolled despite optimal treatment according to GINA (global initiative for asthma) recommendations

• At least 2 exacerbations treated by systemic steroids in the last year

• FEV1 between 40 and 80% of predicted values and dynamic hyperinflation (defined as a decrease in inspiratory capacity by more than 500 ml during exercise)

Exclusion Criteria:

• Current asthma exacerbation or respiratory infection

• History of exacerbation after bronchoscopy

• FEV1 < 40% of predicted values

• Oxygen saturation < 90%

• Contra-indications to ALAIR catheter system : pacemaker or other electronic implanted device

• Allergy to Remifentanyl or Propofol

• pregnancy; breastfeeding

Related Conditions & MeSH terms

• Asthma
• Hyperinflation

Intervention

Procedure:
• Bronchial thermoplasty for treatment of severe asthma
Three sessions of bronchial thermoplasty are needed to treat patients. There will be 3 to 4 weeks between each procedure. Bronchial thermoplasty procedure is performed under general anesthesia. The medical device used in this research to achieve the thermoplasty is the Alair system (class IIb medical device ; Boston scientific) A confocal endomicroscopy will be conducted at the first and final session of thermoplasty. This examination involves analyzing and recording the structure of bronchi microscopy through a small catheter placed on the bronchus. Photographs of the bronchi will be realized.

Locations

Country	Name	City	State
France	DIDIER Alain	Toulouse	Midi Pyrenees

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (6)

Brown RH, Wizeman W, Danek C, Mitzner W. Effect of bronchial thermoplasty on airway distensibility. Eur Respir J. 2005 Aug;26(2):277-82. — View Citation

Castro M, Rubin AS, Laviolette M, Fiterman J, De Andrade Lima M, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Duhamel DR, McEvoy C, Barbers R, Ten Hacken NH, Wechsler ME, Holmes M, Phillips MJ, Erzurum S, Lunn W, Israel E, Jarjour N, Kraft M, Shargill NS, Quiring J, Berry SM, Cox G; AIR2 Trial Study Group. Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. Am J Respir Crit Care Med. 2010 Jan 15;181(2):116-24. doi: 10.1164/rccm.200903-0354OC. Epub 2009 Oct 8. — View Citation

Cox G, Thomson NC, Rubin AS, Niven RM, Corris PA, Siersted HC, Olivenstein R, Pavord ID, McCormack D, Chaudhuri R, Miller JD, Laviolette M; AIR Trial Study Group. Asthma control during the year after bronchial thermoplasty. N Engl J Med. 2007 Mar 29;356(13):1327-37. — View Citation

Moore WC, Bleecker ER, Curran-Everett D, Erzurum SC, Ameredes BT, Bacharier L, Calhoun WJ, Castro M, Chung KF, Clark MP, Dweik RA, Fitzpatrick AM, Gaston B, Hew M, Hussain I, Jarjour NN, Israel E, Levy BD, Murphy JR, Peters SP, Teague WG, Meyers DA, Busse WW, Wenzel SE; National Heart, Lung, Blood Institute's Severe Asthma Research Program. Characterization of the severe asthma phenotype by the National Heart, Lung, and Blood Institute's Severe Asthma Research Program. J Allergy Clin Immunol. 2007 Feb;119(2):405-13. — View Citation

Pavord ID, Cox G, Thomson NC, Rubin AS, Corris PA, Niven RM, Chung KF, Laviolette M; RISA Trial Study Group. Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. Am J Respir Crit Care Med. 2007 Dec 15;176(12):1185-91. Epub 2007 Sep 27. — View Citation

Wechsler ME, Laviolette M, Rubin AS, Fiterman J, Lapa e Silva JR, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Hales JB, McEvoy C, Slebos DJ, Holmes M, Phillips MJ, Erzurum SC, Hanania NA, Sumino K, Kraft M, Cox G, Sterman DH, Hogarth K, Kline JN, Mansur AH, Louie BE, Leeds WM, Barbers RG, Austin JH, Shargill NS, Quiring J, Armstrong B, Castro M; Asthma Intervention Research 2 Trial Study Group. Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma. J Allergy Clin Immunol. 2013 Dec;132(6):1295-302. doi: 10.1016/j.jaci.2013.08.009. Epub 2013 Aug 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of dynamic hyperinflation	A lung plethysmography will be used to patients to see evolution of dynamic hyperinflation after bronchial thermoplasty, defined as a decrease in inspiratory capacity by more than 500 ml during exercise.; The plethysmography will be made before the first procedure and three months after the third procedure.	3 months
Secondary	Structural modification of the bronchial wall	Description of structural modification of the bronchial wall by probe-based confocal LASER endomicroscopy (pCLE) induced by bronchial thermoplasty	3 months
Secondary	Efficiency of bronchial thermoplasty on asthma	Efficiency of bronchial thermoplasty on asthma control (ACQ) and quality of life (AQLQ) in a selected population of patients with severe asthma with dynamic hyperinflation.	3 months
Secondary	Assess side effects	Listing of thermoplasty complications (bronchitis, bronchospasm, exacerbation of asthma, hemoptysis, bronchiectasis) by medical staff	3 months